Department of Health and Human Services Administration,

 
CONTENT

[Federal Register: October 24, 2001 (Volume 66, Number 206)]

[Notices]

[Page 53835-53927]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr24oc01-112]

[[Page 53835]]

Part II

Department of Health and Human Services

Food and Drug Administration

Annual Comprehensive List of Guidance Documents at the Food and Drug Administration; Notice

[[Page 53836]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N-0046]

Annual Comprehensive List of Guidance Documents at the Food and Drug Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is publishing its annual comprehensive list of all guidance documents currently in use at the agency. This list is being published under 21 CFR 10.115(n)(2) of FDA's regulation on Good Guidance Practices (GGPs). This list is intended to inform the public of the existence and availability of all of our current guidance documents. It also provides information on guidance documents that have been added or withdrawn in the past year.

DATES: We welcome general comments on this list and on agency guidance documents at any time.

ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http:// www.fda.gov.dockets/ecomments. We have provided information in the tables below on where to obtain a single copy of any of the guidance documents listed.

FOR FURTHER INFORMATION CONTACT: Carol A. Kimbrough, Office of Policy, Planning, and Legislation (HF-26), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3480.

SUPPLEMENTARY INFORMATION:

  1. Background

    We published our final rule on GGPs in the Federal Register of September 19, 2000 (65 FR 56468), and they became effective October 19, 2000. GGPs are intended to ensure involvement of the public in the development of guidance documents, and to enhance understanding of the availability, nature, and legal effect of such guidance. We committed in the GGPs to publishing annually a comprehensive list of guidance documents. This list updates a comprehensive list published July 21, 2000 (65 FR 45428).

    The following comprehensive list identifies all final guidances that have been issued and are in use, and all draft guidances that have been distributed for comment and not for implementation. Any guidances that have been withdrawn this year are also listed. We have organized the documents by the issuing Center or Office within FDA, and we have identified the pertinent intended users or regulatory activities. The dates in the list refer to the date we issued the guidances or, where applicable, the last date we revised a document. Because each issuing Center or Office maintains its own database, there are slight variations in the way in which they provide information on the tables below.

    The following most frequently used Internet sites for agency guidances are provided for future reference:

    CBER: http://www.fda.gov/cber/guidelines.htm

    CDER: http://www.fda.gov/cder/guidance/index.htm

    CDRH: http://www.fda.gov/cdrh/guidance.html

    CFSAN: http://www.cfsan.fda.gov/6dms/guidance.html

    CVM: http://www.fda.gov/cvm/guidance/published.htm#documents

    ORA: http://www.fda.gov/ora/compliance--;ref

  2. Guidance Documents Issued by the Center for Biologics Evaluation and Research (CBER)

    Intended User or Regulatory Name of Document

    Date of Issuance

    Activity

    How to Obtain a Hard Copy of the Document

    Interpretative Guidelines of the Source Plasma October 2, 1973

    FDA Regulated Industry Office of Communication, Training, and (Human) Standards

    Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 1-800-835-4709 or 301-827-1800, FAX Information System: 1-888- CBER-FAX (within U.S.) or 301-827-3844 (outside U.S. and local to Rockville, MD). Internet access: http://www.fda.gov/cber

    Guidelines for Reviewing Amendments to Include July 20, 1976

    Do

    Do Plasmapheresis of Hemophiliacs

    Package Insert: Immune Serum Globulin (Human) March 30, 1978

    Do

    Do

    Guidelines for Interpretation of Potency Test April 12, 1979

    Do

    Do Results for All Forms of Adsorbed Diphtheria and Tetanus Toxoids

    Guidelines for Immunization of Source Plasma June 1, 1980

    Do

    Do (Human) Donors With Blood Substances

    Collection of Human Leukocytes for Further January 28, 1981

    Do

    Do Manufacturing (Source Leukocytes)

    Platelet Testing Guidelines--Approval of New July 1, 1981

    Do

    Do Procedures and Equipment

    [[Page 53837]]

    Revised Guideline for Adding Heparin to Empty August 1, 1981

    Do

    Do Containers for Collection of Heparinized Source Plasma (Human)

    Requirements for Infrequent Plasmapheresis August 27, 1982

    Do

    Do Donors

    Recommendations to Decrease the Risk of

    March 24, 1983

    Do

    Do Transmitting AIDS From Plasma Donors

    PTC in the Manufacture of In Vitro Monoclonal June 20, 1983

    Do

    Do Antibody Products Subject to Licensure

    Draft PTC in the Production and Testing of July 28, 1983

    Do

    Do Interferon Intended for Investigational Use in Humans (Interferon Test Procedures)

    Interstate Shipment of Interferon for

    November 21, 1983

    Do

    Do Investigational Use in Laboratory Research Animals or Tests in Vitro

    Deferral of Blood Donors Who Have Received the February 28, 1984

    Do

    Do Drug Accutane (Isotretinoin/Roche); 13-cis- retinoic acid)

    Equivalent Methods for Compatibility Testing December 14, 1984

    Do

    Do

    Plasma Derived From Therapeutic Plasma Exchange December 14, 1984

    Do

    Do

    Draft PTC in the Production and Testing of New April 10, 1985

    Do

    Do Drugs and Biologicals Produced by Recombinant DNA Technology

    Guidelines for Meningococcal Polysaccharide July 17, 1985

    Do

    Do Vaccines

    Guideline for the Uniform Labeling of Blood and August 1, 1985

    Do

    Do Blood Components

    Recommended Methods for Short Ragweed Pollen November 1, 1985

    Do

    Do Extracts

    Reduction of the Maximum Platelet Storage

    June 2, 1986

    Do

    Do Period to 5 Days in an Approved Container

    To In Vitro Diagnostic Reagent Manufacturers: December 6, 1986

    Do

    Do Guidance on the Labeling of Human Blood Derived in Vitro Diagnostic Devices in Regard to Labeling for HTLV-III/LAV Antibody Testing

    Guideline for Submitting Documentation for the February 1, 1987

    Do

    Do Stability of Human Drugs and Biologics

    Guideline for Submitting Documentation for February 1, 1987

    Do

    Do Packaging for Human Drugs and Biologics

    Guideline on General Principles of Process May 1, 1987

    Do

    Do Validation

    Guideline on Sterile Drug Products Produced by June 1, 1987

    Do

    Do Aseptic Processing

    [[Page 53838]]

    Deferral of Donors Who Have Received Human November 25, 1987

    Do

    Do Pituitary-Derived Growth Hormone

    Guideline on Validation of the Limulus

    December 1, 1987

    Do

    Do Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices

    Recommendations for the Management of Donors December 2, 1987

    Do

    Do and Units That Are Initially Reactive for Hepatitis B Surface Antigen (HBsAg)

    Extension of Dating Period for Storage of Red December 4, 1987

    Do

    Do Blood Cells, Frozen

    To Licensed In Vitro Diagnostic Manufacturers: December 23, 1987

    Do

    Do Handling of Human Blood Source Materials

    Recommendations for Implementation of

    April 6, 1988

    Do

    Do Computerization in Blood Establishments

    Control of Unsuitable Blood and Blood

    April 6, 1988

    Do

    Do Components

    Discontinuance of Prelicensing Inspection for July 7, 1988

    Do

    Do Immunization Using Licensed Tetanus Toxoid and Hepatitis B and Rabies Vaccines

    Physician Substitutes

    August 15, 1988

    Do

    Do

    To Licensed Manufacturers of Blood Grouping August 26, 1988

    Do

    Do Reagents: Criteria for Exemption of Lot Release

    Revised Guideline for the Collection of

    October 7, 1988

    Do

    Do Platelets, Pheresis

    To Manufacturers of HTLV-I Antibody Test Kits: October 18, 1988

    Do

    Do Antibody to Human T-Cell Lymphotropic Virus, Type I (HTLV-I) Release Panel I

    Draft Guideline for the Design of Clinical November 1, 1988

    Do

    Do Trials for Evaluation of Safety and Efficacy of Allergenic Products for Therapeutic Uses

    HTLV-I Antibody Testing

    November 29, 1988

    Do

    Do

    Use of Recombigen HIV-1 LA Test

    February 1, 1989

    Do

    Do

    Guidelines for Release of Pneumococcal Vaccine, February 1, 1989

    Do

    Do Polyvalent

    Guidance for Autologous Blood and Blood

    March 15, 1989

    Do

    Do Components

    HTLV-I Antibody Testing

    July 6, 1989

    Do

    Do

    Use of Recombigen HIV-1 Latex Agglutination August 1, 1989

    Do

    Do (LA) Test

    Draft PTC in the Manufacture and Clinical

    August 8, 1989

    Do

    Do Evaluation of In Vitro Tests to Detect Antibodies to Human Immunodeficiency Virus Type 1 (1989)

    [[Page 53839]]

    PTC in the Collection, Processing and Testing August 22, 1989

    Do

    Do of Ex Vivo Activated Mononuclear Leukocytes for Administration to Humans

    Information Relevant to the Manufacture of August 23, 1989

    Do

    Do Acellular Pertussis Vaccine

    FDA Regulated Industries for Drug Master Files September 1, 1989

    Do

    Do

    Requirements for Computerization of Blood

    September 8, 1989

    Do

    Do Establishments

    Abbott Laboratories' HIVAG-1 Test for HIV-1 October 4, 1989

    Do

    Do Antigen(s) Not Recommended for Requirements for Computerization of Blood Establishments

    Guideline for Collection of Blood or Blood October 26, 1989

    Do

    Do Products From Donors With PositiveTests for Infectious Disease Markers (``High Risk'' Donors)

    Guideline for Determination of Residual

    January 1, 1990

    Do

    Do Moisture in Dried Biological Products

    Autologous Blood Collection and Processing February 12, 1990

    Do

    Do Procedures

    Cytokine and Growth Factor Pre-Pivotal Trial April 2, 1990

    Do

    Do Information Package

    Use of Genetic Systems HIV-2 EIA

    June 21, 1990

    Do

    Do

    PTC in the Safety Evaluation of Hemoglobin- August 21, 1990

    Do

    Do Based Oxygen Carriers

    Guideline on the Preparation of Investigational March 1, 1991

    Do

    Do New Drug Products (Human and Animal)

    FDA Request for Information on Blood Storage March 15, 1991

    Do

    Do Patterns and Red Cell Contamination by Yersinia Enterocolitica

    Revision to October 26, 1989, Guideline for March 17, 1991

    Do

    Do Collection of Blood or Blood Products From Donors With Positive Tests for Infectious Disease Markers (High Risk Donors)

    Deficiencies Relating to the Manufacture of March 20, 1991

    Do

    Do Blood and Blood Components

    Responsibilities of Blood Establishments

    March 20, 1991

    Do

    Do Related to Errors and Accidents in the Manufacture of Blood and Blood Components

    To Biologic Product Manufacturers--Controlling May 3, 1991

    Do

    Do Materials of Bovine or Ovine Origin

    FDA Recommendations Concerning Testing for September 10, 1991

    Do

    Do Antibody to Hepatitis B Core Antigen (Anti- HBc)

    Disposition of Blood Products Intended for September 11, 1991

    Do

    Do Autologous Use That Test Repeatedly Reactive for Anti-HCV

    [[Page 53840]]

    Clarification of FDA Recommendations for Donor December 12, 1991

    Do

    Do Deferral and Product Distribution Based on the Results of Syphilis Testing

    Recommended Methods for Blood Grouping Reagents March 1, 1992

    Do

    Do Evaluation

    Recommended Methods for Evaluating Potency, March 1, 1992

    Do

    Do Specificity and Reactivity of Anti-Human Globulin

    PTC in the Design and Implementation of Field March 1, 1992

    Do

    Do Trials for Blood Grouping Reagents and Anti- Human Globulin

    PTC in the Manufacture of In Vitro Monoclonal March 1, 1992

    Do

    Do Antibody Products for Further Manufacturing into Blood Grouping Reagent and Anti-Human Globulin

    Supplement to the PTC in the Production and April 6, 1992

    Do

    Do Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology: Nucleic Acid Characterization and Genetic Stability

    Revised Recommendations for the Prevention of April 23, 1992

    Do

    Do Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products

    Use of Fluorognost HIV-1 Immunofluorescent April 23, 1992

    Do

    Do Assay (IFA)

    Revised Recommendations for Testing Whole

    April 23, 1992

    Do

    Do Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)

    Exemptions to Permit Persons With a History of April 23, 1992

    Do

    Do Viral Hepatitis Before the Age of Eleven Years to Serve as Donors of Whole Blood and Plasma; Alternative Procedures, 21 CFR 640.120

    Changes in Equipment for Processing Blood Donor July 21, 1992

    Do

    Do Samples

    Nomenclature for Monoclonal Blood Grouping September 28, 1992

    Do

    Do Reagents

    Volume Limits for Automated Collection of

    November 4, 1992

    Do

    Do Source Plasma

    FDA's Policy Statement Concerning Cooperative November 25, 1992

    Do

    Do Manufacturing Arrangements for Licensed Biologics

    Revision of October 7, 1988, Memo Concerning December 16, 1992

    Do

    Do Red Blood Cell Immunization Programs

    Draft PTC in the Characterization of Cell Lines July 12, 1993

    Do

    Do Used to Produce Biologicals

    CBER Refusal to File (RTF) Guidance for Product July 12, 1993

    Do

    Do and Establishment License Applications

    [[Page 53841]]

    Guidance on Alternatives to Lot Release for July 20, 1993

    Do

    Do Licensed Biological Products

    Recommendations Regarding License Amendments July 22, 1993

    Do

    Do and Procedures for Gamma Irradiation of Blood Products

    Deferral of Blood and Plasma Donors Based on July 28, 1993

    Do

    Do Medications

    Revised Recommendations for Testing Whole

    August 19, 1993

    Do

    Do Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)

    Changes in Administrative Procedures

    September 9, 1993

    Do

    Do

    To Sponsors of INDs Using Retroviral Vectors September 20, 1993

    Do

    Do

    Draft Guideline for the Validation of Blood September 28, 1993

    Do

    Do Establishment Computer Systems

    Methods of the Allergenic Products Testing October 1, 1993

    Do

    Do Laboratory

    Application of Current Statutory Authorities to October 14, 1993

    Do

    Do Human Somatic Cell Therapy Products and Gene Therapy Products; Notice

    Guideline for Adverse Experience Reporting for October 15, 1993

    Do

    Do Licensed Biological Products

    Guidance Regarding Post Donation Information December 10, 1993

    Do

    Do Reports

    To Manufacturers: Bovine Derived Materials December 17, 1993

    Do

    Do (BSE)

    Donor Suitability Related to Laboratory Testing December 22, 1993

    Do

    Do for Viral Hepatitis and a History of Viral Hepatitis

    Compliance Program Guidance Manual (Drugs and 1994

    Do

    National Technical Information Service (NTIS), Biologics)

    5285 Port Royal Rd., Springfield, VA 22161, 703-605-6050 (NTIS Order No. 94-920699)

    Recommendations for the Invalidation of Test January 3, 1994

    Do

    Office of Communication, Training, and Results When Using Licensed Viral Marker

    Manufacturers Assistance (HFM-40), Center for Assays to Screen Donors

    Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 1-800-835-4709 or 301-827-1800, FAX Information System: 1-888- CBER-FAX (within U.S.) or 301-827-3844 (outside U.S. and local to Rockville, MD). Internet access: http://www.fda.gov/cber

    To Sponsors of INDs for Human Immunoglobulin May 23, 1994

    Do

    Do Products

    To Manufacturers of Licensed Anti-HIV Test Kits May 26, 1994

    Do

    Do

    Recommendations for Deferral of Donors for July 26, 1994

    Do

    Do Malaria Risk

    [[Page 53842]]

    ICH Guideline for Industry: Studies in Support August 1, 1994

    Do

    Do of Special Populations

    OELPS, Advertising and Promotional Labeling August 1, 1994

    Do

    Do Staff Procedural Guidance Document (Draft)

    ICH Guideline for Industry: Stability Testing September 1, 1994

    Do

    Do of New Drug Substances and Products

    Guide to Inspections of Blood Banks, Division September 1, 1994

    FDA Personnel

    Do of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs

    Letter to Manufacturers of Immune Globulin October 3, 1994

    FDA Regulated Industry Do Intravenous (Human) (IGIV), Aseptic Meningitis Syndrome

    Guidance on Alternatives to Lot Release for October 27, 1994

    Do

    Do Licensed Biological Products

    Guidance for Industry: For the Submission of November 1994

    Do

    Do Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substances

    Recommendations to Users of Medical Devices December 20, 1994

    Do

    Do That Test for Infectious Disease Markers by Enzyme Immunoassay (EIA) Test Systems

    To Manufacturers of Immune Globulin Products: December 27, 1994

    Do

    Do Testing for Hepatitis C Virus RNA Immunoglobulin

    Timeframe for Licensing Irradiated Blood

    February 3, 1995

    Do

    Do Products

    Home Specimen Collection Kit Systems Intended February 23, 1995

    Do

    Do for Human Immunodeficiency Virus (HIV-1 and/or HIV-2) Antibody Testing; Revisions to Previous Guidance

    ICH Guideline for Industry: Clinical Safety March 1, 1995

    Do

    Do Data Management: Definitions and Standards for Expedited Reporting

    To Manufacturers of Intramuscular Immune

    March 3, 1995

    Do

    Do Globulin Products: HCV RNA Testing by PCR

    Revision of 8/27/82 FDA Memo: Requirements for March 10, 1995

    Do

    Do Infrequent Plasmapheresis Donors

    To Manufacturers of Intramuscular Immune

    March 13, 1995

    Do

    Do Globulin Products: Additional Information Regarding HCV RNA Testing by PCR

    To Health Professionals: Implementation of March 14, 1995

    Do

    Do Testing for HCV RNA by PCR for Immune Globulin Products for Intramuscular Administration

    To All Establishments Performing Red Blood Cell March 14, 1995

    Do

    Do Immunizations: Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma

    [[Page 53843]]

    Recommendations for the Deferral of Current and June 8, 1995

    Do

    Do Recent Inmates of Correctional Institutions as Donors of Whole Blood, Blood Components, Source Leukocytes and Source Plasma

    Guideline for Quality Assurance in Blood

    July 11, 1995

    Do

    Do Establishments

    FDA Guidance Document Concerning Use of Pilot July 11, 1995

    Do

    Do Manufacturing Facilities for the Development and Manufacture of Biological Products

    Disposition of Products Derived From Donors August 8, 1995

    Do

    Do Diagnosed With, or at Known High Risk for, Creutzfeldt-Jakob Disease

    Recommendations for Labeling and Use of Units August 8, 1995

    Do

    Do of Whole Blood, Blood Components, Source Plasma, Recovered Plasma or Source Leukocytes Obtained From Donors With Elevated Levels of Alanine Aminotransferase (ALT)

    Precautionary Measures to Further Reduce the August 8, 1995

    Do

    Do Possible Risk of Transmission of Creutzfeldt- Jakob Disease by Blood and Blood Products

    Recommendations for Donor Screening With a August 8, 1995

    Do

    Do Licensed Test for HIV-1 Antigen

    PTC in the Manufacture and Testing of

    August 22, 1995

    Do

    Do Therapeutic Products for Human Use Derived From Transgenic Animals

    Informed Consent for Plasmapheresis/

    October 1, 1995

    FDA Personnel

    Do Immunization

    Draft Reviewers' Guide: Changes in Personnel October 1, 1995

    FDA Personnel

    Do

    Disease Associated Antibody Collection Program October 1, 1995

    FDA Personnel

    Do

    Guidance Concerning Conversion to FDA-Reviewed November 13, 1995

    FDA Regulated Industry Do Software Products

    Donor Deferral Due to Red Blood Cell Loss

    December 4, 1995

    Do

    Do During Collection of Source Plasma by Automated Plasmapheresis

    Interim Definition and Elimination of Lot-by- December 8, 1995

    Do

    Do Lot Release for Well-Characterized Therapeutic Recombinant DNA-Derived and Monoclonal Antibody Biotechnology Products

    Dear Colleague: Regarding Reverse Transcriptase January 4, 1996

    Do

    Do Activity in Viral Vaccines Produced in Chicken Cells

    Requesting All Manufacturers Immediately to January 4, 1996

    Do

    Do Revise Warning Section for Package Insert on Thrombin

    ICH Final Guideline: Quality of

    February 23, 1996

    Do

    Do Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Dervied Protein Products

    [[Page 53844]]

    ICH Final Guideline on the Need for Long-Term March 1, 1996

    Do

    Do Rodent Carcinogenicity Study of Pharmaceuticals

    Additional Recommendations for Donor Screening March 14, 1996

    Do

    Do With a Licensed Test for HIV-1 Antigen

    FDA Guidance Concerning Demonstration of

    March 26, 1996

    Do

    Do Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived Products

    ICH Guideline on the Detection of Toxicity to April 5, 1996

    Do

    Do Reproduction for Medicinal Products; Addendum on Toxicity to Male Fertility

    ICH Guidance on Specific Aspects of Regulatory April 24, 1996

    Do

    Do Genotoxicity Tests for Pharmaceuticals

    To Manufacturers of FDA-Regulated Drug/

    May 9, 1996

    Do

    Do Biological/Device Products, Bovine Spongiform Encephalopathy (BSE)

    Additional Recommendations for Testing Whole May 16, 1996

    Do

    Do Blood, Blood Components, Source Plasma and Source Leucocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)

    Guidance for Industry--The Content and Format May 23, 1996

    Do

    Do for Pediatric Use Supplements

    Guidance on Applications for Products Comprised May 24, 1996

    Do

    Do of Living Autologous Cells Manipulated Ex Vivo and Intended for Structural Repair of Reconstruction

    Recommendations and Licensure Requirements for May 29, 1996

    Do

    Do Leukocyte-Reduced Blood Products

    Guide to Inspections of Infectious Disease June 1, 1996

    FDA Personnel

    Do Marker Testing Facilities

    To Manufacturers: Implementation of Testing for June 13, 1996

    FDA Regulated Industry Do Hepatitis C Virus RNA by Manufacturers: Implementation of Testing for Hepatitis C Virus RNA by Polymerase Chain Reaction (PCR) of Intramuscular Immune Globulin Preparations

    ICH Final Guidelines on Stablity Testing of July 10, 1996 Biotechnological/Biological Products

    ICH Guideline on Structure and Content of

    July 17, 1996

    Do

    Do Clinical Study Reports

    Recommendations for the Quarantine and

    July 19, 1996

    Do

    Do Disposition of Units From Prior Collections From Donors With Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human T-Lymphotropic Virus Type I (HTLV-I)

    To Manufacturers: HIV-1 Group O

    July 31, 1996

    Do

    Do

    [[Page 53845]]

    Guidance for Industry for the Submission of August 15, 1996

    Do

    Do Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA- Derived Product or a Monoclonal Antibody Product for In Vivo Use

    ICH Revised Guidance: Single Dose Acute

    August 26, 1996

    Do

    Do Toxicity Testing for Pharmaceuticals

    ICH Draft Guideline on Data Elements for

    October 1, 1996

    Do

    Do Transmission of Individual Case Reports

    To All Plasma Derivative Manufacturers and to October 7, 1996

    Do

    Do ABRA: Warning Statement for Plasma Derivative Product Labeling

    Advertising and Promotion; Guidance; Notice October 8, 1996

    Do

    Do

    To Biologic Product Manufacturers: Revised December 3, 1996

    Do

    Do Procedures for Internal Labeling Review Number Assignment

    Interim Recommendations for Deferral of Donors December 11, 1996

    Do

    Do at Increased Risk for HIV-1 Group O Infection

    PTC on Plasmid DNA Vaccines for Preventive December 22, 1996

    Do

    Do Infectious Disease Indications

    Guidance for the Submission of Chemistry,

    January 1997

    Do

    Do Manufacturing, and Controls Information and Establishment Description for Autologous Somatic Cell Therapy Products

    Reviewer Guidance for a Premarket Notification January 13, 1997

    FDA Personnel

    Do Submission for Blood Establishment Computer Software

    PTC in the Manufacturing and Testing of

    February 28, 1997

    Do

    Do Monoclonal Antibody Products for Human Use

    Proposed Approach to Regulation of Cellular and February 27, 1997

    Do

    Do Tissue-Based Products

    Tables 1 and 2 From Proposed Approach to

    March 4, 1997

    Do

    Do Regulation of Cellular and Tissue-Based Products

    Preclearance of Promotional Labeling;

    March 5, 1997

    Do

    Do Clarification

    Guidance for Industry for the Evaluation of April 1997

    Do

    Do Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies

    ICH Draft Guideline on Dose Selection for

    April 2, 1997

    Do

    Do Carcinogenicity Studies for Pharmaceuticals: Addendum on the Limit Dose

    ICH Draft Guideline on the Timing of

    May 2, 1997

    Do

    Do Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals

    ICH Draft Guideline on Impurities: Residual May 2, 1997 (Correction Do

    Do Solvents

    May 19, 1997)

    [[Page 53846]]

    ICH Guideline on Stability Testing for New May 9, 1997

    Do

    Do Dosage Forms

    ICH Draft Guideline on Statistical Principles May 9, 1997

    Do

    Do for Clinical Trials, Part III

    ICH Good Clinical Practice: Consolidated

    May 9, 1997

    Do

    Do Guideline, Part II

    ICH Guideline for the Photostability Testing of May 16, 1997

    Do

    Do New Drug Substances and Products, Part II

    ICH Guideline on Impurities in New Drug

    May 19, 1997

    Do

    Do Products, Part IV

    ICH Guideline on Clinical Safety Data

    May 19, 1997

    Do

    Do Management: Periodic Safety Update Reports for Marketed Drugs, Part VI

    ICH Guideline on the Validation of Analytical May 19, 1997

    Do

    Do Procedures: Methodology, Part V

    To Plasma Fractionators--CBER's View on Product May 29, 1997

    Do

    Do Recalls Conducted by the Plasma Fractionation Industry

    ICH Draft Guideline on General Considerations May 30, 1997

    Do

    Do for Clinical Trials

    Guide to Inspections of Source Plasma

    June 1, 1997

    FDA Personnel

    Do Establishments (Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs)

    Draft Guidance for Industry: Computerized

    June 18, 1997

    FDA Regulated Industry Do Systems Used in Clinical Trials; Availability

    Guidance for Industry--Changes to an Approved July 1997

    Do

    Do Application: Biological Products

    Guidance for Industry--Changes to an Approved July 1997

    Do

    Do Application for Specified Biotechnology and Specified Synthetic Biological Products

    Guidance for Industry--Screening and Testing of July 1997

    Do

    Do Donors of Human Tissue Intended for Transplantation

    Guidance for Industry--Donor Screening for August 1997

    Do

    Do Antibodies to HTLV-II

    Guidance for Industry--Postmarketing Adverse August 1997

    Do

    Do Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report

    Draft Guidance for Industry Efficacy Evaluation September 1997

    Do

    Do of Hemoglobin- and Perfluorocarbon-Based Oxygen Carriers

    Guidance for Industry--The Sourcing and

    September 1997

    Do

    Do Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use

    [[Page 53847]]

    Notification Process for Transfusion Related October 7, 1997

    Do

    Do Fatalities and Donation Related Deaths (revised telephone number)

    Submission Requirements for Requesting

    October 15, 1997

    Do

    Do Certificates for Exporting Products to Foreign Countries

    ICH Guidance on Preclinical Safety Evaluation November 18, 1997

    Do

    Do of Biotechnology-Derived Pharmaceuticals

    ICH Guidance on Genotoxicity: A Standard

    November 21, 1997

    Do

    Do Battery for Genotoxicity Testing for Pharmaceuticals

    ICH Guidance on Nonclinical Safety Studies for November 25, 1997

    Do

    Do the Conduct of Human Clinical Trials for Pharmaceuticals

    Guidance for FDA and Industry: Direct Final November 21, 1997

    FDA Personnel and Regulated Do Rule Procedures

    Industry

    Draft Guidance for Industry: Promoting Medical December 1997

    FDA Regulated Industry Do Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMS)

    Guidance for Industry: Industry-Supported

    December 3, 1997

    Do

    Do Scientific and Educational Activities

    ICH Guidance on Dose Selection for

    December 4, 1997

    Do

    Do Carcinogenicity Studies of Pharmaceuticals: Addendum on a Limit Dose and Related Notes

    To Biologic Product Manufacturers--Withdrawal December 11, 1997

    Do

    Do of Human Blood-Derived Materials Because Donors Diagnosed With, or at Increased Risk for, CJD

    To Allergenic Extract Manufacturers--

    December 23, 1997

    Do

    Do Standardized Grass Pollen Extracts

    ICH Guidance on Data Elements for Transmission January 15, 1998 of Individual Case Safety Reports

    Guidance for Industry: Year 2000 Date Change January 1998

    Do

    Do for Computer Systems and Software Applications Used in the Manufacture of Blood Products

    Draft Guidance for Industry: Container and January 1998

    Do

    Do Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products

    ICH Guidance on Testing for Carcinogenicity of February 28, 1998 Pharmaceuticals

    Draft Guidance for Industry: Manufacturing, March 1998

    Do

    Do Processing or Holding Active Pharmaceutical Ingredients

    Guidance for Industry: Guidance for Human

    March 1998

    Do

    Do Somatic Cell Therapy and Gene Therapy

    [[Page 53848]]

    Draft Guidance for Industry: Instructions for May 1998

    Do

    Do Submitting Electronic Lot Release Protocols to the Center for Biologics Evaluation and Research

    Draft Guidance for Industry: Pilot Program for May 1998

    Do

    Do Electronic Investigational New Drug (eIND) Applications for Biological Products

    Guidance for Industry: Classifying

    May 1998

    Do

    Do Resubmissions in Response to Action Letters

    Guidance for Industry: Pharmacokinetics in May 1998

    Do

    Do Patients With Impaired Renal Function--Study Design, Data Analysis and Impact on Dosing and Labeling

    Guidance for Industry: Standards for the Prompt May 1998

    Do

    Do Review of Efficacy Supplements, Including Priority Efficacy Supplements

    Guidance for Industry: Providing Clinical

    May 1998

    Do

    Do Evidence of Effectiveness for Human Drugs and Biological Products

    Draft Guidance for Industry: Stability Testing June 1998

    Do

    Do of Drug Substances and Drug Products

    Guidance for Industry: Qualifying for Pediatric June 1998

    Do

    Do Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act

    Guidance for Industry: Errors and Accidents June 1998

    Do

    Do Regarding Saline Dilution of Samples Used for Viral Marker Testing

    ICH Draft Guidance on Specifications: Test June 9, 1998

    Do

    Do Procedures and Acceptance Criteria for Biotechnological/Biological Products

    ICH Guidance on Ethnic Factors in the

    June 10, 1998

    Do

    Do Acceptability of Foreign Clinical Data

    Draft Guidance for Industry: Exports and

    June 12, 1998

    Do

    Do Imports Under the FDA Export Reform and Enhancement Act of 1996

    Guidance for Industry: Implementation of

    July 1998

    Do

    Do Section 126 of the Food and Drug Administration Modernization Act of 1997-- Elimination of Certain Labeling Requirements

