Department of Health and Human Services, Food and Drug Administration,
[Federal Register: July 21, 2000 (Volume 65, Number 141)]
[Notices]
[Page 45427-45510]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jy00-120]
[[Page 45427]]
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 45428]]
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 an annual comprehensive list of all guidance documents currently in use at the agency. We committed to publishing this list in our February 1997 ``Good Guidance Practices'' (GGP's), which set forth our policies and procedures for developing, issuing, and using guidance documents. This list is intended to inform the public of the existence and availability of all our current guidance documents.
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. We have provided information on where to obtain a single copy of any of the guidance documents listed in the specific Center's list of guidance documents.
FOR FURTHER INFORMATION CONTACT: LaJuana D. Caldwell, Office of Policy, Planning, and Legislation (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010.
SUPPLEMENTARY INFORMATION:
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Background
In the Federal Register of February 27, 1997 (62 FR 8961), we announced our GGP's--our policies and procedures for developing, issuing, and using guidance documents. We adopted the GGP's to ensure your involvement in the development of guidance documents and to enhance your understanding of the availability, nature, and legal effect of such guidance.
As part of our effort to ensure meaningful interaction with the public regarding guidance documents, we committed to publish an annual comprehensive list of guidance documents and quarterly updates that list all guidance documents that were issued and withdrawn during that quarter, including ``Level 2'' guidance documents.
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Plain Language in Guidance Documents
On June 1, 1998, the President instructed all Federal agencies to ensure the use of ``plain language'' in all new documents. As part of this initiative, We use the principles of ``plain language'' set forth by the President when writing our guidance documents. We seek your comments on the clarity of our guidances.
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How the List is Organized
The following comprehensive list of guidance documents represents all guidances currently in effect. This comprehensive list is maintained on the FDA Internet home page. We will update and publish this list in the Federal Register every year. We organized the guidance documents in this comprehensive list by the issuing Center or Office within FDA, and we further grouped them by 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. We also provide document numbers when they are available.
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Guidance Documents Issued by the Center for Biologics Evaluation and Research (CBER)
Grouped by Intended User or Name of Document
Date of Issuance
Regulatory 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 45429]]
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
Deferral of Donors Who Have Received Human November 25, 1987
Do
Do Pituitary-Derived Growth Hormone
[[Page 45430]]
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-1 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)
PTC in the Collection, Processing and Testing August 22, 1989
Do
Do of Ex Vivo Activated Mononuclear Leukocytes for Administration to Humans
[[Page 45431]]
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 Positive Tests 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 & 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 & 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
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
[[Page 45432]]
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 Reagents 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 Red December 16, 1992
Do
Do 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
Alternatives to Lot Release
July 20, 1993
Do
Do
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
[[Page 45433]]
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 IND's 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, (Publication 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 Blood Establishment Computer Software
March 31, 1994
Do
Do Manufacturers
To Sponsors of IND's 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
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)
[[Page 45434]]
Use of and FDA Cleared or Approved Sterile August 5, 1994
Do
Do Docking Device (STCD) in Blood Bank Practices (transmittal memo 8/12/94) (corrects 7/29/94 Memo)
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
To Blood Establishment Computer Software
February 10, 1995
Do
Do Manufacturers
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 August 27, 1982 FDA Memo:
March 10, 1995
Do
Do Requirements for 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
Reviewer Guidance, Computer Software
March 26, 1995
FDA Personnel
Do
[[Page 45435]]
Recommendations for the Deferral of Current and June 8, 1995
FDA Regulated Industry 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 HighRisk 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
Content and Format of Investigational New Drug November 1, 1995
FDA Regulated Industry Do Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products
Guidance Concerning Conversion to FDA-Reviewed November 13, 1995
Do
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
[[Page 45436]]
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
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)
[[Page 45437]]
To Manufacturers: HIV-1 Group O
July 31, 1996
Do
Do
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
Draft Public Health Service Guideline on
September 23, 1996
Do
Do Infectious Disease Issues in Xenotransplantation; Notice
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
The Food and Drug Administration's Development, February 27, 1997
FDA Regulated Industry Do Issuance, and Use of Guidance Documents
Proposed Approach to Regulation of Cellular and February 27, 1997
Do
Do Tissue-Based Products
PTC in the Manufacture and Testing of
February 28, 1997
Do
Do Monoclonal Antibody Products for Human Use
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
[[Page 45438]]
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
Do
Do Solvents
(Correction May 19, 1997)
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 Validatioin 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
Draft Guidance for Industry on Testing Limits August 1997
Do
Do in Stability Protocols for Standardized Grass Pollen Extracts
[[Page 45439]]
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
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
ICH Draft Guidance on Specifications: Test November 25, 1997
Do
Do Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
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
[[Page 45440]]
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 Carncinogenicity 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
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: Submitting and Reviewing May 1998
Do
Do Complete Responses to Clinical Holds
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
[[Page 45441]]
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
Draft Guidance for Industry: Recommendations July 1998
Do
Do for Collecting Red Blood Cells by Automated Apheresis Methods
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
Draft Guidance for Industry: Developing Medical October 1998
Do
Do Imaging Drugs and Biologics
Guidance for Industry: on Advisory Committees: October 1998
Do
Do Implementing Section 120 of the Food and Drug Administration Act of 1997
Draft Document: United States Industry
December 1997 (Released Do
Do Consensus Standard for the Uniform Labeling of November 1998) Blood and Blood Components Using ISBT 128
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
[[Page 45442]]
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
Guidance for Industry: Providing Regulatory January 1999
Do
Do Submissions in Electronic Format--General Considerations
Guidance for Industry: Population
February 1999
Do
Do Pharmacokinetics
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: 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
[[Page 45443]]
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
Draft Guidance for Industry: Monoclonal
May 1999
Do
Do Antibodies Used as Reagents in Drug Manufacturing
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
[[Page 45444]]
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
International Conference on Harmonisation Draft September 24, 1999
Do
Do Guidance; Choice of Control Group in Clinical Trials
Draft Guidance for Industry: Supplemental
November 1999
Do
Do Guidance on 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: 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 Harmonisation 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
[[Page 45445]]
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
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; E11: April 12, 2000
Do
Do Clinical Investigation of Medicinal Products in the Pediatric Population
International Conference on Harmonisation; April 21, 2000
Do
Do Draft Revised Guidance on Q1A(R) Stability Testing of New Drug Substances and Products
-
Guidance Documents Issued by the Center for Drug Evaluation and Research (CDER)
How to Obtain a Hard Copy of the Document Name of Document
Date of Issuance Grouped by Intended User (Name and Address, Phone, FAX, E-mail or or Regulatory Activity
Internet)
Accelerated Approval Products--Submission of
March 26, 1999
Advertising Draft
http://www.fda.gov/cder/guidance/index.htm Promotional Materials
Product Name, Placement, Size, and Prominence in March 12, 1999
Do
Do Advertising and Promotional Labeling
Promoting Medical Products in a Changing
January 5, 1998
Do
Do Healthcare Environment; Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs)
Aerosol Steroid Product Safety Information in January 12, 1998
Advertising
Do Prescription Drug Advertising and Promotional Labeling
[[Page 45446]]
Consumer-Directed Broadcast Advertisements
August 9, 1999
Do
Do
Antifungal (topical)
February 24, 1990
Biopharmaceutic Draft Do
Antifungal (vaginal)
February 24, 1990
Do
Do
Average, Population, and Individual Approaches to August 27, 1999
Do
Do Establishing Bioequivalence
Bioanalytical Methods Validations for Human
January 5, 1999
Do
Do Studies
Bioavailability and Bioequivalence Studies for June 2, 1999
Do
Do Nasal Aerosols and Nasal Sprays for Local Action
Bioavailability and Bioequivalence Studies for August 27, 1999
Do
Do Orally Administered Drug Products
Conjugated Estrogens, USP: LC-MS Method for Both March 9, 2000
Do
Do Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence
Food-Effect Bioavailability and Bioequivalence December 20, 1997
Do
Do Studies
Topical Dermatological Drug Product NDA's and June 18, 1998
Do
Do ANDA's--In Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated Studies
Waiver of In Vivo Bioavailability and
February 17, 1999
Do
Do Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Containing Certain Active Moieties/Active Ingredients
Buspirone Hydrochloride Tablets In Vivo
May 15, 1998
Biopharmaceutic
Do Bioequivalence and In Vitro Dissolution Testing
Cholestyramine Powder In Vitro Bioequivalence July 15, 1993
Do
Do
Cimetidine Tablets In Vivo Bioequivalence and In June 12, 1992
Do
Do Vitro Dissolution Testing
Clozapine (Tablets) In Vivo Bioequivalence and In November 15, 1996
Do
Do Vitro Dissolution Testing
Corticosteroids, Dermatologic (topical) In Vivo June 2, 1995
Do
Do
Diclofenac Sodium (tablets) In Vivo Bioequivalence October 6, 1994
Do
Do and In Vitro Dissolution Testing
Dissolution Testing of Immediate Release Solid August 25, 1997
Do
Do Oral Dosage Forms
Extended Release Oral Dosage Forms: Development, September 26, 1997
Do
Do Evaluation, and Application of In Vitro/In Vivo Correlations
Glipizide (Tablets) In Vivo Bioequivalence and In April 23, 1993
Do
Do Vitro Dissolution Testing
Glyburide Tablets In Vivo Bioequivalence and In April 23, 1993
Do
Do Vitro Dissolution Testing
Metaproterenol Sulfate and Albuterol Metered Dose June 27, 1989
Do
Do Inhalers In Vitro
[[Page 45447]]
Oral Extended (Controlled) Release Dosage Forms In September 9, 1993
Do
Do Vivo Bioequivalence and In Vitro Dissolution Testing
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 Procedure for Bioequivalence Studies July 1, 1992
Do
Do Using a Standard Two-Treatment Crossover Design
BACPAC I: Intermediates in Drug Substance
November 30, 1998
Chemistry Draft
Do Synthesis (Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation)
IND Meetings for Human Drugs and Biologics;
February 4, 2000
Do
Do Chemistry, Manufacturing, and Controls Information
IND's 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
Metered Dose Inhalers (MDI) and Dry Powder
November 19, 1998
Do
Do Inhalers (DPI) Drug Products; Chemistry, Manufacturing, and Controls Documentation
Monoclonal Antibodies Used as Reagents in Drug June 24, 1999
Do
Do Manufacturing
Nasal Spray and Inhalation Solution, Suspension, June 2, 1999
Do
Do and Spray Drug Products
Stability Testing of Drug Substances and Drug June 8, 1998
Do
Do Products
Submitting Supporting Chemistry Documentation in November 1, 1991
Do
Do Radiopharmaceutical Drug Applications
SUPAC-SS: Nonsterile Semisolid Dosage Forms
January 5, 1999
Do
Do Manufacturing Equipment Addendum
Tracking of NDA and ANDA Reformulations for Solid,
Do
Do Oral, Immediate Release Drug Products
Changes to an Approved Application for Specified July 24, 1997
Chemistry
Do Biotechnology and Specified Synthetic Biological Products
Changes to an Approved NDA or ANDA
November 23, 1999
Do
Do
Container Closure Systems for Packaging Human July 7, 1999
Do
Do Drugs and Biologics
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
[[Page 45448]]
FDA's Policy Statement for the Development of New May 1, 1992
Do
Do Stereoisomeric Drugs
Format and Content for the CMC Section of an
September 1, 1994
Do
Do Annual Report
Format and Content of the Chemistry, Manufacturing February 1, 1987
Do
Do and Controls Section of an Application
Format and Content of the Microbiology Section of February 1, 1987
Do
Do an Application
NDAs: Impurities in Drug Substances
February 25, 2000
Do
Do
PAC-ALTS: Postapproval Changes--Analytical Testing April 28, 1998
Do
Do Laboratory Sites
Reviewer Guidance: Validation of Chromatographic November 1, 1994
Do
Do 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 of February 1, 1987
Do
Do 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 Methods February 1, 1987
Do
Do Validation
Submitting Supporting Documentation in Drug
February 1, 1987
Do
Do Applications for the Manufacture of Drug Substances
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
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; Scale- June 13, 1997
Do
Do Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation
[[Page 45449]]
Acute Bacterial Exacerbation of Chronic
July 22, 1998
Clinical Antimicrobial Do Bronchitis; Developing Antimicrobial Drugs for
Draft Treatment
Acute Bacterial Meningitis; Developing
July 22, 1998
Do
Do Antimicrobial Drugs for Treatment
Acute Bacterial Sinusitis; Developing
July 22, 1998
Do
Do Antimicrobial Drugs for Treatment
Acute Otitis Media; Developing Antimicrobial Drugs July 22, 1998
Do
Do for Treatment
Bacterial Vaginosis; Developing Antimicrobial July 22, 1998
Do
Do Drugs for Treatment
Catheter-Related Bloodstream Infections--
October 18, 1999
Do
Do Developing Antimicrobial Drugs for Treatment
Clinical Considerations for Accelerated and
September 1, 1999
Do
Do Traditional Approval of Antiretroviral Drugs Using Plasma HIV RNA Measurements
Community Acquired Pneumonia; Developing
July 22, 1998
Do
Do Antimicrobial Drugs for Treatment
Complicated Urinary Tract Infections and
July 22, 1998
Do
Do Pylonephritis; Developing Antimicrobial Drugs for Treatment
Developing Antimicrobial Drugs-General
July 22, 1998
Do
Do Considerations for Clinical Trials
Empiric Therapy of Febrile Neutropenia; Developing July 22, 1998
Do
Do Antimicrobial Drugs for Treatment
Evaluating Clinical Studies of Antimicrobials in February 17, 1997
Do
Do the Division of Anti-Infective Drug Products
Lyme Disease; Developing Antimicrobial Drugs for July 22, 1998
Do
Do Treatment
Nosocomial Pneumonia; Developing Antimicrobial July 22, 1998
Do
Do Drugs for Treatment
Secondary Bacterial Infections of Acute
July 22, 1998
Do
Do Bronchitis; Developing Antimicrobial Drugs for Treatment
Streptococcal Pharyngitis and Tonsillitis;
July 22, 1998
Do
Do Developing Antimicrobial Drugs for Treatment
Uncomplicated and Complicated Skin and Skin
July 22, 1998
Do
Do Structure Infections; Developing Antimicrobial Drugs for Treatment
Uncomplicated Gonorrhea--Cervical, Urethral,
July 22, 1998
Do
Do Rectal, and/or Pharyngeal; Developing Antimicrobial Drugs for Treatment
Uncomplicated Urinary Tract Infections; Developing July 22, 1998
Do
Do Antimicrobial Drugs for Treatment
Vuvlovaginal Candidiasis; Developing Antimicrobial July 22, 1998
Do
Do Drugs for Treatment
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)
[[Page 45450]]
Preclinical Development of Antiviral Drugs
November 1, 1990
Do
Do
Abuse Liability Assessment
July 1, 1990
Clinical Medical Draft Do
Clinical Development Programs for Drugs, Devices, July 15, 1999
Do
Do and Biological Products Intended for the Treatment of Osteoarthritis (OA)
Clinical Evaluation of Anti-Anginal Drugs
January 1, 1989
Do
Do
Clinical Evaluation of Anti-Arrhythmic Drugs
July 1, 1985
Do
Do
Clinical Evaluation of Antihypertensive Drugs May 1, 1988
Do
Do
Clinical Evaluation of Drugs for the Treatment of December 1, 1987
Do
Do Congestive Heart Failure
Clinical Evaluation of Drugs for Ulcerative
Do
Do Colitis (3rd draft)
Clinical Evaluation of Lipid-Altering Agents in September 1, 1990
Do
Do Adults and Children
Clinical Evaluation of Motility-Modifying Drugs
Do
Do
Clinical Evaluation of Weight-Control Drugs
September 24, 1996
Do
Do