    Guidance for Industry: Environmental Assessment July 1998

    Do

    Do of Human Drug and Biologics Applications

    [[Page 53849]]

    Guidance for Industry: Current Good

    September 1998

    Do

    Do Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units From Prior Collections From Donors With Repeatedly Reactive Screening Tests for Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCV

    Draft Guidance for Industry: Submitting

    September 1998

    Do

    Do Debarment Certification Statements

    Guidance for Industry: How to Complete the September 1998

    Do

    Do Vaccine Adverse Reporting System Form (VAERS- 1)

    Guidance for Industry: Fast Track Drug

    September 1998

    Do

    Do Development Programs--Designation, Development, and Application Review

    ICH Guidance on Statistical Principles for September 16, 1998

    Do

    Do Clinical Trials

    ICH Guidance on Quality of Biotechnological/ September 21, 1998

    Do

    Do Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products

    ICH Guidance on Viral Safety Evaluation of September 24, 1998

    Do

    Do Biotechnology Products Derived From Cell Lines of Human or Animal Origin

    Guidance for Industry: On Advisory Committees: October 1998

    Do

    Do Implementing Section 120 of the Food and Drug Administration Act of 1997

    Draft Guidance for Industry: General

    November 1998

    Do

    Do Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products

    To Viral Vaccine IND Sponsors--Use of PCR-Based December 18, 1998

    Do

    Do Reverse Transcriptase Assay

    Guidance for Industry: FDA Approval of New December 1998

    Do

    Do Cancer Treatment Uses for Marketed Drug and Biological Products

    Draft Guidance for Industry: Content and Format December 1998

    Do

    Do of Geriatric Labeling

    Draft Guidance for Industry: Product Name

    January 1999

    Do

    Do Placement, Size and Prominence in Advertising and Promotional Labeling

    Guidance for Industry: Content and Format of January 1999

    Do

    Do Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product

    Guidance on Amended Procedures for Advisory January 1999

    Do

    Do Panel Meetings

    [[Page 53850]]

    Guidance for Industry: Providing Regulatory January 1999

    Do

    Do Submissions in Electronic Format--General Considerations

    Guidance for Industry: For the Submission of February 1999

    Do

    Do Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products

    Guidance for Industry: Population

    February 1999

    Do

    Do Pharmacokinetics

    Guidance for Industry: Clinical Development February 1999

    Do

    Do Programs for Drugs, Devices and Biological Products for the Treatment of Rheumatoid Arthritis (RA)

    Guidance for Industry: For the Submission of February 1999

    Do

    Do Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products

    Draft Guidance for Industry: INDs for Phase 2 February 1999

    Do

    Do and 3 Studies of Drugs, Including Specified Therapeutic Biotechnology-Derived Products, Chemistry, Manufacturing and Controls Content and Format

    Draft Guidance for Industry: Accelerated

    March 1999

    Do

    Do Approval Products--Submission of Promotional Materials

    Guidance for Industry: Content and Format of March 1999

    Do

    Do Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product

    Guidance for Industry: Public Health Issues April 1999

    Do

    Do Posed by the Use of Nonhuman Primate Xenografts in Humans

    Guidance for Industry on the Content and Format April 1999

    Do

    Do of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test

    Guidance for Industry for the Submission of May 1999

    Do

    Do Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and for the Completion of the Form FDA 356h ``Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use''

    Guidance for Industry for Platelet Testing and May 1999

    Do

    Do Evaluation of Platelet Substitute Products

    Guidance for Industry: Efficacy Studies to May 1999

    Do

    Do Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use

    [[Page 53851]]

    Guidance for Industry: Container Closure

    May 1999

    Do

    Do Systems for Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Documentation

    Draft Guidance for Industry: Establishing

    June 1999

    Do

    Do Pregnancy Registries

    Draft Reviewer Guidance: Evaluation of Human June 1999

    FDA Personnel

    Do Pregnancy Outcome Data

    Draft Guidance for Industry: Current Good

    June 1999

    FDA Regulated Industry Do Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Prior Collections From Donors With Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV); (2) Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of Donor Test Results for Antibody to HCV (Anti-HCV)

    ICH Guidance on the Duration of Chronic

    June 25, 1999

    Do

    Do Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing)

    Draft Guidance for Industry: Clinical

    July 1999

    Do

    Do Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA)

    Draft Guidance for Industry: Interpreting

    July 1999

    Do

    Do Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations

    Draft Guidance for Industry: Cooperative

    August 1999

    Do

    Do Manufacturing Arrangements for Licensed Biologics

    Guidance for Industry: Consumer-Directed

    August 1999

    Do

    Do Broadcast Advertisements

    Draft Guidance for Industry: Information

    August 1999

    Do

    Do Request and Discipline Review Letters Under the Prescription Drug User Fee Act

    Guidance for Industry: Possible Dioxin/PCB August 1999

    Do

    Do Contamination of Drug and Biological Products

    Guidance for Industry: Submission of

    August 1999

    Do

    Do Abbreviated Reports and Synopses in Support of Marketing Applications

    ICH Guidance on Specifications: Test Procedures August 18, 1999

    Do

    Do and Acceptance Criteria for Biotechnological/ Biological Products

    Draft Guidance for Industry: Revised

    September 1999

    Do

    Do Recommendations for the Invalidation of Test Results When Using Licensed and 510(k) Cleared Bloodborne Pathogen Assays to Test Donors

    Guidance for Industry: Qualifying for Pediatric September 1999

    Do

    Do Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act

    [[Page 53852]]

    International Conference on Harmonisation Draft September 24, 1999

    Do

    Do Guidance; Choice of Control Group in Clinical Trials

    Guidance for Industry: Providing Regulatory November 1999

    Do

    Do Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format--Biologics Marketing Applications [Biologics License Application (BLA), Product License Application (PLA)/Establishment License Application (ELA) and New Drug Application (NDA)]--Revised

    Guidance for Industry: Revised Precautionary November 1999

    Do

    Do Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and New Variant Creutzfeldt-Jakob Disease (nvCJD) by Blood and Blood Products

    Guidance for Industry: In Vivo Drug Metabolism/ November 1999

    Do

    Do Drug Interaction Studies--Study Design, Data Analysis and Recommendations for Dosing and Labeling

    Draft Guidance for Industry: Application of November 1999

    Do

    Do Current Statutory Authority to Nucleic Acid Testing of Pooled Plasma

    Draft Guidance for Industry: Pharmacokinetics November 1999

    Do

    Do in Patients With Impaired Hepatic Function: Study Design, Data Analysis and Impact on Dosing and Labeling

    International Conference on Harmonsation of November 8, 1999

    Do

    Do Technical Requirements for Registration of Pharmaceuticals for Human Use M4: Common Technical Document

    Guidance for Industry: In the Manufacture and December 1999

    Do

    Do Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2

    Draft Guidance for Industry: Precautionary December 1999

    Do

    Do Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products From Xenotransplantation Product Recipients and Their Contacts

    Draft Guidance for Industry: Special Protocol December 1999

    Do

    Do Assessment

    Draft Guidance for Industry: Changes to an January 2000

    Do

    Do Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture

    Draft Guidance for Reviewers: Potency Limits February 2000

    FDA Personnel

    Do for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol

    [[Page 53853]]

    Draft Guidance for Industry: IND Meetings for February 2000

    FDA Regulated Industry Do Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information

    Guidance for Industry: Formal Meetings With February 2000

    Do

    Do Sponsors and Applicants for PDUFA Products

    Guidance for Industry: Formal Dispute

    February 2000

    Do

    Do Resolution: Appeals Above the Division Level

    Guidance for Industry: Gamma Irradiation of February 2000

    Do

    Do Blood and Blood Components: A Pilot Program for Licensing

    Draft Guidance for Industry: Information

    March 2000

    Do

    Do Program on Clinical Trials for Serious or Life- Threatening Diseases: Establishment of a Data Bank

    International Conference on Harmonisation; April 21, 2000

    Do

    Do Draft Revised Guidance on Q1A(R) Stability Testing of New Drug Substances and Products

    Draft Guidance for Industry: Content and Format May 2000

    Do

    Do of the Adverse Reactions Section of Labeling for Human Prescription Drugs and Biologics

    Guidance for Industry: Recognition and Use of a June 2000

    Do

    Do Standard for the Uniform Labeling of Blood and Blood Components

    Draft Guidance for Industry: Recommendations June 2000

    Do

    Do for Donor Questioning Regarding Possible Exposure to Malaria

    Draft Guidance for Industry: Pediatric Oncology June 2000

    Do

    Do Studies in Response to a Written Request

    Guidance for Industry: Availability of Licensed June 2000

    Do

    Do Donor Screening Tests Labeled for Use With Cadaveric Blood Specimens (Level 2)

    Draft Guidance for Industry: Chronic Cutaneous June 2000

    Do

    Do Ulcer and Burn Wounds--Developing Products for Treatment

    Draft Guidance for Industry: CBER Pilot

    June 2000

    Do

    Do Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained From an Outside Supplier

    Draft Guidance for Industry: Developing Medical June 2000

    Do

    Do Imaging Drugs and Biological Products

    International Conference on Harmonisation (ICH) June 2000

    Do

    Do Draft Guidance; Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (March 17, 2000)

    International Conference on Harmonisation (ICH) July 19, 2000

    Do

    Do Draft Revised Guidance on Impurities in New Drug Products

    [[Page 53854]]

    International Conference on Harmonisation (ICH) July 20, 2000

    Do

    Do Draft Revised Guidance on Impurities in New Drug Substances

    International Conference on Harmonisation (ICH) July 20, 2000

    Do

    Do Draft Guideline: Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use

    International Conference on Harmonisation (ICH) August 2000

    Do

    Do Draft Guideline on Safety Pharmacology Studies for Human Pharmaceuticals

    Draft Guidance for Industry: Analytical

    August 2000

    Do

    Do Procedures and Methods Validation--Chemistry, Manufacturing, and Controls Documentation

    Draft Guidance for Industry: Considerations for August 2000

    Do

    Do Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease Indications

    Guidance for Industry: Q & A Content and Format October 2000

    Do

    Do of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products

    Guidance for Industry: Supplemental Guidance on October 2000

    Do

    Do Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors

    Guidance for Industry: Submitting and Reviewing October 2000

    Do

    Do Complete Responses to Clinical Holds

    Draft Guidance for Industry: Cancer Drug and November 2000

    Do

    Do Biological Products--Clinical Data in Marketing Applications

    Guidance for Industry: Testing Limits in

    November 2000

    Do

    Do Stability Protocols for Standardized Grass Pollen Extracts

    Guidance for Industry: Use of Sterile

    November 2000

    Do

    Do Connecting Devices in Blood Bank Practices (Level 2)

    Draft Guidance for Industry: Recommendations November 2000

    Do

    Do for Complying With the Pediatric Rule (21 CFR 314.55(a) and 601.27(a))

    International Conference on Harmonisation (ICH) December 2000

    Do

    Do Guidance for Industry: E11 Clinical Investigation of Medicinal Products in the Pediatric Population

    Draft Guidance for Industry: Variances for December 2000

    Do

    Do Blood Collection From Individuals With Hereditary Hemochromatosis

    [[Page 53855]]

    Draft Guidance for Industry: Submitting

    December 2000

    Do

    Do Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees

    International Conference on Harmonisation; December 29, 2000

    Do

    Do Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances

    PHS Guideline on Infectious Disease Issues in January 19, 2001

    Do

    Do Xenotransplantation

    Draft Guidance for Industry: Pre-Storage

    January 2001

    Do

    Do Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion

    Guidance for Industry: Recommendations for January 2001

    Do

    Do Collecting Red Blood Cells by Automated Apheresis Methods

    Draft Guidance for Industry: Providing

    January 2001

    Do

    Do Regulatory Submissions in Electronic Format-- Prescription Drug Advertising and Promotional Labeling

    Draft Guidance for Industry: Source Animal, February 2001

    Do

    Do Product, Preclinical and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans

    Guidance for Industry: Recommendations for February 2001

    Do

    Do Collecting Red Blood Cells by Automated Apheresis Methods--Technical Correction February 2001

    Draft Guidance for Industry: Disclosing

    February 2001

    Do

    Do Information Provided to Advisory Committees in Connection With Open Advisory Committee Meetings Related to the Testing or Approval of Biologic Products and Convened by the Center for Biologics Evaluation and Research

    Draft Guidance for Industry: Postmarketing March 2001

    Do

    Do Safety Reporting for Human Drug and Biological Products Including Vaccines

    Guidance for Industry: Acceptance of Foreign March 2001

    Do

    Do Clinical Studies

    Guidance for Industry: Financial Disclosure by March 2001

    Do

    Do Clinical Investigators

    Guidance for Industry: Monoclonal Antibodies March 2001

    Do

    Do Used as Reagents in Drug Manufacturing

    Draft Guidance for Industry: Reports on the April 2001

    Do

    Do Status of Postmarketing Studies-- Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997

    Draft Guidance for Industry: Using FDA-Approved April 2001

    Do

    Do Patient Labeling in Consumer-Directed Print Advertisements

    [[Page 53856]]

    Draft Guidance for Industry: Forms for

    April 2001

    Do

    Do Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

    Draft Guidance for Industry: Providing

    May 2001

    Do

    Do Regulatory Submissions in Electronic Format-- Postmarketing Expedited Safety Reports

    Guidance for Industry: E 10 Choice of Control May 2001

    Do

    Do Group and Related Issues in Clinical Trials

    Draft Guidance for Industry: IND Meetings for May 2001

    Do

    Do Human Drugs and Biologics; Chemistry, Manufacturing and Controls Information

  3. Guidance Documents Issued by the Center for Drug Evaluation and Research (CDER)

    Intended User or Regulatory Name of Document

    Date of Issuance

    Activity

    How to Obtain a Hard Copy of the Document

    Accelerated Approval Products--Submission of March 26, 1999

    Advertising Draft

    http://www.fda.gov/cder/guidance/index.htm Promotional Materials--Draft

    Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Product Name, Placement, Size, and Prominence March 12, 1999

    Do

    Do in Advertising and Promotional Labeling--Draft

    Promoting Medical Products in a Changing

    January 5, 1998

    Do

    Do Healthcare Environment; Medical Product Promotion by Healthcare Organizations or Pharmacy Management Companies--Draft

    Using FDA-Approved Patient Labeling in Consumer- April 23, 2001

    Do

    Do Directed Print Advertisements--Draft

    Aerosol Steroid Product Safety Information in January 12, 1998

    Advertising

    Do Prescription Drug Advertising and Promotional Labeling

    Consumer-Directed Broadcast Advertisements August 9, 1999

    Do

    Do

    Industry-Supported Scientific and Educational December 3, 1997

    Do

    Do Activities

    Antifungal (Topical)--Draft

    February 24, 1990

    Biopharmaceutic Draft

    Do

    Antifungal (Vaginal)--Draft

    February 24, 1990

    Do

    Do

    Bioavailability and Bioequivalence Studies for June 2, 1999

    Do

    Do Nasal Aerosols and Nasal Sprays for Local Action--Draft

    Conjugated Estrogens, USP: LC-MS Method for March 9, 2000

    Do

    Do Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence--Draft

    [[Page 53857]]

    Food-Effect Bioavailability and Bioequivalence December 30, 1997

    Do

    Do Studies--Draft

    In Vivo Bioequivalence Studies Based on

    December 10, 1997

    Do

    Do Population and Individual Bioequivalence Studies--Draft

    Topical Dermatological Drug Product NDAs and June 18, 1998

    Do

    Do ANDAs--In Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated Studies--Draft

    Bioanalytical Method Validation

    May 23, 2001

    Biopharmaceutic

    Do

    Bioavailability and Bioequivalence Studies for October 27, 2000

    Do

    Do Orally Administered Drug Products--General Considerations

    Cholestyramine Powder In Vitro Bioequivalence July 15, 1993

    Do

    Do

    Clozapine (Tablets) In Vivo Bioequivalence and November 15, 1996

    Do

    Do In Vitro Dissolution Testing

    Corticosteroids, Detmatologic (Topical) In Vivo June 2, 1995

    Do

    Do

    Dissolution Testing of Immediate Release Solid August 25, 1997

    Do

    Do Oral Dosage Forms

    Extended Release Oral Dosage Forms:

    September 26, 1997

    Do

    Do Development, Evaluation, and Application of In Vitro/In Vivo Correlations

    Levothyroxine Sodium Tablets--In Vivo

    March 8, 2001

    Do

    Do Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing

    Metaproterenol Sulfate and Albuterol Metered June 27, 1989

    Do

    Do Dose Inhalers In Vitro

    Phenytoin/Phenytion Sodium (Capsules, Tablets, March 4, 1994

    Do

    Do Suspension) In Vivo Bioequivalence and In Vitro Dissolution Testing

    Potassium Chloride (Slow-Release Tablets and June 6, 1994

    Do

    Do Capsules) In Vivo Bioequivalence and In Vitro Dissolution Testing

    Statistical Approaches to Establishing

    February 2, 2001

    Do

    Do Bioequivalence

    Waiver of In Vivo Bioavailability and

    August 31, 2000

    Do

    Do Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System

    Analytical Procedures and Methods Validation: August 30, 2000

    Chemistry Draft

    Do Chemistry, Manufacturing, and Controls Documentation--Draft

    Botanical Drug Products--Draft

    August 11, 2000

    Do

    Do

    INDs for Phase 2 and 3 Studies of Drugs,

    April 20, 1999

    Do

    Do Including Specified Therapeutic Biotechnology- Derived Products, Chemistry, Manufacturing, and Controls Content and Format--Draft

    [[Page 53858]]

    Metered Dose Inhalers (MDI) and Dry Powder November 19, 1998

    Do

    Do Inhalers (DPI) Drug Products; Chemistry, Manufacturing, and Controls Documentation-- Draft

    Monoclonal Antibodies Used as Reagents in Drug June 24, 1999

    Do

    Do Manufacturing--Draft

    Nasal Spray and Inhalation Solution,

    June 2, 1999

    Do

    Do Suspension, and Spray Drug Products--Draft

    Stability Testing of Drug Substances and Drug June 8, 1998

    Do

    Do Products--Draft

    Submitting Supporting Chemistry Documentation November 1, 1991

    Do

    Division of Drug Information (HFD-200), Office in Radiopharmaceutical Drug Applications--

    of Training and Communications, Center for Draft

    Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    SUPAC-SS: Nonsterile Semisolid Dosage Forms January 5, 1999

    Do

    http://www.fda.gov/cder/guidance/index.htm Manufacturing Equipment Addendum--Draft

    Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Tracking of NDA and NDA Reformulations for April 12, 1989

    Do

    Division of Drug Information (HFD-200), Office Solid, Oral, Immediate Release Drug Products--

    of Training and Communications, Center for Draft

    Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    BACPAC1: Intermediates in Drug Substance

    February 16, 2001

    Chemistry

    Do Synthesis: Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation

    Changes to an Approved Application for

    July 24, 1997

    Do

    Do Specified Biotechnology and Specified Synthetic Biological Products

    Changes to an Approved NDA or ANDA

    November 23, 1999

    Do

    Do

    Changes to an Approved NDA or ANDA: Questions January 22, 2001

    Do

    Do and Answers

    Container Closure Systems for Packaging Human July 7, 1999

    Do

    Do Drugs and Biologics

    Development of New Stereoisomeric Drugs

    May 1, 1992

    Do

    Do

    Drug Master Files

    September 1, 1989

    Do

    Do

    Drug Master Files for Bulk Antibiotic Drug November 29, 1999

    Do

    Do Substances

    Environmental Assessment of Human Drugs and July 27, 1998

    Do

    Do Biologics Applications

    Format and Content for the CMC Section of an September 1, 1994

    Do

    Do Annual Report

    Format and Content of the Chemistry,

    February 1, 1987

    Do

    Do Manufacturing and Controls Section of an Application

    [[Page 53859]]

    Format and Content of the Microbiology Section February 1, 1987

    Do

    Do of an Application

    IND Meetings for Human Drugs and Biologics; May 25, 2001

    Do

    Do Chemistry, Manufacturing, and Controls Information

    Monoclonal Antibodies Used as Reagents in Drug March 29, 2001

    Do

    Do Manufacturing

    NDAs: Impurities in Drug Substances

    February 25, 2000

    Do

    Do

    PAC-ALTS: Postapproval Changes--Analytical April 28, 1998

    Do

    Do Testing Laboratory Sites

    Reviewer Guidance: Validation of

    November 1, 1994

    Do

    Do Chromatographic Methods

    Submission of Chemistry, Manufacturing, and November 1, 1994

    Do

    Do Controls Information for Synthetic Peptide Substances

    Submission of Documentation for Sterilization November 1, 1994

    Do

    Do Process Validation Applications for Human and Veterinary Drug Products

    Submitting Documentation for the Manufacturing February 1, 1987

    Do

    Do of and Controls for Drug Products

    Submitting Documentation for the Stability of February 1, 1987

    Do

    Do Human Drugs and Biologics

    Submitting Samples and Analytical Data for February 1, 1987

    Do

    Do Methods Validation

    Submitting Supporting Documentation in Drug February 1, 1987

    Do

    Do Applications for the Manufacture of Drug Products

    Submitting Supporting Documentation in Drug February 1, 1987

    Do

    Do Applications for the Manufacture of Drug Substances

    SUPAC IR: Immediate-Release Solid Oral Dosage November 30, 1995

    Do

    Do Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation

    SUPAC IR/MR: Immediate Release and Modified February 26, 1999

    Do

    Do Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum

    SUPAC-IR: Questions and Answers

    February 18, 1997

    Do

    Do

    SUPAC-MR: Modified Release Solid Oral Dosage October 6, 1997

    Do

    Do Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation

    SUPAC-SS: Nonsterile Semisolid Dosage Forms; June 13, 1997

    Do

    Do Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation

    [[Page 53860]]

    The Sourcing and Processing of Gelatin to

    December 20, 2000

    Do

    Do Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy

    Acute Bacterial Exacerbation of Chronic

    July 22, 1998

    Clinical Antimicrobial Do Bronchitis; Developing Antimicrobial Drugs for

    Draft Treatment--Draft

    Acute Bacterial Meningitis; Developing

    July 22, 1998

    Do

    Do Antimicrobial Drugs for Treatment--Draft

    Acute Bacterial Sinusitis; Developing

    July 22, 1998

    Do

    Do Antimicrobial Drugs for Treatment--Draft

    Acute or Chronic Bacterial Prostatitis;

    July 22, 1998

    Do

    Do Developing Antimicrobial Drugs for Treatment-- Draft

    Acute Otitis Media; Developing Antimicrobial July 22, 1998

    Do

    Do Drugs for Treatment--Draft

    Bacterial Vaginosis; Developing Antimicrobial July 22, 1998

    Do

    Do Drugs for Treatment--Draft

    Catheter-Related Bloodstream Infections--

    October 18, 1999

    Do

    Do Developing Antimicrobial Drugs for Treatment-- Draft

    Clinical Considerations for Accelerated and September 1, 1999

    Do

    Do Traditional Approval of Antiretroviral Drugs Using Plasma HIV RNA Measurements--Draft

    Community Acquired Pneumonia; Developing

    July 22, 1998

    Do

    Do Antimicrobial Drugs for Treatment--Draft

    Complicated Urinary Tract Infections and

    July 22, 1998

    Do

    Do Pylonephritis; Developing Antimicrobial Drugs for Treatment--Draft

    Developing Antimicrobial Drugs--General

    July 22, 1998

    Do

    Do Considerations for Clinical Trials--Draft

    Empiric Therapy of Febrile Neutropenia;

    July 22, 1998

    Do

    Do Developing Antimicrobial Drugs for Treatment-- Draft

    Evaluating Clinical Studies of Antimicrobials February 17, 1997

    Do

    Do in the Division of Anti-Infective Drug Products--Draft

    Lyme Disease; Developing Antimicrobial Drugs July 22, 1998

    Do

    Do for Treatment--Draft

    Nosocomial Pneumonia; Developing Antimicrobial July 22, 1998

    Do

    Do Drugs for Treatment--Draft

    Secondary Bacterial Infections of Acute

    July 22, 1998

    Do

    Do Bronchitis; Developing Antimicrobial Drugs for Treatment--Draft

    Streptococcal Pharyngitis and Tonsillitis; July 22, 1998

    Do

    Do Developing Antimicrobial Drugs for Treatment-- Draft

    Uncomplicated and Complicated Skin and Skin July 22, 1998

    Do

    Do Structure Infections; Developing Antimicrobial Drugs for Treatment--Draft

    [[Page 53861]]

    Uncomplicated Gonorrhea--Cervical, Urethral, July 22, 1998

    Do

    Do Rectal, and/or Pharyngeal; Developing Antimicrobial Drugs for Treatment--Draft

    Uncomplicated Urinary Tract Infections;

    July 22, 1998

    Do

    Do Developing Antimicrobial Drugs for Treatment-- Draft

    Vulvovaginal Candidiasis; Developing

    July 22, 1998

    Do

    Do Antimicrobial Drugs for Treatment--Draft

    Clinical Development and Labeling of Anti- October 26, 1992

    Clinical Antimicrobial Do Infective Drug Products

    Clinical Evaluation of Anti-Infective Drugs September 1, 1977

    Do

    Do (Systemic)

    Preclinical Development of Antiviral Drugs November 1, 1990

    Do

    Do

    Abuse Liability Assessment--Draft

    July 1, 1990

    Clinical Medical Draft Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Allergic Rhinitis: Clinical Development

    June 21, 2000

    Do

    http://www.fda.gov/cder/guidance/index.htm Programs for Drug Products--Draft

    Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Cancer Drug and Biological Products--Clinical November 9, 2000

    Do

    Do Data in Marketing Applications--Draft

    Chronic Cutaneous Ulcer and Burn Wounds--

    June 28, 2000

    Do

    Do Developing Products for Treatment--Draft

    Clinical Development Programs for Drugs,

    July 15, 1999

    Do

    Do Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA)--Draft

    Clinical Evaluation of Anti-Anginal Drugs-- January 1, 1989

    Do

    Division of Drug Information (HFD-200), Office Draft

    of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Clinical Evaluation of Anti-Arrhythmic Drugs-- July 1, 1985

    Do

    http://www.fda.gov/cder/guidance/index.htm Draft

    Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Clinical Evaluation of Antihypertensive Drugs-- May 1, 1988

    Do

    Do Draft

    [[Page 53862]]

    Clinical Evaluation of Drugs for the Treatment December 1, 1987

    Do

    Division of Drug Information (HFD-200), Office of Congestive Heart Failure--Draft

    of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Clinical Evaluation of Drugs for Ulcerative January 7, 1991

    Do

    Do Colitis (3rd draft)--Draft

    Clinical Evaluation of Lipid-Altering Agents In September 1, 1990

    Do

    http://www.fda.gov/cder/guidance/index.htm Adults and Children--Draft

    Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Clinical Evaluation of Motility-Modifying

    Date not available

    Do

    Division of Drug Information (HFD-200), Office Drugs--Draft

    of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Clinical Evaluation of Weight-Control Drugs-- September 24, 1996

    Do

    http://www.fda.gov/cder/guidance/index.htm Draft

    Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Developing Medical Imaging Drugs and Biologics-- July 31, 2000

    Do

    Do Revised--Draft

    Development and Evaluation of Drugs for the February 12, 1992

    Do

    Division of Drug Information (HFD-200), Office Treatment of Psychoactive Substance Use

    of Training and Communications, Center for Disorders--Draft

    Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Development of Parathyroid Hormones for the June 14, 2000

    Do

    http://www.fda.gov/cder/guidance/index.htm Prevention and Treatment of Osteoporosis--

    Division of Drug Information (HFD-200), Office Draft

    of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Establishing Pregnancy Registries--Draft

    June 4, 1999

    Do

    Do

    Evaluation of Human Pregnancy Outcome Data-- June 4, 1999

    Do

    Do Draft

    Female Sexual Dysfunction: Clinical Development May 19, 2000

    Do

    Do of Drug Products for Treatment--Draft

    Institutional Review Boards, Clinical

    March 30, 2000

    Do

    Do Investigators, and Sponsors: Exception From Informed Consent Requirements for Emergency Research--Draft

    OTC Treatment of Herpes Labialis With Antiviral March 8, 2000

    Do

    Do Agents--Draft

    Pediatric Oncology Studies in Response to a June 21, 2000

    Do

    Do Written Request--Draft

    [[Page 53863]]

    Postmarketing Safety Reporting for Human Drug March 12, 2001

    Do

    Do and Biological Products Including Vaccines-- Draft

    Preclinical and Clinical Evaluation of Agents April 1, 1994

    Do

    Do Used in the Prevention or Treatment of Postmenopausal Osteoporosis--Draft

    Preparation of IND Applications for New Drugs September 1, 1991

    Do

    Division of Drug Information (HFD-200), Office Intended for the Treatment of HIV-Infected

    of Training and Communications, Center for Individuals--Draft

    Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Recommendations for Complying With the

    December 4, 2000

    Do

    http://www.fda.gov/cder/guidance/index.htm Pediatric Rule--Draft

    Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    System Inflammatory Response Syndrome (SIRS) July 1993

    Do

    Division of Drug Information (HFD-200), Office (1st draft)--Draft

    of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Acceptance of Foreign Clinical Studies

    March 13, 2001

    Clinical Medical

    http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Clinical Development Programs for Drugs,

    February 17, 1999

    Do

    Do Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA)

    Clinical Development Programs for MDI and DPI September 19, 1994

    Do

    Do Drug Products

    Clinical Evaluation of Analgesic Drugs

    December 1, 1992

    Do

    Do

    Clinical Evaluation of Antacid Drugs

    April 1, 1978

    Do

    Do

    Clinical Evaluation of Anti-Inflammatory and April 1, 1988

    Do

    Do Antirheumatic Drugs (Adults and Children)

    Clinical Evaluation of Antianxiety Drugs

    September 1, 1977

    Do

    Do

    Clinical Evaluation of Antidepressant Drugs September 1, 1977

    Do

    Do

    Clinical Evaluation of Antidiarrheal Drugs September 1, 1977

    Do

    Do

    Clinical Evaluation of Antiepileptic Drugs January 1, 1981

    Do

    Do (Adults and Children)

    Clinical Evaluation of Combination Estrogen/ March 20, 1995

    Do

    Do Progestin-Containing Drug Products Used for Hormone Replacement Therapy of Postmenopausal Women

    Clinical Evaluation of Gastric Secretory

    September 1, 1977

    Do

    Do Depressant (GSD) Drugs

    [[Page 53864]]