Conducting a Clinical Safety Review of a New
November 22, 1996
Do
Do Product Application and Preparing a Report on the Review
Conducting a Clinical Safety Review of a New
October 13, 1998
Do
Do Product Application and Preparing a Report on the Review
Development and Evaluation of Drugs for the
February 12, 1992
Do
Do Treatment of Psychoactive Substance Use Disorders
Development of Parathyroid Hormone for the
June 14, 2000
Do
Do Prevention and Treatment of Osteoporosis
Establishing Pregnancy Registries
June 4, 1999
Do
Do
Evaluation of Human Pregnancy Outcome Data
June 4, 1999
Do
Do
Female Sexual Dysfunction: Clinical Development of May 19, 2000
Do
Do Drug Products for Treatment
In Vivo Pharmacokinetics and Bioavailability
June 10, 1999
Do
Do Studies and In Vitro Dissolution Testing for Levothyroxine Sodium Tablets
Institutional Review Boards, Clinical
March 30, 2000
Do
Do Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research
Levothyroxine Sodium
August 18, 1999
Do
Do
OTC Treatment of Herpes Labialis with Antiviral March 8, 2000
Do
Do Agents
Preclinical and Clinical Evaluation of Agents Used April 1, 1994
Do
Do in the Prevention or Treatment of Postmenopausal Osteoporosis
Preparation of IND Applications for New Drugs September 1, 1991
Do
Do Intended for the Treatment of HIV-Infected Individuals
[[Page 45451]]
System Inflammatory Response Syndrome (SIRS) 1st
Do
Do Draft
Clinical Development Programs for Drugs, Devices, February 17, 1999
Clinical Medical
Do and Biological Products for the Treatment of Rheumatoid Arthritis (RA)
Clinical Development Programs for MDI and DPI Drug September 19, 1994
Do
Do 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 (adults January 1, 1981
Do
Do 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
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 Drugs October 1, 1981
Do
Do
Content and Format for Pediatric Use Supplements May 24, 1996
Do
Do
Content and Format of Investigational New Drug November 20, 1995
Do
Do Applications (IND's) for Phase Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products
Development of Vaginal Contraceptive Drugs (NDA) April 19, 1995
Do
Do
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 21, 1991
Do
Do Non-Small Cell 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 Statistical July 1, 1988
Do
Do Sections of an Application
Format and Content of the Summary for New Drug and February 1, 1987
Do
Do Antibiotic Applications
[[Page 45452]]
Formatting, Assembling and Submitting New Drug and February 1, 1987
Do
Do Antibiotic Applications
General Considerations for the Clinical Evaluation February 1, 1978
Do
Do of Drugs
General Considerations for the Clinical
September 1, 1977
Do
Do Evaluation of Drugs in Infants and Children
Oncologic Drugs Advisory Committee Discussion on April 13, 1988
Do
Do FDA Requirements for Approval of New Drugs for Treatment of Ovarian Cancer
Oncologic Drugs Advisory Committee Discussion on April 19, 1988
Do
Do FDA Requirements for Approval of New Drugs for Treatment of Colon and Rectal Cancer
OTC Treatment of Hypercholesterolemia
October 27, 1997
Do
Do
Postmarketing Adverse Experience Reporting for August 27, 1997
Do
Do Human Drugs and Licensed Biological Products; Clarification of What to Report
Postmarketing Reporting of Adverse Drug
March 1, 1992
Do
Do Experiences
Preclinical Development of Immunomodulatory Drugs September 4, 1992
Do
Do for the Treatment of HIV Infection and Associated Disorders
Preparation of Investigational New Drug Products November 1, 1992
Do
Do (Human and Animal)
Providing Clinical Evidence of Effectiveness for May 15, 1998
Do
Do Human Drug and Biological Products
Study and Evaluation of Gender Differences in the July 22, 1993
Do
Do 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 in September 13, 1999
Do
Do Support of Marketing Applications
General Considerations for Pediatric
November 30, 1998
Clinical Pharmacology Do Pharmacokinetic Studies for Drugs and Biological
Draft Products
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 Pharmacokinetics February 1, 1987
Do
Do and Bioavailability Section of an Application
In Vivo Metabolism/Drug Interaction Studies--Study November 24, 1999
Do
Do Design, Data Analysis, and Recommendations for Dosing and Labeling
Pharmacokinetics and Pharmacodynamics in Patients May 15, 1998
Do
Do with Impaired Renal Function: Study Design, Data Analysis, and Impact on Dosing and Labeling
Pharmacokinetics in Patients With Impaired Hepatic December 7, 1999
Do
Do Function: Study Design, Data Analysis, and Impact on Dosing and Labeling
Population Pharmacokinetics
February 10, 1999
Do
Do
[[Page 45453]]
Investigating Out of Specification (OOS) Test November 30, 1998
Compliance Draft
Do Results for Pharmaceutical Production
Manufacture, Processing or Holding of Active
April 17, 1998
Do
Do Pharmaceutical Ingredients
Repackaging of Solid Oral Dosage Form Drug
February 1, 1992
Do
Do Products
A Review of FDA's Implementation of the Drug
Compliance
Do Export Amendments of 1986
Compressed Medical Gases
February 1, 1989
Do
Do
Computerized Systems Used in Clinical Trials
May 10, 1999
Do
Do
Expiration Dating and Stability Testing of Solid June 27, 1997
Do
Do Oral Dosage Form Drugs Containing Iron
General Principles of Process Validation
May 1, 1987
Do
Do
Good Laboratory Practice Regulations Questions and
Do
Do Answers
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
Validation of Limulus Amebocyte Lysate Test as an December 1, 1987
Do
Do End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices
Regulatory Submissions in Electronic Format;
January 28, 1999
Electronic Submissions Do General Considerations
Regulatory Submissions in Electronic Format; New January 28, 1999
Do
Do Drug Applications
ANDA's: Blend Uniformity Analysis
August 26, 1999
Generic Drug Draft
Do
ANDA's: Impurities in Drug Products
January 5, 1999
Do
Do
Abbreviated New Drug Application (ANDA)--Positron April 18, 1997
Do
Do Emission Tomography (PET) Drug Products--With specific information for ANDA's for Fludeoxyglucose F18 Injection
ANDA's: Impurities in Drug Substances
December 3, 1999
Generic Drug
Do
Letter announcing that the OGD will now accept the August 18, 1995
Do
Do ICH long-term storage conditions as well as the stability studies conducted in the past
Letter describing efforts by the CDER & the ORA to October 14, 1994
Do
Do clarify the responsibilities of CDER chemistry review scientists and ORA field investigators in the new & abbreviated drug approval process in order to reduce duplication or redundancy in the process
[[Page 45454]]
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 regulated November 8, 1991
Do
Do 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 December 20, 1984 letter March 26, 1985
Do
Do from the Pharmaceutical Manufacturers Association about the Drug Price Competition and Patent Term Restoration Act
Letter to all ANDA and AADA applicants about the January 15, 1993
Do
Do 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 interested August 4, 1993
Do
Do parties about important detailed information regarding labeling, scale-up, packaging, minor/ major amendment criteria, and bioequivalence requirements
Major, Minor, Facsimile, and Telephone Amendments May 1, 2000
Do
Do to Original Abbreviated New Drug Applications (Revised)
Organization of an ANDA
March 2, 1999
Do
Do
Revising ANDA Labeling Following Revision of the April 25, 2000
Do
Do RLD Labeling
Skin Irritation and Sensitization Testing of
February 3, 2000
Do
Do Generic Transdermal Drug Products
Variations in Drug Products that May Be Included January 27, 1999
Do
Do in a Single ANDA
E10--Choice of Control Group in Clinical Trials September 24, 1999
ICH Draft--Efficacy
Do
E11 Clinical Investigation of Medicinal Products April 12, 2000
Do
Do in the Pediatric Population
M4 Common Technical Document: Request for comments February 11, 2000
ICH Draft--Joint Safety/ Do on Initial Components
Efficacy
Q1A(R) Stability Testing of New Drug Substances April 21, 2000
ICH Draft--Quality
Do and Products
Q6A Specifications: Test Procedures and Acceptance November 25, 1997
Do
Do Criteria for New Drug Substances and New Drug Products: Chemical Substances
[[Page 45455]]
E1A The Extent of Population Exposure to Assess March 1, 1995
ICH--Efficacy
Do Clinical Safety: for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions
E2A Clinical Safety Data Management: Definitions March 1, 1995
Do
Do and Standards for Expedited Reporting
E2B Data Elements for Transmission of Individual January 15, 1998
Do
Do 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 Reports July 17, 1996
Do
Do
E4 Dose-Response Information to Support Drug
November 9, 1994
Do
Do Registration
E5 Ethnic Factors in the Acceptability of Foreign June 10, 1998
Do
Do Clinical Data
E6 Good Clinical Practice: Consolidated Guideline May 9, 1997
Do
Do
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
M3 Nonclinical Safety Studies for the Conduct of November 25, 1997
ICH--Joint Safety/
Do Human Clinical Trials for Pharmaceuticals
Efficacy
Q1A Stability Testing of New Drug Substances and September 22, 1994
ICH--Quality
Do Products
Q1B Photostability Testing of New Drug Substances May 16, 1997
Do
Do and Products
Q1C Stability Testing for New Dosage Forms
May 9, 1997
Do
Do
Q2A Text on Validation of Analytical Procedures May 1, 1995
Do
Do
Q2B Validation of Analytical Procedures:
May 19, 1997
Do
Do Methodology
Q3A Impurities in New Drug Substances
January 4, 1996
Do
Do
Q3B Impurities in New Drug Products
May 19, 1997
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: Analysis of February 23, 1996
Do
Do the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
Q5C Quality of Biotechnological Products:
July 10, 1996
Do
Do Stability Testing of Biotechnology/Biological Products
[[Page 45456]]
Q5D Quality of Biotechnological/Biological
September 21, 1998
Do
Do Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products
Q6B--Test Procedures and Acceptance Criteria for August 18, 1999
Do
Do Biotechnological/Biological Products
S1A The Need for Long-Term Rodent Carcinogenicity March 1, 1996
ICH--Safety
Do Studies of Pharmaceuticals
S1B Testing for Carcinogenicity in Pharmaceuticals February 23, 1998
Do
Do
S1C Dose Selection for Carcinogenicity Studies of March 1, 1995
Do
Do Pharmaceuticals
S1C(R) Dose Selection for Carcinogenicity Studies December 4, 1997
Do
DO of Pharmaceuticals: Addendum on a Limit Dose and Related Notes
S2A Specific Aspects of Regulatory Genotoxicity December 4, 1997
Do
Do 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 Dose March 1, 1995
Do
Do 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 Biotechnology- November 18, 1997
Do
Do Derived Pharmaceuticals
A Revision in Sample Collection Under the
July 15, 1996
Industry Letters
o Compliance Program Pertaining to Pre-Approval Inspections
Certification Requirements for Debarred
July 27, 1992
Do
Do Individuals in Drug Applications
Continuation of a series of letters communicating June 1, 1990
Do
Do interim and informal generic drug policy and guidance. Availability of Policy and Procedure Guides, and further operational changes to the generic drug review program
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 informal October 31, 1986
Do
Do notice to all affected parties about policy developments and interpretations regarding the Act. Three year exclusivity provisions of Title I
[[Page 45457]]
Implementation of the Drug Price Competition and October 11, 1984
Do
Do 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
Do Provisions of SUPAC-IR
Seventh of a series of letters about the Act
July 29, 1988
Do
Do providing guidance on the ``180-day exclusivity'' provision of section 505(j)(4)(B)(iv) of the FD&C
Sixth of a series of informal notice letters about April 22, 1988
Do
Do the Act discussing 3- and 5-year exclusivity provisions of sections 505(c)(3)(D) and 505(j)(4)(D) of the FD&C Act
Streamlining Initiatives
December 24, 1996
Do
Do
Supplement to 10/11/84 letter about policies, November 16, 1984
Do
Do procedures and implementation of the Act (Q & A format)
Third of a series of letters regarding the
May 1, 1985
Do
Do implementation of the Act
Content and Format for Geriatric Labeling
January 21, 1999
Labeling Draft
Do
Non-Contraceptive Estrogen Drug Products--
January 8, 1999
Do
Do Physician and Patient Labeling
Noncontraceptive Estrogen Class Labeling
September 27, 1999
Do
Do
OTC Topical Drug Products for the Treatment of July 16, 1998
Do
Do Vaginal Yeast Infections (Vulvovaginal Candidiasis)
Therapeutic Equivalence Code Placement on
January 28, 1999
Do
Do Prescription Drug Labels and Labeling
Acetaminophen and Codeine Phosphate Oral Solution/ December 1, 1993
Labeling
Do Suspension
Acetaminophen and Codeine Phosphate Tablets/
December 1, 1993
Do
Do Capsules
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
Do
Butalbital, Acetaminophen and Caffeine Capsules/ September 1, 1997
Do
Do Tablets USP
Butalbital, Acetaminophen, Caffeine and Hydocodone September 21, 1997
Do
Do Bitartrate Tablets
Butorphanol Tartrate Injection USP
October 1, 1992
Do
Do
[[Page 45458]]
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
Clorazepate Dipotassium Capsules/Tablets
March 1, 1993
Do
Do
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
Do
Diltiazem Hydrochloride Extended-Release Capsules September 1, 1995
Do
Do
Diphenoxylate Hydrochloride and Atropine Sulfate April 1, 1995
Do
Do Oral Solution USP
Diphenoxylate Hydrochloride and Atropine Sulfate April 1, 1995
Do
Do Tablets USP
Dipivefrin Hydrochloride Ophthalmic Solution, 0.1% November 2, 1998
Do
Do
Ergoloid Mesylates Tablets
January 1, 1988
Do
Do
Fludeoxyglucose F18 Injection
January 1, 1997
Do
Do
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 Tablets April 1, 1994
Do
Do USP
Hydroxyzine Hydrochloride Injection
December 1, 1989
Do
Do
Hypoglycemic Oral Agents--Federal Register
April 1, 1984
Do
Do
Indomethacin Capsules USP
September 1, 1995
Do
Do
Informal Labeling Guidance Texts for Estrogen Drug August 1, 1992
Do
Do Products--Patient Labeling
Informal Labeling Guidance Texts for Estrogen Drug August 1, 1992
Do
Do Products--Professional Labeling
Isoetharine Inhalation Solution
March 1, 1989
Do
Do
Itraconazole Capsules, USP
September 1, 1998
Do
Do
Leucovorin Calcium for Injection
July 1, 1996
Do
Do
[[Page 45459]]
Leucovorin Calcium Tablets, USP
July 1, 1996
Do
Do
Local Anesthetics--Class Labeling
September 1, 1982
Do
Do
Meclofenamate Sodium Capsules
July 1, 1992
Do
Do
Medroxyprogesterone Acetate Tablets, USP
September 1, 1998
Do
Do
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
Do
Naproxen Sodium Tablets, USP
September 1, 1997
Do
Do
Naproxen Tablets, USP
September 1, 1997
Do
Do
Niacin Tablets
July 1, 1992
Do
Do
Paclitaxel Injection
February 1, 1991
Do
Do
Phendimetrazine Tartrate Capsules/Tablets, and February 1, 1991
Do
Do Extended-Release Capsules
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
Do
Ranitidine Tablets USP
November 1, 1993
Do
Do
Risperidone Oral Solution
September 1, 1997
Do
Do
Risperidone Tablets
September 1, 1997
Do
Do
Sulfacetamide Sodium and Prednisolone Acetate January 1, 1995
Do
Do Ophthalmic Suspension and Ointment
Sulfacetamide Sodium Ophthalmic Solution/Ointment August 1, 1992
Do
Do
Sulfamethoxazole and Phenazopyridine Hydrochloride February 1, 1992
Do
Do Tablets
Sulfamethoxazole and Trimethoprim Tablets and Oral August 1, 1993
Do
Do Suspension
Theophylline Immediate-Release Dosage Forms
February 1, 1995
Do
Do
Theophylline Intravenous Dosage Forms
September 1, 1995
Do
Do
Thiamine Hydrochloride Injection
February 1, 1988
Do
Do
Tobramycin Sulfate Injection USP
May 1, 1993
Do
Do
Venlafaxine Hydrochloride Tablets
October 1, 1997
Do
Do
Verapamil Hydrochloride Tablets
October 1, 1991
Do
Do
Vitamin A Capsules
February 1, 1992
Do
Do
[[Page 45460]]
Zolpidem Tartrate Tablets
September 1, 1997
Do
Do
Labeling OTC Human Drug Products Using a Column December 1, 1997
OTC Draft
Do Format
OTC Actual Use Studies
July 22, 1994
Do
Do
OTC Nicotine Substitutes
March 1, 1994
Do
Do
Enforcement Policy on Marketing OTC Combination Products (CPG 7132b.16)
General Guidelines for OTC Combination Products
Do
Do
Upgrading Category III Antiperspirants to Category
Do
Do I (43 FR 46728-46731)
Photosafety Testing
January 10, 2000
Pharmacology/Toxicology Do Draft
Format and Content of the Nonclinical Pharmacology/ February 1, 1987
Pharmacology/Toxicology Do Toxicology Section of an Application
Nonclinical Pharmacology/Toxicology Development of
Do
Do 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
Content and Format of New Drug Applications and March 10, 2000
Do
Do Abbreviated New Drug Applications for Certain Positron Emission Tomography Drug Products
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
Information Program on Clinical Trials for Serious March 29, 2000
Do
Do or Life-Threatening Diseases: Establishment of a Data Bank
Information Request and Discipline Review Letters August 17, 1999
Do
Do Under the Prescription Drug User Fee Act
Special Protocol Assessment
February 9, 2000
Do
Do
Submitting Debarment Certification Statements October 2, 1998
Do
Do
180-Day Generic Drug Exclusivity Under the Hatch- July 14, 1998
Procedural
Do Waxman Amendments to the Federal Food, Drug, and Cosmetic Act
Advisory Committees: Implementing Section 120 of November 2, 1998
Do
Do the Food and Drug Modernization Act of 1997
[[Page 45461]]
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
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: Designation, November 18, 1998
Do
Do Development, and Application Review
Formal Dispute Resolution: Appeals Above the
March 7, 2000
Do
Do Division Level
Formal Meetings With Sponsors and Applicants For March 7, 2000
Do
Do PDUFA Products
Implementation of Section 126 of the FDA
July 21, 1998
Do
Do Modernization Act of 1997--Elimination of Certain Labeling Requirements
National Uniformity for Nonprescription Drugs April 9, 1998
Do
Do Ingredient Labeling for OTC Drugs
Qualifying for Pediatric Exclusivity Under Section October 1, 1999
Do
Do 505A of the Federal Food, Drug, and Cosmetic Act-- Revised
Refusal to File
July 12, 1993
Do
Do
Repeal of Section 507 of the Federal Food, Drug, June 15, 1998
Do
Do and Cosmetic Act
Standards for the Prompt Review of Efficacy