    Clinical Evaluation of General Anesthetics May 1, 1982

    Do

    Do

    Clinical Evaluation of Hypnotic Drugs

    September 1, 1977

    Do

    Do

    Clinical Evaluation of Laxative Drugs

    April 1, 1978

    Do

    Do

    Clinical Evaluation of Local Anesthetics

    May 1, 1982

    Do

    Do

    Clinical Evaluation of Psychoactive Drugs in July 1, 1979

    Do

    Do Infants and Children

    Clinical Evaluation of Radiopharmaceutical October 1, 1981

    Do

    Do Drugs

    Content and Format for Pediatric Use

    May 24, 1996

    Do

    Do Supplements

    Content and Format of Investigational New Drug November 20, 1995

    Do

    Do Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products

    Development of Vaginal Contraceptive Drugs April 19, 1995

    Do

    Do (NDA)

    FDA Approval of New Cancer Treatment Uses for February 2, 1999

    Do

    Do Marketed Drug and Biological Products

    FDA Requirements for Approval of Drugs to Treat January 29, 1991

    Do

    Do Non-Small Lung Cancer

    FDA Requirements for Approval of Drugs to Treat June 20, 1989

    Do

    Do Superficial Bladder Cancer

    Format and Content of the Clinical and

    July 1, 1988

    Do

    Do Statistical Sections of an Application

    Format and Content of the Summary for New Drug February 1, 1987

    Do

    Do and Antibiotic Applications

    Formatting, Assembling and Submitting New Drug February 1, 1987

    Do

    Do and Antibiotic Applications

    General Considerations for the Clinical

    December 1, 1978

    Do

    Do Evaluation of Drugs

    General Considerations for the Clinical

    September 1, 1977

    Do

    Do Evaluation of Drugs in Infants and Children

    Levothyroxine Sodium Tablets--In Vivo

    March 8, 2001

    Do

    Do Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing

    Oncologic Drugs Advisory Committee Discussion April 13, 1988

    Do

    Do on FDA Requirements for Approval of New Drugs for Treatment of Ovarian Cancer

    Oncologic Drugs Advisory Committee Discussion April 19, 1988

    Do

    Do on FDA Requirements for Approval of New Drugs for Treatment of Colon and Rectal Cancer

    Postmarketing Adverse Experience Reporting for August 27, 1997

    Do

    Do Human Drug and Licensed Biological Products; Clarification of What to Report

    [[Page 53865]]

    Postmarketing Reporting of Adverse Drug

    March 1, 1992

    Do

    Do Experiences

    Preclinical Development of Immunomodulatory September 4, 1992

    Do

    Do Drugs for the Treatment of HIV Infection and Associated Disorders

    Preparation of Investigational New Drug

    November 1, 1992

    Do

    Do Products (Human and Animal)

    Providing Clinical Evidence of Effectiveness May 15, 1998

    Do

    Do for Human Drug and Biological Products

    Study and Evaluation of Gender Differences in July 22, 1993

    Do

    Do the Clinical Evaluation of Drugs

    Study of Drugs Likely To Be Used in the Elderly November 1, 1989

    Do

    Do

    Submission of Abbreviated Reports and Synopses September 13, 1999

    Do

    Do in Support of Marketing Applications

    General Considerations for Pediatric

    November 30, 1998

    Clinical Pharmacology Draft Do Pharmacokinetic Studies for Drugs and Biological Products--Draft

    Pharmacokinetics in Patients With Impaired December 7, 1999

    Do

    Do Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling--Draft

    Drug Metabolism/Drug Interaction Studies in the April 7, 1997

    Clinical Pharmacology

    Do Drug Development Process: Studies In Vitro

    Format and Content of the Human

    February 1, 1987

    Do

    Do Pharmacokinetics and Bioavailability Section of an Application

    In Vivo Metabolism/Drug Interaction Studies-- November 24, 1999

    Do

    Do Study Design, Data Analysis, and Recommendations for Dosing and Labeling

    Pharmacokinetics and Pharmacodynamics in

    May 15, 1998

    Do

    Do Patients With Impaired Renal Function: Study Design, Data Analysis, and Impact on Dosing and Labeling

    Population Pharmacokinetics

    February 10, 1999

    Do

    Do

    Guidance for IRBs, Clinical Investigators, and March 30, 2000

    Compliance Draft

    Do Sponsors: Exception from Informed Consent Requirements for Emergency Research (21 CFR 50.24)--Draft

    Investigating Out of Specification (OOS) Test September 30, 1998

    Do

    Do Results for Pharmaceutical Production--Draft

    Manufacture, Processing or Holding of Active April 17, 1998

    Do

    Do Pharmaceutical Ingredients--Draft

    Repacking of Solid Oral Dosage Form Drug

    February 1, 1992

    Do

    Do Products--Draft

    [[Page 53866]]

    A Review of FDA's Implementation of the Drug

    Compliance

    Do Export Amendments of 1986

    Compressed Medical Gases

    December 1, 1989

    Do

    Do

    Computerized Systems Used in Clinical Trials May 10, 1999

    Do

    Do

    Expiration Dating and Stability Testing of June 27, 1997

    Do

    Do Solid Oral Dosage Form Drugs Containing Iron

    General Principles of Process Validation

    May 1, 1987

    Do

    Do

    Good Laboratory Practice Regulations Questions

    Do

    Do and Answers

    Guidance for Hospitals, Nursing Homes, and April 6, 2001

    Do

    Do Other Health Care Facilities

    Monitoring of Clinical Investigations

    January 1, 1988

    Do

    Do

    Nuclear Pharmacy Guideline Criteria for

    May 1, 1984

    Do

    Do Determining When to Register as a Drug Establishment

    Possible Dioxin/PCB Contamination of Drug and August 23, 1999

    Do

    Do Biological Products

    Sterile Drug Products Produced by Aseptic

    May 1, 1987

    Do

    Do Processing

    Street Drug Alternatives

    April 3, 2000

    Do

    Do

    Validation of Limulus Amebocyte Lysate Test as December 1, 1987

    Do

    Do an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices

    Providing Regulatory Submissions in Electronic May 4, 2001

    Electronic Submission Draft Do Format--Postmarketing Expedited Safety Reports--Draft

    Providing Regulatory Submissions in Electronic January 31, 2001

    Do

    Do Format: Prescription Drug Advertising and Promotional Labeling--Draft

    Preparing Data for Electronic Submissions in September 23, 1999

    Electronic Submission

    Do ANDAs

    Regulatory Submissions in Electronic Format; January 28, 1999

    Do

    Do General Considerations

    Regulatory Submissions in Electronic Format; January 28, 1999

    Do

    Do New Drug Applications

    ANDAs; Blend Uniformity Analysis--Draft

    August 26, 1999

    Generic Drug Draft

    Do

    ANDAs; Impurities in Drug Products--Draft

    January 5, 1999

    Do

    Do

    Content and Format of an Abbreviated New Drug April 18, 1997

    Do

    Do Application (ANDA)--Positron Emission Tomography (PET) Drug Products--With Specific Information for ANDAs for Fludeoxyglucose F18 Injection--Draft

    Alternate Source of Active Pharmaceutical

    December 12, 2000

    Do

    Do Ingredients in Pending ANDAs--Draft

    [[Page 53867]]

    ANDAs: Impurities in Drug Substances

    December 3, 1999

    Generic Drugs

    Do

    Court Decisions, ANDA Approvals, and 180-Day March 30, 2000

    Do

    Do Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act

    Letter Announcing That the OGD Will Now Accept August 18, 1995

    Do

    Do the ICH Long-Term Storage Conditions as Well as the Stability Studies Conducted in the Past

    Letter Describing Efforts by CDER and ORA to October 14, 1994

    Do

    Do Clarify the Responsibilities of CDER Chemistry Review Scientists and ORA Field Investigators in the New and Abbreviated Drug Approval Process in Order to Reduce Duplication or Redundancy in the Process

    Letter on Incomplete Abbreviated Applications, April 8, 1994

    Do

    Do Convictions Under GDEA, Multiple Supplements, Annual Reports for Bulk Antibiotics, Batch Size for Transdermal Drugs, Bioequivalence Protocols, Research, Deviations From OGD Policy

    Letter on the Provision of New Information July 1, 1992

    Do

    Do Pertaining to New Bioequivalence Guidelines and Refuse-to-File Letters

    Letter on the Provision of New Procedures and March 15, 1989

    Do

    Do Policies Affecting the Generic Drug Review Process

    Letter on the Request for Cooperation of

    November 8, 1991

    Do

    Do Regulated Industry to Improve the Efficiency and Effectiveness of the Generic Drug Review Process, by Assuring the Completeness and Accuracy of Required Information and Data Submissions

    Letter on the Response to 12/20/84 Letter From March 26, 1985

    Do

    Do the Pharmaceutical Manufacturers Association About the Drug Price Competition and Patent Term Restoration Act

    Letter to all ANDA and AADA Applicants About January 15, 1993

    Do

    Do the Generic Drug Enforcement Act of 1992 (GDEA), and the Office of Generic Drugs intention to Refuse-to-File Incomplete Submissions as Required by the New Law

    Letter to Regulated Industry Notifying

    August 4, 1993

    Do

    Do Interested Parties About Important Detailed Information Regarding Labeling, Scale-up, Packaging, Minor/major Amendment Criteria, and Bioequivalence Requirements

    Major, Minor, Facsimile, and Telephone

    May 1, 2000

    Do

    Do Amendments to Original Abbreviated New Drug Applications (Revised)

    Organization of an ANDA

    March 2, 1999

    Do

    Do

    Revising ANDA Labeling Following Revision of April 25, 2000

    Do

    Do the RLD Labeling

    [[Page 53868]]

    Skin Irritation and Sensitization Testing of February 3, 2000

    Do

    Do Generic Transdermal Drug Products

    Variations in Drug Products That May Be

    January 27, 1999

    Do

    Do Included ANDA

    Conducting a Clinical Safety Review of a New November 22, 1996

    Good Review Practices Draft Do Product Application and Preparing a Report on the Review--Draft

    Pharmacology/Toxicology Review Format

    May 10, 2001

    Good Review Practices

    Do

    Q1A(R)--Stability Testing of New Drug

    April 21, 2000

    ICH Draft--Quality

    Do Substances and Products--Draft

    Q3A(R)--Impurities in New Drug Substances-- July 20, 2000

    Do

    Do Draft

    Q3B(R)--Impurities in New Drug Products--Draft July 19, 2000

    Do

    Do

    Q6A--Specifications: Test Procedures and

    November 25, 1997

    Do

    Do Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances-- Draft

    Q7A--Good Manufacturing Practice for Active August 1, 2000

    Do

    Do Pharmaceutical Ingredients--Draft

    S7--Safety Pharmacology Studies for Human

    August 7, 2000

    ICH Draft--Safety

    Do Pharmaceuticals--Draft

    E12 A--Principles for Clinical Evaluation of August 9, 2000

    ICH Draft--Efficacy

    Do New Antihypertensive Drugs--Draft

    M4--Common Technical Document--Draft

    August 24, 2000

    ICH Draft--Joint Safety/ Do Efficacy (Multidisciplinary)

    Q1A--Stability Testing of New Drug Substances September 22, 1994

    ICH--Quality

    Do and Products

    QIB--Photostability Testing of New Drug

    May 16, 1997

    Do

    Do Substances and Products

    QIC--Stability Testing for New Dosage Forms May 9, 1997

    Do

    Do

    Q2A--Text on Validation of Analytical

    March 1, 1995

    Do

    Do Procedures

    Q2B--Validation of Analytical Procedures:

    May 19, 1997

    Do

    Do Methodology

    Q3A--Impurities in New Drug Substances

    January 4, 1996

    Do

    Do

    Q3B(R)-- Impurities in New Drug Products

    July 19, 2000

    Do

    Do

    Q3C--Impurities: Residual Solvents

    December 24, 1997

    Do

    Do

    Q5A--Viral Safety Evaluation of Biotechnology September 24, 1998

    Do

    Do Products Derived From Cell Lines of Human or Animal Origin

    Q5B--Quality of Biotechnology Products:

    February 23, 1996

    Do

    Do Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products

    [[Page 53869]]

    Q5C--Quality of Biotechnological Products: July 10, 1996

    Do

    Do Stability Testing of Biotechnology/Biological Products

    Q5D--Quality of Biotechnological/Biological September 21, 1998

    Do

    Do Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products

    Q6A--Specifications: Test Procedures and

    December 29, 2000

    Do

    Do Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances

    Q6B--Test Procedures and Acceptance Criteria August 18, 1999

    Do

    Do for Biotechnological/Biological Products

    S1A--The Need for Long-Term Rodent

    March 1, 1996

    ICH--Safety

    Do Carcinogenicity Studies of Pharmaceuticals

    S1B--Testing for Carcinogenicity in

    February 23, 1998

    Do

    Do Pharmaceuticals

    S1C--Dose Selection for Carcinogenicity Studies March 1, 1995

    Do

    Do of Pharmaceuticals

    S1C(R)--Dose Selection for Carcinogenicity December 4, 1997

    Do

    Do Studies of Pharmaceuticals: Addendum on a Limit Dose and Related Notes

    S2A--Specific Aspects of Regulatory

    April 24, 1996

    Do

    Do Genotoxicity Tests for Pharmaceuticals

    S2B--Genotoxicity: Standard Battery Testing November 21, 1997

    Do

    Do

    S3A--Toxicokinetics: The Assessment of Systemic March 1, 1995

    Do

    Do Exposure in Toxicity Studies

    S3B--Pharmacokinetics: Guidance for Repeated March 1, 1995

    Do

    Do Dose Tissue Distribution Studies

    S4A--Duration of Chronic Toxicity Testing in June 25, 1999

    Do

    Do Animals (Rodent and Nonrodent Toxicity Testing)

    S5A--Detection of Toxicity to Reproduction for September 22, 1994

    Do

    Do Medicinal Products

    S5B--Detection of Toxicity to Reproduction for April 5, 1996

    Do

    Do Medicinal Products: Addendum on Toxicity to Male Fertility

    S6--Preclinical Safety Evaluation of

    November 18, 1997

    Do

    Do Biotechnology-Derived Pharmaceuticals

    S7A--Safety Pharmacology Studies for Human July 13, 2001

    Do

    Do Pharmaceuticals

    EIA--The Extent of Population Exposure to

    March 1, 1995

    ICH--Efficacy

    Do Assess Clinical Safety: for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions

    E2A--Clinical Safety Data Management:

    March 1, 1995

    Do

    Do Definitions and Standards for Expedited Reporting

    [[Page 53870]]

    E2B--Data Elements for Transmission of

    January 15, 1998

    Do

    Do Individual Case Safety Reports

    E2C--Clinical Safety Data Management: Periodic May 19, 1997

    Do

    Do Safety Update Reports for Marketed Drugs

    E3--Structure and Content of Clinical Study July 17, 1996

    Do

    Do Reports

    E4--Dose-Response Information to Support Drug November 9, 1994

    Do

    Do Registration

    E5--Ethnic Factors in the Acceptability of June 10, 1998

    Do

    Do Foreign Clinical Data

    E6--Good Clinical Practice: Consolidated

    May 9, 1997

    Do

    Do Guideline

    E7--Studies in Support of Special Populations: August 2, 1994

    Do

    Do Geriatrics

    E8--General Considerations for Clinical Trials December 24, 1997

    Do

    Do

    E9--Statistical Principles for Clinical Trials September 16, 1998

    Do

    Do

    E10--International Conference on Harmonisation: May 14, 2001

    Do

    Do Choice of Control Group and Related Issues in Clinical Trials

    E11--Clinical Investigation of Medicinal

    December 15, 2000

    Do

    Do Products in the Pediatric Population

    M3--Nonclinical Safety Studies for the Conduct November 25, 1997

    ICH--Joint Safety/Efficacy Do of Human Clinical Trials for Pharmaceuticals

    (Multidisciplinary)

    A Revision in Sample Collection Under the

    July 15, 1996

    Industry Letters

    Division of Drug Information (HFD-200), Office Compliance Program Pertaining to Pre-Approval

    of Training and Communications, Center for Inspections

    Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Certification Requirements for Debarred

    June 1, 1990

    Do

    Do Individuals in Drug Applications

    Continuation of a Series of Letters

    March 2, 1998

    Do

    Http://www.fda.gov/cder/guidance/index.htm Communicating Interim and Informal Generic

    Division of Drug Information (HFD-200), Office Drug Policy and Guidance. Availability of

    of Training and Communications, Center for Policy and Procedure Guides, and Further

    Drug Evaluation and Research, Food and Drug Operational Changes to the Generic Drug Review

    Administration, 5600 Fishers Lane, Rockville, Program

    MD 20857, 301-827-4573

    Fifth of a Series of Letters Providing Informal April 10, 1987

    Do

    Do Notice About the Act, Discussing the Statutory Mechanism by Which ANDA Applicants May Make Modifications in Approved Drugs Where Clinical Data Is Required

    Fourth of a Series of Letters Providing

    October 31, 1986

    Do

    Do Informal Notice to Affected Parties About Policy Developments and Interpretations Regarding the Act. Three-Year Exclusivity Provisions of Title 1

    [[Page 53871]]

    Implementation of the Drug Price Competition October 11, 1984

    Do

    Do and Patent Term Restoration Act; Preliminary Guidance

    Implementation Plan USP Injection Nomenclature October 2, 1995

    Do

    Do

    Instructions for Filing Supplements Under the April 11, 1996

    Do

    Division of Drug Information (HFD-200), Office Provisions of SUPAC-IR

    of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Seventh of a Series of Letters About the Act July 29, 1988

    Do

    Http://www.fda.gov/cder/guidance/index.htm Providing Guidance on the ``180-Day

    Division of Drug Information (HFD-200), Office Exclusivity'' Provision of Section

    of Training and Communications, Center for 505(j)(4)(B)(iv) of the Act

    Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Sixth of a Series of Informal Notice Letters April 28, 1988

    Do

    Do About the Act Discussing 3- and 5-year Exclusivity Provisions of Section 505(c)(3)(D) and (j)(4)(D) of the Act

    Streamlining Initiative

    December 24, 1996

    Do

    Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Supplement to 10/11/84 Letter About Policies, November 16, 1984

    Do

    http://www.fda.gov/cder/guidance/index.htm Procedures and Implementation of the Act (Q &

    Division of Drug Information (HFD-200), Office A Format)

    of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Third of a Series of Letters Regarding the May 1, 1985

    Do

    Do Implementation of the Act

    Y2K Letter From Dr. Janet Woodcock

    October 19, 1998

    Do

    Do

    Combined Oral Contraceptives--Labeling for July 10, 2000

    Labeling Draft

    Do Healthcare Providers and Patients--Draft

    Content and Format for Geriatric Labeling-- January 21, 1999

    Do

    Do Draft

    Content and Format of the Adverse Reactions June 21, 2000

    Do

    Do Section of Labeling for Human Prescription Drugs and Biologics--Draft

    Non-Contraceptive Estrogen Drug Products-- January 8, 1999

    Do

    Do Physician and Patient Labeling--Draft

    Noncontraceptive Estrogen Class Labeling--Draft September 27, 1999

    Do

    Do

    Labeling of OTC Topical Drug Products for the July 16, 1998

    Do

    Do Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis)--Draft

    [[Page 53872]]

    Referencing Discontinued Labeling for Listed October 26, 2000

    Do

    Do Drugs in Abbreviated New Drug Applications-- Draft

    Therapeutic Equivalence Code Placement on

    January 28, 1999

    Do

    Do Prescription Drug Labels and Labeling--Draft

    Acetaminophen and Codeine Phosphate Tablets/ December 1, 1993

    Labeling

    Do Capsules

    Acetaminophen and Codeine Phosphate Oral

    December 1, 1993

    Do

    Do Solution/Suspension

    Acetaminophen, Aspirin and Codeine Phosphate December 1, 1993

    Do

    Do Tablets/Capsules

    Alprazolam Tablets USP

    August 1, 1996

    Do

    Do

    Amiloride Hydrochloride and Hydrochlorothiazide September 1, 1997

    Do

    Do Tablets USP

    Amlodipine Besylate Tablets

    September 1, 1997

    Do

    Do

    Astemizole Tablets

    September 1, 1997

    Do

    Do

    Atenolol Tablets USP

    August 1, 1997

    Do

    Do

    Barbiturate, Single Entity-Class Labeling

    March 1, 1981

    Do

    Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Butalbital, Acetaminophen and Caffeine Capsules/ September 1, 1997

    Do

    http://www.fda.gov/cder/guidance/index.htm Tablets USP

    Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Butalbital, Acetaminophen, Caffeine and

    September 21, 1997

    Do

    Do Hydocodone Bitartrate Tablets

    Butorphanol Tartrate Injection USP

    October 1, 1992

    Do

    Do

    Captopril and Hydrochlorothiazide Tablets USP April 1, 1995

    Do

    Do

    Captopril Tablets

    February 1, 1995

    Do

    Do

    Carbidopa and Levodopa Tablets USP

    February 1, 1992

    Do

    Do

    Chlordiazepoxide Hydrochloride Capsules

    January 1, 1988

    Do

    Do

    Cimetidine Hydrochloride Injection

    September 1, 1995

    Do

    Do

    Cimetidine Tablets

    September 1, 1995

    Do

    Do

    Cisapride Oral Suspension

    September 1, 1997

    Do

    Do

    Cisapride Tablets

    September 1, 1997

    Do

    Do

    Clindamycin Phosphate Injection USP

    September 1, 1998

    Do

    Do

    [[Page 53873]]

    Clorazepate Dipotassium Capsules/Tablets

    March 1, 1993

    Do

    Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Combination Oral Contraceptives--Physician and January 1, 1994

    Do

    Do Patient Labeling

    Cyproheptadine Hydrochloride Tablets/Syrup December 1, 1986

    Do

    Do

    Diclofenac Sodium Delayed-Release Tablets

    January 1, 1997

    Do

    http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Diltiazem Hydrochloride Extended-Release

    September 1, 1995

    Do

    Do Capsules

    Diphenoxylate Hydrochloride and Atropine

    April 1, 1995

    Do

    Do Sulfate Oral Solution USP

    Diphenoxylate Hydrochloride and Atropine

    April 1, 1995

    Do

    Do Sulfate Tablets USP

    Dipivefrin Hydrochloride Ophthalmic Solution, November 2, 1998

    Do

    Division of Drug Information (HFD-200), Office 0.1%

    of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Ergoloid Mesylates Tablets

    January 1, 1988

    Do

    Do

    Fludeoxyglucose F18 Injection

    January 1, 1997

    Do

    http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Flurbiprofen Tablets USP

    January 1, 1994

    Do

    Do

    Fluvoxamine Maleate Tablets

    September 1, 1997

    Do

    Do

    Gentamicin Sulfate Ophthalmic Ointment and April 1, 1992

    Do

    Do Solution USP

    Heparin Sodium Injection USP

    March 1, 1991

    Do

    Do

    Hydrocodone Bitartrate and Acetaminophen

    April 1, 1994

    Do

    Do Tablets USP

    Hydroxyzine Hydrochloride Injection

    December 1, 1989

    Do

    Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Hypoglycemic Oral Agents Federal Register

    April 1, 1984

    Do

    Do

    [[Page 53874]]

    Indomethacin Capsules USP

    September 1, 1995

    Do

    http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Informal Labeling Guidance Texts for Estrogen August 1, 1992

    Do

    Division of Drug Information (HFD-200), Office Drug Products Patient Labeling

    of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Informal Labeling Guidance Texts for Estrogen August 1, 1992

    Do

    Do Drug Products: Professional Labeling

    Isoetharine Inhalation Solution

    March 1, 1989

    Do

    Do

    Itraconazole Capsules, USP

    September 1, 1998

    Do

    http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Leucovorin Calcium for Injection

    July 1, 1996

    Do

    Do

    Leucovorin Calcium Tablets, USP

    July 1, 1996

    Do

    Do

    Local Anesthetics Class Labeling

    September 1, 1982

    Do

    Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Meclofenamate Sodium Capsules

    July 1, 1992

    Do

    Do

    Medroxyprogesterone Acetate Tablets, USP

    September 1, 1998

    Do

    http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Metaproterenol Sulfate Inhalation Solution USP May 1, 1992

    Do

    Do

    Metaproterenol Sulfate Syrup USP

    May 1, 1992

    Do

    Do

    Metaproterenol Sulfate Tablets

    May 1, 1992

    Do

    Do

    Metoclopramide Tablets USP/Oral Solution

    February 1, 1995

    Do

    Do

    Naphazoline Hydrochloride Ophthalmic Solution March 1, 1989

    Do

    Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    [[Page 53875]]

    Naproxen Sodium Tablets, USP

    September 1, 1997

    Do

    http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Naproxen Tablets, USP

    September 1, 1997

    Do

    Do

    Niacin Tablets

    July 1, 1982

    Do

    Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Paclitaxel Injection

    September 1, 1997

    Do

    http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Phendimetrazine Tartrate Capsules/T Nets, and February 1, 1991

    Do

    Division of Drug Information (HFD-200), Office Extended-Release Capsules

    of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Phentermine Hydrochloride Capsules/Tablets August 1, 1988

    Do

    Do

    Promethazine Hydrochloride Tablets

    March 1, 1990

    Do

    Do

    Propantheline Bromide Tablets

    August 1, 1988

    Do

    Do

    Pyridoxine Hydrochloride Injection

    June 1, 1984

    Do

    Do

    Quinidine Sulfate Tablets/Capsules USP

    October 1, 1995

    Do

    http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Ranitidine Tablets USP

    November 1, 1993

    Do

    Do

    Risperidone Oral Solution

    September 1, 1997

    Do

    Do

    Risperidone Tablets

    September 1, 1997

    Do

    Do

    Sulfacetainide Sodium and Prednisolone Acetate January 1, 1995

    Do

    Do Ophthalmic Suspension and Ointment

    Sulfacetamide Sodium Ophthalmic Solution/

    August 1, 1992

    Do

    Do Ointment

    Sulfamethoxazole and Phenazopyridine

    February 1, 1992

    Do

    Division of Drug Information (HFD-200), Office Hydrochloride Tablets

    of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    [[Page 53876]]

    Sulfamethoxazole and Trimethoprim Tablets and August 1, 1993

    Do

    http://www.fda.gov/cder/guidance/index.htm Oral Suspension

    Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Theophylline Immediate-Release Dosage Forms February 1, 1995

    Do

    Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Theophylline Intravenous Dosage Forms

    September 1, 1995

    Do

    http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Thiamine Hydrochloride Injection

    February 1, 1988

    Do

    Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Tobramycin Sulfate Injection USP

    May 1, 1993

    Do

    http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    Venlafaxine Hydrochloride Tablets

    October 1, 1997

    Do

    Do

    Verapamil Hydrochloride Tablets

    October 1, 1991

    Do

    Do

    Vitamin A Capsules

    February 1, 1992

    Do

    Do

    Zolpidem Tartrate Tablets

    September 1, 1997

    Do

    Do

    Demonstration of Comparability of Human

    April 1, 1996

    Microbiology

    Do Biological Products, Including Therapeutic Biotechnology-Derived Products

    Labeling OTC Human Drug Products--Submitting December 19, 2000

    OTC Draft

    Do Requests for Exemptions and Deferrals--Draft

    Labeling OTC Human Drug Products: Updating February 22, 2001

    Do

    Do Labeling in ANDAs--Draft

    OTC Actual Use Studies--Draft

    July 22, 1994

    Do

    Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    OTC Nicotine Substitutes--Draft

    March 1, 1994

    Do

    Do

    [[Page 53877]]

    Enforcement Policy on Marketing OTC Combination

    OTC

    http://www.fda.gov/cder/guidance/index.htm Products (CPG 7132b.16)

    Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573

    General Guidelines for OTC Combination Products

    Do

    Do

    Labeling OCT Human Drug Products Using a Column December 19, 2000

    Do

    Do Format

    Upgrading Category III Antiperspirants to

    Do

    Do Category 1 (43 FR 46728-46731)

    Carcinogenicity Study Protocol Submissions-- November 7, 2000

    Pharmacology/Toxicology Do Draft

    Draft

    Immunotoxicology Evaluation of Investigational May 11, 2001

    Do

    Do New Drugs--Draft

    Photosafety Testing--Draft

    January 10, 2000

    Do

    Do

    Statistical Aspects of the Design, Analysis, May 8, 2001

    Do

    Do and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals-- Draft

    Content and Format of INDs for Phase 1 Studies October 4, 2000

    Pharmacology/Toxicology Do of Drugs Including Well-Characterized, Therapeutic, Biotechnology-Derived Products

    Format and Content of the Nonclinical

    February 1, 1987

    Do

    Do Pharmacology/Toxicology Section of an Application

    Nonclinical Pharmacology/Toxicology Development October 16, 1996

    Do

    Do of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal Contraceptives

    Reference Guide for the Nonclinical Toxicity February 1, 1989

    Do

    Do Studies of Antiviral Drugs Indicated for the Treatment of N/A Non-Life Threatening Disease: Evaluation of Drug Toxicity Prior to Phase I Clinical Studies

    Single Dose Acute Toxicity Testing Toxicity August 26, 1996

    Do

    Do Testing for Pharmaceuticals

    Applications Covered by Section 505(b)(2)-- December 8, 1999

    Procedural Draft

    Do Draft

    Content and Format of New Drug Applications and March 10, 2000

    Do

    Do Abbreviated New Drug Applications for Certain Positron Emission Tomography Drug Products-- Draft

    Disclosing Information Provided to Advisory December 22, 1999

    Do

    Do Committees in Connection With Open Advisory Committee Meetings Related to the Testing or Approval of New Drugs and Convened by CDER, Beginning January 1, 2000--Draft

    [[Page 53878]]

    Forms for Registration of Producers of Drugs May 15, 2001

    Do

    Do and Listing of Drugs in Commercial Distribution--Draft

    Information Program on Clinical Trials for March 29, 2000

    Do

    Do Serious or Life-Threatening Diseases: Establishment of a Data Bank--Draft

    Information Program on Clinical Trials for July 9, 2001

    Do

    Do Serious or Life-Threatening Diseases: Implementation Plan--Draft

    Information Request and Discipline Review

    August 17, 1999

    Do

    Do Letters Under the Prescription Drug User Fee Act--Draft

    PET Drug Applications--Content and Format for March 10, 2000

    Do

    Do NDAs and ANDAs--Draft

    Postmarketing Safety Reporting for Human Drug March 12, 2001

    Do

    Do and Biological Products Including Vaccines-- Draft

    Potassium Iodide as a Thyroid Blocking Agent in January 4, 2001

    Do

    Do Radiation Emergencies--Draft

    Reports on the Status of Postmarketing Studies-- April 4, 2001

    Do

    Do Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997-- Draft

    Special Protocol Assessment--Draft

    February 9, 2000

    Do

    Do

    Submitting Debarment Certification Statements-- October 2, 1998

    Do

    Do Draft

    180-Day Generic Drug Exclusivity Under the July 14, 1998

    Procedural

    Do Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act

    Advisory Committees: Implementing Section 120 November 2, 1998

    Do

    Do of the Food and Drug Modernization Act of 1997

    Court Decisions, ANDA Approvals, and 130-Day March 30, 2000

    Do

    Do Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act

    Disclosure of Materials Provided to Advisory November 30, 1999

    Do

    Do Committees in Connection With Open Advisory Committee Meetings Convened by the Center for Drug Evaluation and Research Beginning on January 1, 2000