May 15, 1998
Do
Do Supplements, Including Priority Efficacy Supplements
Street Drug Alternatives
April 3, 2000
Do
Do
Women and Minorities Guidance Requirements
July 28, 1998
Do
Do
Information Request and Discipline Review Letters August 17, 1999
User Fee Draft
Do Under the Prescription Drug User Fee Act
Classifying Resubmissions in Response to Action May 14, 1998
User Fee
Do Letters
Submitting and Reviewing Complete Responses to May 14, 1998
Do
Do Clinical Holds
-
Guidance Documents Issued by the Center for Devices and Radiological Health (CDRH)
Grouped by Intended User or Regulatory How to Obtain a Hard Copy of the Document (Name and Name of Document
Date of Issuance
Activity
Address, Phone, FAX, E-mail or Internet)
Compliance Program Guidance Manual: Inspection of Medical August 12, 1999
Office of Compliance (OC)
Division of Small Manufacturers Assistance; 1-800-638- Devices; Draft
2041 or 301-827-0111 or (FAX) Facts-on-Demand at 1-800- 899-0381 or Internet at http://www.fda.gov/cdrh/ ggpmain.html
[[Page 45462]]
Procedures for Laboratory Compliance Testing of
May 1, 1986
Do
Do Television Receivers-part of TV Packet
A Pocket Guide to Device GMP Inspections-Inspections of November 1, 1991
Do
Do Medical Device Manufacturers and GMP Regulation Requirements
General Principles of Software Validation; Draft Guidance June 9, 1997
Do
Do
Global Harmonization Task Force Study Group 3-Process February 1, 1999
Do
Do Validation Guidance; Final Draft
Civil Money Penalty Policy; Guidance for FDA Staff
June 8, 1999
Do
Do
Guidance on Medical Device Tracking; Guidance for
January 24, 2000
Do
Do Industry and FDA Staff [FDAMA]
Enforcement Priorities for Single-Use Devices Reprocessed February 8, 2000
Do
Do by Third Parties and Hospitals, Draft Guidance-Not for Implementation; Guidance for Industry and for FDA Staff
Cover Letter/Guidance Document on the Performance
March 9, 1998
Do
Do Standard for Electrode Lead Wires and Patient Cable
Commercial Distribution/Exhibit Letter
April 10, 1992
Do
Do
Working Draft of the Current Good Manufacturing Practice July 1, 1995
Do
Do (CGMP) Final Rule
Regulating In Vitro Diagnostic Device (IVD) Studies; December 17, 1999
Office of Compliance (OC)/Division of Do Guidance; Guidance for FDA Staff
Bioresearch Monitoring (DBM)
Preparing Notices of Availability of Investigational March 19, 1999
Do
Do Medical Devices and for Recruiting Study Subjects
A Guide for the Submission of Abbreviated Radiation
March 1, 1996
Office of Compliance (OC)/Division of Do Safety Reports on Cephalometric X-Ray Devices: Defined
Enforcement I (DOEI) as Dental Units with an Attachment for Mandible Work that Holds a Cassette and Beam Limiting Device
A Guide for the Submission of Abbreviated Radiation
March 1, 1996
Do
Do Safety Reports on Image Receptor Support Devices for Mammographic X-Ray Systems
A Guide for the Submission of an Abbreviated Radiation March 1, 1996
Do
Do Safety Report on X-Ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use
Clarification of Radiation Control Regulations for
March 1, 1989
Do
Do Diagnostic X-Ray Equipment (FDA 89-8221)
CPG 7133.19: Retention of Microwave Oven Test Record/ August 24, 1981
Do
Do Cover Letter: August 24, 1981 Retention of Records Required by 21 CFR 1002
[[Page 45463]]
Exemption from Reporting and Recordkeeping Requirements September 16, 1981
Do
Do for Certain Sunlamp Product Manufacturers
Compliance Program Guidance Manual; Field Compliance March 15, 2000
Do
Do Testing of Diagnostic (Medical) X-ray Equipment; Guidance for FDA Staff
Guidance on Information Disclosure by Manufacturers to October 18, 1999
Do
Do Assemblers for Diagnostic X-ray Systems; Guidance for Industry
Guidance on Electrosurgical Devices and the Application November 15, 1999
Do
Do of the Performance Standard for Electrode Lead Wires and Patient Cables
Guide for the Submission of Initial Reports on Diagnostic January 1, 1982
Do
Do X-Ray Systems and their Major Components
Guideline for the Manufacture of In Vitro Diagnostic January 10, 1994
Do
Do Products
Letter to Medical Device Industry on Endoscopy and
May 17, 1993
Do
Do Laparoscopy Accessories (Galdi)
Manufacturers/Assemblers of Diagnostic X-ray Systems: October 13, 1993
Do
Do Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g)
Abbreviated Reports on Radiation Safety for Microwave August 1, 1995
Office of Compliance (OC)/Division of Do Products (Other Than Microwave Ovens)- E.G. Microwave
Enforcement I & III (DOEI & III) Heating, Microwave Diathermy, RF Sealers, Induction, Dielectric Heaters, Security Systems
Abbreviated Reports on Radiation Safety of Non-Medical August 1, 1995
Do
Do Ultrasonic Products
Guide for Filing Annual Reports for X-Ray Components and July 1, 1980
Do
Do Systems
Guide for Preparing Abbreviated Reports of Microwave and September 1, 1996
Do
Do RF Emitting Electronic Products Intended for Medical Use
Guide for Preparing Product Reports for Medical
September 1, 1996
Do
Do Ultrasound Products
Guide for Preparing Reports on Radiation Safety of
March 1, 1985
Do
Do Microwave Ovens
Guide for Submission of Information on Accelerators
April 1, 1971
Do
Do Intended to Emit X-Radiation Required Pursuant to 21 CFR 1002.10
Letter to Manufacturers and Importers of Microwave Ovens: October 31, 1988
Do
Do Information Requirements for Cookbooks and User and Service Manuals
Reporting and Compliance Guide for Television Products October 1, 1995
Do
Do including Product Report, Supplemental Report, Radiation Safety Abbreviated Report, Annual Report, Information and Guidance
[[Page 45464]]
Reporting Guide for Laser Light Shows and Displays (21 September 1, 1995
Do
Do CFR 1002) (FDA 88-8140)
Revised Guide for Preparing Annual Reports on Radiation September 1, 1995
Do
Do Safety Testing of Laser and Laser Light Show Products (replaces FDA 82-8127)
All U.S. Condom Manufacturers, Importers and Repackagers April 7, 1987
Office of Compliance (OC)/Division of Do Enforcement II (DOEII)
Compliance Guide for Laser Products (FDA 86-8260)
September 1, 1985
Do
Do
Condoms: Inspection and Sampling at Domestic
April 8, 1987
Do
Do Manufacturers and of all Repackers; Sampling from all Importers (Damaska Memo to Field on April 8, 1987)
Dental Handpiece Sterilization (Dear Doctor Letter)
September 28, 1992
Do
Do
Ethylene Oxide; Ethylene Chlorohydrin; and Ethylene
June 23, 1978
Do
Do Glycol; Proposed Maximum Residue Limits and Maximum Levels of Exposure
Guidance on Quality System Regulation Information for August 3, 1999
Do
Do Various Premarket Submissions; Guidance for Industry; Draft
Guidance on Quality System Regulation Information for August 3, 1999
Do
Do Various Premarket Submissions; Guidance for Industry; Draft
Guide for Preparing Product Reports for Lasers and
September 1, 1995
Do
Do Products Containing Lasers
Hazards of Volume Ventilators and Heated Humidifiers September 15, 1993
Do
Do
Latex Labeling Letter (Johnson)
March 18, 1993
Do
Do
Letter--Condom Manufacturers and Distributors
April 5, 1994
Do
Do
Letter--Manufacturers, Distributors and Importers of February 23, 1994
Do
Do Condom Products
Letter--Manufacturers, Importers, and Repackagers of February 13, 1989
Do
Do Condoms for Contraception or Sexually-Transmitted Disease Prevention (Holt)
Letter to All Foreign Manufacturers and Importers of May 28, 1981
Do
Do Electronic Products for Which Applicable FDA Performance Standards Exist
Letter to Industry, Powered Wheelchair Manufacturers from May 10, 1993
Do
Do RMJohnson
Letter to Manufacturers/Repackers Using Cotton
April 22, 1994
Do
Do
Letter to: Manufacturers and Users of Lasers for
October 10, 1996
Do
Do Refractive Surgery [excimer]
Manufacturers and Initial Distributors of Hemodialyzers May 23, 1996
Do
Do
[[Page 45465]]
Manufacturers and Initial Distributors of Sharps
February 3, 1994
Do
Do Containers and Destroyers Used by Health Care Professionals
Pesticide Regulation Notice 94-4: Interim Measures for June 30, 1994
Do
Do the Registration of Antimicrobial Products/Liquid Chemical Germicides with Medical Device Use Claims Under the Memorandum of Understanding Between EPA and FDA
Application for a Variance from 21 CFR 1040.11(c) for a July 1, 1998
Office of Compliance (OC)/Division of Do Laser Light Show, Display, or Device [form FDA 3147]
Enforcement III (DOEIII)
Computerized Devices/Processes Guidance--Application of May 1, 1992
Do
Do the Medical Device GMP to Computerized Devices and Manufacturing Processes
Design Control Guidance for Medical Device Manufacturers March 11, 1997
Do
Do
Final Design Control Report and Guidance
June 1, 1998
Do
Do
Guidance for the Submission of Cabinet X-Ray System
February 1, 1975
Do
Do Reports Pursuant to 21 CFR 1020.40
Guide for Preparing Annual Reports for Ultrasonic Therapy September 1, 1996
Do
Do Products
Guide for Preparing Annual Reports on Radiation Safety September 1, 1995
Do
Do Testing of Sunlamps and Sunlamp Products (replaces FDA 82-8127)
Guide for Preparing Annual Reports on Radiation Safety September 1, 1995
Do
Do Testing of Mercury Vapor Lamps (replaces FDA 82-8127)
Guide for Preparing Annual Reports on Radiation Safety October 1, 1987
Do
Do Testing of Electronic Products (General)
Guide for Preparing Product Reports for Ultrasonic
August 1, 1996
Do
Do Therapy Products (physical therapy only)
Guide for Preparing Product Reports on Sunlamps and
September 1, 1995
Do
Do Sunlamp Products (21 CFR 1002)
Guide for Submission of Information on Analytical X-Ray April 30, 1974
Do
Do Equipment Required Pursuant to 21 CFR 1002.10
Guide for Submission of Information on Industrial
September 1, 1980
Do
Do Radiofrequency Dielectric Heater and Sealer Equipment Pursuant to 21 CFR 1002.10 and 1002.12 (FDA 81-8137)
Guide for Submission of Information on Industrial X-Ray March 1, 1973
Do
Do Equipment Required Pursuant to 21 CFR 1002.10
Guide for the Submission of Initial Reports on Computed September 1, 1984
Do
Do Tomography X-Ray Systems
[[Page 45466]]
Impact Resistant Lenses: Questions and Answers (FDA 87- September 1, 1987
Do
Do 4002)
Keeping Medical Devices Safe from Electromagnetic
July 1, 1995
Do
Do Interference
Keeping Up With the Microwave Revolution (FDA Pub No. 91- March 1, 1990
Do
Do 4160)
Laser Light Show Safety--Who's Responsibility (FDA 86- May 1, 1986
Do
Do 8262)
Letter to Manufacturers and Importers of Microwave Ovens-- March 28, 1980
Do
Do Open Door Operation of Microwave Ovens as a Result of Oven Miswiring
Letter to Trade Association: ReUse of Single-use or
December 27, 1995
Do
Do Disposable Medical Devices
Letter: Policy on Maximum Timer Interval and Exposure August 21, 1986
Do
Do Schedule for Sunlamp Products
Medical Device Electromagnetic Interference Issues,
Do
Do Problem Reports, Standards, and Recommendations
Medical Devices and EMI: The FDA Perspective
January 1, 1995
Do
Do
Policy on Lamp Compatability (sunlamps)
September 2, 1986
Do
Do
Policy on Warning Label Required on Sunlamp Products June 25, 1985
Do
Do
Quality Assurance Guidelines for Hemodialysis Devices February 1, 1991
Do
Do
Quality Control Guide for Sunlamp Products (FDA 88-8234) March 1, 1988
Do
Do
Quality Control Practices for Compliance with the Federal May 1, 1980
Do
Do Mercury Vapor Lamp Performance Standard
Reporting Guide for Product Reports on High Intensity September 1, 1995
Do
Do Mercury Vapor Discharge Lamps (21 CFR 1002)
Reporting of New Model Numbers to Existing Model Families June 14, 1983
Do
Do
Safety of Electrically Powered Products: Letter To
September 18, 1996
Do
Do Medical Device and Electronic Product Manufacturers From Lillian Gill & BHB correction memo
Shielded Trocars and Needles used for Abdominal Access August 23, 1996
Do
Do during Laparoscopy
Suggested State Regulations for Control of Radiation-- January 1, 1982
Do
Do Volume II Nonionizing Radiation--Lasers (FDA Pub No. 83- 8220)
Unsafe Patient Lead Wires and Cables
September 3, 1993
Do
Do
Imports: Radiation-Producing Electronic Products (FDA 89- November 1, 1988
Do
Do 8008)
[[Page 45467]]
Guidance for Industry on the Likelihood of Facilities August 5, 1999
Office of Compliance (OC)/Division of Do Inspections When Modifying Devices Subject to Premarket
Program Operations (DOP) Approval
Letter to Medical Device Manufacturer on Pentium
February 14, 1995
Office of Compliance (OC)/Office of the Do Processors
Center Director (OCD)
Sec. 300.600 Commercial Distribution with Regard to
September 24, 1987
Do
Do Premarket Notification [510(k)] [CPG 7124.19]
Letter to Industry, Powered Wheelchair/Scooter or
May 26, 1994
Office of the Center Director (OCD)/ Do Accessory/ Component Manufacturer from Susan Alpert,
Office of Device Evaluation (ODE) Ph.D.,M.D.
General/Specific Intended Use; Guidance for Industry; November 4, 1998
Do
Do Final
ODE Executive Secretary Guidance Manual
August 7, 1987
Do
Do
Preamendments Class III Strategy; SXAlpert
April 19, 1994
Do
Do
Early Collaboration Meetings Under the FDA Modernization February 19, 1998
Do
Do Act (FDAMA), Guidance for Industry and CDRH Staff [FDAMA]
``Real-Time'' Review Program for Premarket Approval
April 22, 1997
Office of Device Evaluation (ODE)
Do Application (PMA) Supplements
30-Day Notices and 135-Day PMA Supplements for
February 19, 1998
Do
Do Manufacturing Method or Process Changes, Guidance for Industry and CDRH [FDAMA]; Final
510(k) Quality Review Program (Blue Book Memo)
March 29, 1996
Do
Do
Convenience Kits Interim Regulatory Guidance (include May 20, 1997
Do
Do 874)
Determination of Intended Use for 510(k) Devices Guidance January 30, 1998
Do
Do for Industry and CDRH Staff [FDAMA]; Final
Distribution and Public Availability of Premarket
October 10, 1997
Do
Do Approval Application Summary of Safety and Effectiveness Data Packages [Blue Book Memo #P98-1]; Final
Document Review by the Office of the Chief Counsel (Blue June 6, 1996
Do
Do Book Memo G96-1))
Modifications to Devices Subject to Premarket Approval-- August 6, 1998
Do
Do The PMA Supplement Decision Making Process; Guidance for Industry, Draft
Contents of Product Development Protocol; Guidance for July 27, 1998
Do
Do Industry, Draft
Frequently Asked Questions on The New 510(k) Paradigm; October 22, 1998
Do
Do Guidance for Industry; Final
[[Page 45468]]
Evidence Models for the Least Burdensome Means to Market; September 1, 1999
Do
Do Guidance for Industry and FDA Reviewers; Draft
Supplements to Approved Applications for Class III
May 20, 1998
Do
Do Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review [FDAMA]; Guidance for Industry; Final
New Model Medical Device Development Process; Guidance July 21, 1998
Do
Do for Industry; Final
Guidance for Off-the-Shelf Software Use in Medical
September 9, 1999
Do
Do Devices; Final
Guidance for Submitting Reclassification Petition
June 1, 1989
Do
Do
Guidance on Amended Procedures for Advisory Panel
January 26, 1999
Do
Do Meetings [FDAMA]; Final
Guidance on PMA Interactive Procedures for Day-100
February 19, 1998
Do
Do Meetings and Subsequent Deficiencies--For Use by CDRH & Industry [FDAMA]; Final
Guidance on the Use of Standards in Substantial
March 12, 2000
Do
Do Equivalence Determinations; Final
PMA Shell Development and Modular Review; Guidances for November 6, 1998
Do
Do the Medical Device Industry; Final
New Section 513(f)(2)--Evaluation of Automatic Class III February 19, 1998
Do
Do Designation, Guidance for Industry and CDRH Staff [FDAMA]; Final
Procedures for Class II Device Exemptions from Premarket February 19, 1998
Do
Do Notification, Guidance for Industry and CDRH Staff [FDAMA]; Final
SMDA Changes-Premarket Notification; Regulatory
April 17, 1992
Do
Do Requirements for Medical Devices [510(k)] Manual Insert
The New 510(k) Paradigm-Alternate Approaches to
March 20, 1998
Do
Do Demonstrating Substantial Equivalence in Premarket Notifications; Final
4-of-A-Kind PMA's
October 1, 1991
Do
Do
Application of the Device Good Manufacturing Practice December 1, 1983
Do
Do (GMP) Regulation to the Manufacture of Sterile Devices
CDRH Submissions Coversheet [PMA/PDP/510k/IDE]
May 8, 1998
Do
Do
CDRH's 510(k)/IDE/PMA Refuse to Accept/Accept/File
June 30, 1993
Do
Do Policies
Classified Convenience Kits
April 30, 1993
Do
Do
Color Additive Petitions (p. II-19 of PMA Manual)
June 1, 1987
Do
Do
Color Additive Status List (Inspection Operations Manual) February 1, 1989
Do
Do
[[Page 45469]]
Color Additives for Medical Devices (Snesko)
November 15, 1995
Do
Do
Deciding When to Submit a 510(k) for a Change to an
January 10, 1997
Do
Do Existing Device
Device Specific Guidance Documents (List)
May 11, 1993
Do
Do
FDA Guide for Validation of Biological Indicator
January 1, 1986
Do
Do Incubation Time
FDA Policy For The Regulation Of Computer Products
November 13, 1989
Do
Do (DRAFT)
Format for IDE Progress Reports
June 1996
Do
Do
Guidance for the Content of Premarket Submissions for May 29, 1998
Do
Do Software Contained in Medical Devices; Guidance for FDA and Reviewers and Industry; Final
Guidance for Preparation of PMA Manufacturing Information August 1, 1992
Do
Do
Guide for Establishing and Maintaining a Calibration March 1, 1988
Do
Do Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264)
Guideline for the Monitoring of Clinical Investigations January 1, 1988
Do
Do
Guideline on General Principles of Process Validation May 1, 1987
Do
Do
Guideline on Sterile Drug Products Produced by Aseptic June 1, 1987
Do
Do Processing
Guideline on Validation of the Limulus Amebocyte Lysate December 1, 1987
Do
Do (LAL) Test as an End-Product Endotoxin Test
Indications for Use Statement
January 2, 1996
Do
Do
Industry Representatives on Scientific Panels
March 27, 1987
Do
Do
Labeling Reusable Medical Devices for Reprocessing in April 1, 1996
Do
Do Health Care Facilities: FDA Reviewer Guidance
Limulus Amebocyte Lysate; Reduction of Samples for
October 23, 1987
Do
Do Testing
Master Files Part III; Guidance on Scientific and
June 1, 1987
Do
Do Technical Information
Electromagnetic Compatibility for Medical Devices: Issues June 13, 1995
Do
Do and Solutions; Memorandum
Methods for Conducting Recall Effectiveness Checks
June 16, 1978
Do
Do
Necessary Information for Diagnostic Ultrasound 510(k) November 24, 1987
Do
Do (Draft)
PMA Review Schedule [P87-1]
March 31, 1988
Do
Do
Points to Consider in the Characterization of Cell Lines June 1, 1984
Do
Do Used to Produce Biological Products (from John C. Petricciani, M.D.)
[[Page 45470]]
Preamendment Class III Devices
March 11, 1992
Do
Do
Premarket Notification [510(k)] Status Request Form, March 14, 1997
Do
Do revised
Preproduction Quality Assurance Planning: Recommendations September 1, 1989
Do
Do for Medical Device Manufacturers (FDA 90-4236)
Proposal for Establishing Mechanisms for Setting Review June 30, 1993
Do
Do Priorities Using Risk Assessment and Allocating Review Resources and T93-28 dated June 25, 1993 Device ``Fast Track'' Plan Announcement (include with 926 930)
Questions and Answers for the FDA Reviewer Guidance: September 3, 1996
Do
Do Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities
Shelf Life of Medical Devices
March 1, 1991
Do
Do
Substantial Equivalence (SE) Decision Making
January 1, 1990
Do
Do Documentation ATTACHED: ``SE'' Decision Making Process (Detailed), i.e., the decision making tree
Suggested Content for Original IDE Application Cover February 27, 1996
Do
Do Letter--Version 4
Suggestions for Submitting a Premarket Approval (PMA) April 1, 1993
Do
Do Application
Threshold Assessment of the Impact of Requirements for January 1, 1990
Do
Do Submission of PMA's for 31 Medical Devices Marketed Prior to May 28, 1976
Interagency Agreement between FDA & HCFA; #D95-2,
September 15, 1995
Office of Device Evaluation (ODE)/
Do Attachment A
BlueBook
Criteria for Categorization of Investigational Devices September 15, 1995
Do
Do (HCFA); #D95-2, Attachment B
Deciding When to Submit a 510(k) for a Change to an
January 10, 1997
Do
Do Exisiting Device; Blue Book Memo #K97-1
510(k) Additional Information Procedures #K93-1 (Blue July 23, 1993
Do
Do Book Memo)
510(k) Refuse to Accept Procedures #K94-1 (Blue Book May 20, 1994
Do
Do Memo)
510(k) Sign-Off Procedures #K94-2 (Blue Book Memo)
June 3, 1994
Do
Do
510(k) Sterility Review Guidance and Revision of
February 12, 1990
Do
Do November18/1994 #K90-1 (Blue Book Memo)
Announcement: Implementation of the FDA/HCFA Interagency September 15, 1995
Do
Do Agreement Regarding Reimbursement Categorization of Investigational Devices, Att. A Interagency Agreement, Att. B Criteria for Categorization of Investigational Devices #D95-2 (Blue Book Memo)
Assignment of Review Documents #I90-2 (Blue Book Memo) August 24, 1990
Do
Do
[[Page 45471]]
Center for Devices and Radiological Health's
June 30, 1993
Do
Do Investigational Device Exemption (IDE) Refuse to Accept Policy
Center for Devices and Radiological Health's Premarket June 30, 1993
Do
Do Notification [510(k)] Refuse to Accept Policy--(updated Checklist March 14, 1995)
Clinical Utility and Premarket Approval #P91-1 (Blue Book May 3, 1991
Do
Do Memo)
Consolidated Review of Submissions for Diagnostic
October 19, 1990
Do
Do Ultrasound Equipment, Accessories and Related Measurement Devices #G90-2 (Blue Book Memo)
Consolidated Review of Submissions for Lasers and
October 19, 1990
Do
Do Accessories #G90-1 (Blue Book Memo)
Continued Access to Investigational Devices During PMA July 15, 1996
Do
Do Preparation and Review (Blue Book Memo)
Cover Letter: 510(k) Requirements During Firm-Initiated November 21, 1995
Do
Do Recalls; Attachment A: Guidance on Recall and Premarket Notification Review Procedures During Firm-Initiated Recalls of Legally Marketed Devices (Blue Book Memo #K95- 1)
Criteria for Panel Review of PMA Supplements #P86-3 (Blue January 30, 1986
Do
Do Book Memo)
Delegation of IDE Actions #D88-1 (Blue Book Memo)
April 26, 1988
Do
Do
Device Labeling Guidance #G91-1 (Blue Book Memo)
March 8, 1991
Do
Do
Document Review Processing #I91-1 (Blue Book Memo)
February 12, 1992
Do
Do
Documentation and Resolution of Differences of Opinion on December 23, 1993
Do
Do Product Evaluations #G93-1 (Blue Book Memo)
Executive Secretaries Guidance Manual #G87-3
August 7, 1987
Do
Do
Goals and Initiatives for the IDE Program #D95-1 (Blue July 12, 1995
Do
Do Book Memo)
Guidance on the Center for Devices and Radiological
June 30, 1986
Do
Do Health's Premarket Notification Review Program #K86-3 (Blue Book Memo)
HCFA Reimbursement Categorization Determinations for FDA- October 31, 1995
Do
Do approved IDEs
IDE Refuse to Accept Procedures #D94-1 (Blue Book Memo) May 20, 1994
Do
Do
Integrity of Data and Information Submitted to ODE #I91-2 May 29, 1991
Do
Do (Blue Book Memo)
Meetings with the Regulated Industry #I89-3 (Blue Book November 20, 1989
Do
Do Memo)
[[Page 45472]]
Memorandum of Understanding Regarding Patient Labeling August 9, 1996
Do
Do Review (Blue Book Memo #G96-3))
Nondisclosure of Financially Sensitive Information #I92-1 March 5, 1992
Do
Do (Blue Book Memo)
ODE Regulatory Information for the Office of Compliance-- May 15, 1987
Do
Do Information Sharing Procedures #G87-2 (Blue Book Memo)
Overdue IDE Annual Progress Report Procedures #D93-1 July 23, 1993
Do
Do (Blue Book Memo)
Panel Report and Recommendations on PMA Approvals #P86-5 April 18, 1986
Do
Do (Blue Book Memo)
Panel Review of ``Me-Too'' Devices #P86-6 (Blue Book July 1, 1986
Do
Do Memo)
Panel Review of Premarket Approval Applications #P91-2 May 3, 1991
Do
Do (Blue Book Memo)
PMA Compliance Program #P91-3 (Blue Book Memo)
May 3, 1991
Do
Do
PMA Filing Decisions #P90-2 (Blue Book Memo)
May 18, 1990
Do
Do
PMA Refuse to File Procedures #P94-1 (Blue Book Memo) May 20, 1994
Do
Do
PMA Supplements: ODE letter to manufacturers; identifies April 24, 1990
Do
Do situations which may require the submission of a PMA supplement (When PMA Supplements are Required) #P90-1 (Blue Book Memo)
PMA/510(k) Triage Review Procedures #G94-1 (Blue Book May 20, 1994
Do
Do Memo)
PMA's--Early Review and Preparation of Summaries of
January 27, 1986
Do
Do Safety and Effectiveness #P86-1 (Blue Book Memo)
Policy Development and Review Procedures #I90-1 (Blue February 15, 1990
Do
Do Book Memo)
Premarket Approval Application (PMA) Closure #P94-1 (Blue July 8, 1994
Do
Do Book Memo)
Premarket Notification--Consistency of Reviews #K89-1 February 28, 1989
Do
Do (Blue Book Memo)
Review and Approval of PMA's of Licensees #P86-4 (Blue October 22, 1990
Do
Do Book Memo)
Review of 510(k)s for Computer Controlled Medical Devices August 29, 1991
Do
Do #K91-1 (Blue Book Memo)
Review of Final Draft Medical Device Labeling #P91-4 August 29, 1991
Do
Do (Blue Book Memo)
Review of IDEs for Feasibility Studies #D89-1 (Blue Book May 17, 1989
Do
Do Memo)
Review of Laser Submissions #G88-1 (Blue Book Memo)
April 15, 1988
Do
Do
[[Page 45473]]
Telephone Communications Between ODE Staff and
January 29, 1993
Do
Do Manufacturers #I93-1 (Blue Book Memo)
Toxicology Risk Assessment Committee #G89-1 (Blue Book August 9, 1989
Do
Do Memo)
Use of International Standard ISO-10993, ``Biological May 1, 1995
Do
Do Evaluation of Medical Devices Part 1: Evaluation and Testing'' (Replaces #G87-1 #8294) (Blue Book Memo)
Points to Consider for Portable Blood Glucose Monitoring February 20, 1996
Office of Device Evaluation (ODE)/
Do Devices Intended for Bedside Use in the Neonate Nursery
Division of Clinical Laboratory Devices (DCLD)
Letter to IVD Manufacturers on Streamlined PMA; Final December 22, 1997
Assessing the Safety/Effectiveness of Home-use In Vitro October 1, 1988
Do
Do Diagnostic Devices (IVD's): Points to Consider Regarding Labeling and Premarket Submissions; Draft
Data for Commercialization of Original Equipment
June 10, 1996
Do
Do Manufacturer, Secondary and Generic Reagents for Automated Analyzers
Criteria for Assessment of In Vitro Diagnostic Devices August 31, 1995
Do
Do for Drugs of Abuse Assays Using Various Methodologies; Draft
Guidance Document for 510(k) Submission of Fecal Occult July 29, 1992
Do
Do Blood Tests; Draft
Guidance Document for 510(k) Submission of
September 30, 1991
Do
Do Glycohemoglobin (Glycated or Glycosylated) Hemoglobin for IVDs; Draft
Guidance Document for 510(k) Submission of
September 1, 1992
Do
Do Immunoglobulins A, G, M, D and E Immunoglobulin System In Vitro Devices; Draft
Guidance for 510(k) Submission of Lymphocyte
September 26, 1991
Do
Do Immunophenotyping IVDs using Monoclonal Antibodies; Draft
Premarket Approval Applications for Assays Pertaining to October 8, 1999
Do
Do Hepatitis C Viruses (HCV) that are Indicated for Diagnosis or Monitoring of HCV Infection or Associated Disease; Draft
Review Criteria for Nucleic Acid Amplification Based In June 14, 1993
Do
Do Vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms; Draft
Premarketing Approval Review Criteria for Premarket
September 10, 1992
Do
Do 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
Guidance Criteria for Cyclosporine PMA's
January 24, 1992
Do
Do
[[Page 45474]]
Guidance Document for the Submission of Tumor Associated September 19, 1996
Do
Do Antigen Premarket Notification [510(k)] to FDA
Guidance for 510(k)s on Cholesterol Tests for Clinical July 14, 1995
Do
Do Laboratory, Physicians' Office Laboratory, and Home Use
Guidance for Industry--Abbreviated 510(k) Submissions for February 22, 1999
Do
Do In Vitro Diagnostic Calibrators; Final
Document for Special Controls for Erythropoietin Assay April 28, 1999
Do
Do Premarket Notifications [510(k)s] Guidance for Industry; Final
Guidance for Premarket Submissions for Kits for Screening December 30, 1998
Do
Do Drugs of Abuse to Be Used By The Consumer; Guidance for Industry; Draft
Guidance on Labeling for Laboratory Tests; Guidance for June 24, 1999
Do
Do Industry; Draft
In Vitro Diagnostic Bicarbonate/Carbon Dioxide Test
July 6, 1998
Do
Do System; Guidance for Industry; Final
In Vitro Diagnostic Chloride Test System; Guidance for July 6, 1998
Do
Do Industry; Final
In Vitro Diagnostic C-Reactive Protein Immunological Test July 20, 1998
Do
Do System; Guidance for Industry; Final
In Vitro Diagnostic Creatinine Test System; Guidance for July 2, 1998
Do
Do Industry; Final
In Vitro Diagnostic Glucose Test System; Guidance for July 6, 1998
Do
Do Industry ; Final
Guidance for Industry--In Vitro Diagnostic Potassium Test July 6, 1998
Do
Do System; Final
In Vitro Diagnostic Sodium Test System; Guidance for July 6, 1998
Do
Do Industry; Final
In Vitro Diagnostic Urea Nitrogen Test System; Guidance July 6, 1998
Do
Do for Industry; Final
Points to Consider Guidance Document on Assayed and
February 3, 1999
Do
Do Unassayed Quality Control Material; Guidance for Industry;
In Vitro Diagnostic Fibrin Monomer Paracoagulation Test; April 27, 1999
Do
Do Guidance for Industry and FDA Reviewers/Staff; Final
Guidance for Labeling for Over-the-Counter Sample
December 21, 1999
Do
Do Collection Systems for Drugs of Abuse Testing; Draft
Guidance for Submission of Immunohistochemistry
June 3, 1998
Do
Do Applications to the FDA
Points to Consider for Cervical Cytology Devices
July 25, 1994
Do
Do
Points to Consider for Collection of Data in Support of September 26, 1994
Do
Do In-Vitro Device Submissions for 510(k) Clearance
[[Page 45475]]
Points to Consider for Hematology Quality Control
September 30, 1997
Do
Do Materials
Points to Consider for Review of Calibration and Quality February 1, 1996
Do
Do Control Labeling for In Vitro Diagnostic Devices/Cover Letter dated March 14/1996
Review Criteria for Assessment of Alpha-Fetoprotein (AFP) July 15, 1994
Do
Do in vitro Diagnostic Devices for Fetal Open Neural Tube Defects Using Immunological Test Methodologies
Guidance on Review Criteria for Assessment of
March 8, 2000
Do
Do Antimicrobial Susceptibility Devices; Draft
Review Criteria for Assessment of Antimicrobial
October 30, 1996
Do
Do Susceptibility Test Discs
Review Criteria for Assessment of Cytogenetic Analysis July 15, 1991
Do
Do Using Automated and Semi-Automated Chromosome Analyzers
Review Criteria for Assessment of Human Chorionic
September 27, 1995
Do
Do Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs)
Review Criteria for Assessment of In Vitro Diagnostic July 6, 1993
Do
Do Devices for Direct Detection of Mycobacterium Spp. Tuberculosis [(TB)]
Review Criteria for Assessment of In Vitro Diagnostic January 1, 1992
Do
Do Devices for Direct Detection of Chlamydiae in Clinical Specimens
Review Criteria for Assessment of Laboratory Tests for September 17, 1992
Do
Do the Detection of Antibodies to Helicobacter pylori
Review Criteria for Assessment of Portable Blood Glucose February 14, 1996
Do
Do In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase, or Hexokinase Methodology
Review Criteria for Assessment of Rheumatoid Factor(RF) February 21, 1997
Do
Do In Vitro Diagnostic Devices Using Enzyme-Linked Immunoassay (EIA), Enzyme Linked Immunosorbent Assay (ELISA), Particle Agglutination Tests, and Laser and Rate Nephelometry
Review Criteria for Blood Culture Systems
August 12, 1991
Do
Do
Review Criteria for Devices Assisting in the Diagnosis of May 31, 1990
Do
Do C. Difficile Associated Diseases
Review Criteria for Devices Intended for the Detection of December 30, 1991
Do
Do Hepatitis B ``e'' Antigen and Antibody to Hbe
Review Criteria for In Vitro Diagnostic Devices for
August 1, 1992
Do
Do Detection of IGM Antibodies to Viral Agents
[[Page 45476]]
Review Criteria for In Vitro Diagnostic Devices for the February 1, 1994
Do
Do Assessment of Thyroid Autoantibodies using Indirect Immunofluorescence Assay (IFA), Indirect Hemagglutination Assay (IHA), Radioimmunoasay (RIA), and Enzyme Linked Immunosorbent Assay (ELISA).
Review Criteria for In Vitro Diagnostic Devices that February 15, 1996
Do
Do Utilize Cytogenetic In Situ Hybridization Technology for the Detection of Human Genetic Mutations (Germ Line and Somatic)
Review Criteria For Premarket Approval of In Vitro
May 15, 1992
Do
Do Diagnostic Devices for Detection of Antibodies to Parvovirus B19
Review Criteria for the Assessment of Allergen-Specific March 2, 1993
Do
Do Immunoglobulin E (IGE) In-Vitro Diagnostic Devices Using Immunological Test Methodologies
Review Criteria for the Assessment of Anti-nuclear
September 1, 1992
Do
Do Antibodies (ANA) In-Vitro Diagnostic Devices Using Indirect Immunofluorescence Assay (IFA), Immunodiffusion (IMD) and Enzyme Linked Immunosorbant Assay (ELISA).