    Enforcement Policy During Implementation of November 23, 1998

    Do

    Do Section 503A of the Federal Food, Drug, and Cosmetic Act

    Fast Track Drug Development Programs:

    November 18, 1998

    Do

    Do Designation, Development, and Application Review

    Financial Disclosure by Clinical Investigators March 20, 2001

    Do

    Do

    Formal Dispute Resolution: Appeals Above the March 7, 2000

    Do

    Do Division Level

    [[Page 53879]]

    Formal Meetings With Sponsors and Applicants March 7, 2000

    Do

    Do for PDUFA Products

    Implementation of Section 120 of the FDA

    November 20, 1998

    Do

    Do Modernization Act of 1997--Advisory Committees

    Implementation of Section 126 of the FDA

    July 21, 1998

    Do

    Do Modernization Act of 1997--Elimination of Certain Labeling Requirements

    Levothyroxine Sodium Products--Enforcement of July 13, 2001

    Do

    Do August 14, 2001, Compliance Date and Submission of New Applications

    National Uniformity for Nonprescription Drugs April 9, 1998

    Do

    Do Ingredient Labeling for OTC Drugs

    Qualifying for Pediatric Exclusivity Under October 1, 1999

    Do

    Do Section 505A of the Federal Food, Drug, and Cosmetic Act--Revised

    Reduction of Civil Money Penalties for Small March 20, 2001

    Do

    Do Business Entities

    Refusal to File

    July 12, 1993

    Do

    Do

    Repeal of Section 507 of the Federal Food, June 15, 1998

    Do

    Do Drug, and Cosmetic Act

    Standards for the Prompt Review of Efficacy May 15, 1998

    Do

    Do Supplements Including Priority Efficacy Supplements

    Women and Minorities Guidance Requirements July 20, 1998

    Do

    Do

    Information Request and Discipline Review

    August 17, 1999

    User Fee Draft

    Do Letters Under the Prescription Drug User Fee Act

    Submitting Separate Marketing Applications and February 22, 2001

    Do

    Do Definitions of Clinical Data for Purposes of Assessing User Fees--Draft

    Waivers of and Reductions in User Fees

    July 16, 1993

    Do

    Do (Attachment G)--Draft

    Applicability of User Fees to: (1) Applications July 12, 1993

    User Fee

    Do Withdrawn Before Filing Decision, or (2) Applications the Agency Has Refused to File and That Are Resubmitted or FiledOver Protest (Attachment F)

    Application, Product, and Establishment Fees: December 16, 1994

    Do

    Do Common Issues and Their Resolution (Attachment D)

    Classifying Resubmissions in Response to Action May 14, 1998

    Do

    Do Letters

    Fees-Exceed-the-Costs Waivers Under the

    August 25, 1999

    Do

    Do Prescription Drug User Fee Act

    Formal Meetings With Sponsors and Applicants March 7, 2000

    Do

    Do for PDUFA Products

    Submitting and Reviewing Complete Responses to October 26, 2000

    Do

    Do Clinical Holds (Revised)

    [[Page 53880]]

    Withdrawals

    Intended User or Regulatory Name of Document

    Date of Issuance

    Activity

    Date of Withdrawal

    Dissemination and Reprints of Certain Published Original October 8, 1996

    Advertising

    February 16, 2000 Data (No Replacement)

    Funded Dissemination of Reference Texts (No Replacement) October 8, 1996

    Advertising

    February 16, 2000

    Buspirone Hydrochloride Tablets In Vivo Bioequivalence (No May 14, 1998

    Biopharmaceutics

    November 30, 2000 Replacement)

    Cimetidine Tablets In Vivo Bioequivalence and In Vitro Unknown

    Biopharmaceutics

    November 30, 2000 Dissolution (No Replacement)

    Diclofenac Sodium (Tablets) In Vivo Bioequivalence and In October 6, 1994

    Biopharmaceutics

    November 30, 2000 Vitro Dissolution Testing (No Replacement)

    Glipizide In Vivo Bioequivalence and In Vivo Dissolution Unknown

    Biopharmaceutics

    November 30, 2000 Testing (No Replacement)

    Glyburide In Vivo Bioequivalence and In Vivo Dissolution Unknown

    Biopharmaceutics

    November 30, 2000 Testing (No Replacement)

    Oral Extended (Controlled) Release Dosage Forms In Vivo Unknown

    Biopharmaceutics

    November 30, 2000 Bioequivalence and In Vitro Dissolution Testing (No Replacement)

    Statistical Procedures for Bioequivalence Studies Using a July 1, 1992

    Biopharmaceutics

    November 30, 2000 Standard Two-Treatment Crossover Design (No Replacement)

    Clinical Evaluation of Drugs to Prevent Dental Caries (No November 1, 1978

    Clinical Medical

    May 18, 2000 Replacement)

    Clinical Evaluation of Drugs to Prevent, Control, and/or November 1, 1978

    Clinical Medical

    May 18, 2000 Treat Periodontal Disease (No Replacement)

    OTC Treatment of Hypercholesterolemia (No Replacement) October 27, 1997

    OTC

    August 3, 2000

    Levothyroxine Sodium: Questions and Answers (Replaced by March 8, 2001

    Procedural

    July 13, 2001 Levothyroxine Sodium Products Enforcement of August 14, 2001, Compliance Date and Submission of New Applications issued on July 13, 2001)

  4. Guidance Documents Issued by the Center for Devices and Radiological Health (CDRH)

    How to Obtain a Hard Copy Intended User or of the Document (Name and Name of Document

    Date of Issuance

    Regulatory Activity Address, Phone, FAX, E- FOD No. mail or Internet)

    The FDA Export Reform and Enhancement Act of 1996/Export February 7, 2000

    Office of Compliance (OC) Division of Small

    865 Certification Package Including ``Instructions for

    Manufacturers Requests for Certificate to Foreign Governments''

    Assistance; 1-800-638- 2041 or 301-827-0111 or (FAX) Facts-on-Demand (FOD) at 1-800-899-0381 or Internet at http:// www.fda.gov/ cdrh/ ggpmain.html

    Commercial Distribution/Exhibit Letter

    April 10, 1992

    OC

    Do

    246

    Color Additive Status List (Inspection Operations

    February 1, 1989

    OC

    Do

    268 Manual)

    FDA Guide for Validation of Biological Indicator

    January 1, 1986

    OC

    Do

    283 Incubation Time

    [[Page 53881]]

    Guide for Establishing and Maintaining a Calibration March 1, 1988

    OC

    Do

    286 Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264)

    Preproduction Quality Assurance Planning:

    September 1, 1989

    OC

    Do

    295 Recommendations for Medical Device Manufacturers (FDA 90-4236)

    Color Additive Petitions (p. 11-19 of PMA Manual)

    June 1, 1987

    OC

    Do

    296

    Guidance for Preparation of PMA Manufacturing

    August 1, 1992

    OC

    Do

    448 Information

    Civil Money Penalty Policy; Guidance for FDA Staff

    June 8, 1999

    OC

    Do

    1124

    General Principles of Software Validation; Draft

    June 9, 1997

    OC

    Do

    938 Guidance

    Classification Names for Medical Devices and In Vitro March 1, 1995

    OC

    Do

    10 Diagnostic Products (FDA Pub. No. 95-4246)

    Cover Letter/Guidance Document on the Performance

    March 9, 1998

    OC

    Do

    1197 Standard for Electrode Lead Wires and Patient Cable

    Guidance on Medical Device Tracking [FDAMA]; Guidance January 24, 2000

    OC

    Do

    169 for Industry and FDA Staff

    Compliance Program Guidance Manual: Inspection of

    August 12, 1999

    OC

    Do

    1702 Medical Devices; Draft

    Procedures for Laboratory Compliance Testing of

    May 1, 1986

    OC

    Do

    945 Television Receivers--Part of TV Packet

    Sec. 300.600 Commercial Distribution with Regard to September 24, 1987

    OC

    Do

    181 Premarket Notification [510(k)] [CPG 7124.19]

    Letter to Medical Device Manufacturer on Pentium

    February 14, 1995

    OC

    Do

    456 Processors

    Implementation of the Biomaterials Access Assurance Act April 2, 2001

    OC

    Do

    1324 of 1998

    Guideline for the Monitoring of Clinical Investigations January 1, 1988

    OC

    Do

    428

    Regulating In Vitro Diagnostic Device (IVD) Studies; December 17, 1999

    OC/Division of

    Do

    1132 Guidance for FDA Staff

    Bioresearch Monitoring (DBM)

    Preparing Notices of Availability of Investigational March 19, 1999

    OC/DBM

    Do

    2229 Medical Devices and for Recruiting Study Subjects

    Guidance on Electrosurgical Devices and the Application November 15, 1999

    OC/Division of

    Do

    1129 of the Performance Standard for Electrode Lead Wires

    Enforcement (DOE) I and Patient Cables

    Guidance on Quality System Regulation Information for August 3, 1999

    OC/DOEII

    Do

    1140 Various Premarket Submissions; Draft

    Surveillance and Detention Without Physical Examination July 26, 2000

    OC/DOEII

    Do

    1141 of Surgeons' and/or Patient Examination Gloves; Guidance for Industry--Draft

    Manufacturers/Assemblers of Diagnostic X-Ray Systems: October 13, 1993

    OC/DOEI

    Do

    116 Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g)

    Guide for the Submission of Initial Reports on

    January 1, 1982

    OC/DOEI

    Do

    257 Diagnostic X-Ray Systems and their Major Components

    [[Page 53882]]

    Exemption From Reporting and Recordkeeping Requirements September 16, 1981

    OC/DOEI

    Do

    343 for Certain Sunlamp Product Manufacturers

    Letter to Medical Device Industry on Endoscopy and

    May 17, 1993

    OC/DOEI

    Do

    545 Laparoscopy Accessories (Galdi)

    Clarification of Radiation Control Regulations for

    March 1, 1989

    OC/DOEI

    Do

    758 Diagnostic X-Ray Equipment (FDA 89-8221)

    CPG 7133.19: Retention of Microwave Oven Test Record/ March 1, 1995

    OC/DOEI

    Do

    880 Cover Letter: 08/24, 1981 Retention of Records Required by 21 CFR [Part] 1002

    Guideline for the Manufacture of In Vitro Diagnostic January 10, 1994

    OC/DOEI

    Do

    918 Products

    A Guide for the Submission of Abbreviated Radiation March 1, 1996

    OC/DOEI

    Do

    977 Safety Reports on Cephalometric X-Ray Devices: Defined as Dental Units With an Attachment for Mandible Work That Holds a Cassette and Beam Limiting Device

    A Guide for the Submission of an Abbreviated Radiation March 1, 1996

    OC/DOEI

    Do

    978 Safety Report on X-Ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use

    A Guide for the Submission of Abbreviated Radiation March 1, 1996

    OC/DOEI

    Do

    979 Safety Reports on Image Receptor Support Devices for Mammographic X-Ray Systems

    Compliance Program Guidance Manual; Field Compliance March 15, 2000

    OC/DOEI

    Do

    1133 Testing of Diagnostic (Medical) X-Ray Equipment; Guidance for FDA Staff

    Information Disclosure by Manufacturers to Assemblers April 2, 2001

    OC/DOEI

    Do

    2619 for Diagnostic X-Ray Systems; Final Guidance for Industry and FDA

    Guide for Submission of Information on Accelerators April 1, 1971

    OC/DOEI&III

    Do

    235 Intended to Emit X-Radiation Required Pursuant to 21 CFR 1002.10

    Abbreviated Reports on Radiation Safety for Microwave August 1, 1995

    OC/DOEI&III

    Do

    236 Products (Other Than Microwave Ovens)--E.G. Microwave Heating, Microwave Diathermy, RF Sealers, Induction, Dielectric Heaters, Security Systems

    Guide for Preparing Reports on Radiation Safety of

    March 1, 1985

    OC/DOEI&III

    Do

    239 Microwave Ovens

    Reporting Guide for Laser Light Shows and Displays (21 September 1, 1995

    OC/DOEI&III

    Do

    251 CFR [Part] 1002) (FDA 88-8140)

    Guide for Filing Annual Reports for X-Ray Components and July 1, 1980

    OC/DOEI&III

    Do

    253 Systems

    Reporting and Compliance Guide for Television Products October 1, 1995

    OC/DOEI&III

    Do

    260 Including Product Report, Supplemental Report, Radiation Safety Abbreviated Report, Annual Report, Information and Guidance

    Revised Guide for Preparing Annual Reports on Radiation September 1, 1995

    OC/DOEI&III

    Do

    264 Safety Testing of Laser and Laser Light Show Products (Replaces FDA 82-8127)

    [[Page 53883]]

    Guide for Preparing Abbreviated Reports of Microwave and September 1, 1996

    OC/DOEI&III

    Do

    399 RF Emitting Electronic Products Intended for Medical Use

    Letter to Manufacturers and Importers of Microwave

    October 31, 1988

    OC/DOEI&III

    Do

    697 Ovens: Information Requirements for Cookbooks and User and Service Manuals

    Abbreviated Reports on Radiation Safety of Non-Medical August 1, 1995

    OC/DOEI&III

    Do

    951 Ultrasonic Products

    Guide for Preparing Product Reports for Medical

    September 1, 1996

    OC/DOEI&III

    Do

    960 Ultrasound Products

    Letter--Manufacturers, Distributors and Importers of February 23, 1994

    OC/DOEII

    Do

    52 Condom Products

    Letter--Manufacturers, Importers, and Repackagers of February 13, 1989

    OC/DOEII

    Do

    53 Condoms for Contraception or Sexually-Transmitted Disease Prevention (Holt)

    Letter--Condom Manufacturers and Distributors

    April 5, 1994

    OC/DOEII

    Do

    56

    Letter to Manufacturers/Repackers Using Cotton

    April 22, 1994

    OC/DOEII

    Do

    101

    Guide for Preparing Product Reports for Lasers and

    September 1, 1995

    OC/DOEII

    Do

    277 Products Containing Lasers

    Compliance Guide for Laser Products (FDA 86-8260)

    September 1, 1985

    OC/DOEII

    Do

    278

    Condoms: Inspection and Sampling at Domestic

    April 8, 1987

    OC/DOEII

    Do

    293 Manufacturers and of All Repackers; Sampling From All Importers (Damaska Memo to Field on 4/8, 1987)

    Dental Handpiece Sterilization (Dear Doctor Letter) September 28, 1992

    OC/DOEII

    Do

    589

    Latex Labeling Letter (Johnson)

    March 18, 1993

    OC/DOEII

    Do

    831

    Pesticide Regulation Notice 94-4: Interim Measures for June 30, 1994

    OC/DOEII

    Do

    851 the Registration of Antimicrobial Products/Liquid Chemical Germicides With Medical Device Use Claims Under the Memorandum of Understanding Between EPA and FDA

    Letter to Industry, Powered Wheelchair Manufacturers May 10, 1993

    OC/DOEII

    Do

    869 From RM Johnson

    Hazards of Volume Ventilators and Heated Humidifiers September 15, 1993

    OC/DOEII

    Do

    901

    Manufacturers and Initial Distributors of Sharps

    February 3, 1994

    OC/DOEII

    Do

    933 Containers and Destroyers Used by Health Care Professionals

    Ethylene Oxide; Ethylene Chlorohydrin; and Ethylene June 23, 1978

    OC/DOEII

    Do

    1019 Glycol; Proposed Maximum Residue Limits and Maximum Levels of Exposure

    Letter to: Manufacturers and Users of Lasers for

    October 10, 1996

    OC/DOEII

    Do

    1093 Refractive Surgery [Excimer]

    Shielded Trocars and Needles Used for Abdominal Access August 23, 1996

    OC/DOEII

    Do

    1122 During Laparoscopy

    Surveillance and Detention Without Physical Examination August 14, 2000

    OC/DOEII

    Do

    1139 of Condoms; Guidance for Industry; Draft

    All U.S. Condom Manufacturers, Importers and Repackagers April 7, 1987

    OC/DOEII

    Do

    2510

    [[Page 53884]]

    Manufacturers and Initial Distributors of Hemodialyzers May 23, 1996

    OC/DOEII

    Do

    2507

    Laser Light Show Safety--Who's Responsible? (FDA 86- May 1, 1986

    OC/DOEIII

    Do

    13 8262)

    Suggested State Regulations for Control of Radiation-- January 1, 1982

    OC/DOEIII

    Do

    70 Volume II Nonionizing Radiation--Lasers (FDA Pub. No. 83-8220)

    Letter to All Foreign Manufacturers and Importers of May 28, 1981

    OC/DOEIII

    Do

    231 Electronic Products for Which Applicable FDA Performance Standards Exist

    Guide for Submission of Information on Industrial X-Ray March 1, 1973

    OC/DOEIII

    Do

    237 Equipment Required Pursuant to 21 CFR 1002.10

    Guide for Submission of Information on Analytical X-Ray April 30, 1974

    OC/DOEIII

    Do

    240 Equipment Required Pursuant to 21 CFR 1002.10

    Guidance for the Submission of Cabinet X-Ray System February 1, 1975

    OC/DOEIII

    Do

    241 Reports Pursuant to 21 CFR 1020.40

    Guide for Preparing Annual Reports on Radiation Safety October 1, 1987

    OC/DOEIII

    Do

    243 Testing of Electronic Products (General)

    Computerized Devices/Processes Guidance--Application of May 1, 1992

    OC/DOEIII

    Do

    247 the Medical Device GMP to Computerized Devices and Manufacturing Processes

    Guide for Preparing Product Reports for Ultrasonic

    August 1, 1996

    OC/DOEIII

    Do

    249 Therapy Products (Physical Therapy Only)

    Guide for Submission of Information on Industrial

    September 1, 1980

    OC/DOEIII

    Do

    254 Radiofrequency Dielectric Heater and Sealer Equipment Pursuant to 21 CFR 1002.10 and 1002.12 (FDA 81-8137)

    Guide for Preparing Annual Reports for Ultrasonic

    September 1, 1996

    OC/DOEIII

    Do

    261 Therapy Products

    Guide for Preparing Annual Reports on Radiation Safety September 1, 1995

    OC/DOEIII

    Do

    262 Testing of Sunlamps and Sunlamp Products (Replaces FDA 82-8127)

    Guide for Preparing Annual Reports on Radiation Safety September 1, 1995

    OC/DOEIII

    Do

    263 Testing of Mercury Vapor Lamps (Replaces FDA 82-8127)

    Quality Control Guide for Sunlamp Products (FDA 88-8234) March 1, 1988

    OC/DOEIII

    Do

    270

    Guide for the Submission of Initial Reports on Computed September 1, 1984

    OC/DOEIII

    Do

    271 Tomography X-Ray Systems

    Guide for Preparing Product Reports on Sunlamps and September 1, 1995

    OC/DOEIII

    Do

    279 Sunlamp Products (21 CFR [Part] 1002)

    Letter: Policy on Maximum Timer Interval and Exposure August 21, 1986

    OC/DOEIII

    Do

    342 Schedule for Sunlamp Products

    Reporting Guide for Product Reports on High Intensity September 1, 1995

    OC/DOEIII

    Do

    348 Mercury Vapor Discharge Lamps (21 CFR [Part] 1002)

    Quality Control Practices for Compliance With the

    May 1, 1980

    OC/DOEIII

    Do

    349 Federal Mercury Vapor Lamp Performance Standard

    [[Page 53885]]

    Keeping Up With the Microwave Revolution (FDA Pub. No. March 1, 1990

    OC/DOEIII

    Do

    356 91-4160)

    Quality Assurance Guidelines for Hemodialysis Devices February 1, 1991

    OC/DOEIII

    Do

    507

    Letter to Manufacturers and Importers of Microwave

    March 28, 1980

    OC/DOEIII

    Do

    646 Ovens--Open Door Operation of Microwave Ovens as a Result of Oven Miswiring

    Reporting of New Model Numbers to Existing Model

    June 14, 1983

    OC/DOEIII

    Do

    675 Families

    Import: Radiation-Producing Electronic Products (FDA 89- November 1, 1988

    OC/DOEIII

    Do

    756 8008)

    Unsafe Patient Lead Wires and Cables

    September 3, 1993

    OC/DOEIII

    Do

    889

    Application for a Variance from 21 CFR 1040.11(c) for a July 1, 1998

    OC/DOEIII

    Do

    903 Laser Light Show, Display, or Device [Form FDA 3147]

    Letter to Trade Association: Reuse of Single-Use or December 27, 1995

    OC/DOEIII

    Do

    961 Disposable Medical Devices

    Design Control Guidance for Medical Device Manufacturers March 11, 1997

    OC/DOEIII

    Do

    994

    Keeping Medical Devices Safe From Electromagnetic

    July 1, 1995

    OC/DOEIII

    Do

    1081 Interference

    Medical Devices and EMI: The FDA Perspective

    January 1, 1995

    OC/DOEIII

    Do

    1082

    Medical Device Electromagnetic Interference Issues,

    OC/DOEIII

    Do

    1086 Problem Reports, Standards, and Recommendations

    Safety of Electrically Powered Products: Letter to

    September 18, 1996

    OC/DOEIII

    Do

    1087 Medical Device and Electronic Product Manufacturers From Lillian Gill and BHB Correction Memo

    Enforcement Priorities for Single-Use Devices

    August 14, 2000

    OC/DOEIII

    Do

    1168 Reprocessed by Third Parties and Hospitals; Guidance for Industry and for FDA Staff

    Labeling for Electronic Anti-Theft Systems; Guidance for August 15, 2000

    OC/DOEIII

    Do

    1170 Industry; Final

    Wireless Medical Telemetry Risks and Recommendations, September 27, 2000

    OC/DOEIII

    Do

    1173 Guidance for Industry; Final

    Policy on Warning Label Required on Sunlamp Products June 25, 1985

    OC/DOEIII

    Do

    1343

    Policy on Lamp Compatibility (Sunlamps)

    September 2, 1986

    OC/DOEIII

    Do

    2343

    Guidance for Industry on the Likelihood of Facilities August 5, 1999

    OC/Division of Program Do

    1269 Inspections When Modifying Devices Subject to Premarket

    Operations (DPO) Approval

    Guidance on IDE Policies and Procedures [FDAMA]; Final January 20, 1998

    Office of Device

    Do

    882 Evaluation (ODE)

    Color Additives for Medical Devices

    November 15, 1995

    ODE

    Do

    575

    Preamendment Class III Devices

    March 11, 1992

    ODE

    Do

    584

    Viable Bacteriophage in CO2 Laser Plume: Aerodynamic Date not available

    ODE

    Do

    595 Size Distribution

    Guidance for Submitting Reclassification Petition

    June 1, 1989

    ODE

    Do

    609

    [[Page 53886]]

    Electromagnetic Compatibility for Medical Devices:

    June 13, 1995

    ODE

    Do

    639 Issues and Solutions; Memorandum

    SMDA Changes--Premarket Notification; Regulatory

    April 17, 1992

    ODE

    Do

    655 Requirements for Medical Devices [510(k)] Manual Insert

    ``Real-Time'' Review Program for Premarket Approval April 22, 1997

    ODE

    Do

    673 Application (PMA) Supplements

    Classified Convenience Kits

    April 30, 1993

    ODE

    Do

    789

    30-Day Notices and 135-Day PMA Supplements for

    February 19, 1998

    ODE

    Do

    795 Manufacturing Method or Process Changes, Guidance for Industry and CDRH [FDAMA]; Final

    Suggested Content for Original IDE Application Cover February 27, 1996

    ODE

    Do

    797 Letter--Version 4

    Device Specific Guidance Documents (List)

    May 11, 1993

    ODE

    Do

    815

    PMA Shell Development and Modular Review; Guidances for November 6, 1998

    ODE

    Do

    835 the Medical Device Industry; Final

    Determination of Intended Use for 510(k) Devices--

    January 30, 1998

    ODE

    Do

    857 Guidance for Industry and CDRH Staff [FDAMA]; Final

    Premarket Notification [510(k)] Status Request Form, March 14, 1997

    ODE

    Do

    858 Revised

    CDRH's 510(k)/IDE/PMA Refuse to Accept/Accept/File

    June 30, 1993

    ODE

    Do

    859 Policies

    Indications for Use Statement

    February 6, 1996

    ODE

    Do

    879

    The New 510(k) Paradigm--Alternate Approaches to

    March 20, 1998

    ODE

    Do

    905 Demonstrating Substantial Equivalence in Premarket Notifications; Final

    Preamendments Class III Strategy; SXAlpert

    April 19, 1994

    ODE

    Do

    611

    Letter to Industry, Powered Wheelchair/Scooter or

    May 26, 1994

    ODE

    Do

    883 Accessory/Component Manufacturer From Susan Alpert, Ph.D., M.D.

    ODE Executive Secretary Guidance Manual

    August 7, 1987

    ODE

    Do

    1338

    Modifications to Devices Subject to Premarket Approval-- August 6, 1998

    ODE

    Do

    102 The PMA Supplement Decision Making Process; Guidance for Industry; Draft

    CDRH Submissions Coversheet [PMA/PDP/510k/IDE]

    May 8, 1998

    ODE

    Do

    147

    Procedures for Class II Device Exemptions from Premarket February 19, 1998

    ODE

    Do

    159 Notification, Guidance for Industry and CDRH Staff [FDAMA]; Final

    Limulus Amebocyte Lysate; Reduction of Samples for

    October 23, 1987

    ODE

    Do

    178 Testing

    Labeling Reusable Medical Devices for Reprocessing in April 1, 1996

    ODE

    Do

    198 Health Care Facilities: FDA Reviewer Guidance

    New Section 513(f)(2)--Evaluation of Automatic Class III February 19, 1998

    ODE

    Do

    199 Designation; Guidance for Industry and CDRH Staff [FDAMA]; Final

    [[Page 53887]]

    Methods for Conducting Recall Effectiveness Checks

    June 16, 1978

    ODE

    Do

    225

    Suggestions for Submitting a Premarket Approval (PMA) April 1, 1993

    ODE

    Do

    228 Application

    Guidance for Off-the-Shelf Software Use in Medical

    September 9, 1999

    ODE

    Do

    1252 Devices; Final

    Application of the Device Good Manufacturing Practice December 1, 1983

    ODE

    Do

    267 (GMP) Regulation to the Manufacture of Sterile Devices

    Points to Consider in the Characterization of Cell Lines June 1, 1984

    ODE

    Do

    269 Used to Produce Biological Products (From John C. Petricciani, M.D.)

    Early Collaboration Meetings Under the FDA Modernization February 19, 1998

    ODE

    Do

    310 Act (FDAMA), Guidance for Industry and CDRH Staff [FDAMA]

    Format for IDE Progress Reports

    June 1, 1996

    ODE

    Do

    311

    Guidance on PMA Interactive Procedures for Day-100

    February 19, 1998

    ODE

    Do

    322 Meetings and Subsequent Deficiencies--For Use by CDRH and Industry [FDAMA]; Final

    Industry Representatives on Scientific Panels

    March 27, 1987

    ODE

    Do

    329

    PMA Review Schedule [P87-1]

    March 31, 1988

    ODE

    Do

    333

    Necessary Information for Diagnostic Ultrasound 510(k) November 24, 1987

    ODE

    Do

    335 (Draft)

    Guidance for the Content of Premarket Submissions for May 29, 1998

    ODE

    Do

    337 Software Contained in Medical Devices; Guidance for FDA and Reviewers and Industry; Final

    Master Files Part III; Guidance on Scientific and

    June 1, 1987

    ODE

    Do

    338 Technical Information

    510(k) Quality Review Program (Blue Book Memo) (I96-1) March 29, 1996

    ODE

    Do

    344

    FDA Policy for the Regulation of Computer Products

    November 13, 1989

    ODE

    Do

    351 (Draft)

    Threshold Assessment of the Impact of Requirements for January 1, 1990

    ODE

    Do

    352 Submission of PMAs for 31 Medical Devices Marketed Prior to May 28, 1976

    4-of-A-Kind PMAs

    October 1, 1991

    ODE

    Do

    371

    Supplements to Approved Applications for Class III

    May 20, 1998

    ODE

    Do

    380 Medical Devices: Use Published Literature, Use of Previously Submitted Materials, and Priority Review [FDAMA]; Guidance for Industry; Final

    Substantial Equivalence (SE) Decision Making

    January 1, 1990

    ODE

    Do

    390 Documentation ATTACHED: ``SE'' Decision Making Process (Detailed), i.e., the Decision Making Tree

    Shelf Life of Medical Devices

    March 1, 1991

    ODE

    Do

    415

    Guideline on General Principles of Process Validation May 1, 1987

    ODE

    Do

    425

    Guideline on Sterile Drug Products Produced by Aseptic June 1, 1987

    ODE

    Do

    426 Processing

    [[Page 53888]]

    Guideline on Validation of the Limulus Amebocyte Lysate December 1, 1987

    ODE

    Do

    427 (LAL) Test as an End-Product Endotoxin Test

    General/Specific Intended Use [FDAMA]; Draft Guidance November 4, 1998

    ODE

    Do

    499 for Industry

    Distribution and Public Availability of Premarket

    October 10, 1997

    ODE

    Do

    563 Approval Application Summary of Safety and Effectiveness Data Packages [Blue Book Memo #P98-1]; Final

    Proposal for Establishing Mechanisms for Setting Review June 30, 1993

    ODE

    Do

    931 Priorities Using Risk Assessment and Allocating Review Resources and T93-28 dated 6/25, 1993, Device ``Fast Track'' Plan Announcement (Include with 926-930)

    New Model Medical Device Development Process; Guidance July 21, 1998

    ODE

    Do

    1101 for Industry; Final

    Guidance on the Use of Standards in Substantial

    March 12, 2000

    ODE

    Do

    1131 Equivalence Determinations; Final

    Guidance for Industry and for FDA Reviewers;

    August 9, 2000

    ODE

    Do

    1135 Interpretive Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997

    Evidence Models for the Least Burdensome Means to

    September 1, 1999

    ODE

    Do

    1154 Market; Guidance for Industry and FDA Reviewers; Draft

    Questions and Answers for the FDA Reviewer Guidance: September 3, 1996

    ODE

    Do

    1198 Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities

    Deciding When to Submit a 510(k) for a Change to an November 30, 2000

    ODE

    Do

    1073 Existing Wireless Telemetry Medical Device; Final Guidance for FDA Reviewers and Industry

    Guidance on Amended Procedures for Advisory Panel

    July 22, 2000

    ODE

    Do

    413 Meetings

    Medical Devices Containing Materials Derived From Animal November 16, 1998

    ODE

    Do

    2206 Sources (Except for In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry; Final

    Frequently Asked Questions on the New 510(k) Paradigm; October 22, 1998

    ODE

    Do

    2230 Guidance for Industry; Final

    The Least Burdensome Provisions of the FDA Modernization May 3, 2001

    ODE

    Do

    1332 Act of 1997: Concept and Principles; Draft Guidance for FDA and Industry

    Guidance for the Content of Premarket Notifications for September 12, 1994

    ODE Division of

    Do

    97 Conventional and Antimicrobial Foley Catheters

    Reproductive, Abdominal, and Radiological Devices (DRARD)

    Checklist for Mechanical Lithotripters and Stone

    November 1, 1994

    ODE/DRARD

    Do

    98 Dislodgers Used in Gastroenterology and Urology

    Convenience Kits Interim Regulatory Guidance (Include May 20, 1997

    ODE/510K

    Do

    562 874)

    [[Page 53889]]

    Announcement: Implementation of the FDA/HCFA Interagency September 15, 1995

    ODE/BlueBook

    Do

    106 Agreement Regarding Reimbursement Categorization of Investigational Devices, Att. A Interagency Agreement, Att. B Criteria for Categorization of Investigational Devices #D95-2 (Blue Book Memo)

    Consolidated Review of Submissions for Diagnostic

    October 19, 1990

    ODE/BlueBook

    Do

    30 Ultrasound Equipment, Accessories and Related Measurement Devices #G90-2 (Blue Book Memo)

    Consolidated Review of Submissions for Lasers and

    October 19, 1990

    ODE/BlueBook

    Do

    31 Accessories #G90-1 (Blue Book Memo)

    Review of Final Draft Medical Device Labeling #P91-4 August 29, 1991

    ODE/BlueBook

    Do

    34 (Blue Book Memo)

    Review of 510(k)s for Computer Controlled Medical

    August 29, 1991

    ODE/BlueBook

    Do

    35 Devices #K91-1 (Blue Book Memo)

    Use of International Standard ISO-10993, ``Biological May 1, 1995

    ODE/BlueBook

    Do

    164 Evaluation of Medical Devices Part 1: Evaluation and Testing'' (Replaces #G87-1 #8294) (Blue Book Memo)

    ODE Regulatory Information for the Office of Compliance-- May 15, 1987

    ODE/BlueBook

    Do

    276 Information Sharing Procedures #G87-2 (Blue Book Memo)

    Panel Review of ``Me-Too'' Devices #P86-6 (Blue Book July 1, 1986

    ODE/BlueBook

    Do

    280 Memo)

    Guidance on the Center for Devices and Radiological June 30, 1986

    ODE/BlueBook

    Do

    289 Health's Premarket Notification Review Program #K86-3 (Blue Book Memo)

    PMA Filing Decisions #P90-2 (Blue Book Memo)

    May 18, 1990

    ODE/BlueBook

    Do

    297

    PMAs--Early Review and Preparation of Summaries of

    January 27, 1986

    ODE/BlueBook

    Do

    302 Safety and Effectiveness #P86-1 (Blue Book Memo)

    Criteria for Panel Review of PMA Supplements #P86-3 January 30, 1986

    ODE/BlueBook

    Do

    304 (Blue Book Memo)

    Review and Approval of PMAs of Licensees #P86-4 (Blue October 22, 1990

    ODE/BlueBook

    Do

    305 Book Memo)

    Panel Report and Recommendations on PMA Approvals #P86-5 April 18, 1986

    ODE/BlueBook

    Do

    306 (Blue Book Memo)

    510(k) Sign-Off Procedures #K94-2 (Blue Book Memo)

    June 3, 1994

    ODE/BlueBook

    Do

    308

    Review of Laser Submissions #G88-1 (Blue Book Memo) April 15, 1988

    ODE/BlueBook

    Do

    330

    Delegation of IDE Actions #D88-1 (Blue Book Memo)

    April 26, 1988

    ODE/BlueBook

    Do

    331

    Premarket Notification--Consistency of Reviews #K89-1 February 28, 1989

    ODE/BlueBook

    Do

    339 (Blue Book Memo)

    Telephone Communications Between ODE Staff and

    January 29, 1993

    ODE/BlueBook

    Do

    360 Manufacturers #I93-1 (Blue Book Memo)

    510(k) Sterility Review Guidance--and Revision of 11/18/ February 12, 1990

    ODE/BlueBook

    Do

    361 1994 #K90-1 (Blue Book Memo)

    Review of IDEs for Feasibility Studies #D89-1 (Blue Book May 17, 1989

    ODE/BlueBook

    Do

    362 Memo)

    [[Page 53890]]

    Toxicology Risk Assessment Committee #G89-1 (Blue Book August 9, 1989

    ODE/BlueBook

    Do

    363 Memo)

    Assignment of Review Documents #I90-2 (Blue Book Memo) August 24, 1990

    ODE/BlueBook

    Do

    366

    Meetings With the Regulated Industry #I89-3 (Blue Book November 20, 1989

    ODE/BlueBook

    Do

    367 Memo)

    Policy Development and Review Procedures #I90-1 (Blue February 15, 1990

    ODE/BlueBook

    Do

    368 Book Memo)

    PMA Supplements: ODE Letter to Manufacturers; Identifies April 24, 1990

    ODE/BlueBook

    Do

    387 Situations Which May Require the Submission of a PMA Supplement (When PMA Supplements Are Required) #P90-1 (Blue Book Memo)

    510(k) Refuse to Accept Procedures #K94-1 (Blue Book May 20, 1994

    ODE/BlueBook

    Do

    401 Memo)

    PMA Refuse to File Procedures #P94-1 (Blue Book Memo) May 20, 1994

    ODE/BlueBook

    Do

    402

    Premarket Approval Application (PMA) Closure #P94-2 July 8, 1994

    ODE/BlueBook

    Do

    403 (Blue Book Memo)

    PMA/510(k) Triage Review Procedures #G94-1 (Blue Book May 20, 1994

    ODE/BlueBook

    Do

    404 Memo)

    Goals and Initiatives for the IDE Program #D95-1 (Blue July 12, 1995

    ODE/BlueBook

    Do

    405 Book Memo)

    Cover Letter: 510(k) Requirements During Firm-Initiated November 21, 1995

    ODE/BlueBook

    Do

    406 Recalls; Attachment A: Guidance on Recall and Premarket Notification Review Procedures During Firm-Initiated Recalls of Legally Marketed Devices (Blue Book Memo #K95-1)

    IDE Refuse to Accept Procedures #D94-1 (Blue Book Memo) May 20, 1994

    ODE/BlueBook

    Do

    410

    Device Labeling Guidance #G91-1 (Blue Book Memo)

    March 8, 1991

    ODE/BlueBook

    Do

    414

    Clinical Utility and Premarket Approval #P91-1 (Blue May 3, 1991

    ODE/BlueBook

    Do

    443 Book Memo)

    Panel Review of Premarket Approval Applications #P91-2 May 3, 1991

    ODE/BlueBook

    Do

    444 (Blue Book Memo)

    PMA Compliance Program #P91-3 (Blue Book Memo)

    May 3, 1991

    ODE/BlueBook

    Do

    445

    Document Review Processing #I91-1 (Blue Book Memo)

    February 12, 1992

    ODE/BlueBook

    Do

    446

    Integrity of Data and Information Submitted to ODE #I91- May 29, 1991

    ODE/BlueBook

    Do

    447 2 (Blue Book Memo)

    Nondisclosure of Financially Sensitive Information #I92- March 5, 1992

    ODE/BlueBook

    Do

    587 1 (Blue Book Memo)

    Memorandum of Understanding Regarding Patient Labeling August 9, 1996

    ODE/BlueBook

    Do

    806 Review (Blue Book Memo #G96-3))

    Continued Access to Investigational Devices During PMA July 15, 1996

    ODE/BlueBook

    Do

    872 Preparation and Review (Blue Book Memo) (D96-1)

    [[Page 53891]]

    510(k) Additional Information Procedures #K93-1 (Blue July 23, 1993

    ODE/BlueBook

    Do

    886 Book Memo)

    Overdue IDE Annual Progress Report Procedures #D93-1 July 23, 1993

    ODE/BlueBook

    Do

    887 (Blue Book Memo)

    Documentation and Resolution of Differences of Opinion December 23, 1993

    ODE/BlueBook

    Do

    920 on Product Evaluations #G93-1 (Blue Book Memo)

    Deciding When to Submit a 510(k) for a Change to an January 10, 1997

    ODE/BlueBook

    Do

    1935 Exisiting Device; (Blue Book Memo #K97-1)

    Interagency Agreement Between FDA and HCFA; #D95-2, September 15, 1995

    ODE/BlueBook

    Do

    2106 Attachment A

    Executive Secretaries Guidance Manual #G87-3

    August 7, 1987

    ODE/BlueBook

    Do

    2326

    Criteria for Categorization of Investigational Devices September 15, 1995

    ODE/BlueBook

    Do

    3106 (HCFA); #D95-2, Attachment B

    Center for Devices and Radiological Health's Premarket June 30, 1993

    ODE/BlueBook

    Do

    3859 Notification [510(k)] Refuse to Accept Policy--(Updated Checklist March 14, 1995)

    HCFA Reimbursement Categorization Determinations for FDA- October 31, 1995

    ODE/BlueBook

    Do

    4106 Approved IDEs

    Center for Devices and Radiological Health's

    June 30, 1993

    ODE/BlueBook

    Do

    4859 Investigational Device Exemption (IDE) Refuse to Accept Policy

    Guidance for Prescription Use Drugs of Abuse Assays November 14, 2000

    ODE Division of Clinical Do

    152 Premarket Notifications; Guidance for Industry and/or

    Laboratory Devices for FDA Reviewers/Staff and/or Compliance; Draft

    (DCLD) Guidance--Not for Implementation

    Review Criteria for Assessment of In Vitro Diagnostic August 31, 1995

    ODE/DCLD

    Do

    1191 Devices for Drugs of Abuse Assays Using Various Methodologies

    Guidance for Labeling for Over-the-Counter Sample

    December 21, 1999

    ODE/DCLD

    Do

    1359 Collection Systems for Drugs of Abuse Testing; Draft

    Review Criteria for In Vitro Diagnostic Devices for the February 1, 1994

    ODE/DCLD

    Do

    51 Assessment of Thyroid Autoantibodies Using Indirect Immunofluorescence Assay (IFA), Indirect Hemagglutination Assay (IHA), Radioimmunoasay (RIA), and Enzyme Linked Immunosorbent Assay (ELISA)

    Review Criteria for Blood Culture Systems

    August 12, 1991

    ODE/DCLD

    Do

    82

    Points to Consider for Collection of Data in Support of September 26, 1994

    ODE/DCLD

    Do

    95 In Vitro Device Submissions for 510(k) Clearance

    Points to Consider for Portable Blood Glucose Monitoring February 20, 1996

    ODE/DCLD

    Do

    122 Devices Intended for Bedside Use in the Neonate Nursery

    Criteria for Assessment of In Vitro Diagnostic Devices August 31, 1995

    ODE/DCLD

    Do

    1191 for Drugs of Abuse Assays Using Various Methodologies; Draft

    Review Criteria for Assessment of Rheumatoid Factor (RF) February 21, 1997

    ODE/DCLD

    Do

    165 In Vitro Diagnostic Devices Using Enzyme-Linked Immunoassay (EIA), Enzyme Linked Immunosorbent Assay (ELISA), Particle Agglutination Tests, and Laser and Rate Nephelometry

    [[Page 53892]]

    Assessing the Safety/Effectiveness of Home-Use In Vitro October 1, 1988

    ODE/DCLD

    Do

    272 Diagnostic Devices (IVDs): Points to Consider Regarding Labeling and Premarket Submissions; Draft

    Guidance for Submission of Immunohistochemistry

    June 3, 1998

    ODE/DCLD

    Do

    364 Applications to the FDA; Final

    Review Criteria for Assessment of Cytogenetic Analysis July 15, 1991

    ODE/DCLD

    Do

    417 Using Automated and Semi-Automated Chromosome Analyzers

    Review Criteria for Assessment of Alpha-Fetoprotein July 15, 1994

    ODE/DCLD

    Do

    459 (AFP) In Vitro Diagnostic Devices for Fetal Open Neural Tube Defects Using Immunological Test Methodologies

    Guidance for 510(k) Submission of Lymphocyte

    September 26, 1991

    ODE/

    Do

    475 Immunophenotyping IVDs using Monoclonal Antibodies; Draft

    Points to Consider for Hematology Quality Control

    September 30, 1997

    ODE/DCLD

    Do

    512 Materials

    Review Criteria for In Vitro Diagnostic Devices for August 1, 1992

    ODE/DCLD

    Do

    527 Detection of IGM Antibodies to Viral Agents

    Points to Consider for Review of Calibration and Quality February 1, 1996

    ODE/DCLD

    Do

    553 Control Labeling for In Vitro Diagnostic Devices/Cover Letter Dated March 14, 1996

    Review Criteria for Devices Intended for the Detection December 30, 1991

    ODE/DCLD

    Do

    554 of Hepatitis B ``e'' Antigen and Antibody to HBe

    Guidance Criteria for Cyclosporine PMAs

    January 24, 1992

    ODE/DCLD

    Do

    564

    Review Criteria for Assessment of Laboratory Tests for September 17, 1992

    ODE/DCLD

    Do

    588 the Detection of Antibodies to Helicobacter Pylori

    Review Criteria for Assessment of Human Chorionic

    September 27, 1995

    ODE/DCLD

    Do

    592 Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs)

    Premarketing Approval Review Criteria for Premarket September 10, 1992

    ODE/DCLD

    Do

    603 Approval of Estrogen (ER) or Progesterone (PGR) Receptors In Vitro Diagnostic Devices Using Steroid Hormone Binding (SBA) With Dextran-Coated Charcoal (DCC) Separation, Histochemical Receptor Bi; Draft

    Review Criteria for Assessment of Portable Blood Glucose February 14, 1996

    ODE/DCLD

    Do

    604 In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase, or Hexokinase Methodology

    Guidance for 510(k)s on Cholesterol Tests for Clinical July 14, 1995

    ODE/DCLD

    Do

    605 Laboratory, Physicians' Office Laboratory, and Home Use

    Review Criteria for Devices Assisting in the Diagnosis May 31, 1990

    ODE/DCLD

    Do

    629 of C. Difficile Associated Diseases

    Guidance Document for 510(k) Submission of

    September 30, 1991

    ODE/DCLD

    Do

    658 Glycohemoglobin (Glycated or Glycosylated) Hemoglobin for IVDs; Draft

    Review Criteria For Premarket Approval of In Vitro

    May 15, 1992

    ODE/DCLD

    Do

    770 Diagnostic Devices for Detection of Antibodies to Parvovirus B19

    [[Page 53893]]

    Guidance Document for 510(k) Submission of Fecal Occult July 29, 1992

    ODE/DCLD

    Do

    772 Blood Tests; Draft

    Review Criteria for Assessment of In Vitro Diagnostic January 1, 1992

    ODE/DCLD

    Do

    778 Devices for Direct Detection of Chlamydiae in Clinical Specimens

    Guidance Document for 510(k) Submission of

    September 1, 1992

    ODE/DCLD

    Do

    785 Immunoglobulins A, G, M, D and E Immunoglobulin System In Vitro Devices; Draft

    Review Criteria for the Assessment of Allergen-Specific March 2, 1993

    ODE/DCLD

    Do

    800 Immunoglobulin E (IGE) In Vitro Diagnostic Devices Using Immunological Test Methodologies

    Review Criteria for the Assessment of Anti-Nuclear

    September 1, 1992

    ODE/DCLD

    Do

    848 Antibodies (ANA) In Vitro Diagnostic Devices Using Indirect Immunofluorescence Assay (IFA), Immunodiffusion (IMD) and Enzyme Linked Immunosorbant Assay (ELISA).

    Review Criteria for Nucleic Acid Amplification Based In June 14, 1993

    ODE/DCLD

    Do

    861 Vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms; Draft

    Review Criteria for Assessment of In Vitro Diagnostic July 6, 1993

    ODE/DCLD

    Do

    862 Devices for Direct Detection of Mycobacterium Spp. [Tuberculosis (TB)]

    Data for Commercialization of Original Equipment

    June 10, 1996

    ODE/DCLD

    Do

    950 Manufacturer, Secondary and Generic Reagents for Automated Analyzers

    Guidance Document for the Submission of Tumor Associated September 19, 1996

    ODE/DCLD

    Do

    957 Antigen Premarket Notification [510(k)] to FDA

    Points to Consider for Cervical Cytology Devices

    July 25, 1994

    ODE/DCLD

    Do

    968

    Review Criteria for In Vitro Diagnostic Devices That February 15, 1996

    ODE/DCLD

    Do

    980 Utilize Cytogenetic In Situ Hybridization Technology for the Detection of Human Genetic Mutations (Germ Line and Somatic)

    In Vitro Diagnostic Bicarbonate/Carbon Dioxide Test July 6, 1998

    ODE/DCLD

    Do

    1102 System; Guidance for Industry; Final

    In Vitro Diagnostic Chloride Test System; Guidance for July 6, 1998

    ODE/DCLD

    Do

    1103 Industry; Final

    In Vitro Diagnostic Creatinine Test System; Guidance for July 2, 1998

    ODE/DCLD

    Do

    1104 Industry; Final

    In Vitro Diagnostic Glucose Test System; Guidance for July 6, 1998

    ODE/DCLD

    Do

    1105 Industry; Final

    In Vitro Diagnostic Potassium Test System; Guidance for July 6, 1998

    ODE/DCLD

    Do

    1107 Industry; Final

    In Vitro Diagnostic Sodium Test System; Guidance for July 6, 1998

    ODE/DCLD

    Do

    1109 Industry; Final

    In Vitro Diagnostic Urea Nitrogen Test System; Guidance July 6, 1998

    ODE/DCLD

    Do

    1110 for Industry; Final

    Guidance for Administrative Procedures for CLIA

    August 14, 2000

    ODE/DCLD

    Do

    1143 Categorization; Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance; Draft

    [[Page 53894]]

    Guidance for Clinical Laboratory Improvement Amendments March 1, 2001

    ODE/DCLD

    Do

    1147 of 1988 (CLIA) Criteria for Waiver; Draft Guidance for Industry and FDA Applications

    Guidance for Over-the-Counter (OTC) Ovulation Predictor July 22, 2000

    ODE/DCLD

    Do

    1171 510(k)s

    Guidance for Over-the-Counter (OTC) Human Chorionic July 22, 2000

    ODE/DCLD

    Do

    1172 Gonadotropin (hCG) 510(k)s

    Guidance on Review Criteria for Assessment of

    March 8, 2000

    ODE/DCLD

    Do

    631 Antimicrobial Susceptibility Devices; Draft

    In Vitro Diagnostic C-Reactive Protein Immunological July 20, 1998

    ODE/DCLD

    Do

    1246 Test System; Guidance for Industry; Final

    Abbreviated 510(k) Submissions for In Vitro Diagnostic February 22, 1999

    ODE/DCLD

    Do

    1247 Calibrators; Guidance for Industry: Final

    Guidance on Labeling for Laboratory Tests; Guidance for June 24, 1999

    ODE/DCLD

    Do

    1352 Industry; Draft

    Premarket Approval Applications for Assays Pertaining to October 8, 1999

    ODE/DCLD

    Do

    1353 Hepatitis C Viruses (HCV) That Are Indicated for Diagnosis or Monitoring of HCV Infection or Associated Disease; Draft

    Class II Special Control Guidance Document for Anti- August 23, 2000

    ODE/DCLD

    Do

    1183 Saccharomyces Cerevisiae (S. Cerevisiae) Antibody (ASCA) Premarket Notifications; Final

    Guidance for Premarket Notifications for Automated

    November 1, 2000

    ODE/DCLD

    Do

    1184 Differential Cell Counters for Immature or Abnormal Blood Cells; Final; Guidance for Industry and FDA

    Review Criteria for Assessment of Antimicrobial

    October 30, 1996

    ODE/DCLD

    Do

    1631 Susceptibility Test Discs

    Over the Counter (OTC) Screening Tests for Drugs of November 14, 2000

    ODE/DCLD

    Do

    2209 Abuse: Guidance for Premarket Notifications; Guidance for Industry; Draft

    Points to Consider Guidance Document on Assayed and February 3, 1999

    ODE/DCLD

    Do

    2231 Unassayed Quality Control Material; Guidance for Industry

    Document for Special Controls for Erythropoietin Assay April 28, 1999

    ODE/DCLD

    Do

    2241 Premarket Notifications [510(k)s]; Guidance for Industry; Final

    In Vitro Diagnostic Fibrin Monomer Paracoagulation Test; April 27, 1999

    ODE/DCLD

    Do

    2242 Guidance for Industry and FDA Reviewers/Staff; Final

    Class II Special Control Guidance Document for B-Type November 30, 2000

    ODE/DCLD

    Do

    1072 Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers

    Guidance for Electrical Safety, Electromagnetic

    June 28, 2000

    ODE Division of

    Do

    1161 Compatibility and Mechanical Testing for Indwelling

    Cardiovascular and Blood Gas Analyzer Premarket Notification Submissions

    Respiratory Devices (DCRD)

    Guidance for the Submission of Research and Marketing November 1, 2000

    ODE/DCRD

    Do

    372 Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions; Final

    [[Page 53895]]

    Investigational Device Exemption (IDE) Study Enrollment November 8, 2000

    ODE/DCRD

    Do

    1199 for Cardiac Ablation of Typical Atrial Flutter; Final Guidance for Industry and FDA Reviewers

    Guidance Document for Vascular Prostheses 510(k)

    November 1, 2000

    ODE/DCRD

    Do

    1357 Submissions; Guidance for Industry and FDA Staff; Final

    Guidance for Annuloplasty Rings 510(k) Submissions; January 31, 2001

    ODE/DCRD

    Do

    1358 Final Guidance for Industry and FDA Staff

    1-Consolidated Annual Report for a Device Product Line July 6, 2000

    ODE/DCRD

    Do

    1167 (1-CARD); Pilot for Preparation of Annual Reports for Pacemaker Premarket Approval Applications

    Excerpts Related to EMI From November 1993

    November 1, 1993

    ODE/DCRD

    Do

    638 Anesthesiology and Respiratory Devices Branch (Including Electromagnetic Compatibility Standard for Medical Devices; 10/1/79)

    Guidance for Infant/Child Apnea Monitor 510(k)

    September 22, 2000

    ODE/DCRD

    Do

    1178 Submissions

    Guidance for Industry and for FDA Reviewers: Recommended May 7, 1999

    ODE/DCRD

    Do

    2244 Clinical Study Design for Ventricular Tachycardia Ablation

    Guidance for Industry: Electro-Optical Sensors for the August 25, 1999

    ODE/DCRD

    Do

    266 In Vivo Detection of Cervical Cancer and its Precursors: Submission Guidance for an IDE/PMA; Draft

    Guidance for Cardiovascular Intravascular Filter 510(k) November 26, 1999

    ODE/DCRD

    Do

    24 Submission; Final

    Guidance for the Submission of 510(k) Premarket

    February 11, 1997

    ODE/DCRD

    Do

    25 Notifications for Electrocardiograph (ECG) Electrode-- Version 1.0

    Guidance for the Submission of 510(k) Premarket

    February 11, 1997

    ODE/DCRD

    Do

    26 Notifications for Electrocardiograph (ECG) Lead Switching Adapter--Version 1.0

    Guidance Document Device: Electrocardiograph (ECG)

    February 11, 1997

    ODE/DCRD

    Do

    27 Surface Electrode Tester--Version 1.0

    Draft Guidance Outline--Points to Consider for Clinical November 30, 1993

    ODE/DCRD

    Do

    100 Studies for Vasovasostomy Devices

    Medical Device Labeling--Suggested Format and Content; April 25, 1997

    ODE/DCRD

    Do

    119 Draft Document

    Non-Invasive Blood Pressure (NIBP) Monitor Guidance March 10, 1997

    ODE/DCRD

    Do

    123

    Policy for Expiration Dating (DCRD RB92-G)

    October 30, 1992

    ODE/DCRD

    Do

    137

    Human Heart Valve Allografts; Draft

    June 21, 1991

    ODE/DCRD

    Do

    224

    Guidance for Extracorporeal Blood Circuit Defoamer

    February 16, 2000

    ODE/DCRD

    Do

    1632 510(k) Submissions; Final

    Guidance for Cardiopulmonary Bypass Arterial Line Blood February 21, 2000

    ODE/DCRD

    Do

    1622 Filter 510(k) Submissions; Final

    Balloon Valvuloplasty Guidance for the Submission of an January 1, 1989

    ODE/DCRD

    Do

    370 IDE Application and a PMA Application

    Replacement Heart Valve Guidance; Draft

    October 14, 1994

    ODE/DCRD

    Do

    375

    [[Page 53896]]

    Implantable Pacemaker Testing Guidance

    January 12, 1990

    ODE/DCRD

    Do

    383

    Letter/Guidance: Vascular Graft Manufacturer, Developer, May 11, 1990

    ODE/DCRD

    Do

    391 or Representative

    Reviewer Guidance for Ventilators; Draft

    July 1, 1995

    ODE/DCRD

    Do

    500

    Draft 510(k) Checklist for Urological Irrigation System August 1, 1995

    ODE/DCRD

    Do

    515 and Tubing Set

    Draft Guidance to Firms on Biliary Lithotripsy Studies August 2, 1990

    ODE/DCRD

    Do

    522

    Draft Guidance for Clinical Investigations of Devices November 11, 1994

    ODE/DCRD

    Do

    533 Used for the Treatment of Benign Prostatic Hyperplasia (BPH)

    Letter: Notice to Manufacturers of Bone Mineral

    September 25, 1997

    ODE/DCRD

    Do

    552 Densitometers

    Information for Manufacturers Seeking Marketing

    September 30, 1997

    ODE/DCRD

    Do

    560 Clearance of Diagnostic Ultrasound Systems and Transducers: Draft

    Draft Guidance for the Content of Premarket

    January 24, 1992

    ODE/DCRD

    Do

    567 Notifications for Urological Balloon Dilatation Catheters

    Guideline for the Arrangement and Content of a Premarket May 1, 1990

    ODE/DCRD

    Do

    577 Approval (PMA) Application for a Cochlear Implant in Adults at Least 18 Years of Age

    Guidance for the Preparation of the Annual Report to the April 1, 1990

    ODE/DCRD

    Do

    582 PMA Approved Heart Valve Prostheses

    Draft Version: Electrode Recording Catheter Preliminary March 1, 1995

    ODE/DCRD

    Do

    602 Guidance (Data to Be Sumitted to the FDA in Support of Premarket Notifications [510(k)s])

    Cardiac Ablation Preliminary Guidance (Data to Be

    March 1, 1995

    ODE/DCRD

    Do

    619 Submitted to the FDA in Support Investigation Device Exemption Application; Draft

    Premarket Testing Guidelines for Falloposcopes

    November 20, 1992

    ODE/DCRD

    Do

    621

    Guidelines for Evaluation of Non-Drug IUDs

    September 28, 1976

    ODE/DCRD

    Do

    641

    Simplified 510(k) procedures for certain radiology

    December 21, 1993

    ODE/DCRD

    Do

    708 devices: 12/21, 1993, letter from L Yin, ODE/ODE/DRARD, to NEMA

    Draft 510(k) Checklist for Endoscopic Electrosurgical August 16, 1995

    ODE/DCRD

    Do

    768 Unit (ESU) and Accessories Used in Gastroenterology and Urology

    Heated Humidifier Review Guidance

    August 30, 1991

    ODE/DCRD

    Do

    780

    Reviewer Guidance for Nebulizers, Metered Dose Inhalers, October 1, 1993

    ODE/DCRD

    Do

    784 Spacers and Actuators

    Reviewer Guidance for Automatic X-Ray Film Processor February 1, 1990

    ODE/DCRD

    Do

    788 510(k)

    Guidance for the Technical Content of a Premarket

    April 1, 1990

    ODE/DCRD

    Do

    791 Approval (PMA) Application for an Endolymphatic Shunt Tube With Valve

    Guidance for Magnetic Resonance Diagnostic Devices-- September 29, 1997

    ODE/DCRD

    Do

    793 Criteria for Significant Risk Investigations

    [[Page 53897]]

    Draft Guidance for Preparation of PMA Applications for March 16, 1993

    ODE/DCRD

    Do

    809 Testicular Prostheses

    Draft Guidance for Preparation of PMA Applications for March 16, 1993

    ODE/DCRD

    Do

    810 Penile Inflatable Implants

    Draft Guidance for the Content of Premarket

    May 30, 1997

    ODE/DCRD

    Do

    842 Notifications for Water Purification Components and Systems for Hemodialysis

    Guidance for the Submission of Research and Marketing May 1, 1995

    ODE/DCRD

    Do

    846 Applications for Interventional Cardiology Devices: PTCA Catheters, Atherectomy Catheters, Lasers, Intravascular Stents; Draft

    Draft Guidance for Preclinical and Clinical

    November 29, 1995

    ODE/DCRD

    Do

    850 Investigations of Urethral Bulking Agents Used in the Treatment of Urinary Incontinence

    Draft Guidance for Review of Bone Densitometer 510(k) November 9, 1992

    ODE/DCRD

    Do

    866 Submissions

    Battery Guidance

    July 12, 1993

    ODE/DCRD

    Do

    873

    Guidance for the Preparation of Research and Marketing August 1, 1993

    ODE/DCRD

    Do

    885 Applications for Vascular Graft Prostheses; Draft

    510(k) Checklist for Sterile Lubricating Jelly Used With September 19, 1994

    ODE/DCRD

    Do

    892 Transurethral Surgical Instruments

    Draft Guidance for Hemodialyzer Reuse Labeling

    October 6, 1995

    ODE/DCRD

    Do

    899

    Hysteroscopes and Gynecology Laparoscopes--Submission March 27, 1996

    ODE/DCRD

    Do

    907 Guidance for a 510(k)--Includes 00192

    Draft Guidance for the Content of Premarket

    July 29, 1991

    ODE/DCRD

    Do

    953 Notifications for Loop and Rollerball Electrodes for GYN Electrosurgical Excisions

    Intravascular Brachytherapy--Guidance for Data to be May 24, 1996

    ODE/DCRD

    Do

    955 Submitted to the Food and Drug Administration in Support of Investigational Device Exemption (IDE) Applications; Draft