Guidance for Industry and FDA; Guidance for Indwelling February 21, 2000
Office of Device Evaluation (ODE)/
Do Blood Gas Analyzer 510(k) Submissions
Division of Cardiovascular, Respiratory & Neurological Devices (DCRND)
Balloon Valvuloplasty Guidance For The Submission Of an January 1, 1989
Do
Do IDE Application and a PMA Application
Battery Guidance
July 12, 1993
Do
Do
Carotid Stent--Suggestions for Content of Submissions to October 26, 1996
Do
Do the Food and Drug Administration in Support of Investigational Devices Exemption (IDE) Applications
Coronary and Cerebrovascular Guidewire Guidance
January 1, 1995
Do
Do
510(K) Submission Requirements for Peak Flow Meters; January 13, 1994
Do
Do Draft
Emergency Resuscitator Guidance; Draft
April 14, 1993
Do
Do
Guidance for Implantable Cardioverter-Defibrillators; June 24, 1996
Do
Do Draft
Guidance for the Preparation of Research and Marketing August 1, 1993
Do
Do Applications for Vascular Graft Prostheses; Draft
Guidance for the Submission of Research and Marketing May 1, 1995
Do
Do Applications for Interventional Cardiology Devices: PTCA Catheters, Atherectomy Catheters, Lasers, Intravascular Stents; Draft
Guidance: Human Heart Valve Allografts; Draft
June 21, 1991
Do
Do
[[Page 45477]]
Intravascular Brachytherapy--Guidance for Data to be May 24, 1996
Do
Do Submitted to the Food and Drug Administration in Support of Investigational Device Exemption (IDE) Applications; Draft
Percutaneous Transluminal Coronary Angioplasty Package February 7, 1995
Do
Do Insert Template; Draft
Replacement Heart Valve Guidance; Draft
October 14, 1994
Do
Do
Reviewer Guidance for Ventilators; Draft
July 1, 1995
Do
Do
Reviewer Guidance on Face Masks and Shield for CPR; Draft March 16, 1994
Do
Do
Cardiac Ablation Preliminary Guidance (Data to be
March 1, 1995
Do
Do Submitted to the FDA in Support Investigation Device Exemption Application; Draft
Electrode Recording Catheter Preliminary Guidance (Data March 1, 1995
Do
Do to be Submitted to the FDA in Support of Premarket Notifications [510(k)s]) ; Draft
Excerpts Related to EMI from November 1993 Anesthesiology November 1, 1993
Do
Do and Respiratory Devices Branch/EMC Standard for Medical Devices (to be used with EMI Standard)
General Guidance Document: Non-Invasive Pulse Oximeter September 7, 1992
Do
Do
Guidance Document: Electrocardiograph (ECG) Surface
February 11, 1997
Do
Do Electrode Tester--Version 1.0
Guidance Document for Premarket Notification Submission January 24, 2000
Do
Do for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer; Final
Guidance Document for Vascular Prostheses 510(k)
November 26, 1999
Do
Do Submission; Final
Guidance for Annuloplasty Rings 510(k) Submissions; Final November 26, 1999
Do
Do
Guidance for Cardiopulmonary Bypass Arterial Line Blood February 21, 2000
Do
Do Filter 510(k) Submissions; Final
Guidance for Cardiopulmonary Bypass Oxygenators 510(k) January 17, 2000
Do
Do Submissions; Final
Guidance for Cardiovascular Intravascular Filter 510(k) November 26, 1999
Do
Do Submission; Final
Guidance for Extracorporeal Blood Circuit Defoamer 510(k) February 16, 2000
Do
Do Submissions; Final
Cardiac Monitor Guidance (including Cardiotachometer and November 5, 1998
Do
Do Rate Alarm); Guidance for Industry; Final
Diagnostic ECG Guidance (Including Non-Alarming ST
November 5, 1998
Do
Do Segment Measurement); Guidance for Industry; Final
[[Page 45478]]
Recommended Clinical Study Design for Ventricular
May 7, 1999
Do
Do Tachycardia Ablation; Guidance for Industry and for FDA Reviewers
Guidance for Oxygen Conserving Device 510(k) Review 73 February 1, 1989
Do
Do BZD 868.5905 Non-continuous Ventilator Class II
Guidance for Peak Flow Meters for Over-the-Counter Sale June 23, 1992
Do
Do
Guidance for the Preparation of the Annual Report to the April 1, 1990
Do
Do PMA Approved Heart Valve Prostheses
Guidance for the Submission of 510(k) Premarket
February 11, 1997
Do
Do Notifications for Electrocardiograph (ECG) Electrode Version 1.0
Guidance for the Submission of 510(k) Premarket
February 11, 1997
Do
Do Notifications for Electrocardiograph (ECG) Lead Switching Adapter Version 1.0
Guidance for the Submission of Research and Marketing January 14, 2000
Do
Do Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions; Final
Heated Humidifier Review Guidance
August 30, 1991
Do
Do
Implantable Pacemaker Testing Guidance
January 12, 1990
Do
Do
Vascular Graft Manufacturer, Developer, or
May 11, 1990
Do
Do Representative; Letter/Guidance
Medical Device Labeling--Suggested Format and Content; April 25, 1997
Do
Do Draft Document
Non-Invasive Blood Pressure (NIBP) Monitor Guidance
March 10, 1997
Do
Do
Policy for Expiration Dating (DCRND RB92-G)
October 30, 1992
Do
Do
Review Guidelines for Oxygen Generators and Oxygen
April 14, 1993
Do
Do Equipment; Draft Document
Reviewer Guidance for Nebulizers, Metered Dose Inhalers, October 1, 1993
Do
Do Spacers and Actuators
Reviewer Guidance for Nebulizers, Metered Dose Inhalers, November 9, 1990
Do
Do Spacers and Actuators
Reviewer's Guidance for Oxygen Concentrator
August 30, 1991
Do
Do
Guidance for Conducting Stability Testing to Support an November 16, 1999
Office of Device Evaluation (ODE)/
Do Expiration Date Labeling Claim for Medical Gloves; Draft
Division of Dental, Infection Control and General Hospital Devices (DDIGD)
Devices for the Treatment and/or Diagnosis of
June 10, 1998
Do
Do Temporomandibular Joint Dysfunction and/or Orofacial Pain; Final
Guidance on the Content and Format of Premarket
November 5, 1998
Do
Do Notification [510(k)] Submission of Washers and Washer- Disinfectors; Draft
[[Page 45479]]
Guidance Document for Washers and Washer-Disinfectors June 2, 1998
Do
Do Intended for Processing Reusable Medical Devices
Overview of Information Necessary for Premarket
April 21, 1999
Do
Do Notification Submissions for Endoseous Implants; Final
Reprocessing and Reuse of Single-Use Devices: Review February 8, 2000
Do
Do Prioritization Scheme; Draft
Guidance on Premarket Notification [510(k)] Submissions September 19, 1995
Do
Do for Sterilizers Intended for Use in Health Care Facilities; Addendum
Guidance Document for the Preparation of Premarket
March 3, 1997
Do
Do Notification [510(k)'S] for Dental Alloys; Draft
Supplementary Guidance on the Content of Premarket
March 1, 1995
Do
Do Notification [510(k)] Submissions for Medical Devices with Sharps Injury Prevention Features (Antistick); Draft
Guidance and Format of Premarket Notification [510(k)] January 3, 2000
Do
Do Submissions for Liquid Chemical Sterilants/High Level Disinfectants; Final
Guidance Document on Dental Handpieces
July 1, 1995
Do
Do
Premarket Notification [510(k)] Submissions for Testing January 13, 1999
Do
Do for Skin Sensitization to Chemicals in Natural Latex Products; Guidance for Industry and FDA Reviewers/Staff; Final
Testing for Sensitizing Chemicals in Natural Rubber Latex July 27, 1997 Medical Devices; (Addendum to Premarket Notification [510(k) Submissions for Testing for Skin Sensitization to Chemicals in Natural Latex Products; Guidance for Industry and FDA Reviewers/Staff; Final)
Neonatal and Neonatal Transport Incubators-Premarket September 18, 1998
Do
Do Notifications; Guidance for Industry and FDA Reviewers; Final
Dental Cements Premarket Notification; Final
August 18, 1998
Do
Do
Guidance For The Arrangement and Content of a Premarket May 16, 1989
Do
Do Approval (PMA) Application For An Endosseous Implant For Prosthetic Attachment
Guidance for the Preparation of a Premarket Notification November 27, 1998
Do
Do [510(k)] for Direct Filling Dental Composites
Guidance for the Preparation of Premarket Notification April 1991
Do
Do [510(k)] for Resorbable Periodontal Barriers
Guidance on 510(k) Submissions for Implanted Infusion October 1, 1990
Do
Do Ports
[[Page 45480]]
Guidance on Premarket Notification [510(k)] Submissions August 1, 1993
Do
Do for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities
Guidance on Premarket Notification [510(K)] Submissions March 16, 1995
Do
Do for Short-Term and Long-Term Intravascular Catheters
Guidance on Premarket Notification [510(k)] Submissions March 1, 1993
Do
Do for Sterilizers Intended for Use in Health Care Facilities
Guidance on Premarket Notification [510(k)] Submissions August 1, 1993
Do
Do for Surgical Gowns and Surgical Drapes
Guidance on the Content and Format of Premarket
February 13, 1998
Do
Do Notification [510(k)] for Testing for Skin Sensitization to Chemicals in Latex Products [Draize Testing]
Guidance on the Content and Format of Premarket
October 1, 1993
Do
Do Notification [510(k)] Submissions for Sharps Containers
Guidance on the Content and Format of Premarket
October 1, 1993
Do
Do Notification [510(k)] Submissions for General Purpose Disinfectants (includes Addendum of March 9, 1994)
Guidance on the Content and Format of Premarket
December 6, 1996
Do
Do Notification 510(k) Submissions for Liquid Chemical Germicides
Guidance on the Content of Premarket Notification
December 1, 1995
Do
Do [510(k)] Submissions for Protective Restraints
Guidance on the Content of Premarket Notification
April 1, 1993
Do
Do [510(K)] Submissions for Hypodermic Single Lumen Needles
Guidance on the Content of Premarket Notification
April 1, 1993
Do
Do [510(K)] Submissions for Piston Syringes
Guidance on the Content of Premarket Notification
March 1, 1993
Do
Do [510(K)] Submissions for Clinical Electronic Thermometers
Guidance on the Content of Premarket Notification
March 1, 1993
Do
Do [510(k)] Submissions for External Infusion Pumps
Dental Impression Materials Premarket Notification; Final August 17, 1998
Do
Do
OTC Denture Cushions, Pads, Reliners, Repair Kits and August 18, 1998
Do
Do Partially Fabricated Denture Kits; Final
Information Necessary for Premarket Notification
December 9, 1996
Do
Do Submissions For Screw-Type Endossesous Implants
510(k) Information Needed for Hydroxyapatite Coated
February 20, 1997
Office of Device Evaluation (ODE)/
Do Orthopedic Implants
Division of General & Restorative Devices (DGRD)
[[Page 45481]]
Alternate Suture Labeling Resulting From the January 11, January 11, 1993
Do
Do 1993 Meeting with HIMA (Reformatted December 17, 1997)
Calcium Phosphate (Ca-P) Coating Draft Guidance for
February 21, 1997
Do
Do Preparation of FDA Submissions for Orthopedic and Dental Endosseous Implants
Copy of October 9, 1992 Letter and Original Suture
October 9, 1992
Do
Do Labeling Guidance (Reformatted December 17, 1997)
510(k) Guideline for General Surgical Electrosurgical May 10, 1995
Do
Do Devices; Draft
Data Requirements for Ultrahigh Molecular Weight
March 28, 1995
Do
Do Polyethylene (Uhmupe) Used in Orthopedic Devices; Draft
Guidance Document for Femoral Stem Prostheses; Draft August 1, 1995
Do
Do
Guidance Document for Testing Acetabular Cup Prostheses; May 1, 1995
Do
Do Draft
Guidance Document for the Preparation of Premarket
July 16, 1997
Do
Do Notification [510(k)] Applications for Orthopedic Devices-The Basic Elements; Draft
Guidance for Arthroscopes and Accessory 510(k)s; Draft May 1, 1994
Do
Do
Guidance for Testing MR Interaction with Aneurysm Clips; May 22, 1996
Do
Do Draft
Guidance for the Preparation of a Premarket Notification May 31, 1995
Do
Do for a Non-Interactive Wound and Burn Dressing [510(k)] ; Draft
Guidance for the Preparation of a Premarket Notification August 30, 1994
Do
Do for Extended Laparoscopy Devices (ELD); Draft
Guidance for the Preparation of an IDE Submission for a April 4, 1995
Do
Do Interactive Wound and Burn Dressing; Draft
Guidance for the Preparation of Premarket Notifications April 1, 1993
Do
Do [510(k)] s for Cemented, Semi-Constrained Total Knee Prostheses; Draft
Outline for a Guidance Document for Testing Orthopedic November 1, 1993
Do
Do Bone Cement, request for comments by December 10, 1993; Draft
Premarket Notification Review Guidance for Evoked
June 1, 1994
Do
Do Response Somatosensory Stimulators; Draft
Guidance on Biocompatibility Requirements for Long Term September 12, 1994
Do
Do Neurological Implants: Part-3 Implant Model; Draft
Biofeedback Devices--Guidance for 510(k) Content; Draft August 1, 1994
Do
Do
Cranial Perforator Guidance; Draft
July 13, 1994
Do
Do
[[Page 45482]]
Guidance for Clinical Data to be Submitted for Premarket August 20, 1992
Do
Do Approval Application for Cranial Electrotherapy Stimulators; Draft
Guide for Cortical Electrode 510(k) Content; Draft
August 10, 1992
Do
Do
Neuro Endoscope Guidance; Draft
July 7, 1994
Do
Do
Electroencephalograph Devices Guidance for 510(k)
November 3, 1997
Do
Do Content; Draft
Galvanic Skin Response Measurement Devices-Draft Guidance August 1, 1994
Do
Do for 510(k) Content
Guidance Document for the Preparation of IDEs for Spinal January 13, 2000
Do
Do Systems; Final
Preparation of Investigational Device Exemptions and March 18, 1998
Do
Do Premarket Approval Applications for Bone Growth Stimulator Devices; Guidance Document for Industry and CDRH Staff; Draft
Guidance Document for Surgical Lamp 510Ks; Final
July 13, 1998
Do
Do
Guidance Document for Testing Biodegradable Polymer
April 20, 1996
Do
Do Implant Devices; Draft
Guidance Document for Testing Bone Anchor Devices; Draft April 20, 1996
Do
Do
Guidance Document for Testing Non-Articulating,
May 1, 1995
Do
Do ``Mechanically Locked'', Modular Implant Components; Draft
Guidance Document for Testing Orthopedic Implants with April 28, 1994
Do
Do Modified Metallic Surfaces Apposing Bone or Bone Cement (replaces 8623 and 8093)
Guidance Document for the Preparation of IDE and PMA February 18, 1993
Do
Do Applications for Intra-Articular Prosthetic Knee Ligament Devices
Guidance Document for the Preparation of Premarket
July 26, 1995
Do
Do Notification [510(k)] Applications for Submerged (Underwater) Exercise Equipment
Guidance Document for the Preparation of Premarket
July 26, 1995
Do
Do Notification [510(k)] Applications for Electromyograph Needle Electrodes
Guidance Document for the Preparation of Premarket
July 26, 1995
Do
Do Notification [510(k)] Applications for Exercise Equipment
Guidance Document for the Preparation of Premarket
July 26, 1995
Do
Do Notification [510k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles
Guidance Document for the Preparation of Premarket
July 26, 1995
Do
Do Notification [510(k)] Applications for Beds
[[Page 45483]]
Guidance Document for the Preparation of Premarket
July 26, 1995
Do
Do Notification [510(k)] Applications for Immersion Hydrobaths
Guidance Document for the Preparation of Premarket
July 26, 1995
Do
Do Notification [510(k)] Applications for Powered Tables and Multifunctional Physical Therapy Tables
Guidance Document for the Preparation of Premarket
July 26, 1995
Do
Do Notification [510(k)] Applications for Communications Systems (Powered and Non-Powered) and Powered Environmental Control Systems
Guidance Document for the Preparation of Premarket
July 26, 1995
Do
Do Notification [510(k)] Applications for Therapeutic Massagers and Vibrators
Guidance Document for the Preparation of Premarket
July 26, 1995
Do
Do Notification [510(k)] Applications for Heating and Cooling Devices
Guidance Document For The Preparation of Premarket
January 10, 1995
Do
Do Notification For Ceramic Ball Hip Systems
Guidance Document for Dura Substitute Devices; Final August 13, 1999
Do
Do
Guidance Document for Neurological Embolization Devices; August 13, 1999
Do
Do Guidance for Industry; Final
Guidance for the Preparation of a Premarket Notification August 30, 1999
Do
Do Application for Processed Human Dura Mater; Guidance for Industry; Final
Guidance for Dermabrasion Devices; Final
March 2, 1999
Do
Do
Guidance on Preclinical and Clinical Data and Labeling October 5, 1999
Do
Do for Breast Prostheses; Guidance for Industry; Draft
Guidance for Spinal System 510(k)s; Final
May 7, 1999
Do
Do
Guidance Document for Powered Suction Pump 510(k)s;
October 30, 1998
Do
Do Guidance for Industry and/or for FDA Reviewers/Staff and/ or Compliance; Final
Guidance Document for Powered Muscle Stimulator 510(k)s; June 9, 1999
Do
Do Guidance for Industry, FDA Reviewers/Staff and Compliance; Final
Guidance for the Content of Premarket Notifications for April 28, 1998
Do
Do Esophageal and Tracheal Prostheses; Guidance for Industry; Final
Guidance for Studies for Pain Therapy Devices--General May 12, 1988
Do
Do Considerations in the Design of Clinical Studies for Pain-Alleviating Devices
Guidance for the Preparation of a Premarket Notification March 2, 1999
Do
Do Application for a Surgical Mesh; Final
[[Page 45484]]
Guidance on the Content and Organization of a Premarket June 1, 1995
Do
Do Notification for a Medical Laser
Guide for TENS 510(k) Content; Draft
August 1, 1994
Do
Do
Guidelines for Reviewing Premarket Notifications that February 1997
Do
Do Claim Substantial Equivalence to Evoked Response Stimulators
Core Study for Silicone Breast Implants; Letter
January 11, 1996
Do
Do
ORDB 510(k) Sterility Review Guidance
July 3, 1997
Do
Do
Protocol for Dermal Toxicity Testing for Devices in
January 1985
Do
Do Contact with Skin; Draft
Reviewers Guidance Checklist for Intramedullary Rods February 21, 1997
Do
Do
Reviewers Guidance Checklist for Orthopedic External February 21, 1997
Do
Do Fixation Devices
Premarket Notification [510(k)] Guidance Document for June 28, 1994
Office of Device Evaluation (ODE)/
Do Class II Daily Wear Contact Lenses; Amendment 1; Draft
Division of Ophthalmic Devices (DOD)
Guidance for Premarket Submission of Orthokeratology April 10, 2000
Do
Do Rigid Gas Permeable Contact Lenses; Final
An FDA Survey of U.S. Contact Lens Wearers (Carol L. July 1, 1987
Do
Do Herman) Reprinted from Contact Lens Spectrum
Announcement by Dr. Alpert at July 26, 1996 Ophthalmic August 26, 1996
Do
Do Panel Meeting concerning Manufacturers & Users of Lasers for Refractive Surgery [Excimer]
Announcement: Information for Manufacturers & Users of September 22, 1997
Do
Do Lasers for Refractive Surgery [Excimer]
Checklist of Information Usually Submitted in an
October 10, 1996
Do
Do Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [Excimer]
Contact Lenses: The Better the Care the Safer the Wear; April 1, 1991
Do
Do Publication No. FDA 91-4220
Discussion Points for Expansion of the ``Checklist of September 5, 1997
Do
Do Information Usually Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers''; Draft
Premarket Notification [510(k)] Guidance Document for May 12, 1994
Do
Do Class II Daily Wear Contact Lenses and June 28, 1994 corrections to pages 18 & 20; Draft
Premarket Notification 510(k) Guidance for Contact Lens May 1, 1997
Do
Do Care Products; Draft
Facts for Consumers from the Federal Trade Commission- April 1, 1986
Do
Do Eyeglasses
[[Page 45485]]
FDA Guidelines for Multifocal Intraocular Lens IDE
May 29, 1997
Do
Do Studies and PMA's
Ophthalmoscope Guidance (Direct and Indirect); Guidance July 8, 1998
Do
Do for Industry
Guidance Document for Nonprescription Sunglasses; Final October 9, 1998
Do
Do
Retinoscope Guidance; Final
July 8, 1998
Do
Do
Slit Lamp Guidance; Final
July 13, 1998
Do
Do
Revised Procedures for Adding Lens Finishing Laboratories August 11, 1998
Do
Do to Approved Premarket Approval (PMA) Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear; Guidance for Industry and FDA Staff; Final
Accountability Analysis for Clinical Studies for
August 4, 1999
Do
Do Ophthalmic Devices; Draft
Aqueous Shunts--510(k) Submissions; Final
November 16, 1998
Do
Do
Guidance on 510(k) Submissions for Keratoprostheses; March 3, 1999
Do
Do Final
Guidance on the Content and Format of Premarket
January 16, 1998
Do
Do Notification [510(k)] Submissions for Surgical Mask; Draft
Important Information About Rophae Intraocular Lenses August 20, 1992
Do
Do
Intraocular Lens (IOL) Guidance Document; Draft
October 14, 1999
Do
Do
New FDA Recommendations & Results of Contact Lens Study May 30, 1989
Do
Do (7 Day Letter)
Owners Certification of Lasers as PMA Approved Devices September 26, 1996
Do
Do Excimer]
Third Party Review Guidance for Vitreous Aspiration and January 31, 1997
Do
Do Cutting Device Premarket Notification [510(k)]
Update on Excimer Lasers for Nearsightedness
May 20, 1996
Do
Do
Guidance for Manufacturers Seeking Marketing Clearance of March 12, 2000
Do
Do Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers; Final
510(k) Checklist for Sterile Lubricating Jelly Used With September 19, 1994
Office of Device Evaluation (ODE)/
Do Transurethral Surgical Instruments
Division of Reproductive, Abdominal, ENT & Radiological Devices (DRAERD)
Guidance for Hemodialyzer Reuse Labeling; Draft
November 6, 1995
Do
Do
Content of Premarket Notification for Hemodialysis
August 7, 1998
Do
Do Delivery Systems; Guidance for Industry and CDRH Reviewers; Final
[[Page 45486]]
Guidance for the Content of Premarket Notifications
February 8, 1999
Do (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi
CDRH Interim Regulatory Policy for External Penile
September 10, 1997
Do
Do Rigidity Devices
Checklist for Mechanical Lithotripters and Stone
November 1, 1994
Do
Do Dislodgers used in Gastroenterology and Urology
510(k) Checklist for Conditioned Response Enuresis
November 23, 1994
Do
Do Alarms; Draft
510(k) Checklist for Condom Catheters; Draft
February 23, 1995
Do
Do
510(k) Checklist for Endoscopic Electrosurgical Unit August 16, 1995
Do
Do (ESU) and Accessories Used in Gastroenterology and Urology; Draft
510(k) Checklist for Endoscopic Light Sources Used in June 22, 1995
Do
Do Gastroenterology and Urology; Draft
510(k) Checklist for Non-Implanted Electrical Stimulators June 6, 1995
Do
Do Used for the Treatment of Urinary Incontinence; Draft
510(k) Checklist for Urological Irrigation System and August 1, 1995
Do
Do Tubing Set; Draft
Guidance for Clinical Investigations of Devices Used for November 11, 1994
Do
Do the Treatment of Benign Prostatic Hyperplasia (BPH); Draft
Guidance for Information on Clinical Safety and
February 5, 1992
Do
Do Effectiveness Data for Extracorporeal Shock Wave Lithotripsy of Upper Urinary Tract (Renal Pelvis, Renal Calyx and Upper Ureteral) Calculi; Draft
Guidance for Preclinical and Clinical Investigations of November 29, 1995
Do
Do Urethral Bulking Agents Used in the Treatment of Urinary Incontinence; Draft
Guidance for Preparation of PMA Applications for Penile March 16, 1993
Do
Do Inflatable Implants; Draft
Guidance for Preparation of PMA Applications for
March 16, 1993
Do
Do Testicular Prostheses; Draft
Guidance for Preparation of PMA Applications for the May 1, 1995
Do
Do Implanted Mechanical/Hydraulic Urinary Continence Device (Artificial Urinary Sphincter); Draft
Guidance for Review of Bone Densitometer 510(k)
November 9, 1992
Do
Do Submissions; Draft
Guidance for the Clinical Investigation of Urethral
November 2, 1995
Do
Do Stents; Draft
Guidance for the Content of Premarket Notifications for March 17, 1995
Do
Do Endoscopes used in Gastroenterology and Urology; Draft
[[Page 45487]]
Guidance for the Content of Premarket Notifications for July 29, 1991
Do
Do Loop and Rollerball Electrodes for GYN Electrosurgical Excisions; Draft
Guidance for the Content of Premarket Notifications for May 25, 1995
Do
Do Menstrual Tampons; Draft
Guidance for the Content of Premarket Notifications for January 24, 1992
Do
Do Urological Balloon Dilatation Catheters; Draft
Guidance for the Content of Premarket Notifications for May 30, 1997
Do
Do Water Purification Components and Systems for Hemodialysis; Draft
Guidance Outline-Points to Consider for Clinical Studies November 30, 1993
Do
Do for Vasovasostomy Devices; Draft
Guidance to Firms on Biliary Lithotripsy Studies; Draft August 2, 1990
Do
Do
Suggested Information for Reporting Extracorporeal Shock January 18, 1991
Do
Do Wave Lithotripsy Device Shock Wave Measurements; Draft
Thermal Endometrial Ablation Devices (Submission Guidance March 14, 1996
Do
Do for an IDE); Draft
Devices Used for In Vitro Fertilization and Related
September 10, 1998
Do
Do Assisted Reproduction Procedures: Submission Guidance for a 510(k); Draft Availability
Guidance for the Content of Premarket Notifications for November 30, 1998
Do
Do Intracorporeal Lithotripters; Guidance for Industry; Final
Guidance (``Guidelines'') for Evaluation of Fetal Clip March 8, 1977
Do
Do Electrode
Guidance (``Guidelines'') for Evaluation of Hysteroscopic May 10, 1978
Do
Do Sterilization Devices
Guidance (``Guidelines'') for Evaluation of Laparoscopic May 1978
Do
Do Bipolar and Thermal Coagulators (and Accessories)
Guidance (``Guidelines'') for Evaluation of Tubal
November 22, 1977
Do
Do Occlusion Devices
Guidance for the Submission of Premarket Notifications December 3, 1998
Do
Do for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems; Guidance for Industry; Final
Guidance for the Submission of Premarket Notifications November 20, 1998
Do
Do for Radionuclide Dose Calibrators; Guidance for Industry; Final
Guidance for the Submission of Premarket Notifications November 14, 1998
Do
Do for Magnetic Resonance Diagnostic Devices; Guidance for Industry; Final
[[Page 45488]]
Harmonic Imaging With/Without Contrast Premarket
November 16, 1998
Do
Do Notification; Guidance for Industry; Final
Non-Automated Sphygmomanometer (Blood Pressure Cuff) November 19, 1998
Do
Do Guidance; Version 1; Guidance for Industry; Final
Uniform Contraceptive Labeling; Guidance for Industry; July 23, 1998
Do
Do Final
Guidance for the Content of Premarket Notifications for January 16, 2000
Do
Do Penile Rigidity Implants; Final
Electro-optical Sensors for the In Vivo Detection of August 25, 1999
Do
Do Cervical Cancer and its Precursors: Submission Guidance for an IDE/PMA; Guidance for Industry; Draft
Noise Claims in Hearing Aid Labeling; Final
October 21, 1998
Do
Do
Guidance for Magnetic Resonance Diagnostic Devices-- September 29, 1997
Do
Do Criteria for Significant Risk Investigations
Guidance for Resorbable Adhesion Barrier Devices for Use December 16, 1999
Do
Do in Abdominal and/or Pelvic Surgery; Draft
Guidance for the Arrangement and Content of a Premarket May 1, 1990
Do
Do Approval (PMA) Application for a Cochlear Implant in Children Ages 2 through 17 Years
Guidance for the Comment and Review of 510(k)
August 1, 1993
Do
Do Notifications for Picture Archiving and Communications Systems (PACS) and Related Devices
Guidance for the Content of Premarket Notifications for February 10, 1993
Do
Do Biopsy Devices Used in Gastroenterology and Urology
Guidance for the Content of Premarket Notifications for September 12, 1994
Do
Do Conventional and Antimicrobial Foley Catheters
Guidance for the Content of Premarket Notifications for February 5, 1998
Do
Do Metal Expandable Biliary Stents; Final
Guidance for the Content of Premarket Notifications for February 10, 1993
Do
Do Urethral Stents
Guidance for the Content of Premarket Notifications for June 7, 1994
Do
Do Urine Drainage Bags
Guidance for the Content of Premarket Notifications for July 29, 1994
Do
Do Urodynamic/Uroflowmetry Systems
Guidance for the Submission of 510(k)'s for Solid State X- August 6, 1999
Do
Do ray Imaging Devices; Final
Guidance for the Technical Content of a Premarket
April 1, 1990
Do
Do Approval (PMA) Application for an Endolymphatic Shunt Tube with Valve
[[Page 45489]]
Guidance for the Content of Premarket Notifications for August 7, 1998
Do
Do Conventional and Permeability Hemodialyzers; Guidance to Industry and CDRH Reviewers; Final
Guideline for the Arrangement and Content of a Premarket May 1, 1990
Do
Do Approval (PMA) Application for a Cochlear Implant in Adults at Least 18 Years of Age
Guidelines for Evaluation of Non-Drug IUD's
September 28, 1976
Do
Do
Home Uterine Activity Monitors: Guidance for the
July 30, 1999
Do
Do Submission of 510(k) Premarket Notifications; Draft
Hysteroscopes and Gynecology Laparoscopes--Submission March 27, 1996
Do
Do Guidance for a 510(k) includes 00192
Hysteroscopic and Laparoscopic Insufflators: Submission August 1, 1995
Do
Do Guidance for a 510(k)
Information for a Latex Condom 510(k) Submission for July 1, 1997
Do
Do Obstetrics-Gynecology Devices Branch; Draft
Information for Manufacturers Seeking Marketing Clearance September 30, 1997
Do
Do of Diagnostic Ultrasound Systems and Transducers; Draft
Intrapartum Continuous Monitors for Fetal Oxygen
June 14, 1997
Do
Do Saturation and Fetal pH; Submission Guidance for a PMA; Draft
Latex Condoms for Men-Information for 510(k) Premarket July 23, 1998
Do
Do Notifications: Use of Consensus Standards for Abbreviated Submissions
Notice to Manufacturers of Bone Mineral Densitometers; September 25, 1997
Do
Do Letter
Premarket Testing Guidelines for Falloposcopes
November 20, 1992
Do
Do
Premarket Testing Guidelines for Female Barrier
April 4, 1990
Do
Do Contraceptive Devices Also Intended to Prevent Sexually Transmitted Diseases
Reviewer Guidance for Automatic X-Ray Film Processor February 1, 1990
Do
Do 510(k)
Simplified 510(k) Procedures For Certain Radiology
December 21, 1993
Do
Do Devices (December 21, 1993 letter from L Yin, ODE/ DRAERD, to NEMA)
Information for Manufacturers Seeking Marketing Clearance June 19, 1996
Do
Do of Digital Mammography Systems; Status Update
Testing Guidance for Male Condoms Made from New Material June 29, 1995
Do
Do (Non-Latex)
Tympanostomy Tubes Submission Guidance for a 510(k)
January 14, 1998
Do
Do Premarket Notification; Final
[[Page 45490]]
Guidance on Amended Procedures for Advisory Panel
March 20, 1998
ODE/Program Operations Staff (POS)
Do Meetings [FDAMA] Final
PMA/510(k) Expedited Review-Guidance for Industry and March 20, 1998
Do
Do CDRH Staff [FDAMA] Final
PMA/510(k) Expedited Review #G98-4 (Blue Book Memo)
March 20, 1998
Do
Do
Guidance on IDE Policies and Procedures [FDAMA]; Final January 20, 1998
Do
Do
FDA Modernization Act of 1997 Guidance for the Device February 6, 1998
Office of Health and Industry Programs Do Industry on Implementation of Highest Priority
(OHIP) Provisions [FDAMA]; Final
Overview of FDA Modernization Act of 1997 Medical Device June 5, 1998
Do
Do Provisions [FDAMA]; Final
Guidance: The Mammography Quality Standards Act Final March 4, 1999
Office of Health and Industry Programs Do Regulations Document #1; Final
(OHIP)/Division of Mammography Quality and Radiation Programs (DMQRP)
Guidance: The Mammography Quality Standards Act Final February 25, 2000
Do
Do Regulations Document #2; Final
Guidance: The Mammography Quality Standards Act Final December 8, 1999
Do
Do Regulations Document #3; Draft
Guidance The Mammography Quality Standards Act Final May 5, 1999
Do
Do Regulations--Mammography Facility Survey and Medical Physicist Qualification Requirements Under MQSA; Final
Guidance The Mammography Quality Standards Act Final May 5, 1999
Do
Do Regulations--Preparing for MQSA Inspections; Final
Guidance for Request and Issuance of Interim Notice
May 4, 1999
Do
Do Letters for Mammography Facilities Under the Mammography Quality Standards Act, 42 U.S.C. Section 263(b); Final
Guidance for Review of Cases of Possible Suspension or March 26, 1998
Do
Do Revocation of Mammography Facility Certificates Under the Mammography Quality Standards Act, 42 U.S.C. 263(b); Final
Guidance for Review of Requests for Reconsideration of March 26, 1998
Do
Do Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Act, 42 U.S. C. 263(b); Final
Guidance for Submission of Request for Reconsideration of March 26, 1998
Do
Do Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Acts, 42 U.S.C. 263(b); Final
[[Page 45491]]
Accidental Radioactive Contamination of Human Food and August 13, 1998
Do
Do Animal Feeds: Recommendations for State and Local Agencies; Final
Guidance for Policy and Standard Operating Procedures April 15, 1998
Do
Do When Mammography Facilities in States that Have Accreditation Bodies Intend to Change Accreditation Bodies; Final
Guidance: The Mammography Quality Standards Act Final May 5, 1999
Do
Do Regulations Preparing for MQSA Inspections; Final
Guidance: The Mammography Quality Standards Act Final March 23, 1999
Do
Do Regulations Motion of Tube-Image Receptor Assembly; Final
Guidance: The Mammography Quality Standards Act Final December 7, 1999
Do
Do Regulations: Quality Assurance Documentation; Final
Premarket Notification: 510(k)-Regulatory Requirements August 1, 1995
Office of Health and Industry Programs Do for Medical Devices (FDA 95-4158) [available on disk]
(OHIP)/Division of Small Manufacturers Assistance (DSMA)
Labeling-Regulatory Requirements for Medical Devices (FDA September 1, 1989
Do
Do 89-4203)
Classification Names for Medical Devices and In Vitro March 1, 1995
Do
Do Diagnostic Products (FDA Pub No. 95-4246)
An Introduction to Medical Device Regulations (FDA 92- January 1, 1992
Do
Do 4222)
Comparison Chart: 1996 Quality System Reg vs. 1978 Good November 11, 1996
Do
Do Manufacturing Practices Reg vs. ANSI/ISO/ASQC Q9001 and ISO/DI 13485:1996
Medical Glove Guidance Manual; FDA 99-4257; Draft
August 30, 1999
Do
Do
In Vitro Diagnostic Devices: Guidance for the Preparation January 1, 1997
Do
Do of 510(k) Submissions (FDA 97-4224) [available on disk]
Instructions for Completion of Medical Device
July 1, 1997
Do
Do Registration and Listing Forms FDA 2891, 2891a and 2892
Investigational Device Exemptions [IDE] Manual (FDA 96- June 1, 1996
Do
Do 4159) [available on disk]
Medical Device Appeals and Complaints: A Guidance on February 19, 1998
Do
Do Dispute Resolution; Final
Medical Device Reporting for Manufacturers [available on March 1, 1997
Do
Do disk]
Premarket Approval (PMA) Manual; Final
January 1, 1998
Do
Do
Regulatory Requirements for Devices for the Handicapped August 1, 1987
Do
Do (FDA 87-4221)
Small Business Guide to FDA (FDA 96-1092)
January 1, 1996
Do
Do
[[Page 45492]]
The FDA Export Reform and Enhancement Act of 1996/Export February 7, 2000
Do
Do Certification Package including ``Instructions for Requests for Certificate to Foreign Governments''; Final
U.S.-FDA-Regulation of Medical Devices; Background
April 14, 1999
Do
Do Information for International Officials (entire document available on disk); Final
510(k) Manual-Premarket Notification: 510(k)-Regulatory August 1, 1995
Do
Do Requirements for Medical Devices
Export--Foreign Liaison (part of ``Exporting Medical
December 2, 1998
Do
Do Devices,'' February 25, 1999)
Exporting Medical Devices; Final
February 25, 1999
Do
Do
Third Party Programs Under the Sectoral Annex on Medical January 6, 1999
Do
Do Devices to the Agreement on Mutual Recognition Between the United States of America and the European Community (MRA); Guidance for Staff, Industry, and Third Parties; Final
Implementation of Third Party Programs Under the FDA October 30, 1998
Do
Do Modernization Act of 1997; Guidance for Staff, Industry, and Third Parties; Final
Medical Device Quality Systems Manual: A Small Entity December 1, 1996
Do
Do Compliance Guide
Do It By Design--An Introduction to Human Factors in December 1, 1996
Office of Health and Industry Programs Do Medical Devices
(OHIP)/Division of Device User Programs and Systems Analysis (DUPSA)
Guidance on Medical Device Patient Labeling; Guidance for March 3, 2000
Do
Do Industry; Draft
DUPSA
Device Use Safety: Incorporating Human Factors in Risk August 3, 1999
Do
Do Management; Guidance For Industry and FDA Premarket and
DUPSA Postmarket Review Staff; Draft
Human Factors Points to Consider for IDE Devices; Draft January 17, 1997
Do
Do DUPSA
Human Factors Principles for Medical Device Labeling September 1, 1993
Do
Do DUPSA
Medical Device Reporting for User Facilities
April 1, 1996
Do
Do DUPSA
Write it Right; Recommendations for Developing User
August 1, 1993
Do
Do Instruction Manuals for medical Devices Used in Home Health Care
Perspectives on Clinical Studies for Medical Device
Unknown Pre-1997
Office of Surveillance and Biometrics Do Submissions (Statistical)
(OSB)/
PMA Review Statistical Checklist
Unknown Pre-1997
Do
Do
Statistical Aspects of Submissions to FDA: A Medical June 1, 1984
Office of Surveillance and Biometrics Do Device Perspective (also includes an Appendix the
(OSB)/Division of Biostatistics (DB) article ``Observed Uses and Abuses of Statistical Procedures in Medical Device Submissions''
[[Page 45493]]
Amendment to Guidance on Discretionary Postmarket
March 30, 1994
Office of Surveillance and Biometrics Do Surveillance on Pacemaker Leads; Final
(OSB)/Issues Management Staff (IMS)
Guidance on Procedures for Review of Postmarket
February 19, 1998
Do
Do Surveillance Submissions [FDAMA]; Final
Guidance on Procedures to Determine Application of
February 19, 1998
Do
Do Postmarket Surveillance Strategies [FDAMA]; Final
SMDA to FDAMA: Guidance on FDA's Transition Plan for November 2, 1998
Do
Do Existing Postmarket Surveillance Protocols [FDAMA]; Guidance for Industry and FDA Staff; Final
Guidance to Sponsors on the Development of a
June 9, 1993
Do
Do Discretionary Postmarket Surveillance Study for Permanent Implantable Cardiac Pacemaker Electrodes (Leads); Final
Testing of Metallic Plasma Sprayed Coatings on Orthopedic February 2, 2000
Office of Surveillance and Biometrics Do Implants to Support Reconsideration of Postmarket
(OSB)/Division of Postmarket Surveillance Requirements; Guidance for Industry; Final
Surveillance (DPS)
Common Problems: Baseline Reports and Medwatch Form 3500A January 1997
Office of Surveillance and Biometrics Do (OSB)/Division of Surveillance Systems (DSS)
Instructions for Completing FDA Form 3500A with Coding December 15, 1995
Do
Do Manual for Form 3500A (MEDWATCH) (MDR)
MDR Documents Access Information for National Technical May 10, 1996
Do
Do Information Service (NTIS)
MDR Internet List Server (listserv) Instruction sheet August 29, 1996
Do
Do
MEDWATCH FDA Form 3500A For Use By User Facilities,
June 1, 1993
Do
Do Distributors and Manufacturers for Mandatory Reporting (MDR)
MDR Reporting Guidance For Breast Implants--E1996002 August 7, 1996
Do
Do
Addendum to the Instructions for Completing FDA Form June 9, 1999
Do
Do 3500A with Coding Manual (MEDWATCH) (MDR)
Instructions for Completing Form 3417: Medical Device March 31, 1997
Do
Do Reporting Baseline Report MDR]
Summary Reporting Approval for Adverse Events; Letter to July 31, 1997
Do
Do Manufacturers; Final