    Percutaneous Transluminal Coronary Angioplasty Package February 7, 1995

    ODE/DCRD

    Do

    959 Insert Template; Draft

    Coronary and Cerebrovascular Guidewire Guidance

    January 1, 1995

    ODE/DCRD

    Do

    964

    Guidance for Implantable Cardioverter-Defibrillators; June 24, 1996

    ODE/DCRD

    Do

    965 Draft

    Carotid Stent--Suggestions for Content of Submissions to October 26, 1996

    ODE/DCRD

    Do

    974 the Food and Drug Administration in Support of Investigational Devices Exemption (IDE) Applications

    Emergency Resuscitator Guidance; Draft

    April 14, 1993

    ODE/DCRD

    Do

    985

    Review Guidelines for Oxygen Generators and Oxygen

    April 14, 1993

    ODE/DCRD

    Do

    986 Equipment; Draft Document

    Draft 510(k) Checklist for Condom Catheters

    February 23, 1995

    ODE/DCRD

    Do

    991

    CDRH Interim Regulatory Policy for External Penile

    September 10, 1997

    ODE/DCRD

    Do

    992 Rigidity Devices

    [[Page 53898]]

    Reviewer Guidance on Face Masks and Shield for CPR; March 16, 1994

    ODE/DCRD

    Do

    996 Draft

    General Guidance Document: Non-Invasive Pulse Oximeter September 7, 1992

    ODE/DCRD

    Do

    997

    Guidance for Peak Flow Meters for Over-the-Counter Sale June 23, 1992

    ODE/DCRD

    Do

    998

    510(K) Submission Requirements for Peak Flow Meters; January 13, 1994

    ODE/DCRD

    Do

    999 Draft

    Guidance for Industry and FDA; Guidance for Indwelling February 21, 2000

    ODE/DCRD

    Do

    1126 Blood Gas Analyzer 510(k) Submissions

    Guidance Document for Premarket Notification Submission January 24, 2000

    ODE/DCRD

    Do

    1157 for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer; Final

    Latex Condoms for Men--Information for 510(k) Premarket July 23, 1998

    ODE/DCRD

    Do

    1250 Notifications: Use of Consensus Standards for Abbreviated Submissions

    Guidance for Industry--Uniform Contraceptive Labeling; July 23, 1998

    ODE/DCRD

    Do

    1251 Final

    Guidance for Cardiopulmonary Bypass Oxygenators 510(k) January 17, 2000

    ODE/DCRD

    Do

    1361 Submissions; Final

    Guidance for the Content of Premarket Notifications for January 16, 2000

    ODE/DCRD

    Do

    177 Penile Rigidity Implants; Final

    Federal Register Notice; Devices Used for In Vitro

    September 10, 1998

    ODE/DCRD

    Do

    1620 Fertilization and Related Assisted Reproduction Procedures: Submission Guidance for a 510(k); Draft; Availability

    Hysteroscopic and Laparoscopic Insufflators: Submission August 1, 1995

    ODE/DCRD

    Do

    1907 Guidance for a 510(k)

    Guidance for Industry and CDRH Reviewers--Guidance for August 7, 1998

    ODE/DCRD

    Do

    2202 the Content of Premarket Notifications for Hemodialysis Delivery Systems; Final

    Noise Claims in Hearing Aid Labeling; Final

    October 21, 1998

    ODE/DCRD

    Do

    2210

    Guidance for Industry--Diagnostic ECG Guidance

    November 5, 1998

    ODE/DCRD

    Do

    2232 (Including Non-Alarming ST Segment Measurement); Final

    Guidance for Industry--Cardiac Monitor Guidance

    November 5, 1998

    ODE/DCRD

    Do

    2233 (including Cardiotachometer and Rate Alarm); Final

    Guidance for Industry--Harmonic Imaging With/Without November 16, 1998

    ODE/DCRD

    Do

    2234 Contrast--Premarket Notification; Final

    Guidance for Industry--Guidance for the Content of

    November 30, 1998

    ODE/DCRD

    Do

    2235 Premarket Notifications for Intracorporeal Lithotripters; Final

    Guidance for Industry--Guidance for the Submission of November 20, 1998

    ODE/DCRD

    Do

    2238 Premarket Notifications for Radionuclide Dose Calibrators; Final

    Guidance for Industry--Non-Automated Sphygmomanometer November 19, 1998

    ODE/DCRD

    Do

    2239 (Blood Pressure Cuff) Guidance; Version 1; Final

    [[Page 53899]]

    Guidance for Industry--Guidance for the Submission of December 3, 1998

    ODE/DCRD

    Do

    2240 Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems; Final

    Guidance for the Content of Premarket Notifications for February 5, 1998

    ODE/DCRD

    Do

    2243 Metal Expandable Biliary Stents; Final

    Guidance for the Submission of 510(k)'s for Solid State August 6, 1999

    ODE/DCRD

    Do

    644 X-Ray Imaging Devices; Final

    Class II Special Control Guidance Document for Acute July 30, 2000

    ODE/DCRD

    Do

    1138 Upper Airway Obstruction Devices

    Guidance for Conducting Stability Testing to Support an November 16, 1999

    ODE Division of Dental, Do

    1355 Expiration Date Labeling Claim for Medical Gloves;

    Infection Control and Draft

    General Hospital Devices (DDIGD)

    Reprocessing and Reuse of Single-Use Devices: Review February 8, 2000

    ODE/DDIGD

    Do

    1156 Prioritization Scheme; Draft

    Premarket Approval Applications (PMA) for Sharps Needle March 2, 2001

    ODE/DDIGD

    Do

    891 Destruction Devices; Final Guidance for Industry and FDA

    Guidance on the Content and Format of Premarket

    June 2, 1998

    ODE/DDIGD

    Do

    4 Notification 510(k) Submissions of Washers and Washer- Disinfectors

    Overview of Information Necessary for Premarket

    April 21, 1999

    ODE/DDIGD

    Do

    86 Notification Submissions for Endosseous Implants; Final

    Guidance for the Arrangement and Content of a Premarket May 16, 1989

    ODE/DDIGD

    Do

    353 Approval (PMA) Application for an Endosseous Implant for Prosthetic Attachment

    Guidance on 510(k) Submissions for Implanted Infusion October 1, 1990

    ODE/DDIGD

    Do

    392 Ports

    Guidance on the Content of Premarket Notification

    April 1, 1993

    ODE/DDIGD

    Do

    450 [510(K)] Submissions for Hypodermic Single Lumen Needles

    Guidance Document on Dental Handpieces

    July 1, 1995

    ODE/DDIGD

    Do

    556

    Guidance on the Content and Format of Premarket

    December 6, 1996

    ODE/DDIGD

    Do

    576 Notification 510(k) Submissions for Liquid Chemical Germicides

    Guidance on the Content of Premarket Notification

    April 1, 1993

    ODE/DDIGD

    Do

    821 [510(K)] Submissions for Piston Syringes

    Guidance on the Content of Premarket Notification

    March 1, 1993

    ODE/DDIGD

    Do

    822 [510(K)] Submissions for Clinical Electronic Thermometers

    Guidance on the Content of Premarket Notification

    March 1, 1993

    ODE/DDIGD

    Do

    823 [510(k)] Submissions for External Infusion Pumps

    Guidance on Premarket Notification [510(K)] Submissions March 16, 1995

    ODE/DDIGD

    Do

    824 for Short-Term and Long-Term Intravascular Catheters

    Guidance on Premarket Notification [510(k)] Submissions March 1, 1993

    ODE/DDIGD

    Do

    833 for Sterilizers Intended for Use in Health Care Facilities

    [[Page 53900]]

    Guidance on Premarket Notification [510(k)] Submissions August 1, 1993

    ODE/DDIGD

    Do

    881 for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities

    Guidance on Premarket Notification [510(k)] Submissions August 1, 1993

    ODE/DDIGD

    Do

    888 for Surgical Gowns and Surgical Drapes

    Guidance on the Content and Format of Premarket

    October 1, 1993

    ODE/DDIGD

    Do

    895 Notification [510(k)] Submissions for Sharps Containers

    Draft Supplementary Guidance on the Content of Premarket March 1, 1995

    ODE/DDIGD

    Do

    934 Notification [510(k)] Submissions for Medical Devices With Sharps Injury Prevention Features (Antistick)

    Guidance for Industry and FDA Reviewers/Staff--Premarket January 13, 1999

    ODE/DDIGD

    Do

    944 Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Latex Products [Draize Testing]

    Information Necessary for Premarket Notification

    December 9, 1996

    ODE/DDIGD

    Do

    948 Submissions for Screw-Type Endossesous Implants

    Draft Guidance Document for the Preparation of Premarket March 3, 1997

    ODE/DDIGD

    Do

    984 Notification [510(k)'s] for Dental Alloys

    Guidance on the Content of Premarket Notification

    December 1, 1995

    ODE/DDIGD

    Do

    993 [510(k)] Submissions for Protective Restraints

    Guidance on Premarket Notifications for Intravascular October 12, 2000

    ODE/DDIGD

    Do

    1189 Administration Sets; Guidance for Industry and FDA Review Staff; Final

    Addendum to: Guidance on Premarket Notification [510(k)] September 19, 1995

    ODE/DDIGD

    Do

    1833 Submissions for Sterilizers Intended for Use in Health Care Facilities

    Groups Capable of Testing for Latex Skin Sensitization July 28, 1997

    ODE/DDIGD

    Do

    1944 (Addendum to #944)

    Guidance for Industry and FDA Reviewers; Neonatal and September 18, 1998

    ODE/DDIGD

    Do

    2201 Neonatal Transport Incubators--Premarket Notifications; Final

    Dental Impression Materials--Premarket Notification; August 17, 1998

    ODE/DDIGD

    Do

    2203 Final

    Dental Cements Premarket Notification; Final

    August 18, 1998

    ODE/DDIGD

    Do

    2204

    OTC Denture Cushions, Pads, Reliners, Repair Kits and August 18, 1998

    ODE/DDIGD

    Do

    2205 Partially Fabricated Denture Kits; Final

    Guidance for the Preparation of a Premarket Notification November 27, 1998

    ODE/DDIGD

    Do

    642 [510(k)] for Direct Filling Dental Composites

    Guidance and Format of Premarket Notification [510(k)] January 3, 2000

    ODE/DDIGD

    Do

    397 Submissions for Liquid Chemical Sterilants/High Level Disinfectants; Final

    Class II Special Control Guidance Document: Pharmacy March 12, 2001

    ODE/DDIGD

    Do

    1326 Compounding Devices; Final Guidance for Industry and FDA

    Guidance for Industry: Guidance for the Content of

    April 28, 1998

    ODE Division of General, Do

    6 Premarket Notifications for Esophageal and Tracheal

    Restorative and Prostheses; Final

    Neurological Devices (DGRND)

    [[Page 53901]]

    Calcium Phosphate (Ca-P) Coating Draft Guidance for February 21, 1997

    ODE/DGRND

    Do

    33 Preparation of FDA Submissions for Orthopedic and Dental Endosseous Implants

    510(k) Information Needed for Hydroxyapatite Coated February 20, 1997

    ODE/DGRND

    Do

    47 Orthopedic Implants

    Letter: Core Study for Silicone Breast Implants

    January 11, 1996

    ODE/DGRND

    Do

    107

    Protocol for Dermal Toxicity Testing for Devices in January 1, 1985

    ODE/DGRND

    Do

    124 Contact With Skin (Draft)

    Draft Version 1--Biofeedback Devices--Draft Guidance for August 1, 1994

    ODE/DGRND

    Do

    143 510(k) Content

    Draft Data Requirements for Ultrahigh Molecular Weight March 28, 1995

    ODE/DGRND

    Do

    180 Polyethylene (Uhmupe) Used in Orthopedic Devices

    Draft Guidance Document for Femoral Stem Prostheses August 1, 1995

    ODE/DGRND

    Do

    187

    Draft Premarket Notification Review Guidance for Evoked June 1, 1994

    ODE/DGRND

    Do

    207 Response Somatosensory Stimulators

    Draft Version Guide for Cortical Electrode 510(k)

    August 10, 1992

    ODE/DGRND

    Do

    208 Content

    Draft Version Guidance for Clinical Data to be Submitted August 20, 1992

    ODE/DGRND

    Do

    209 for Premarket Approval Application for Cranial Electrotherapy Stimulators

    Draft Version Cranial Perforator Guidance

    July 13, 1994

    ODE/DGRND

    Do

    212

    Draft Version Neuro Endoscope Guidance

    July 7, 1994

    ODE/DGRND

    Do

    214

    Galvanic Skin Response Measurement Devices--Draft

    August 1, 1994

    ODE/DGRND

    Do

    215 Guidance for 510(k) Content

    Guidance Document for the Preparation of IDE and PMA February 18, 1993

    ODE/DGRND

    Do

    233 Applications for Intra-Articular Prosthetic Knee Ligament Devices

    Guidance for Industry, FDA Reviewers/Staff and

    June 9, 1999

    ODE/DGRND

    Do

    2246 Compliance Guidance Document for Powered Muscle Stimulator 510(k)s; Final

    Guidance for Industry--Guidance for the Preparation of a August 30, 1999

    ODE/DGRND

    Do

    54 Premarket Notification Application for Processed Human Dura Mater; Final

    Guide for TENS 510(k) Content (Draft)

    August 1, 1994

    ODE/DGRND

    Do

    300

    Guidance Document for the Preparation of Premarket

    July 26, 1995

    ODE/DGRND

    Do

    307 Notification [510(k)] Applications for Submerged (Underwater) Exercise Equipment

    Guidance Document for the Preparation of Premarket

    July 26, 1995

    ODE/DGRND

    Do

    325 Notification [510(k)] Applications for Electromyograph Needle Electrodes

    Guidance Document for the Preparation of Premarket

    July 26, 1995

    ODE/DGRND

    Do

    326 Notification [510(k)] Applications for Exercise Equipment

    Guidance Document for the Preparation of Premarket

    July 26, 1995

    ODE/DGRND

    Do

    346 Notification [510k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles

    [[Page 53902]]

    Guidance Document for the Preparation of Premarket

    January 10, 1995

    ODE/DGRND

    Do

    355 Notification for Ceramic Ball Hip Systems

    Guidance on the Content and Organization of a Premarket June 1, 1995

    ODE/DGRND

    Do

    386 Notification for a Medical Laser

    Draft Guidance Document for Testing Acetabular Cup

    May 1, 1995

    ODE/DGRND

    Do

    453 Prostheses

    Guidance Document for Industry and CDRH Staff for the March 18, 1998

    ODE/DGRND

    Do

    487 Preparation of Investigational Device Exemptions and Premarket Approval Applications for Bone Growth Stimulator Devices; Draft

    Copy of October 9, 1992, Letter and Original Suture October 9, 1992

    ODE/DGRND

    Do

    502 Labeling Guidance (Reformatted 12/17/1997)

    Alternate Suture Labeling Resulting From the January 11, January 11, 1993

    ODE/DGRND

    Do

    503 1993, Meeting With HIMA (Reformatted 12/17/1997)

    Guidelines for Reviewing Premarket Notifications that February 1, 1997

    ODE/DGRND

    Do

    593 Claim Substantial Equivalence to Evoked Response Stimulators

    Draft Version--Guidance on Biocompatibility Requirements September 12, 1994

    ODE/DGRND

    Do

    627 for Long Term Neurological Implants: Part 3--Implant Model

    Guidance for Studies for Pain Therapy Devices--General May 12, 1988

    ODE/DGRND

    Do

    640 Considerations in the Design of Clinical Studies for Pain-Alleviating Devices

    ORDB 510(k) Sterility Review Guidance

    July 3, 1997

    ODE/DGRND

    Do

    659

    Draft Guidance for the Preparation of a Premarket

    August 30, 1994

    ODE/DGRND

    Do

    667 Notification for Extended Laparoscopy Devices (ELD)

    Draft Outline for a Guidance Document for Testing

    November 1, 1993

    ODE/DGRND

    Do

    668 Orthopedic Bone Cement, Request for Comments by December 10, 1993

    Guidance Document for the Preparation of Premarket

    July 26, 1995

    ODE/DGRND

    Do

    689 Notification [510(k)] Applications for Beds

    Guidance Document for the Preparation of Premarket

    July 26, 1995

    ODE/DGRND

    Do

    729 Notification [510(k)] Applications for Immersion Hydrobaths

    Guidance Document for the Preparation of Premarket

    July 26, 1995

    ODE/DGRND

    Do

    735 Notification [510(k)] Applications for Powered Tables and Multifunctional Physical Therapy Tables

    Guidance Document for the Preparation of Premarket

    July 26, 1995

    ODE/DGRND

    Do

    762 Notification [510(k)] Applications for Communications Systems (Powered and Non-Powered) and Powered Environmental Control Systems

    Electroencephalograph Devices Guidance for 510(k)

    November 3, 1997

    ODE/DGRND

    Do

    767 Content; Draft

    Guidance Document for the Preparation of Premarket

    July 26, 1995

    ODE/DGRND

    Do

    818 Notification [510(k)] Applications for Therapeutic Massagers and Vibrators

    Guidance Document for Testing Orthopedic Implants With April 28, 1994

    ODE/DGRND

    Do

    827 Modified Metallic Surfaces Apposing Bone or Bone Cement (Replaces 8623 and 8093)

    [[Page 53903]]

    Guidance Document for the Preparation of Premarket

    July 26, 1995

    ODE/DGRND

    Do

    828 Notification [510(k)] Applications for Heating and Cooling Devices

    Reviewers Guidance Checklist for Orthopedic External February 21, 1997

    ODE/DGRND

    Do

    829 Fixation Devices

    Draft Guidance for the Preparation of Premarket

    April 1, 1993

    ODE/DGRND

    Do

    830 Notifications [510(k)]s for Cemented, Semi-Constrained Total Knee Prostheses

    Draft Guidance Document for the Preparation of Premarket July 16, 1997

    ODE/DGRND

    Do

    832 Notification [510(k)] Applications for Orthopedic Devices--The Basic Elements

    Draft 510(k) Guideline for General Surgical

    May 10, 1995

    ODE/DGRND

    Do

    904 Electrosurgical Devices

    Draft Guidance for Arthroscopes and Accessory 510(k)s May 1, 1994

    ODE/DGRND

    Do

    909

    Guidance Document for Testing Biodegradable Polymer April 20, 1996

    ODE/DGRND

    Do

    914 Implant Devices; Draft

    Guidance Document for Testing Bone Anchor Devices; Draft April 20, 1996

    ODE/DGRND

    Do

    915

    Guidance Document for Testing Non-Articulating,

    May 1, 1995

    ODE/DGRND

    Do

    916 ``Mechanically Locked'', Modular Implant Components; Draft

    Reviewers Guidance Checklist for Intramedullary Rods February 21, 1997

    ODE/DGRND

    Do

    956

    Draft Guidance for Testing MR Interaction With Aneurysm May 22, 1996

    ODE/DGRND

    Do

    958 Clips

    Guidance for Industry--Guidance Document for Dura

    August 13, 1999

    ODE/DGRND

    Do

    1152 Substitute Devices; Final

    Guidance Document for Surgical Lamp 510Ks; Final

    July 13, 1998

    ODE/DGRND

    Do

    1244

    Guidance for Industry--Guidance on Preclinical and

    October 5, 1999

    ODE/DGRND

    Do

    1354 Clinical Data and Labeling for Breast Prostheses; Draft

    Guidance Document for the Preparation of IDEs for Spinal January 13, 2000

    ODE/DGRND

    Do

    2250 Systems; Final

    Draft Guidance for the Preparation of an IDE Submission April 4, 1995

    ODE/DGRND

    Do

    1817 for a Interactive Wound and Burn Dressing

    Guidance for Industry and/or for FDA Reviewers/Staff and/ October 30, 1998

    ODE/DGRND

    Do

    2207 or Compliance--Guidance Document for Powered Suction Pump 510(k)s

    Guidance for the Preparation of a Premarket Notification March 2, 1999

    ODE/DGRND

    Do

    2247 Application for a Surgical Mesh; Final

    Class II Special Controls Guidance Shoulder Joint Metal/ October 31, 2000

    ODE/DGRND

    Do

    1193 Polymer/Metal Nonconstrained or Semi-Constrained Porous- Coated Uncemented Prosthesis; Final

    Guidance for Dermabrasion Devices; Final

    March 2, 1999

    ODE/DGRND

    Do

    2248

    Draft Guidance for the Preparation of a Premarket

    May 31, 1995

    ODE/DGRND

    Do

    2817 Notification for a Non-Interactive Wound and Burn Dressing [510(k)]

    [[Page 53904]]

    Guidance for Resorbable Adhesion Barrier Devices for Use December 16, 1999

    ODE/DGRND

    Do

    1356 in Abdominal and/or Pelvic Surgery; Draft

    Special Control Guidance for Premarket Notifications for September 6, 2000

    ODE/DGRND

    Do

    1179 Totally Implanted Spinal Cord Stimulators for Pain Relief; Guidance for Industry; Draft

    Guidance for Surgical Suture 510(k)s; Guidance for

    August 10, 2000

    ODE/DGRND

    Do

    1180 Industry; Final

    Guidance for Neurological Embolization Devices; Guidance November 1, 2000

    ODE/DGRND

    Do

    1151 for Industry; Final

    Guidance for Spinal System 510(k)s

    September 27, 2000

    ODE/DGRND

    Do

    636

    FDA Guidelines for Multifocal Intraocular Lens IDE

    May 29, 1997

    ODE Division of

    Do

    55 Studies and PMAs

    Ophthalmic and Ear, Nose, and Throat Devices (DOED)

    Announcement: Information for Manufacturers and Users of September 22, 1997

    ODE/DOED

    Do

    93 Lasers for Refractive Surgery [Excimer]

    Guidance on the Content and Format of Premarket

    January 16, 1998

    ODE/DOED

    Do

    94 Notification [510(k)] Submissions for Surgical Mask-- Draft

    New FDA Recommendations and Results of Contact Lens May 30, 1989

    ODE/DOED

    Do

    265 Study (7-Day Letter)

    Draft Premarket Notification 510(k) Guidance for Contact May 1, 1997

    ODE/DOED

    Do

    674 Lens Care Products

    Important Information About Rophae Intraocular Lenses August 20, 1992

    ODE/DOED

    Do

    811

    Draft Premarket Notification [510(k)] Guidance Document May 12, 1994

    ODE/DOED

    Do

    896 for Class II Daily Wear Contact Lenses and 6/28, 1994, Corrections to Pages 18 and 20

    Retinoscope Guidance; Final

    July 8, 1998

    ODE/DOED

    Do

    1240

    Guidance for Industry--Ophthalmoscope Guidance (Direct July 8, 1998

    ODE/DOED

    Do

    1241 and Indirect)

    Slit Lamp Guidance; Final

    July 13, 1998

    ODE/DOED

    Do

    1242

    Guidance for Industry and FDA Staff--Revised Procedures August 11, 1998

    ODE/DOED

    Do

    1249 for Adding Lens Finishing Laboratories to Approved Premarket Approval (PMA) Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear; Final

    Accountability Analysis for Clinical Studies for

    August 4, 1999

    ODE/DOED

    Do

    1350 Ophthalmic Devices; Draft

    Guidance on 510(k) Submissions for Keratoprostheses; March 3, 1999

    ODE/DOED

    Do

    1351 Final

    Amendment 1: Draft Premarket Notification [510(k)]

    June 28, 1994

    ODE/DOED

    Do

    1896 Guidance Document for Class II Daily Wear Contact Lenses

    Checklist of Information Usually Submitted in an

    October 10, 1996

    ODE/DOED

    Do

    2093 Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [Excimer]

    Third Party Review Guidance for Vitreous Aspiration and January 31, 1997

    ODE/DOED

    Do

    2196 Cutting Device Premarket Notification [510(k)]

    [[Page 53905]]

    Guidance Document for Nonprescription Sunglasses; Final October 9, 1998

    ODE/DOED

    Do

    2208

    Aqueous Shunts--510(k) Submissions; Final

    November 16, 1998

    ODE/DOED

    Do

    2236

    Discussion Points for Expansion of the ``Checklist of September 5, 1997

    ODE/DOED

    Do

    7093 Information Usually Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers'' Draft Document

    Intraocular Lens (IOL) Guidance Document; Draft

    October 14, 1999

    ODE/DOED

    Do

    834

    Refractive Implants: Guidance for Investigational Device August 1, 2000

    ODE/DOED

    Do

    1145 Exemptions (IDE) and Premarket Approval (PMA) Applications

    Guidance on Premarket Submissions of Orthokeratology April 10, 2000

    ODE/DOED

    Do

    1134 Rigid Gas Permeable Contact Lenses; Final

    Guidance for Manufacturers Seeking Marketing Clearance March 12, 2000

    ODE/DOED

    Do

    954 of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers; Final

    Information for a Latex Condom 510(k) Submission for April 13, 1994

    ODE Division of

    Do

    398 Obstetrics-Gynecology Devices Branch--Draft

    Reproductive, Abdominal, and Radiological Devices (DRARD)

    Guidance for the Content of Premarket Notifications for June 7, 1994

    ODE/DRARD

    Do

    96 Urine Drainage Bags

    Draft--510(k) Checklist for Conditioned Response

    November 23, 1994

    ODE/DRARD

    Do

    99 Enuresis Alarms

    Draft Guidance for Preparation of PMA Applications for May 1, 1995

    ODE/DRARD

    Do

    161 the Implanted Mechanical/Hydraulic Urinary Continence Device (Artificial Urinary Sphincter)

    Draft Guidance for the Content of Premarket

    March 17, 1995

    ODE/DRARD

    Do

    162 Notifications for Endoscopes Used in Gastroenterology and Urology

    Draft Guidance for the Content of Premarket

    May 25, 1995

    ODE/DRARD

    Do

    166 Notifications for Menstrual Tampons

    Draft 510(k) Checklist for Non-Implanted Electrical June 6, 1995

    ODE/DRARD

    Do

    189 Stimulators Used for the Treatment of Urinary Incontinence

    Draft 510(k) Checklist for Endoscopic Light Sources Used June 22, 1995

    ODE/DRARD

    Do

    190 in Gastroenterology and Urology

    Guidance (``Guidelines'') for Evaluation of Laparoscopic May 1, 1978

    ODE/DRARD

    Do

    232 Bipolar and Thermal Coagulators (and Accessories)

    Guidance (``Guidelines'') for Evaluation of Fetal Clip March 8, 1977

    ODE/DRARD

    Do

    244 Electrode

    Guidance (``Guidelines'') for Evaluation of Tubal

    November 22, 1977

    ODE/DRARD

    Do

    245 Occlusion Devices

    Guidance (``Guidelines'') for Evaluation of

    May 10, 1978

    ODE/DRARD

    Do

    248 Hysteroscopic Sterilization Devices

    Intrapartum Continuous Monitors for Fetal Oxygen

    June 14, 1997

    ODE/DRARD

    Do

    298 Saturation and Fetal pH; Submission Guidance for a PMA; Draft Document

    [[Page 53906]]

    Guidance for the Arrangement and Content of a Premarket May 1, 1990

    ODE/DRARD

    Do

    327 Approval (PMA) Application For A Cochlear Implant in Children Ages 2 Through to 17 Years

    Guidance for Industry--Guidance for the Submission of November 14, 1998

    ODE/DRARD

    Do

    340 Premarket Notifications for Magnetic Resonance Diagnostic Devices; Final

    Premarket Testing Guidelines for Female Barrier

    April 4, 1990

    ODE/DRARD

    Do

    384 Contraceptive Devices Also Intended to Prevent Sexually Transmitted Diseases

    Draft of Suggested Information for Reporting

    January 18, 1991

    ODE/DRARD

    Do

    418 Extracorporeal Shock Wave Lithotripsy Device Shock Wave Measurements

    Guidance for the Content of Premarket Notifications for August 7, 1998

    ODE/DRARD

    Do

    421 Conventional and Permeability Hemodialyzers; Final

    Guidance for the Content of Premarket Notifications for February 10, 1993

    ODE/DRARD

    Do

    431 Urethral Stents

    Testing Guidance for Male Condoms Made From New Material June 29, 1995

    ODE/DRARD

    Do

    455 (Non-Latex)

    Guidance for the Content of Premarket Notifications for February 10, 1993

    ODE/DRARD

    Do

    482 Biopsy Devices Used in Gastroenterology and Urology

    Guidance for the Content of Premarket Notifications for July 29, 1994

    ODE/DRARD

    Do

    490 Urodynamic/Uroflowmetry Systems

    Guidance for Investigational Device Exemptions for

    January 16, 2001

    ODE/DRARD

    Do

    1164 Solutions for Hypothermic Flushing, Transport, and Storage of Organs for Transplantation; Final Guidance for Industry and FDA Reviewers

    Guidance for the Submission of Premarket Notifications July 27, 2000

    ODE/DRARD

    Do

    416 for Medical Image Management Devices; Guidance for Industry; Final

    Guidance for the Content of Premarket Notifications August 9, 2000

    ODE/DRARD

    Do

    1226 (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi; Final

    Guidance for the Submission of Premarket Notifications August 2, 2000

    ODE/DRARD

    Do

    1177 for Photon-Emitting Brachytherapy Sources; Guidance for Industry; Final

    Premarket Applications for Digital Mammography Systems; February 16, 2001

    ODE/DRARD

    Do

    983 Final Guidance for Industry and FDA

    Class II Special Controls Guidance for Home Uterine March 9, 2001

    ODE/DRARD

    Do

    820 Activity Monitors; Final Guidance for Industry and FDA Reviewers

    Class II Special Controls Guidance Document for Clitoral July 3, 2000

    ODE/DRARD

    Do

    1144 Engorgement Devices; Guidance for Industry and FDA Reviewers

    Thermal Endometrial Ablation Devices (Submission

    March 14, 1996

    ODE/DRARD

    Do

    547 Guidance for an IDE); Final

    Draft Guidance for the Clinical Investigation of

    November 2, 1995

    ODE/DRARD

    Do

    573 Urethral Stents

    [[Page 53907]]

    Tympanostomy Tubes Submission Guidance for a 510(k) January 14, 1998

    ODE/DRARD

    Do

    930 Premarket Notification; Final

    Early Collaboration Meetings Under the FDA Modernization February 28, 2001

    ODE Program Operations Do

    310 Act (FDAMA); Final Guidance for Industry and for CDRH

    Staff (POS) Staff

    PMA/510(k) Expedited Review #G98-4 (Blue Book Memo) March 20, 1998

    ODE/POS

    Do

    7

    PMA/510(k) Expedited Review--Guidance for Industry and March 20, 1998

    ODE/POS

    Do

    108 CDRH Staff [FDAMA]; Final

    Deciding When to Submit a 510(k) for a Change to an January 10, 1997

    ODE/POS

    Do

    935 Existing Device

    A Suggested Approach to Resolving Least Burdensome

    September 11, 2000

    ODE/POS

    Do

    1188 Issues

    Suggested Format for Developing and Responding to

    November 2, 2000

    ODE/POS

    Do

    1195 Deficiencies in Accordance with the Least Burdensome Provisions of FDAMA; Final; Guidance for Industry and FDA Staff