MDR Guidance Document No. 1--IOL--E1996004
August 7, 1996
Do
Do
MDR Guidance Document No. 3-Needlestick & Blood Exposure-- August 9, 1996
Do
Do E1996003
MDR Guidance Document: Remedial Action Exemption--
July 30, 1996
Do
Do E1996001
[[Page 45494]]
MDR Reporting Guidance for Date-Related Problems
April 16, 1999
Do
Do Including Y2K
Medical Device Reporting: An Overview; Final
April 1, 1996
Do
Do
Variance from Manufacturer Report Number Format [MDR July 16, 1996
Do
Do letter]; Final
A Primer on Medical Device Interactions with Magnetic February 7, 1997
Office of Science and Technology (OST) Do Resonance Imaging Systems; Draft
Frequently Asked Questions on Recognition of Consensus December 21, 1998
Do
Do Standards [FDAMA]; Final
Viable Bacteriophage in CO2 Laser Plume: Aerodynamic Size Unknown pre-1997
Do
Do Distribution
Guidance on the Recognition and Use of Consensus
February 19, 1998
Do
Do Standards/Appendix A [FDAMA]; Final
CDRH Standard Operating Procedures for the Identification August 6, 1999
Do
Do and Evaluation of Candidate Consensus Standard for Recognition; Final
Medical Devices Containing Materials Derived from Animal November 16, 1998
Do
Do Sources (Except for In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry; Final
Guidance on FDA's Expectations of Medical Device
May 15, 1998
Do
Do Manufacturers Concerning the Year 2000 Date Problems; Final
Guidance on Immunotoxicity Testing; Final
May 6, 1999
Office of Science and Technology (OST)/ Do Division of Life Sciences (DLS)
-
Guidance Documents Issued by the Center for Food Safety and Applied Nutrition (CFSAN)
How To Obtain A Hard Copy of The Name of Document
Date of Issuance
Grouped by Intended User or Document (Name and Address, Phone, Regulatory Activity
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, PB96- 920500
Compliance Programs Guidance Manual
1995
FDA Regulated Industries
National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, 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, PB-95- 913399
[[Page 45495]]
Regulatory Procedures Manual
August 1995
FDA Regulated Industries
National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, PB95- 265534
Requirements of Laws and Regulations Enforced 1997
FDA Regulated Industries
Superintendent of Documents, by the U.S. Food and Drug Administration
Government Printing Office, ``Blue Book''
Washington, DC 20402
Action Levels for Poisonous or Deleterious 1995
Food and Animal Feed Industries Industry Activities Staff (HFS-565), Substances in Human Food and Animal Feed
Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, PB96-920500
Pesticides Analytical Manual
1994
Food Industry
National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, PB94- 911899
FDA Advisory for Deoxynivanol (DON) in
September 16, 1993
Food and Animal Feed Industries Office of Plant & Dairy Foods & Finished Wheat Products Intended for Human
Beverages, Food and Drug Consumption and in Grain and Grain By-
Administration (HFS-306), 200 C St. Products for Animal Feed
SW., Washington, DC 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 May 29, 1992 (57 FR 22984) Developers of New Plant Food
Office of Premarket Approval, Food Plant Varieties: Notice
Varieties
and Drug Administration (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
Appendix I--Model Small Business Food
June 1996
Food Industry
Do Labeling Exemption Notice
Food Labeling: Questions and Answers
August 1994
Food Industry
Do
Food Labeling: Questions and Answers: Volume February 1996
Food Industry
Superintendent of Documents, II
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, 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 1985
Food Industry
Industry Activities Staff (HFS- and Acidified Foods
565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205- 5251
[[Page 45496]]
Fabrication of Single Service Containers and 1995
States
Milk Safety Branch (HFS-626), Closures for Milk and Milk Products
Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20202, 202-205-9175
Evaluation of Milk Laboratories
1995
States
Do
Methods of Making Sanitation Ratings Of Milk 1995
States
Do Supplies
Dry Milk Ordinance
1995
States
Do
Procedures Governing the Cooperative State- 1995
Dairy Industry
Do Public 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
1995
States
Milk Safety Branch (HFS-626), Center for Food Safety and Applied Nutrition 200 C St. SW., Washington, DC 20204, 202-205-9175
FDA Nutrition Labeling Manual: A Guide for 1993
Food Industry
Office of Nutritional Products, Developing and Using Databases
Labeling, and Dietary Supplements, Food and Drug Administration (HFS- 800), 200 C St. SW., Washington, DC 20204, 202-205-4561
Guidelines for Determining Metric Equivalents October 1, 1993
Food Industry
Do of Household Measures
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 1995
Food and Animal
Do Substances in Human Food and Feed (Also Found in CPG's)
1997 FDA Food Code
1997
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
1992
States
Office of Seafood, Office of Seafood Sanitation
(HFS-407), Shellfish Sanitation Branch, 200 C St. SW., Washington, DC 20204, 202-418-3150
Fish and Fisheries Products Hazards and
1996
Seafood Industry
Do Controls Guide
[[Page 45497]]
Guidance for Submitting Requests under 21 CFR 1996
Food Packaging Industry,
Office of Premarket Approval, Food 170.39, Threshold of Regulation for
and Drug Administration (HFS-200), Substances Used in Food Articles
200 C St. SW., Washington, DC 20204, 202-418-3100
Guidelines for the Preparation of Petition 1996
Food Ingredient or Packaging
Do Submissions
Industry
Guidelines for Approval of Color Additives in 1996
Color or Contact Lens Industry
Do Contact Lenses Intended as Colors
FDA Recommendations for Submission of
February 1993
Color Additives Industry
Do Chemical and Technological Data on Color Additives for Food, Drugs or Cosmetics Use
Points to Consider for the Use of Recycled December 1992
Food Packaging Industry
Do Plastics in Food Packaging: Chemistry Considerations
Recommendations for Submission of Chemical May 1993
Food Packaging Industry
Do and Technological Data for Direct Food Additive and GRAS Food Ingredient Petitions
Recommendations for Chemistry Data for
June 1995
Food Packaging Industry
Do Indirect Food Additive Petitions
Enzyme Preparations: Chemistry
January 1993
Food Enzyme Industry
Do Recommendations for Food Additive and GRAS Affirmation Petitions
Estimating Exposure to Direct Food Additive September 1995
Food and Food Ingredient Industry Do and Chemical Contaminants in the Diet
Toxicological Principles for the Safety
1982
Petitioners for Food or Color
Do Assessment of Direct Food Additives and
Additives Color Additives Used in Food (also known as Redbook I)
Environmental Assessment Technical Handbook March 1987
Petitioners for Food or Color
National Technical Inion Service Additives
(NTIS), 5285 Port Royal Rd., Springfield, VA 22161, Pub. No. PB87175345-AS, Ab-01
Color Additive Petitions Information and 1996
Petitioners for Color Additives Office of Premarket Approval, Food Guidance
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
Office of Premarket Approval, Food Additives
and Drug Administration (HFS-200), 200 C St. SW., Washington, DC 20204, 202-418-3100
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 June 10, 1996
Food Industry
Do Foods; Notice to Manufacturers
Guidance on Labeling of Foods that Need
February 24, 1997 (62 FR Food Industry
Do Refrigeration by Consumers
8248)
[[Page 45498]]
Guidelines Concerning Notification and
1985
Infant Formula Manufacturers
Do Testing of Infant Formula
Clinical Testing of Infant Formulas with
1988
Infant Formula Manufacturers
Do Respect to Nutritional Suitability for Term Infants
Guidelines for the Evaluation of the Safety 1988
Infant Formula Manufacturers
Do and Suitability of New Infant Formulas for Feeding Infants with Allergic Diseases
Guidelines for the Evaluation of the Safety 1990
Infant Formula Manufacturers
Do and 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 January 1993
States
Office of Seafood, Food and Drug in Seafood)
Administration (HFS-400), 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 January 1993
States
Do in Seafood)
Guidance Document for Chromium (Trace
January 1993
States
Do Elements in Seafood)
Guidance Document for Lead (Trace Elements in August 1993
States
Do Seafood)
Guidance Document for Nickel (Trace Elements January 1993
States
Do in Seafood)
FDA's Policy for Foods Developed by
1995
Food Industry
Do Biotechnology
Bovine Spongiform Encephalopathy (BSE) In 1997
Food Industry
Office of Plant and Dairy Foods and Products for Human Use
Beverages (HFS-302), 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 February 1994
Regulated Industry
Office of Nutritional Products, Milk and Milk Products that have not been
Labeling, and Dietary Supplements treated with Recombinant Bovine Somatropin
(HFS-800), Food and Drug Administration, 200 C 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 1998
Farmers and Food Packers
Lou Carson, Food Safety Initiative Fruits and Vegetables
(HFS-3), FDA-CFSAN, 200 C St. SW., Washington, DC 20204 or jsaltsman@bangate.fda.gov
[[Page 45499]]
Iron-Containing Supplements and Drugs: Label 1997
Dietary Supplement Manufacturers: Office of Nutritional Products, Warning and Unit Dose Packaging; Small
Small Entities
Labeling, and Dietary Supplements Entity Compliance Guide
(HFS-450), FDA-CFSAN, 200 C. St. SW., Washington, DC 20204
Partial List of Enzyme Preparations That are 1998
FDA Regulated Industry
Do Used in Foods
Partial List of Microorganisms and Microbial- 1998
FDA Regulated Industry
Office of Premarket Approval (HFS- Derived Ingredients That Are Used in Food
200), FDA-CFSAN, 200 C St. SW., Washington, DC 20204
Fish and Fishery Products Hazards and
January 1998
FDA Regulated Industry
Office of Seafood (HFS-400), FDA- Controls Guide, 2nd Edition
CFSAN, 200 C St. SW., Washington DC 20204
HACCP Regulations for Fish and Fishery
1998
FDA Regulated Industry
Do Products: Questions and Answers
Notification of a Health Claim or Nutrient 1998
FDA Regulated Industry
Office of Nutritional Products, Content Claim Based on an Authoritative
Labeling, and Dietary Supplements Statement of a Scientific Body
(HFS-150), 200 C St. SW., Washington, DC 20204
Small Business Juice Labeling: Questions and 1998
Small Business
Office of Nutritional Products, Answers
Labeling, and Dietary Supplements (HFS-150), 200 C St. SW., Washington, DC 20204, Geraldine June, 202-205-5099
FDA Nutrition Labeling Manual, A Guide for March 1998
FDA Regulated Industry
Office of Nutritional Products, Developing and Using Data Bases
Labeling, and Dietary Supplements (HFS-150), 200 C St. SW., Washington, DC 20204
HACCP Regulation for Fish and Fishery
January 1999
Seafood Processors
Office of Seafood, CFSAN/FDA (HFS- Products: Questions and Answers, Issue
400), 200 C St. SW., Washington, DC Three, Revised January 1999
20204, Ellen Nesheim, 202-418-3150
Foods--Adulteration Involving Hard or Sharp February 1999
FDA Field Offices
Office of Plant and Dairy Foods and Foreign Objects (CPG)
Beverages (HFS-300), 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/ Food Safety and Applied Nutrition CFSAN/FDA, 200 C St. SW., Staff
Washington, DC 20204, 202-418-3074, premarkt@cfsan.fda.gov OR http:// vm.cfsan.fda.gov/dms/ opa-expe.html
Use of Antibiotic Resistance Marker Genes in September 1998
Guidance for Industry
Nega Beru (HFS-206), OPA/CFSAN/FDA, Transgenic Plants
200 C. St. SW., Washington, DC 20204, 202-418-3097, premarkt@cfsan.fda.gov OR http:// vm.cfsan.fda.gov//dms/ opa- armg.html
Draft Guidance: Channels of Trade Policy for June 2000
Regulated Industry
Office of Plant and Dairy Foods and Commodities with Methyl Parathion Residues
Beverages, Center for Food Safety and Applied Nutrition (HFS-300), FDA, 200 C St. SW., Washington, DC 20204, http://vm.cfsan.fda.gov/dms
[[Page 45500]]
Draft Guidance: Fumonisin Levels in Human June 2000
Regulated Industry
Do Foods and Animal Feeds
Statement of Identity, Nutrition Labeling, January 1999
Small Business Entities
Industry Activities Staff (HFS-565), and Ingredient Labeling of Dietary
Center for Food Safety and Applied Supplements Small Entity Compliance Guide
Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-5251
Significant Scientific Agreement in the
December 1999
Regulated Industry,
Office of Nutritional Products, Review of Health Claims for Conventional
Labeling, and Dietary Supplements, Foods and Dietary Supplements (December
Center For Food Safety and Applied 1999)
Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-4561
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 November 1999
Regulated Industry
Do Food Contact Substances: Chemistry Recommendations
Preparation of Premarket Notifications for November 1999
Regulated Industry
Do Food Contact Substances: Toxicology Recommendations
Guidance for Small Businesses: Submission of October 1999
Small Business Entities
Division of Market Studies (HFS- Comments for CFSAN Rulemaking
726), Center for Food Safety and Applied Nutrition, Food and Drug Administration, Washington, DC 20204, 202-401-4590
Warning and Notice Statement: Labeling of September 1998
Regulated Industry
Office of Nutritional Products, Juice Products Small Entity Compliance Guide
Labeling, and Dietary 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 October 1999
Regulated Industry
Office of Plant and Dairy Foods and Sprouted Seeds
Beverages, Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202- 205-4064
Seafood HACCP Transition Policy
December 1999
Regulated Industry
Office of Seafood (HFS-400), 200 C St. SW., Washington DC 20204, 202- 205-3150
-
Guidance Documents Issued by the Center for Veterinary Medicine (CVM)
Grouped by Intended User or
How to Obtain a Hard Copy of the Document (Name and Name of Document
Date of Issuance
Regulatory Activity
Address, Phone, FAX, E-mail or Internet)
Guideline 3--General Principles for Evaluating the Safety July 1994
Animal Drug Industry
Internet via: http://www.fda.gov/cvm or Communications of Compounds Used in Food-Producing Animals
Staff (HFV-12), FDA/CVM, 7500 Standish Pl., Rockville, MD 20855, 301-594-1755, FAX 301-594-1831
Guideline 4--Guidelines for Efficacy Studies for Systemic
Do
Do Sustained Release Sulfonamide Boluses for Cattle
[[Page 45501]]
Guideline 5--Stability Guidelines
December 1990
Do
Do
Guideline 6--Guidelines for Submitting NADA's for Generic
Do
Do Drugs Reviewed by NAS/NRC
Guideline 9--Preclearance Guidelines for Production Drugs October 1975
Do
Do
Guideline 10--Amendment of Section II (G)(1)(b)(4) of the October 1975
Do
Do Preclearance Guidelines
Guideline 13--Guidelines for Evaluation of Effectiveness of January 1985
Do
Do New Animal Drugs for Use in Free-Choice Feeds
Guideline 14--Guideline and Format for Reporting the
Do
Do Details of Clinical Trials Using An Investigational New Animal Drug in FOOD Producing Animals
Guideline 15--Guideline and Format for Reporting the
February 1977
Do
Do Details of Clinical Trials Using An Investigational New Animal Drug in Non-Food Producing Animals
Guideline 16--FOI Summary Guideline
May 1985
Do
Do
Guideline 18--Antibacterial Drugs in Animal Feeds: Human
Do
Do Health Safety Criteria
Guideline 19--Antibacterial Drugs in Animal Feeds: Animal
Do
Do Health Safety Criteria
Guideline 20--Antibacterial Drugs in Animal Feeds:
Do
Do Antibacterial Effectiveness Criteria
Guideline 22--Guideline Labeling of Arecoline Base Drugs
Do
Do Intended for Animal Use
Guideline 23--Medicated Free Choice Feeds--Manufacturing July 1985
Do
Do Control
Guideline 24--Guidelines for Drug Combinations for Use in October 1983
Do
Do Animals
Guideline 25--Guidelines for the Efficacy Evaluation of January 1979
Do
Do Equine Anthelmintics
Guideline 29--Guidelines for the Effectiveness Evaluation September 1980
Do
Do of Swine Anthelmintics
Guideline 31-- Guidelines for the Evaluation of Bovine July 1981
Do
Do Anthelmintics
Guideline 33--Target Animal Safety Guidelines for New
June 1989
Do
Do Animal Drugs
Guideline 35--Bioequivalence Guideline--Final
1996
Do
Do
Guideline 36--Guidelines for Efficacy Evaluation of Canine/ July 1985
Do
Do Feline Anthelmintics
Guideline 37--Guidelines for Evaluation of Effectiveness of March 1984
Do
Do New Animal Drugs for Use in Poultry Feed for Pigmentation
Guideline 38--Guideline for Effectiveness Evaluation of August 1984
Do
Do Topical/Otic Animal Drugs
Guideline 40--Draft Guideline for the Evaluation of the April 1992
Do
Do Efficacy of Anticoccidial Drugs and Anticoccidial Drug Combinations in Poultry
[[Page 45502]]
Guideline 41--Draft Guideline: Formatting, Assembling, and June 1992
Do
Do Submitting New Animal Drug Applications
Guideline 42--Animal Drug Manufacturing Guidelines, 1994 1994
Do
Do
Guideline 43--Guidance on Generic Animal Drug Products October 1995
Do
Do Containing Fermentation-Derived Drug Substances
Guideline 45--Guideline for Uniform Labeling of Drugs for August 1993
Do
Do Dairy and Beef Cattle
Guideline 48--Guidance for Industry for the Submission of November 1994
Do
Do Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products
Guideline 49--Guidance Document for Target Animal Safety April 1996
Do
Do and Drug Effectiveness Studies for Anti-Microbial Bovine Mastitis Products
Guideline 50--Draft Guideline for Target Animal and Human February 1993
Do
Do Food Safety, Drug Efficacy, Environmental and Manufacturing Studies for Teat Antiseptic Products
Guideline 52--Guidance--Microbiological Testing of
January 1996
Do
Do Antimicrobial Drug Residues in Food
Guideline 53--Guideline for the Evaluation of the Utility May 1994
Do
Do of Food Additives in Diets Fed to Aquatic Animals
Guideline 54--Draft Guideline for Utility Studies for Anti- June 1994
Do
Do Salmonella Chemical Food Additives in Animal Feeds
Guideline 55--Supportive Data for Cat Food Labels Bearing June 1994
Do
Do ``Reduces Urinary pH Claims: Guideline in Protocol Development''
Guideline 56--Protocol Development Guideline for Clinical November 1994
Do
Do Effectiveness and Target Animal Safety Trials
Guideline 57--Master Files--Guidance for Industry for the July 1995
Do
Do Preparation and Submission of Veterinary Master Files
Guideline 58--Guidance for Industry for Good Target Animal May 1997
Do
Do Study Practices: Clinical Investigators and Monitors
Guideline 59--Guidance for Industry: Submitting a Notice of January 1999
Do
Do Claimed Investigational Exemption in Electronic Format to CVM via E-Mail
Guidance 61--Guidance for Industry--FDA Approval of Animal January 1999
Do
Do Drugs for Minor Uses and for Minor Species
Guideline 62--Guidance for Industry--Consumer-Directed August 1997
Do
Do Broadcast Advertisements
Guideline 63--Guidance for Industry--Validation of
December 1997
Do
Do Analytical Procedures: Definition and Terminology--Draft Guidance
[[Page 45503]]
Guideline 64--Guidance for Industry--Validation of
December 1997
Do
Do Analytical Procedures: Methodology--Draft Guidance
Guideline 65--Guidance for Industry--Industry-Supported November 1997
Do
Do Scientific and Educational Activities
Guideline 66--Guidance for Industry-- Professional Flexible January 1998
Do
Do Labeling of Antimicrobial Drugs--Draft Guidance
Guideline 67--Guidance for Industry--Small Entities
February 1998
Do
Do Compliance Guide for Renderers
Guideline 68--Guidance for Industry--Small Entities
February 1998
Do
Do Compliance Guide for Protein Blenders, Feed Manufacturers, and Distributors
Guideline 69--Guidance for Industry--Small Entities
February 1998
Do
Do Compliance Guide for Feeders of Ruminant Animals With On- Farm Feed Mixing Operations
Guideline 70--Guidance for Industry--Small Entities
February 1998
Do
Do Compliance Guide for Feeders of Ruminant Animals Without On-Farm Feed Mixing Operations
Guideline 71--Guidance for Industry--Use of Human Chorionic April 1998
Do
Do Gonadotropic (HCG) as a Spawning Aid for Fish
Guideline 72--Guidance for Industry--GMP's for Medicated May 1998
Do
Do Feed Manufacturers Not Required to Register and Be Licensed With FDA
Guideline 73--Draft Guidance for Industry--Stability
July 1998
Do
Do Testing of New Animal Drug Substances and Products
Guideline 74--Draft Guidance for Industry--Stability
July 1998
Do
Do Testing for New Dosage Forms of New Animal Drugs
Guideline 75--Guidance for Industry--Stability Testing: July 1998
Do
Do Photostability Testing of New Animal Drug Substances and Products: Draft Guidance
Guideline 76--Guidance for Industry--Questions and Answers-- September 1998
Do
Do BSE Feed Regulation
Guideline 77--Guidance for Industry--Interpretation of On- September 1998
Do
Do Farm Feed Manufacturing and Mixing Operations--Draft Guidance
Guideline 78--Guidance for Industry--Evaluation of the December 1999
Do
Do Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food- Producing Animals
Guidance for Industry: Chemistry, Manufacturing and
June 1999
Do
Do Controls Changes to an Approved NADA or ANADA: Draft Guidance
Draft Guidance for Industry: Good Clinical Practices
July 1999
Do
Do
[[Page 45504]]
Guidance for Industry: Efficacy of Anthelmintics: General July 1999
Do
Do Recommendations: Draft Guidance
Guidance for Industry: Stability Testing for Medicated July 1999
Do
Do Premixes Draft Guidance
Guidance for Industry: Impurities in New Veterinary Drug July 1999
Do
Do Substances Draft Guidance
Guidance for Industry: Impurities in New Veterinary Medical July 1999
Do
Do Products Draft Guidance
Guidance for Industry: Efficacy of Anthelmintics: Specific July 1999
Do
Do Recommendations for Bovines: Draft Guidance
Guidance for Industry: Efficacy of Anthelmintics: Specific July 1999
Do
Do Recommendations for Ovines: Draft Guidance
Guidance for Industry--Validation of Analytical Procedures: July 1999
Do
Do Definition and Terminology
Guidance for Industry--Validation of Analytical Procedures: July 1999
Do
Do Methodology: Final Guidance
Guidance for Industry: Efficacy of Anthelmintics: Specific July 1999
Do
Do Recommendations for Caprines: Draft Guidance
Guidance for Industry: Manufacture and Distribution of August 1999
Do
Do Unapproved Piperazine Products
Guidance for Industry: Possible Dioxin/PCB Contamination of August 1999
Do
Do Drug and Biological Products
Guidance for Industry--Consumer-Directed Broadcast
August 1999
Do
Do Advertisements: Final Guidance
Guidance for Industry: Stability Testing of New Veterinary September 1999
Do
Do Dosage Forms VICH GL4: Final Guidance
Guidance for Industry: Stability Testing of New Veterinary September 1999
Do
Do Drug Substances and Medicinal Products VICH GL3: Final Guidance
Guidance for Industry: Environmental Impact Assessments September 1999
Do
Do (EIA's) for Veterinary Medicinal Products (VMP's)--Phase I: Draft Guidance
Guidance for Industry: Quality of Biotechnological Products September 1999
Do
Do in the Veterinary Field: Stability Testing of Biotechnological/Biological Products VICH GL 17: Draft Guidance
Guidance for Industry: Impurities: Residual Solvents VICH September 1999
Do
Do GL 18: Draft Guidance
Guidance for Industry--Content and Format of Effectiveness September 1999
Do
Do and Target Animal Safety Technical Sections and Final Study Reports for Submission to the Division of Therapeutic Drugs for Non-Food Animals
Guidance for Industry: Stability Testing: Photostability September 1999
Do
Do Testing of New Veterinary Drug Substances and Medicinal Products: Final Guidance
[[Page 45505]]
Computerized Systems Used in Clinical Trials
October 1999
Do
Do
Dioxin in Anti-Caking Agents Used in Animal Feed and Feed October 1999
Do
Do Ingredients
Guidance for Industry--Evaluation of the Human Health
December 1999
Do
Do Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals
Guidance for Industry: Development of Supplemental
January 2000
Do
Do Applications for Approved New Animal Drugs--Draft Guidance
Guidance for Industry: Stability Testing for Medicated March 2000
Do
Do Premixes Guidance
Guidance for Industry: The Use of Published Literature in April 11, 2000
Do
Do Support of New Animal Drug Approval--Draft Guidance
Guidance for Industry: Dioxin In Anti-Caking Agents Used In Revised April 12, 2000
Do
Do Animal Feed And Feed Ingredients
Guidance for Industry: Fumonisin Levels in Human Foods and June 6, 2000
Do
Do Animal Feeds--Draft Guidance
-
Guidance Documents Issued by the Office of Policy (OP)
How To Obtain A Hard Copy of The Name of Document
Date of Issuance
Grouped by Intended User or Document (Name and Address, Phone, Regulatory Activity
FAX, E-mail, or Internet)
FDA's Development, Issuance, and Use of Guidance February 27, 1997
FDA Personnel and Regulated Internet via www.fda.gov/opacom/ Documents
Industry
morechoices/moreindu.html or Office of Policy (301-827-3360)
Draft Guidance for Industry; Exports and Imports June 12, 1998
Regulated Industry
Internet via www.fda.gov/opacom/ under the FDA Export Reform and Enhancement Act of
fedregister/frexport.html 1996
Direct Final Rule Guidance
November 21, 1997
FDA Personnel
Internet via www.fda.gov/opacom/ morechoices/industry/guidedc.htm or Carol Kimbrough (301-827-3480)
Industry Supported Scientific and Educational
December 3, 1997
Regulated Industry
Internet via www.fda.gov/cder/ Activities
guidance/index.htm or Office of Policy (301-827-3360)
Draft Guidance of Broadcast Advertisements
February 1997
Do
Do
Small Entities Compliance Guide On: Regulations to February 1997
Do
Internet via www.fda.gov/opacom/ Restrict the Sale and Distribution of Cigarettes and
campaigns/tobacco/tobret.htm or 1- Smokeless Tobacco in Order to Protect Children and
888-FDA-4KIDS Adolescents (21 CFR Part 897)
Children & Tobacco--Frequently Asked Questions about July 1997
Do
Do the new regulations (DRAFT)
Children & Tobacco--A Retailer's Guide to the New October 1997
Do
Do Federal Regulations
Children & Tobacco--A Guide to the New Federal
October 1997
Do
Do Regulations
[[Page 45506]]
FDA's Standards Policy
October 1995
FDA Personnel and Regulated 60 FR 53078, October 11, 1995 or Industry
Office of Policy (301-827-3360)
-
Guidance Documents Issued by the Office of Regulatory Affairs (ORA)
Grouped by Intended User or
How To Obtain A Hard Copy of The Document (Name and Address, Name of Document
Date of Issuance
Regulatory Activity
Phone, FAX, E-mail, or Internet)
Compliance Policy Guides Manual
August 1996
FDA Staff Personnel
National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161 (Order No. PB96-915499) or via Internet www.fda.gov/ora/compliance__ref/cpg/cpgtc.html
Compliance Policy Guide-DRAFT Commercialization of In January 5, 1998
Do
Do--Internet at www.fda.gov/cdrh/comp/ivddrfg.html Vitro Diagnostic Devices (IVD's) Labeled for Research Use Only or Investigational Use Only
Compliance Policy Guide 675.400 (CPG 7126.24) REVISION November 13, 1998
Do
Do--Internet at www.fda.gov/ora/compliance__ref/cpg/cpgvet/ Rendered Animal Feed Ingredients
cpg675.400.html
Compliance Policy Guide DRAFT Distributor Medical Device August 28, 1997
FDA Staff Personnel and Regulated Do--Internet at www.fda.gov/ora/compliance__ref/cpg__mdr3.txt Reporting
Industry
Compliance Policy Guide, Chapter 5, Sec. 555.425, NEW: March 23, 1999
FDA Staff Personnel
Do--Internet at http://www.fda.gov/ora/compliance__ref/cpg/cpgfod/ Foods Adulteration Involving Hard or Sharp Foreign
cpg555-425.htm Objects
Compliance Policy Guide, Chapter 1, Sec.160.800, NEW:Year April 26, 1999
Do
Do--Internet at http://www.fda.gov/ora/compliance__ref/cpg/ 2000 (Y2K) Computer Compliance
cpggenl/cpt160.800.html
Compliance Policy Guide, Chapter 1, Sec. 140.100, REVISION/ April 26, 1999
Do
Do--Internet at http://www.fda.gov/ora/compliance__ref/cpg/cpgfod/ DRAFT: Regulatory Policy on the Disposition of
draftrev-cpg715313.htm Publications That Constitute Labeling (CPG 7153.13)
Compliance Policy Guide, Chapter 1, Sec. 160.850: NEW, May 13, 1999
Do
Do--Internet at htpp://www.fda.gov/ora/compliance__ref/cpg/ Enforcement Policy: 21 CFR Part 11; Electronic Records;
cpggenl/cpg160-180.htm Electronic Signatures (CPG 7153.17)
Compliance Policy Guide, Chapter 2, Sec. 230.140, NEW, July 9, 1999
Do
Do--Internet at http://www.fda.gov/ora/compliance__ref/ Evaluation and Processing of Post Donation Information
default.htm Reports
Compliance Policy Guide, Chapter 2, Sec. 252.110, NEW: March 6, 2000
Do
Do--Internet at http://www.fda.gov/ora/compliance__ref/cpgbio/ Volume Limits for Automated Collection of Source Plasma
cpg252.110.htm
Compliance Policy Guide, Chapter 2, Sec. 257.100, REVISED: March 22, 2000
Do
Do--Internet at http://www.fda.gov/ora/cmpliance__ref/cpg/cpgbio/ Deferral of Source Plasma Donors Due to Red Cell Loss
cpg257.100.htm During Collection of Source Plasma by Automated Plasmapheresis
Compliance Policy Guide, Chapter 1, Sec. 110.100: REVISED: April 14, 2000
Do
Do--Internet at http://www.fda.gov/ora/compliance__ref/cpg/ Certificates for Export
cpggenl/cpg110-100.html
Medical Device Warning Letter Pilot
March 8, 1999
FDA Staff Personnel and Regulated Do--Internet at http://www.fda.gov/ohrms/Dockets/98fr/030899e.pdf Industry
[[Page 45507]]
Draft Guidance Policy Statement: Draft Civil Money Penalty May 18, 1999
Do
Do--Internet at http://www.fda.gov/ohrms/Dockets/98fr/051899.txt Reduction Policy for Small Entities
Glossary of Computerized System and Software Development August 1995
Do
National Technical Information Service (NTIS), 5285 Port Royal Terminology
Rd., Springfield, VA 22161 (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 Personnel
Division of Import Operations and Policy (HFC-170), Office of Electronic Devices
Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-1218
Import Alerts
Continuous
Do
FDA/Freedom of Information Staff (HFI-35), 5600 Fishers Lane, Rockville, MD 20857 or via Internetwww.fda.gov/ora/fiars/ ora__import__alerts.html
Investigations Operations Manual
March 2000
Do
Division of Emergency and Investigational Operations (HFC-130), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 301-443-3276 2000 Edition is not yet available on Internet. 1999 Edition is available on Internet at http:// www.fda.gov/ora/inspect__ref/iom/iomtc.html
Investigations Operations Manual, REVISION: Chapter 4, July 1998
Do
Do Sampling
Investigations Operations Manual, REVISION: Chapter 5, July 1998
Do
Do Establishment Inspections
Memorandum: ORA Investigational Strategy on Gamma-
May 15, 2000
Do
Do--Not available on Internet Butyrolactone (GBL) and Related Products
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, ATTN: Donna Porter or via Internet www.fda.gov/ora/ science__ref/lpm/lpmtc.html
Laboratory Procedures Manual, Chapter X, NEW: Method
May 1999
Do
Do--Not available on Internet Validation Samples
Regulatory Procedures Manual
August 1997
Do
National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161 (Order No. PB97-196182) or via Internet www.fda.gov/ora/compliance__ref/rpm/rpmtc.html
Regulatory Procedures Manual: UPDATE/New Subchapter/
March 1998
Do
Division of Compliance Policy (HFC-230), Office of Enforcement, Application Integrity Policy
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420 or via Internet www.fda.gov/ora/ compliance__ref/rpm/rpmtc.html
Regulatory Procedures Manual: UPDATE Subchapter/Warning March 1998
Do
Do Letters
Regulatory Procedures Manual: UPDATE/REVISION Subchapter/ April 1998
Do
Do Import Procedures
Regulatory Procedures Manual; UPDATE/REVISION Subchapter/ April 1998
Do
Do Priority Enforcement Strategy for Problem Importers
[[Page 45508]]
Regulatory Procedures Manual: UPDATE/REVISION Subchapter/ April 1998
Do
Do Import Procedures
Regulatory Procedures Manual: UPDATE/REVISION Subchapter/ April 1998
Do
Do 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 Subchapter/ June 1998
Do
Do--Internet at www.fda.gov/ora/compliance__ref/rpm__new2/ Seizure
ch6.html
Regulatory Procedures Manual: UPDATE/REVISION Subchapter/ June 1998
Do
Do--Internet at www.fda.gov/ora/compliance__ref/rpm__new2/ Supervisory Charges
ch9chgs.html
Regulatory Procedures Manual: NEW Subchapter/Civil
July 1998
Do
Do--Internet at www.fda.gov/ora/compliance__ref/ch6civpen.html Penalties--Electronic Product Radiation Control
Regulatory Procedures Manual, UPDATE/REVISION: Chapter 4, March 21, 2000
Do
Do Internet at http://www.fda.gov/ora/compliance__ref/rpm__new2/ Subchapter/Warning Letters
ch4.html
Guide to Inspections of Bulk Pharmaceutical Chemicals May 1994
Do
National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161 (Order No. PB96-127154) or via Internet www.fda.gov/ora/inspect__ref/igs/iglist.html
Guide to Inspections of Pharmaceutical Quality Control July 1993
Do
Do--(NTIS Order No. PB96-127279) Laboratories
Guide to Inspections of Microbiological Pharmaceutical July 1993
Do
Do--(NTIS Order No. PB96-127287) Quality Control Laboratories
Guide to Inspections of Validation of Cleaning Processes July 1993
Do
Do--(NTIS Order No. PB96-127246)
Guide to Inspections of Lyophilization of Parenterals July 1993
Do
Do--(NTIS Order No. PB96-127253)
Guide to Inspections of High Purity Water Systems
July 1993
Do
Do--(NTIS Order No. PB96-127261)
Guide to Inspections of Dosage Form Drug Manufacturers- October 1993
Do
Do--(NTIS Order No. PB96-127212) CGMPs
Guide to Inspections of Oral Solid Dosage Forms Pre/Post January 1994
Do
Do--(NTIS Order No. PB96-127345) Approval Issues for Development and Validation
Guide to Inspections of Topical Drug Products
July 1994
Do
Do--(NTIS Order No. PB96-127394)
Guide to Inspections of Sterile Drug Substance
July 1994
Do
Do--(NTIS Order No. PB96-127295) Manufacturers
Guide to Inspections of Oral Solutions and Suspensions August 1994
Do
Do--(NTIS Order No. PB96-127147)
Guide to Inspections of Nutritional Labeling and Education February 1995
Do
Do--(NTIS Order No. PB96-127378) Act (NLEA) Requirements
Guide to Inspections of Interstate Carriers and Support April 1995
Do
Do--(NTIS Order No. PB96-127386) Facilities
[[Page 45509]]
Guide to Inspections of Dairy Product Manufacturers
April 1995
Do
Do--(NTIS Order No. PB96-127329)
Guide to Inspections of Miscellaneous Foods Vol. I
May 1995
Do
Do--(NTIS Order No. PB96-127220)
Guide to Inspections of Miscellaneous Foods Vol. II
September 1996
Do
Do--(NTIS Order No. PB97-196133)
Guide to Inspections of Low Acid Canned Foods
November 1996
Do
Do--(NTIS Order No. PB97-196141) Manufacturers, Part 1-Administrative Procedures/Scheduled Processes
Guide to Inspections of Low Acid Canned Foods
April 1997
Do
Do--(NTIS Order No. PB97-196158) Manufacturers, Part 2- Processes/Procedures
Guide to Inspections of Cosmetic Product Manufacturers February 1995
Do
Do--(NTIS Order No. PB96-127238)
Guide to Inspections of Blood Banks
September 1994
Do
Do--(NTIS Order No. PB96-127303)
Guide to Inspections of Source Plasma Establishments
December 1994
Do
Do--(NTIS Order No. PB96-127360)
Guide to Inspections of Infectious Disease Marker Testing June 1996
Do
Do--(NTIS Order No. PB96-199476) Facilities
Biotechnology Inspections Guide
November 1991
Do
Do--(NTIS Order No. PB96-127402)
Guide to Inspections of Computerized Systems in Drug
February 1983
Do
Do--(NTIS Order No. PB96-127337) Processing
Guide to Inspections of Foreign Medical Device
September 1995
Do
Do--(NTIS Order No. PB96-127311) Manufacturers
Guide to Inspections of Foreign Pharmaceutical
May 1996
Do
Do--(NTIS Order No. PB96-199468) Manufacturers
Mammography Quality Standards Act (MQSA) Auditors Guide January 1998
Do
Do--(NTIS Order No. PB98-127178)
Guide to Inspections of Electromagnetic Compatibility December 1997
Do
Do--(NTIS Order No. PB98-127152) Aspects of Medical Device Quality Systems
Guide to Inspections of Grain Product Manufacturers
March 1998
Do
Division of Emergency and Investigational Operations (HFC-130), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 301-443-3276
Guide to Bioresearch Monitoring Inspections of In Vitro February 1998
Do
Do Devices
Guide to Inspections of Viral Clearance Processes for March 1998
Do
Do Plasma Derivatives
Guide to Traceback of Fresh Fruits and Vegetables
August 1998
Do
Do Implicated in Epidemiological Investigations
Guide to Inspections of Computerized Systems in the Food August 1998
Do
Do--Internet at www.fda.gov/ora/inspect__ref/igf/iglist.html Processing Industry
Guide to International Inspections and Travel, REVISION July 1999
Do
Do Revision not available on Internet (Formerly: FDA/ORA International Inspection Manual and Travel Guide)
Guide to Inspections of Quality Systems
August 1999
Do
Do--Internet at http://www.fda.gov/ora/inspect__ref/igs/qsit/ QSITGUIDE.PDF
[[Page 45510]]
Guideline for the Monitoring of Clinical Investigators January 1988
FDA Regulated Industry
Division of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420
Computerized Systems Used in Clinical Trials
April 1999
Do
Do--Internet at http://www.fda.gov/ora/compliance__ref/bimo/ ffinalcct.htm
Draft Guidance for Institutional Review Boards, Clinical March 30, 2000
Do
Do--Internet at http;//www.fda.gov/ora/compliance__ref/bimo__err- Investigators, and Sponsors: Exception from Informed
guide.htm Consent Requirements for Emergency Research
Compliance Program 7348.808: Bioresearch Monitoring; Good Revised August 17, 1998 FDA Staff Personnel
Do--Internet http://www.fda.gov/ora/compliance__ref/bimo/ Laboratory Practices (Nonclinical)
default.html
Compliance Program 7348.810: Sponsors, Contract Research Revised October 30, 1998 Do
Do Organizations and Monitors
Compliance Program 7348.811: Bioresearch Monitoring;
Revised September 2, 1998 Do
Do Clinical Investigations
Food Laboratory Practice Program (Nonclinical
October 1, 1991
Do
Division of Compliance Policy (HFC-230), Office of Enforcement, Laboratories) 7348.808A; EPA Data Audit Inspections
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420
Compliance Program 7348.809; Bioresearch Monitoring;
August 18, 1994
Do
Do Institutional Review Board
Good Laboratory Practice Regulations Management Briefings August 1979
Do
Do--Internet at www.fda.gov/ora/compliance__ref/bimo/default.html
Dated: July 14, 2000. Margaret M. Dotzel, Associate Commissioner for Policy.
[FR Doc. 00-18497Filed7-20-00; 8:45 am]
BILLING CODE 4160-01-F