    FDA Modernization Act of 1997 Guidance for the Device February 6, 1998

    Office of Health and Do

    434 Industry on Implementation of Highest Priority

    Industry Programs (OHIP) Provisions [FDAMA]

    Accidental Radioactive Contamination of Human Food and August 13, 1998

    OHIP

    Do

    1071 Animal Feeds: Recommendations to State and Local Agencies

    Compliance Guidance--The Mammography Quality Standards May 5, 1999

    OHIP Division of

    Do

    6400 Act Final Regulations--Preparing for MQSA Inspections

    Mammography Quality and Radiation Programs (DMQRP)

    Guidance for Submission of Request for Reconsideration March 26, 1998

    OHIP/DMQRP

    Do

    69 of Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Acts, 42 U.S.C. 263(b)/4/8, 1998

    Guidance for Review of Requests for Reconsideration of March 26, 1998

    OHIP/DMQRP

    Do

    83 Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Act, 42 U.S.C. 263(b)/4/8, 1998

    Compliance Guidance; The Mammography Quality Standards September 13, 2000

    OHIP/DMQRP

    Do

    1159 Act Final Regulations Document #4; Draft

    The Mammography Quality Standards Act Final Regulations; January 24, 2001

    OHIP/DMQRP

    Do

    1317 Modifications and Additions to Policy Guidance Help System #2; Final Guidance for Industry and FDA (Incorporated into PGHS)

    Compliance Guidance: The Mammography Quality Standards December 8, 1999

    OHIP/DMQRP

    Do

    1496 Act Final Regulations Document #3 (Incorporated into PGHS)

    Guidance: The Mammography Quality Standards Act Final March 4, 1999

    OHIP/DMQRP

    Do

    1499 Regulations Document #1 (Incorporated into PGHS)

    Policy and Standard Operating Procedures When

    April 15, 1998

    OHIP/DMQRP

    Do

    1186 Mammography Facilities in States That Have Accreditation Bodies Intend to Change Accreditation Bodies

    [[Page 53908]]

    Guidance for Request and Issuance of Interim Notice May 4, 1999

    OHIP/DMQRP

    Do

    2217 Letters for Mammography Facilities Under the Mammography Quality Standards Act, 42 U.S.C. Section 263(b)

    Continuing Education Credit for Reading/Writing Articles/ March 17, 1998

    OHIP/DMQRP

    Do

    66206 Papers and Presenting Courses/Lectures (Incorporated into PGHS)

    Guidance for Industry--Requalification for Interpreting May 28, 1998

    OHIP/DMQRP

    Do

    66301 Physician's Continuing Experience Requirement (Incorporated into PGHS)

    Compliance Guidance: The Mammography Quality Standards March 23, 1999

    OHIP/DMQRP

    Do

    2256 Act Final Regulations Motion of Tube-Image Receptor Assembly (Incorporated into PGHS)

    Compliance Guidance: The Mammography Quality Standards December 7, 1999

    OHIP/DMQRP

    Do

    1194 Act Final Regulations Quality Assurance Documentation (Incorporated into PGHS)

    Compliance Guidance: The Mammography Quality Standards February 25, 2000

    OHIP/DMQRP

    Do

    1498 Act Final Regulations Document #2 (Incorporated into PGHS)

    Compliance Guidance--Mammography Facility Survey,

    November 6, 2000

    OHIP/DMQRP

    Do

    6409 Equipment Evaluation and Medical Physicist Qualification Requirements Under MQSA; Final

    Medical Glove Guidance Manual Draft FDA 99-4257

    August 12, 1999

    OHIP Division of Small Do

    852 Manufacturers Assistance (DSMA)

    Instructions for Completion of Medical Device

    July 1, 1997

    OHIP/DSMA

    Do

    12 Registration and Listing Forms FDA 2891, 2891a and 2892

    An Introduction to Medical Device Regulations (FDA 92- January 1, 1992

    OHIP/DSMA

    Do

    18 4222)

    Regulatory Requirements for Devices for the Handicapped August 1, 1987

    OHIP/DSMA

    Do

    22 (FDA 87-4221)

    Impact Resistant Lenses: Questions and Answers (FDA 87- September 1, 1987

    OHIP/DSMA

    Do

    23 4002)

    Comparison Chart: 1996 Quality System Reg vs. 1978 Good November 29, 1996

    OHIP/DSMA

    Do

    133 Manufacturing Practices Reg vs. ANSI/ISO/ASQC Q9001 and ISO/DI 13485:1996 (Include 126)

    Medical Device Appeals and Complaints: A Guidance on February 19, 1998

    OHIP/DSMA

    Do

    396 Dispute Resolution

    Premarket Notification: 510(k)--Regulatory Requirements August 1, 1995

    OHIP/DSMA

    Do

    469 for Medical Devices (FDA 95-4158) [Available on Disk]

    Labeling--Regulatory Requirements for Medical Devices September 1, 1989

    OHIP/DSMA

    Do

    470 (FDA 89-4203)

    In Vitro Diagnostic Devices: Guidance for the

    January 1, 1997

    OHIP/DSMA

    Do

    471 Preparation of 510(k) Submissions (FDA 97-4224) [Available on Disk]

    Investigational Device Exemptions [IDE] Manual (FDA 96- June 1, 1996

    OHIP/DSMA

    Do

    472 4159) DSMA [Available on Disk]

    [[Page 53909]]

    Regulation of Medical Devices; Background Information April 14, 1999

    OHIP/DSMA

    Do

    610 for International Officials (Entire Document Available on Disk)

    Medical Device Reporting for Manufacturers [Available on March 1, 1997

    OHIP/DSMA

    Do

    987 Disk]

    Premarket Approval (PMA) Manual

    January 1, 1998

    OHIP/DSMA

    Do

    1051

    Overview of FDA Modernization Act of 1997 Medical Device February 19, 1998

    OHIP/DSMA

    Do

    1174 Provisions [FDAMA]

    Mutual Recognition Agreement Between the European Union June 29, 2000

    OHIP/DSMA

    Do

    1175 and the United States of America: Confidence Building Programme: Overview and Procedure; Medical Device Annex, Version 7, June 29, 2000; Draft

    Implementation of Third Party Programs Under the FDA February 2, 2001

    OHIP/DSMA

    Do

    1160 Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties

    CDRH Manual for the Good Guidance Practices (GGP)

    February 9, 2001

    OHIP Division of Device Do

    1323 Regulations; Final Guidance for FDA Staff

    User Programs and Systems Analysis (DUPSA)

    Human Factors Principles for Medical Device Labeling September 1, 1993

    OHIP/DUPSA

    Do

    227

    Human Factors Points to Consider for IDE Devices

    January 17, 1997

    OHIP/DUPSA

    Do

    839

    Write It Right

    August 1, 1993

    OHIP/DUPSA

    Do

    897

    Medical Device Reporting for User Facilities

    April 1, 1996

    OHIP/DUPSA

    Do

    989

    Do It By Design--An Introduction to Human Factors in December 1, 1996

    OHIP/DUPSA

    Do

    995 Medical Devices

    Medical Device Use--Safety: Incorporating Human Factors July 18, 2000

    OHIP/DUPSA

    Do

    1497 Engineering into Risk Management; Guidance for Industry and FDA Premarket and Design Control Reviewers

    Guidance on Medical Device Patient Labeling; Final

    April 19, 2001

    OHIP/DUPSA

    Do

    1128 Guidance for Industry and FDA Reviewers

    Perspectives on Clinical Studies for Medical Device

    Office of Surveillance Do

    78 Submissions (Statistical)

    and Biometrics (OSB) Division of Biostatistics (DB)

    PMA Review Statistical Checklist

    (no date available)

    OSB/DB

    Do

    84

    Statistical Aspects of Submissions to FDA: A Medical June 1, 1984

    OSB/DB

    Do

    537 Device Perspective (Also Includes as Appendix the Article Observed Uses and Abuses of Statistical Procedures in Medical Device Submissions

    MDR Guidance Document: Remedial Action Exemption--

    July 30, 1996

    OSB/DSS

    Do

    188 E1996001; Final

    Guidance on Adverse Event Reporting for Hospitals That April 24, 2001

    OSB/DSS

    Do

    1334 Reprocess Devices Intended by the Originial Equipment Manufacturer for Single Use

    MDR Guidance Document No. 1-IOL-E1996004; Final

    August 7, 1996

    OSB/DSS

    Do

    216

    MDR Guidance Document No. 3--Needlestick and Blood

    August 9, 1996

    OSB/DSS

    Do

    250 Exposure--E1996003; Final

    [[Page 53910]]

    Common Problems: Baseline Reports and Medwatch Form January 1, 1997

    OSB/DSS

    Do

    379 3500A

    MDR Reporting Guidance for Breast Implants--E1996002; August 7, 1996

    OSB/DSS

    Do

    452 Final

    Medical Device Reporting: An Overview; Final

    April 1, 1996

    OSB/DSS

    Do

    509

    Instructions for Completing FDA Form 3500A With Coding December 15, 1995

    OSB/DSS

    Do

    853 Manual for Form 3500A (MEDWATCH)(MDR); Final

    MEDWATCH FDA Form 3500A for Use by User Facilities, June 1, 1993

    OSB/DSS

    Do

    854 Distributors and Manufacturers for Mandatory Reporting (MDR); Final

    Variance From Manufacturer Report Number Format [MDR July 16, 1996

    OSB/DSS

    Do

    1059 Letter]; Final

    Instructions for Completing Form 3417: Medical Device March 31, 1997

    OSB/DSS

    Do

    1061 Reporting Baseline Report [MDR]; Final

    MDR Internet List Server (listserv) Instruction Sheet; August 29, 1996

    OSB/DSS

    Do

    1094 Final

    Medical Device Reporting-Alternative Summary Reporting October 19, 2000

    OSB/DSS

    Do

    315 (ASR) Program; Guidance for Industry

    Addendum to the Instructions for Completing FDA Form June 9, 1999

    OSB/DSS

    Do

    1853 3500A With Coding Manual (MEDWATCH) (MDR); Final

    Guidance to Sponsors on the Development of a

    June 9, 1993

    OSB Issues Management Do

    206 Discretionary Postmarket Surveillance Study for

    Staff (IMS) Permanent Implantable Cardiac Pacemaker Electrodes (Leads)

    Guidance on Criteria and Approaches for Postmarket

    November 2, 1998

    OSB/IMS

    Do

    9 Surveillance

    Guidance on Procedures to Determine Application of

    February 19, 1998

    OSB/IMS

    Do

    316 Postmarket Surveillance Strategies [FDAMA]; Final

    Guidance on Procedures for Review of Postmarket

    February 19, 1998

    OSB/IMS

    Do

    317 Surveillance Submissions [FDAMA]; Final

    Guidance for Industry and FDA Staff--SMDA to FDAMA: November 2, 1998

    OSB/IMS

    Do

    318 Guidance on FDA's Transition Plan for Existing Postmarket Surveillance Protocols [FDAMA]; Final

    Amendment to Guidance on Discretionary Postmarket

    March 30, 1994

    OSB/IMS

    Do

    374 Surveillance on Pacemaker Leads; Final

    Guidance for Industry on the Testing of Metallic Plasma February 2, 2000

    OSB/IMS

    Do

    946 Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket

    Guidance on Frequently Asked Questions on Recognition of December 21, 1998

    Office of Science and Do

    109 Consensus Standards [FDAMA]

    Technology (OST)

    Guidance on the Recognition and Use of Consensus

    February 19, 1998

    OST

    Do

    321 Standards/Appendix A [FDAMA]

    A Primer on Medical Device Interactions With Magnetic February 7, 1997

    OST

    Do

    952 Resonance Imaging Systems; Draft

    CDRH Standard Operating Procedures for the

    August 6, 1999

    OST

    Do

    616 Identification and Evaluation of Candidate Consensus Standard for Recognition

    [[Page 53911]]

    Guidance on FDA's Expectations of Medical Device

    May 15, 1998

    OST

    Do

    2000 Manufacturers Concerning the Year 2000 Date Problems

    Guidance for Industry and FDA Reviewers: Guidance on May 6, 1999

    OST Division of Life Do

    635 Immunotoxicity Testing

    Sciences (DLS)

    Withdrawals

    Intended User or Name of Document

    Date of Issuance

    Regulatory Activity

    Date of Withdrawal

    FOD No.

    Guidance for Industry and for FDA Staff: Enforcement February 8, 2000

    OC

    August 8, 2000

    801029 Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals, Draft Guidance--Not for Implementation (Replaced by Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals; Guidance for Industry and for FDA Staff 8/14/ 00)

    Guidance on Information Disclosure by Manufacturers to October 18, 1999

    OC/DOEI

    March 30, 2001

    802619 Assemblers for Diagnostic X-Ray Systems; Guidance for Industry (Replaced by Information Disclosure by Manufacturers to Assemblers for Diagnostic X-Ray Systems; Final Guidance for Industry and FDA 4/2/01)

    Final Design Control Report and Guidance (No

    June 1, 1998

    OC/DOEIII

    July 24, 2000

    800949 Replacement)

    Working Draft of the Current Good Manufacturing Practice July 1, 1995

    OC/OT

    April 24, 2000

    800303 (CGMP) Final Rule (No Replacement)

    Guidance on Amended Procedures for Advisory Panel

    January 26, 1999

    ODE

    August 4, 2000

    800413 Meetings [FDAMA]; Final (Replaced by Guidance on Amended Procedures for Advisory Panel Meetings, 7/22/ 00)

    Review Criteria for Assessment of Antimicrobial

    May 31, 1991

    ODE/DCLD

    June 16, 2000

    800631 Susceptibility Devices (Replaced by Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices, 3/8/00)

    Guidance for Premarket Submissions for Kits for

    December 30, 1998

    ODE/DCLD

    October 30, 2000

    802209 Screening Drugs of Abuse to Be Used by the Consumer; Guidance for Industry; Draft (Replaced by Over-the- Counter (OTC) Screening Tests for Drugs of Abuse: Guidance for Premarket Notifications; Guidance for Industry; Draft 11/14/00)

    Guidance Document for Vascular Prostheses 510(k)

    November 1, 2000

    ODE/DCRD

    January 16, 2000

    801357 Submission; Final (Replaced by Guidance Document for Vascular Prostheses 510(k) Submissions; Guidance for Industry and FDA Staff; Final 11/1/00)

    Guidance to Manufacturers on the Development of Required Date not available

    ODE/DCRD

    June 15, 2000

    800202 Postapproval Epidemiological Study Protocols for Testicular Implants (No Replacement)

    510(k) Reviewer Guidelines--Tracheostomy Tubes 868.5800 Date not available

    ODE/DCRD

    June 15, 2000

    800550 (No Replacement)

    [[Page 53912]]

    Guidance for the Comment and Review of 510(k)

    August 1, 1993

    ODE/DCRD

    August 8, 2000

    800416 Notifications for Picture Archiving and Communications Systems (PACS) and Related Devices (Replaced by Guidance for the Submission of Premarket Notifications for Medical Image Management Devices; Guidance for Industry; Final 7/27/00)

    Guidance for Industry--Guidance for the Content of

    February 8, 1999

    ODE/DCRD

    August 10, 2000

    801226 Premarket Notifications [510(k)s] for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi (Replaced by Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi; Final 8/9/00)

    Guidance for Oxygen Conserving Device 510(k) Review 73 February 1, 1989

    ODE/DCRD

    August 30, 2000

    800583 BZD 868.5905 Non-continuous Ventilator Class II (No Replacement)

    Reviewer's Guidance for Oxygen Concentrator (No

    August 30, 1991

    ODE/DCRD

    August 30, 2000

    800781 Replacement)

    Guidance Document for Vascular Prostheses 510(k)

    November 26, 1999

    ODE/DCRD

    November 16, 2000

    801357 Submission; Final (Replaced by Guidance Document for Vascular Prostheses 510(k) Submissions; Guidance for Industry and FDA Staff; Final 11/1/00)

    Guidance for the Submission of Research and Marketing January 14, 2000

    ODE/DCRD

    January 21, 2000

    800372 Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions; Final (Replaced by Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions; Final 11/1/00)

    Draft Guidance for Information on Clinical Safety and February 5, 1992

    ODE/DCRD

    January 10, 2001

    800864 Effectiveness Data for Extracorporeal Shock Wave Lithotripsy of Upper Urinary Tract (Renal Pelvis, Renal Calyx and Upper Ureteral) Calculi (Replaced by Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi; Final 8/9/00)

    Guidance for Annuloplasty Rings 510(k) Submissions; November 26, 1999

    ODE/DCRD

    February 12, 2001

    801358 Final (Replaced by Guidance for Annuloplasty Rings 510(k) Submissions; Final Guidance for Industry and FDA Staff 1/31/01)

    Home Uterine Activity Monitors: Guidance for the

    July 30, 1999

    ODE/DCRD

    March 2001

    800820 Submission of 510(k) Premarket Notifications (Replaced by Class II Special Controls Guidance for Home Uterine Activity Monitors; Final Guidance for Industry and FDA Reviewers, 3/9/01)

    Status Update--Information for Manufacturers Seeking February 4, 1999

    ODE/DCRD

    February 27, 2001

    800983 Marketing Clearance of Digital Mammography Systems (Replaced by Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDA 2/16/01)

    Guidance on the Content and Format of Premarket

    October 1, 1993

    ODE/DDIGD

    August 10, 2000

    800902 Notification [510(k)] Submissions for General Purpose Disinfectants (includes Addendum of 3/9, 1994) (No Replacement)

    Guidance for the Preparation of Premarket Notification April 1, 1991

    ODE/DDIGD

    September 1, 2000

    800028 [510(k)] for Resorbable Periodontal Barriers (No Replacement)

    [[Page 53913]]

    Guidance for Spinal System 510(k); Final (Replaced by May 7, 1999

    ODE/DGRND

    October 2, 2000

    800636 Guidance for Spinal System 510(k)s 9/27/00)

    Guidance for Industry--Guidance Document for

    August 13, 1999

    ODE/DGRND

    November 7, 2000

    801151 Neurological Embolization Devices; Final (Replaced by Guidance for Neurological Embolization Devices; Guidance for Industry; Final 11/1/00)

    Ophthalmic Device Triage (No Replacement)

    March 19, 1998

    ODE/DOED

    June 20, 2000

    800160

    Announcement by Dr Alpert at 7/26, 1996, Ophthalmic August 26, 1996

    ODE/DOED

    July 17, 2000

    803093 Panel Meeting Concerning Manufacturers and Users of Lasers for Refractive Surgery [Excimer] (No Replacement)

    Owners Certification of Lasers as PMA Approved Devices September 26, 1996

    ODE/DOED

    July 17, 2000

    804093 [Excimer] (No Replacement)

    Compliance Guidance--Mammography Facility Survey and May 5, 1999

    OHIP/DMORP

    April 8, 2000

    806409 Medical Physicist Qualification Requirements Under MQSA (Replaced by Compliance Guidance--Mammography Facility Survey and Medical Physicist Qualification Requirements Under MQSA; Final 11/6/00)

    A Pocket Guide to Device GMP Inspections--Inspections of November 1, 1991

    OHIP/DSMA

    June 28, 2000

    800508 Medical Device Manufacturers and GMP Regulation Requirements (No Replacement)

    Guidance for Staff, Industry, and Third Parties

    June 12, 2000

    OHIP/DSMA

    February 2, 2001

    801160 Implementation of Third Party Programs Under the FDA Modernization Act of 1997--June 2000; Draft (Replaced by Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties 2/2/01)

    Guidance for Industry--Device Use Safety: Incorporating August 3, 1999

    OHIP/DUPSA

    July 20, 2000

    801497 Human Factors in Risk Management (No Replacement)

    Guidance on Medical Device Patient Labeling; Final

    March 3, 2000

    OHIP/DUPSA

    April 9, 2001

    801128 Guidance for Industry (Replaced by Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers 4/19/01)

    MDR Documents Access Information for National Technical May 10, 1996

    OSB

    June 28, 2000

    803799 Information Service (NTIS) (No Replacement)

    Proposed Draft Guidance to Sponsors Regarding Required October 7, 1994

    OSB/DPS

    June 16, 2000

    800323 Postmarket Surveillance Studies of Plasma-Sprayed Porous-Coated Hip Prostheses (Archived by OSB--Replaced by Guidance Testing Metallic Plasma Sprayed Orthopedic Implants, 2/2/00)

    Letter to Manufacturers: Summary Reporting Approval for July 31, 1997

    OSB/DSS

    October 30, 2000

    800315 Adverse Events; Final (Replaced by Medical Device Reporting--Alternative Summary Reporting (ASR) Program; Guidance for Industry 10/19/00)

    Draft Thermal Endometrial Ablation Devices (Submission March 14, 1996

    ODE/DCRD

    March 1996

    800547 Guidance for an IDE) (Replaced by Thermal Endometrial Ablation Devices (Submission Guidance for an IDE); Final 3/14/96))

    Guidance for Review of Cases of Possible Suspension or March 26, 1998

    OHIP/DMORP

    May 23, 2001

    800080 Revocation of Mammography Facility Certificates Under the Mammography Quality Standards Act, 42 U.S.C. 263(b)/ 4/8, 1998 (No Replacement)

    [[Page 53914]]

    Compliance Guidance--Mammography Facility Survey and May 5, 1999

    OHIP/DMORP

    November 8, 2000

    806409 Medical Physicist Qualification Requirements Under MQSA , Draft (replaced by Compliance Guidance--Mammography Facility Survey and Medical Physicist Qualification Requirements Under MQSA; Final 11/6/00

  5. Guidance Documents Issued by the Center for Food Safety and Applied Nutrition (CFSAN)

    How to Obtain A Hard Copy of the Document (Name and Address, Name of Document

    Date of Issuance

    Intended User or Regulatory Activity

    Phone, Fax, E-Mail or Internet)

    Compliance Policy Guides Manual

    1998

    FDA Regulated Industries

    National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, NTIS Order No. PB96- 920500

    Compliance Programs Guidance Manual

    1995

    FDA Regulated Industries

    Do (NTIS Order No. PB95-915499

    FDA Recall Policy

    1995

    FDA Regulated Industries

    Industry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204

    Investigators' Operations Manual

    May 1996

    FDA Regulated Industries

    National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, (NTIS Order No. PB-95- 913399)

    Regulatory Procedures Manual

    August 1995

    FDA Regulated Industries

    Do (NTIS Order No. PB95-265534)

    Requirements of Laws and Regulations Enforced by the 1997

    FDA Regulated Industries

    Superintendent of Documents, Government Printing Office, U.S. Food and Drug Administration ``Blue Book''

    Washington, DC 20402

    Action Levels for Poisonous or Deleterious Substances 1995

    Food and Animal Feed Industries

    Industry Activities Staff (HFS-565), Center for Food Safety in Human Food and Animal Feed

    and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, (NTIS Order No. PB96-920500)

    Pesticides Analytical Manual

    1996

    Food Industry

    National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, (NTIS Order No. PB94- 911899)

    FDA Advisory for Deoxynivanol (DON) in Finished September 16, 1993

    Food and Animal Feed Industries

    Office of Plant and Dairy Foods and Beverages, Food and Drug Wheat Products Intended for Human Consumption and in

    Administration (HFS-306), 200 C St. SW., Washington, DC Grain and Grain By-Products for Animal Feed

    20204, 202-205-4681

    FDA's Cosmetic Labeling Manual

    October 1991

    Cosmetic Industry

    Food and Drug Administration, Office of Colors and Cosmetics (HFS-105), 200 C St. SW., Washington, DC 20204, 202-205- 4493

    Statement of Policy: Foods Derived From New Plant May 29, 1992

    Developers of New Plant Food Varieties Office of Premarket Approval, Food and Drug Administration Varieties: Notice

    (HFS-200), 200 C St. SW., Washington, DC 20204, 202-418- 3100

    A Food Labeling Guide

    May 1997

    Food Industry

    Industry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-5251

    Model Small Business Food Labeling Exemption Notice 1998

    Food Industry

    Do

    Food Labeling: Questions and Answers

    August 1994

    Food Industry

    Do

    [[Page 53915]]

    Food Labeling: Questions and Answers: Volume II

    February 1996

    Food Industry

    Superintendent of Documents, Government Printing Office, Washington, DC 20420, 202-512-1800

    Fair Packaging and Labeling Act Manual

    June 1978

    Food Industry

    National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, 703-487-4650, (NTIS Order No. PB-83-222117)

    Bacteriological Analytical Manual 7th Edition

    1992

    FDA Regulated Industries

    AOAC International, 481 N. Frederick Ave., suite 500, Gaithersburg, MD 20877-2417, 301-924-7077

    FDA Food Importer's Guide for Low-Acid Canned and 1985

    Food Industry

    Industry Activities Staff (HFS-565), Center for Food Safety Acidified Foods

    and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-5251

    Evaluation of Milk Laboratories

    1995

    States

    Milk Safety Branch (HFS-626), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202- 205-9175

    Methods of Making Sanitation Ratings of Milk Supplies 1999

    States

    Do

    Dry Milk Ordinance

    1995

    States

    Do

    Procedures Governing the Cooperative State-Public 1999

    Dairy Industry

    Do Health Service/Food and Drug Administration Program for Certification of Interstate Milk Shippers

    Frozen Dessert Processing Guidelines

    1989

    Dairy Industry

    Office of Plant and Dairy Foods and Beverages (HFS-302), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202-205-9175

    Pasteurized Milk Ordinance

    1999

    States

    Milk Safety Branch (HFS-626), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202- 205-9175

    Guidelines for Determining Metric Equivalents of October 1, 1993

    Food Industry

    Office of Nutritional Products, Labeling, and Dietary Household Measures

    Supplements, Food and Drug Administration (HFS-800), 200 C St. SW., Washington, DC 20204, 202-205-4561

    List of Food Defect Action Levels (DALs)

    1995

    Food and Animal Feed Industries

    Industry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-5251

    Action Levels for Poisonous or Deleterious Substances 1995

    Food and Animal Feed Industries

    Do in Human Food and Feed (Also Found in CPGs)

    FDA Food Code

    1999

    States

    National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, 703-487-4650

    Seafood List

    1993

    Seafood Industry

    Superintendent of Documents, Government Printing Office, Washington, DC 20402, 202-512-1800

    Manual of Operations National Shellfish Sanitation 1992

    States

    Office of Seafood (HFS-407), Shellfish Sanitation Branch, 200 C St. SW., Washington, DC 20204, 202-418-3150

    [[Page 53916]]

    Fish and Fisheries Product Hazards and Control Guide 1996

    Seafood Industry

    Do

    Guidance for Submitting Requests Under 21 CFR 170.39, 1996

    Food Packaging Industry

    Office of Premarket Approval, Food and Drug Administration Threshold of Regulation for Substances Used in Food

    (HFS-200), 200 C St. SW., Washington, DC 20204, 202-418- Articles

    3100

    Guidelines for the Preparation of Petition

    1996

    Food Ingredient or Packaging Industry Do Submissions

    Guideline for Approval of Color Additives in Contact 1996

    Color or Contact Lens Industry

    Do Lenses Intended as Colors

    FDA Recommendations for Submission of Chemical and February 1993

    Color Additives Industry

    Do Technological Data on Color Additives for Food, Drugs or Cosmetics Use

    Points to Consider for the Use of Recycled Plastics December 1992

    Food Packaging Industry

    Do in Food Packaging: Chemistry Considerations

    Recommendations for Submission of Chemical and

    May 1993

    Food Packaging Industry

    Do Technological Data for Direct Food Additive and GRAS Food Ingredient Petitions

    Recommendations for Chemistry Data for Indirect Food June 1995

    Food Packaging Industry

    Do Additive Petitions

    Enzyme Preparations: Chemistry Recommendations for January 1993

    Food Enzyme Industry

    Do Food Additive and GRAS Affirmation Petitions

    Estimating Exposure to Direct Food Additive and

    September 1995

    Food and Food Ingredient Industry

    Do Chemical Contaminants in the Diet

    Toxicological Principles for the Safety Assessment of 1982

    Petitioners for Food or Color Additives National Technical Information Service (NTIS), 5285 Port Direct Food Additives and Color Additives Used in

    Royal Rd., Springfield, VA 2216, (NT IS Order No. PR-83- Food (also known as Redbook I)

    170696

    Environmental Assessment Technical Handbook

    March 1987

    Petitioners for Food or Color Additives Do (NTIS Order No. PB87175345-AS, A-01)

    Color Additive Petitions Information and Guidance 1996

    Petitioners for Color Additives

    Office of Premarket Approval, Food and Drug Administration (HFS-200), 200 C St. SW., Washington, DC 20204, 202-418- 3100

    Toxological Testing of Food Additives

    1983

    Petitioners for Food or Color Additives Do

    List of Products for Each Product Category

    October 8, 1992

    Food Industry

    Office of Nutritional Products, Labeling, and Dietary Supplements (HFS-800), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4561

    Label Declaration of Allergenic Substances in Foods; June 10, 1996

    Food Industry

    Do Notice to Manufacturers

    Guidance on Labeling of Foods That Need Refrigeration February 24, 1997

    Food Industry

    Do by Consumers

    Guidelines Concerning Notification and Testing of 1985

    Infant Formula Manufacturers

    Do Infant Formula

    [[Page 53917]]

    Guidelines for the Evaluation of Safety and

    1988

    Infant Formula Manufacturers

    Do Suitability of New Infant Formulas for Feeding Preterm Infants

    Clinical Testing of Infant Formulas With Respect to 1988

    Infant Formula Manufacturers

    Do Nutritional Suitability for Term Infants

    Guidelines for the Evaluation of the Safety and

    1990

    Infant Formula Manufacturers

    Do Suitability of Infant Formulas for Feeding Infants With Allergic Diseases

    Guidelines for the Clinical Evaluation of New

    1987

    Infant Formula Manufacturers

    Do Products Used in the Dietary Management of Infants, Children and Pregnant Women With Metabolic Disorders

    Guidance Document for Arsenic (Trace Elements in January 1993

    States

    Office of Seafood, Food and Drug Administration (HFS-400), Seafood)

    200 C St. SW., Washington, DC 20204, 202-418-3150, Internet: FDA Home Page Http://vm.cfsan.fda.gov/list.html

    Guidance Document for Cadmium (Trace Elements in January 1993

    States

    Do Seafood)

    Guidance Document for Chromium (Trace Elements in January 1993

    States

    Do Seafood)

    Guidance Document for Lead (Trace Elements in

    August 1993

    States

    Do Seafood)

    Guidance Document for Nickel (Trace Elements in

    January 1993

    States

    Do Seafood)

    Guidance on Consultation Procedures for Foods Derived October 1997

    Regulated Industry

    Office of Premarket Approval (HFS-200), 200 C St. SW., From New Plant Varieties

    Washington, DC 20204, 202-418-3100, Internet: FDA Home Page Http://vm.cfsan.fda.gov

    FDA's Policy for Foods Developed by Biotechnology 1995

    Food Industry

    Do

    Bovine Spongiform Encephalopathy (BSE) in Products 1997

    Food Industry

    Office of Plant and Dairy Foods and Beverages (HFS-302), for Human Use

    Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202-205-9175, Internet: FDA Home Page Http://www.fda.gov/opacom/morechoices/industry/ guidance/gelguide.htm

    Interim Guidance on the Voluntary Labeling of Milk February 1994

    Regulated Industry

    Office of Nutritional Products, Labeling, and Dietary and Milk Products That Have Not Been Treated With

    Supplements (HFS-800), Food and Drug Administration, 200 C Recombinant Bovine Somatropin

    St. SW., Washington, DC 20204, 202-205-4168

    Shellfish Sanitation Model Ordinance

    1995

    States

    Shellfish Program Implementation Branch, Division of Cooperative Programs, Office of Field Programs (HFS-628), 200 C St. SW., Washington, DC 20204, 202-205-8137

    Guide to Minimize Microbial Hazards for Fresh Fruits 1998

    Farmers and Food Packers

    Food Safety Initiative (HFS-32), Center for Food Safety and and Vegetables (Available in English, Spanish,

    Applied Nutrition, 200 C St. SW., Washington, DC 20204, or Portuguese, and French)

    jsaltsman@bangate.fda.gov

    [[Page 53918]]

    Iron-Containing Supplements and Drugs: Label Warning 1997

    Dietary Supplement Manufacturers: Small Office of Nutritional Products, Labeling, and Dietary and Unit Dose Packaging; Small Entity Compliance

    Entities

    Supplements (HFS-450), Center for Food Safety and Applied Guide

    Nutrition, 200 C St. SW., Washington, DC 20204

    Partial List of Enzyme Preparations That Are Used in 1998

    FDA Regulated Industry

    Office of Premarket Approval (HFS-200), Center for Food Foods

    Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204

    Partial List of Microorganisms and Microbial-Derived 1998

    FDA Regulated Industry

    Do Ingredients That Are Used in Food

    Fish and Fishery Products Hazards and Controls Guide, January 1998

    FDA Regulated Industry

    Office of Seafood (HFS-400), Center for Food Safety and 2d Edition

    Applied Nutrition, 200 C St. SW., Washington, DC 20204

    HACCP Regulations for Fish and Fishery Products: 1998

    FDA Regulated Industry

    Do Questions and Answers

    Notification of a Health Claim or Nutrient Content 1998

    FDA Regulated Industry

    Office of Nutritional Products, Labeling, and Dietary Claim Based on an Authoritative Statement of a

    Supplements (HFS-150), Center for Food Safety and Applied Scientific Body

    Nutrition, 200 C St. SW., Washington, DC 20204

    FDA Nutrition Labeling Manual, A Guide for Developing March 1998

    FDA Regulated Industry

    Do and Using Data Bases

    HACCP Regulation for Fish and Fishery Products:

    January 1999

    Seafood Processors

    Office of Seafood (HFS-400), Center for Food Safety and Questions and Answers, Issue Three, Revised January

    Nutrition, 200 C St. SW., Washington, DC 20204, Ellen 1999

    Nesheim, 202-418-3150

    Foods--Adulteration Involving Hard or Sharp Foreign February 1999

    FDA Field Offices

    Office of Plant and Dairy Foods and Beverages (HFS-300), Objects (CPG)

    Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204

    Food Additive Petition Expedited Review

    January 1999

    Guidance for Industry and Center for Robert L. Martin (HFS-215), OPA/CFSAN/FDA, 200 C St. SW., Food Safety and Applied Nutrition Staff Washington, DC 20204, 202-418-3074, premarkt@cfsan.fda.gov or http://vm.cfsan.fda.gov/6dms/opa-expe.html

    Use of Antibiotic Resistance Marker Genes in

    September 1998

    Guidance for Industry

    Nega Beru (HFS-206), OPA/CFSAN/FDA, 200 C St. SW., Transgenic Plants

    Washington, DC 20204, 202-418-3097, premarkt@cfsan.fda.gov or http://vm.cfsan.fda.gov//6dms/opa-armg.html

    Guidance: Channels of Trade Policy for Commodities December 2000

    Regulated Industry

    Office of Plant and Dairy Foods and Beverages, Center for With Methyl Parathion Residues

    Food Safety and Applied Nutrition (HFS-300), FDA, 200 C St. SW., Washington, DC 20204, http://vm.cfsan.fda.gov/`dms

    Draft Guidance: Fumonisin Levels in Human Foods and June 2000

    Regulated Industry

    Do Animal Feeds

    Statement of Identity, Nutrition Labeling, and

    January 1999

    Small Business Entities

    Industry Activities Staff (HFS-565), Center for Food Safety Ingredient Labeling of Dietary Supplements Small

    and Applied Nutrition, FDA, 200 C St. SW., Washington, DC Entity Compliance Guide

    20204, 202-205-5251

    Significant Scientific Agreement in the Review of December 1999

    Regulated Industry

    Office of Nutritional Products, Labeling, and Dietary Health Claims for Conventional Foods and Dietary

    Supplements, Center for Food Safety and Applied Nutrition, Supplements (December 1999)

    FDA, 200 C St. SW., Washington, DC 20204, 202-205-4561

    [[Page 53919]]

    Antimicrobial Food Additives

    July 1999

    Regulated Industry

    Office of Premarket Approval (HFS-200), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-418-3100

    Preparation of Premarket Notifications for Food

    November 1999

    Regulated Industry

    Do Contact Substances: Chemistry Recommendations

    Preparation of Premarket Notifications for Food

    November 1999

    Regulated Industry

    Do Contact Substances: Toxicology Recommendations

    Guidance for Small Businesses: Submission of Comments October 1999

    Small Business Entities

    Division of Market Studies (HFS-726), Center for Food Safety for CFSAN Rulemaking

    and Applied Nutrition, Food and Drug Administration, Washington, DC 20204, 202-401-4590

    Warning and Notice Statement: Labeling of Juice

    September 1998

    Regulated Industry

    Office of Nutritional Products, Labeling, and Dietary Products Small Entity Compliance Guide

    Supplements, Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-4561

    Reducing Microbial Food Safety Hazards for Sprouted October 1999

    Regulated Industry

    Office of Plant and Dairy Foods and Beverages, Center for Seeds

    Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-4064

    Sampling and Microbial Testing of Spent Irrigation October 1999

    Regulated Industry

    Do Water During Sprout Production

    Seafood HACCP Transition Policy

    December 1999

    Regulated Industry

    Office of Seafood (HFS-400), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-3150

    FDA Recommendations for Sampling and Testing Yellow January 19, 2001

    Regulated Industry

    Office of Plant and Dairy Foods and Beverages, Center for Corn Shipments for Cry9C Protein Residues

    Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-4064

    Draft Guidance: Voluntary Labeling Indicating Whether January 2001

    Regulated Industry

    Office of Premarket Approval (HFS-200), Center for Food Foods Have or Have Not Been Developed Using

    Safety and Applied Nutrition, FDA, 200 C St. SW., Bioengineering

    Washington, DC 20204, 202-418-3100

    Bacteriological Analytical Manual

    2001

    Regulated Industry

    Do

    Importation of PMO Defined Dairy Products

    April 11, 2000

    Dairy Industry

    Milk Safety Branch (HFS-626), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202- 205-9175

    Draft Guidance: Apple Juice, Apple Juice

    June 2000

    Juice Industry

    Office of Plant and Dairy Foods and Beverages, Center for Concentrates, and Apple Juice Products--Adulteration

    Food Safety and Applied Nutrition, FDA, 200 C St. SW., with Patulin

    Washington, DC 20204, 202-205-4064

    Draft Guidance for Industry on Refusal of Inspection November 2000

    Seafood Industry

    Office of Seafood (HFS-400), Food and Drug Administration, or Access to HACCP Records Pertaining to the Safe

    200 C St. SW., Washington, DC 20204, 202-205-3150 and Sanitary Processing of Fish and Fishery Products

    [[Page 53920]]

    Withdrawals

    How to Obtain A Hard Copy of the Document (Name and Address, Name of Document

    Date of Issuance/Date Withdrawn Intended User or Regulatory Activity

    Phone, Fax, E-Mail or Internet)

    FDA Nutrition Labeling Manual: A Guide for Developing 1993/June 2001

    Food Industry

    Office of Nutritional Products, Labeling, and Dietary and Using Databases (Replaced by 1998 update with

    Supplements, Food and Drug Administration (HFS-800), 200 C the same title.)

    St. SW., Washington, DC 20204, 202-205-4561

    Fabrication of Single Service Containers and Closures 1995/June 2001

    States

    Milk Safety Branch, Center for Food Safety and Applied for Milk and Milk Products (Incorporated into

    Nutrition, Food and Drug Administration, 200 C St. SW., Pasteurized Milk Ordinance as an appendix.)

    Washington, DC 20204, 202-205-9175

  6. Guidance Documents Issued by the Center for Veterinary Medicine (CVM)

    Name of Document

    Date of Issuance

    Intended User or Regulatory Activity

    How to Obtain a Hard Copy of the Document

    Guidance for Industry: Effectiveness of

    September 2000

    Animal Drug Industry

    Internet via: http://www.fda.gov/cvm Communications Staff Anthelmintics: Specific Recommendations for Equine

    (HFV-12), FDA/CVM, 7500 Standish Pl., Rockville, MD 20855, (VICH GL15)--Draft

    301-827-4582, FAX 301-594-1831

    Guidance for Industry: Effectiveness of

    September 2000

    Do

    Do Anthelmintics: Specific Recommendations for Porcine (VICH GL16)--Draft

    Guidance for Industry: Effectiveness of

    September 2000

    Do

    Do Anthelmintics: Specific Recommendations for Canine (VICH GL19)--Draft

    Guidance for Industry: Effectiveness of

    December 2000

    Do

    Do Anthelmintics: Specific Recommendations for Feline (VICH GL20)--Draft

    Guidance for Industry: Effectiveness of

    December 2000

    Do

    Do Anthelmintics: Specific Recommendations for Poultry (VICH GL21)--Draft

    Guidance for Industry: Safety Studies for Veterinary December 2000

    Do

    Do Drug Residues in Human Food: Reproduction Studies (VICH GL22)--Draft

    Guidance for Industry: Safety Studies for Veterinary December 2000

    Do

    Do Drug Residues in Human Food: Genotoxicity Studies (VICH GL23)--Draft

    Guidance for Industry: Pharmacovigilance of

    December 2000

    Do

    Do Veterinary Medicinal Products: Management of Adverse Event Reports (AERs)(VICH GL24)--Draft

    Guidance for Industry: Efficacy of Anthelmintics: March 2000

    Do

    Do General Recommendations (VICH GL7)--Final

    Guidance for Industry: Efficacy of Anthelmintics: March 2000

    Do

    Do Specific Recommendations for Bovines (VICH GL12)-- Final

    Guidance for Industry: Efficacy of Anthelmintics: March 2000

    Do

    Do Specific Recommendations for Ovines (VICH GL13)-- Final

    Guidance for Industry: Efficacy of Anthelmintics: March 2000

    Do

    Do Specific Recommendations for Caprines (VICH GL14)-- Final

    [[Page 53921]]

    Guidance for Industry: Environmental Impact

    March 2000

    Do

    Do Assessments (EIAs) for Veterinary Medicinal Products (VMPs)--Phase I (VICH GL6)--Final

    Guidance for Industry: Stability Testing of New

    March 2000

    Do

    Do Biotechnological/Biological Veterinary Medicinal Products (VICH GL17)--Final

    Guidance for Industry: Good Clinical Practices (VICH May 2000

    Do

    Do GL9)--Final

    Guidance for Industry: Impurities: Residual Solvents May 2000

    Do

    Do in New Veterinary Medicinal Products, Active Substances and Excipients (VICH GL18)--Final

    Guidance for Industry: How to Use E-Mail to Submit a February 2000

    Do

    Do Notice of Final Disposition of Animals Not Intended for Immediate Slaughter (NFDAs)

    Guidance for Industry: How to Use E-Mail to Submit a February 2000

    Do

    Do Notice of Intent to Slaughter for Human Food Purposes

    Guidance for Industry: How to Use E-Mail to Submit a February 2000

    Do

    Do Request for a Meeting or Teleconference to the Office of New Animal Drug Evaluation

    How to Use E-Mail to Submit Information to the Center February 2000

    Do

    Do for Veterinary Medicine--Final

    Dioxin in Anti-Caking Agents Used in Animal Feed and Revised April 2000

    Do

    Do Feed Ingredients

    Guidance for Industry: Fumonisin Levels in Human June 2000

    Do

    Do Foods and Animal Feeds--Draft

    The Use of Published Literature in Support of New November 2000

    Do

    Do Animal Drug Approval

    Guidance for Industry: Bioequivalence Guidance

    Revised October 2000

    Do

    Do

    Guidance for Industry #124: Voluntary Labeling

    January 2001

    Do

    Do Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering--Draft

    Guidance for Industry #126: BACPAC I: Intermediates February 2001

    Do

    Do in Drug Substance Synthesis Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation, February 2001

    Guidance for Industry #120: Veterinary Feed Directive March 2001

    Do

    Do Regulation

    Guidance for Industry #121: Expedited Review for New March 2001

    Do

    Do Animal Drug Applications for Human Pathogen Reduction Claims

    [[Page 53922]]

    Guidance for Industry and Reviewers: How the Center March 2001

    Do

    Do for Veterinary Medicine Intends to Handle Deficient Submissions FiledDuring the Investigation of a New Animal Drug--Draft

  7. Guidance Documents Issued by the Office of Policy (OP)

    Name of Document

    Date of Issuance

    Intended User or Regulatory Activity

    How to Obtain a Hard Copy of the Document

    Draft Guidance for Industry; Exports and Imports June 12, 1998

    Regulated Industry

    Internet via www.fda.gov/opacom/fedregister/frexport.html or Under the FDA Export Reform and Enhancement Act of

    63 FR 32219, June 12, 1998, or Office of Policy, 301-827- 1996

    3360

    Direct Final Rule Guidance

    November 21, 1997

    FDA Personnel

    Internet via www.fda.gov/opacom/morechoices/industry/ guidance.htm or 62 FR 62467, November 21, 1997, or Office of Policy, 301-827-3480

    International Harmonization; Policy on Standards October 1995

    FDA Personnel and Regulated Industry 60 FR 53078, October 11, 1995, or Office of Policy, 301-827- 3360

    Withdrawals

    Name of Document

    Date of Issuance

    Intended User or Regulatory Activity

    Date Withdrawn

    FDA's Development, Issuance and Use of Guidance

    February 27, 1997

    FDA Personnel and Regulated Industry September 19, 2000 Documents

    Small Entities Compliance Guide On: Regulations To February 1997

    Regulated Industry

    March 31, 2000 Restrict the Sale and Distribution of Cigarettes and Smokeless Tobacco in Order to Protect Children and Adolescents (21 CFR Part 897)

    Children and Tobacco--Frequently Asked Questions July 1997

    Regulated Industry

    March 31, 2000 About the New Regulations (Draft)

    Children and Tobacco--A Retailers Guide to the New October 1997

    Regulated Industry

    March 31, 2000 Federal Regulations

    Children and Tobacco--A Guide to the New Federal October 1997

    Regulated Industry

    March 31, 2000 Regulations

  8. Guidance Documents Issued by the Office of Regulatory Affairs (ORA)

    Name of Document

    Date of Issuance

    Intended User or Regulatory Activity

    How to Obtain a Hard Copy of the Document

    Compliance Policy Guide Manual--Compliance Policy August 2000

    FDA Staff

    National Technical Information Service (NTIS) 5285 Port Guidance for FDA Staff (Replaces Compliance Policy

    Royal Rd., Springfield, VA 22161 or Internet at: Guide--January 1996)

    www.fda.gov/ora/cpgm/default.html

    Compliance Policy Guide, New Sec. 615.115 Extra-Label April 2001

    Do

    Division of Compliance Policy (HFC-230), Office of Use of Medicated Feeds for Minor Species

    Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420 or via Internet at: www.fda.gov/ora/compliance--;ref/rpm/rpmtc.html

    [[Page 53923]]

    Compliance Policy Guide, New Sec. 555.250 Statement April 2001

    Do

    Do of Policy for Labeling and Preventing Cross-Contact of Common Food Allergens

    Compliance Policy Guide, Reformat Sec. 220.100

    March 2001

    Do

    Do Interstate Shipment of Biological Products for Use in Medical Emergencies

    Compliance Policy Guide, Reformat Sec. 270.100 Final March 2001

    Do

    Do Container Labels--Allergenic Extracts Containing Glycerin; Reporting Changes

    Compliance Policy Guide, Draft Sec. 230.150, Blood December 2000

    Do

    Do Donor Incentives

    Compliance Policy Guide, Draft Distributor Medical August 28, 1997

    FDA Staff Personnel and Regulated

    Do Internet at: www.fda.gov/ora/compliance--;ref/cpg-- Reporting

    Industry

    ;mdr3.txt

    Compliance Policy Guide Sec. 7150.09 Fraud,

    July 1991

    FDA Staff and Regulated Industry

    Do Internet at: www.fda.gov/ora/compliance--;ref/aip-- Statements of Material Facts, Bribery, and Illegal

    ;page.html Gratuities

    Medical Device Warning Letter Pilot

    March 8, 1999

    FDA Staff and Regulated Industry

    Do Internet at: www.fda.gov/ohrms/Dockets/98fr/030899e.pdf

    Glossary of Computerized System and Software

    August 1995

    Do

    National Technical Information Service (NTIS) 5285 Port Development Terminology

    Royal Rd., Springfield, VA 22161 (NTIS Order No. PB96- 127352) or via Internet: www.fda.gov/ora/inspect--;ref/igs/ iglist.html

    Guidelines for Entry Review of Radiation-Emitting March 12, 1999

    FDA Staff

    Division of Import Operations and Policy (HFC-170), Office Electronic Devices

    of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-1218

    Laboratory Procedures Manual

    June 1994

    Do

    Division of Field Science (HFC-141), Food and Drug Administration, 5600 Fishers Lane, rm. 12-41, Rockville, MD 20857, or Internet at: www.fda.gov/ora/science--;ref/lpm/ lpmtc.html

    Laboratory Procedures Manual Chapter X, New: Method May 1999

    Do

    Do Validation Samples

    Memorandum: ORA Investigational Strategy on Gamma- May 15, 2000

    Do

    Division of Emergency and Investigational Operations (HFC- Butyrolactone (GBL) and Related Products

    130), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, Not Available on the Internet

    Investigations Operations Manual

    January 2001

    Do

    National Technical Information Service (NTIS) 5285 Port Royal Rd., Springfield, VA 22161 (NTIS Order No. PB2001- 913399 and Internet at www.fda.gov/ora/inspect--;ref/iom/ default.htm)

    Medical Devices: Draft Guidance entitled ``Guidance Released for Comment June 8, 1999 FDA Staff

    Division of Compliance Policy (HFC-230), Office of for FDA Staff on Civil Money Penalty Policy''

    Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420, or Internet at: http://www.fda.gov/ohrms/dockets/98fr/060899e.pdf

    [[Page 53924]]

    Regulatory Procedures Manual Update/New Subchapter 5 April 19, 2001

    Do

    Do Internet at: www.fda.gov/ora/compliance--;ref/rpm/ Civil Money Penalty Reduction Policy for Small

    rpmtc.html Entities

    Regulatory Procedures Manual New RPM Subchapter: January 2001

    Do

    Do Internet at: www.fda.gov/ora/compliance--;ref/rpm/ Communication Concerning Assessment of Civil

    rpmtc.html Monetary Penalties by U.S. Customs Service in Cases Involving Imported Food

    Regulatory Procedures Manual: Update, New Subchapter March 1998

    Do

    Division of Compliance Policy (HFC-230), Office of Application Integrity Policy

    Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420 or via Internet at: www.fda.gov/ora/compliance--;ref/rpm/rpmtc.html

    Regulatory Procedures Manual: Update/Revision

    April 1998

    Do

    Do Subchapter/Priority Enforcement Strategy for Problem Importers

    Regulatory Procedures Manual: Update/Revision

    April 1998

    Do

    Do Subchapter/Import Procedures

    Regulatory Procedures Manual: Update/Revision

    April 1998

    FDA Staff

    Do Subchapter/Notice of Sampling

    Regulatory Procedures Manual: Update New Subchapter/ May 1998

    Do

    Do Granting and Denying Transportation and Exportation (T&E) Entries

    Regulatory Procedures Manual: Update/Revision

    June 1998

    Do

    Do Internet at: www.fda.gov/ora/compliance--;ref/rpm--;new2/ Subchapter/Seizure

    ch6.html

    Regulatory Procedures Manual: Update/Revision

    June 1998

    Do

    Do Internet at: www.fda.gov/ora/compliance--;ref/new2/ Subchapter/Supervisory Charges

    ch9chgs.html

    Regulatory Procedures Manual: New Subchapter: Civil July 1998

    Do

    Do Internet at: www.fda.gov/ora/compliance--;ref/ Penalties--Electronic Product Radiation Control

    ch6civpen.html

    Regulatory Procedures Manual: Update/Revision,

    March 21, 2000

    Do

    Do Internet at: www.fda.gov/ora/compliance--;ref/rpm--;new2/ Chapter 4, Subchapter/Warning Letters

    ch4.html

    Regulatory Procedures Manual New Chapter 9,

    January 2001

    Do

    Do Internet at: www.fda.gov/ora/compliance--;ref/rpm--;new2/ Communication Concerning Assessment of Civil

    ch9civmonpen.html Monetary Penalties by U.S. Customs in Cases Involving Imported Food

    Regulatory Procedures Manual New Chapter 9, Secured January 2001

    Do

    Do Internet at: www.fda.gov/ora/compliance--;ref/rpm--;new2/ Storage

    ch9securedstorage.html

    Guide to Inspections of Bulk Pharmaceutical Chemicals May 1994

    Do

    National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, (NTIS Order No. PB96- 127154) or via Internet at: www.fda.gov/ora/inspect)--;ref/ igs/iglist.html

    Guide to Inspections of Pharmaceutical Quality

    July 1993

    Do

    Do (NTIS Order No. PB96-127279) or via Internet at: Control Laboratories

    www.fda.gov/ora/inspect--;ref/igs/iglist.html

    [[Page 53925]]

    Guide to Inspections of Microbiological

    July 1993

    Do

    Do (NTIS Order No. PB96-127287) or via Internet at: Pharmaceutical Quality Control Laboratories

    www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Guide to Inspections of Validation of Cleaning

    July 1993

    Do

    Do (NTIS Order No. PB96-127246) or via Internet at: Processes

    www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Guide to Inspections of Lyophilization of Parenterals July 1993

    Do

    Do (NTIS Order No. PB96-127253) or via Internet at: www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Guide to Inspections of High Purity Water Systems July 1993

    Do

    Do (NTIS Order No. PB96-127261) or via Internet at: www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Guide to Inspections of Dosage Form Drug

    October 1993

    Do

    Do (NTIS Order No. PB96-127212) or via Internet at: Manufacturers--CGMPs

    www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Guide to Inspections of Oral Solid Dosage Forms Pre/ January 1994

    Do

    Do (NTIS Order No. PB96-127345) or via Internet at: Post Approval Issues for Development and Vaccination

    www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Guide to Inspections of Topical Drug Products

    July 1994

    Do

    Do (NTIS Order No. PB96-127394) or via Internet at: www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Guide to Inspections of Sterile Drug Substance

    July 1994

    Do

    Do (NTIS Order No. PB96-127295) or via Internet at: Manufacturers

    www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Guide to Inspections of Oral Solutions and

    August 1994

    Do

    Do (NTIS Order No. PB96-127147) or via Internet at: Suspensions

    www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Guide to Inspections of Nutritional Labeling and February 1995

    Do

    Do (NTIS Order No. PB96-127378) or via Internet at: Education Act (NLEA) Requirements

    www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Guide to Inspections of Interstate Carriers and

    April 1995

    Do

    Do (NTIS Order No. PB96-127386) or via Internet at: Support Facilities

    www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Guide to Inspections of Dairy Product Manufacturers April 1995

    Do

    Do (NTIS Order No. PB96-127329) or via Internet at: www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Guide to Inspections of Miscellaneous Foods Vol. 1 May 1995

    Do

    Do (NTIS Order No. PB97-127220) or via Internet at: www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Guide to Inspections of Miscellaneous Foods Vol. 11 September 1996

    Do

    Do (NTIS Order No. PB97-196133) or via Internet at: www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Guide to Inspections of Low Acid Canned Foods

    November 1996

    Do

    Do (NTIS Order No. PB97-196141) or via Internet at: Manufacturers, Part 1--Administrative Procedures/

    www.fda.gov/ora/inspect--;ref/igs/iglist.html Scheduled Processes

    Guide to Inspections of Cosmetic Product

    February 1995

    Do

    Do (NTIS Order No. PB96-127238) or via Internet at: Manufacturers

    www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Guide to Inspections of Low Acid Canned Foods

    April 1997

    Do

    Do (NTIS Order No. PB97-196158) or via Internet at: Manufacturers, Part 2--Processes/ Procedures

    www.fda.gov/ora/inspect--;ref/igs/iglist.html

    [[Page 53926]]

    Guide to Inspections of Low Acid Canned Foods

    July 2001

    FDA Staff

    Do (NTIS Order No. PB00-133795) Manufacturers, Part 3--Container Closurers

    Guide to Inspections of Blood Banks

    September 1994

    Do

    Do (NTIS Order No. PB96-127303) or via Internet at: www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Guide to Inspections of Source Plasma Establishments December 1994

    Do

    Do (NTIS Order No. PB96-127360) or via Internet at: www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Guide to Inspections of Infectious Disease Marker June 1996

    Do

    Do (NTIS Order No. PB96-199476) or via Internet at: Testing Facilities

    www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Biotechnology Inspections Guide

    November 1991

    Do

    Do (NTIS Order No. PB96-127402) or via Internet at: www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Guide to Inspections of Computerized Systems in Drug February 1983

    Do

    Do (NTIS Order No. PB96-127337) or via Internet at: Processing

    www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Guide to Inspections of Foreign Medical Device

    September 1995

    Do

    Do (NTIS Order No. PB96-127311) or via Internet at: Manufacturers

    www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Guide to Inspections of Foreign Pharmaceutical

    May 1996

    Do

    Do (NTIS Order No. PB96-199468) or via Internet at: Manufacturers

    www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Mammography Quality Standards Act (MQSA) Auditors January 1998

    Do

    Do (NTIS Order No. PB98-127178) or via Internet at: Guide

    www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Guide to Inspections of Electromagnetic Compatibility December 1997

    Do

    Do (NTIS Order No. PB98-127152) or via Internet at: Aspects of Medical Device Quality Systems

    www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Guide to Inspections of Acidified Food Manufacturers May 1998

    Do

    http://www.fda.gov/ora/inspect--;ref/igs/acidfgde.htm

    Guide to Inspection of Aseptic Processing and

    February 2001

    Do

    Division of Emergency and Investigational Operations (HFC- Packaging for the Food Industry

    130), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301- 443-1240

    Guide to Inspections of Grain Product Manufacturers March 1998

    Do

    (NTIS Order No. PB-98-137128) or via Internet at: www.fda.gov/ora/inspect--;ref/igs/iglist.html

    Guide to Bioresearch Monitoring Inspections of In February 1998

    Do

    Do Internet at: www.fda.gov/ora/inspect--;ref/igs/ Vitro Devices

    iglist.html

    Guide to Inspections of Viral Clearance Processes for March 1998

    Do

    Do Internet at: www.fda.gov/ora/inspect--;ref/igs/ Plasma Derivatives

    iglist.html

    Guide to Trace Back of Fresh Fruits and Vegetables April 2001

    Do

    Do Internet at: www.fda.gov/ora/inspect--;ref/igs/ Implicated in Epidemiological Investigations

    iglist.html

    Guide to Inspections of Computerized Systems in the August 1998

    Do

    Do Internet at: www.fda.gov/ora/inspect--;ref/igf/ Food Processing Industry

    foodcomp.html

    Guide to International Inspections and Travel,

    July 1999

    Do

    Do Revision not available on Internet Revision (Formerly, FDA/ORA International Inspection Manual and Travel Guide)

    [[Page 53927]]

    Guide to Inspections of Quality Systems

    August 1999

    Do

    Do Internet at: www.fda.gov/ora/inspect--;ref/igs/qsit/ QSITGUIDE.PDF

    Guide to Inspection of Firms Producing Food Products April 2001

    Do

    Do Internet at: http://www.fda.gov/ora/inspect--;ref/igs/ Susceptible to Contamination with Allergenic

    iglist.html Ingredients

    Computerized Systems Used in Clinical Trials

    April 1999

    Do

    Do Internet at: www.fda.gov/ora/compliance--;ref/bimo/ ffinalact.html

    Compliance Program 7348.001: Bioresearch Monitoring, October 1, 1999

    D0

    Do Internet at: www.fda.gov/ora/compliance--;ref/Bimo/7348-- Human Drugs, In Vivo Bioequivalence

    ;001/default.html

    Good Laboratory Practice Program (Nonclinical

    October 1, 1991

    Do

    Division of Compliance Policy (HFC-230), Office of Laboratories) 7348.808A; EPA Data Audit Inspections

    Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420

    Guideline for the Monitoring of Clinical

    January 1988

    FDA Regulated Industry

    Division of Compliance Policy (HFC-230), Office of Investigators

    Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420

    Small Business Guide to FDA (FDA 96-1092)

    January 1, 1996

    Do

    Federal-State Relations (HFC-150), Office of Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2905 Internet at: www.fda.gov/ ora/indust--;assit/default.htm

    Compliance Program 7348.808 Bioresearch Monitoring: Revised August 17, 1998

    FDA Staff

    Do Internet at: www.fda.gov/ora/compliance--;ref/bimo/ Good Laboratory Practices (Nonclinical)

    default.html

    Compliance Program 7348.809 Bioresearch Monitoring: August 18, 1994

    Do

    Do Institutional Review Board

    Compliance Program 7348.810: Sponsors, Contract

    Revised October 30, 1998

    Do

    Do Research Organizations and Monitors

    Good Laboratory Practice Regulations Management

    August 1979

    Do

    Do Internet at: www.fda.gov/ora/compliance--;ref/bimo/ Briefings

    default.html

    Draft: Guidance for Institutional Review Boards, March 31, 2000

    FDA Regulated Industry

    Do Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research

    Dated: October 9, 2001. Margaret M. Dotzel, Associate Commissioner for Policy.

    [FR Doc. 01-26650Filed10-23-01; 8:45 am]

    BILLING CODE 4160-01-S