Reports and guidance documents; availability, etc.: Current guidance documents at FDA; annual comprehensive list,
[Federal Register: June 10, 1999 (Volume 64, Number 111)]
[Notices]
[Page 31228-31280]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10jn99-101]
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. FDA committed to publishing this list in its February 1997 ``Good Guidance Practices'' (GGP's), which set forth the agency's policies and procedures for the development, issuance, and use of guidance documents. This list is intended to inform the public of the existence and availability of all current guidance documents.
DATES: General comments on this list and on agency guidance documents are welcome 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. Information on where to obtain a single copy of listed guidance documents is provided for each agency Center individually in the specific Center's list of guidance documents.
FOR FURTHER INFORMATION CONTACT: Lisa M. Helmanis, Office of Policy (HF-22), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3480.
SUPPLEMENTARY INFORMATION:
-
Background
In the Federal Register of February 27, 1997 (62 FR 8961), FDA published a notice announcing its GGP's, which set forth the agency's policies and procedures for the development, issuance, and use of guidance documents. The agency adopted the GGP's to ensure public involvement in the development of guidance documents and to enhance public understanding of the availability, nature, and legal effect of such guidance.
As part of FDA's effort to ensure meaningful interaction with the public regarding guidance documents, the agency 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comprehensive list of guidance documents and quarterly updates that list all guidance documents that were issued and withdrawn during that quarter, including ``Level 2'' guidance documents.
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,
[[Page 31229]]
FDA uses the principles of ``plain language'' set forth by the President when writing its guidance documents. The agency seeks public comment on the clarity of its guidances.
The following comprehensive list of guidance documents represents all guidances currently in effect. This comprehensive list is maintained on the FDA World Wide Web home page. This list will be updated and published annually in the Federal Register. The guidance documents on this comprehensive list are organized by the issuing Center or Office within FDA, and are further grouped by the intended users or regulatory activities to which they pertain. Dates provided in the following list refer to the date of issuance or, where applicable, the date of last revision of the document. Document numbers are provided where available.
-
Guidance Documents Issued by the Center for Biologics Evaluation and Research (CBER)
How to Obtain a Hard Copy of Grouped by Intended the Document (Name and Name of Document
Date of Issuance User or Regulatory Address, Phone, FAX, E-mail Activity
or Internet)
Requirements for Infrequent
August 27, 1982 FDA regulated
Office of Communication, Plasmapheresis Donors
industry
Training, and Manufacturers Assistance (HFM-40), 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: http://www.fda.gov/ cber Recommendations to Decrease the Risk March 24, 1983 Do
Do of Transmitting AIDS from Plasma Donors Deferral of Blood Donors Who Have February 28, 1984 Do
Do Received the Drug Accutane (isotretinoin/Roche); 13-cis-retinoic acid) Equivalent Methods for Compatibility December 14, 1984 Do
Do Testing Plasma Derived from Therapeutic Plasma December 14, 1984 Do
Do Exchange Reduction of the Maximum Platelet June 2, 1986
Do
Do Storage Period to 5 Days in an Approved Container Deferral of Donors Who Have Received November 25, 1987 Do
Do Human Pituitary-Derived Growth Hormone Recommendations for the Management of December 2, 1987 Do
Do Donors and Units That Are Initially Reactive for Hepatitis B Surface Antigen (HBsAg) Extension of Dating Period for Storage December 4, 1987 Do
Do of Red Blood Cells, Frozen To Licensed In-Vitro Diagnostic
December 23, 1987 Do
Do Manufacturers: 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
July 7, 1988
Do
Do Inspection for Immunization Using Licensed Tetanus Toxoid and Hepatitis B and Rabies Vaccines Physician Substitutes
August 15, 1988 Do
Do To Licensed Manufacturers of Blood August 26, 1988 Do
Do Grouping Reagents: Criteria for Exemption of Lot Release To Manufacturers of HTLV-I Antibody October 18, 1988 Do
Do Test Kits: Antibody to Human T-Cell Lymphotropic Virus, Type I (HTLV-I) Release Panel I HTLV-1 Antibody Testing
November 29, 1988 Do
Do Use of Recombigen HIV-1 LA Test
February 1, 1989 Do
Do Guidance for Autologous Blood and March 15, 1989 Do
Do Blood Components HTLV-I Antibody Testing
July 6, 1989
Do
Do Use of Recombigen HIV-1 Latex
August 1, 1989 Do
Do Agglutination (LA) Test Requirements for Computerization of September 8, 1989 Do
Do Blood Establishments Abbott Laboratories' HIVAG-1 Test for October 4, 1989 Do
Do HIV-1 Antigen(s) Not Recommended for Requirements for Computerization of Blood Establishments Autologous Blood Collection and
February 12, 1990 Do
Do Processing Procedures Use of Genetic Systems HIV-2 EIA
June 21, 1990 Do
Do Deficiencies Relating to the
March 20, 1991 Do
Do Manufacture of Blood and Blood Components
[[Page 31230]]
Responsibilities of Blood
March 20, 1991 Do
Do Establishments Related to Errors & Accidents in the Manufacture of Blood and Blood Components Revision to October 26, 1989 Guideline April 17, 1991 Do
Do for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers (High Risk Donors) FDA Recommendations Concerning Testing September 10, 1991 Do
Do for Antibody to Hepatitis B Core Antigen (Anti-HBc) Disposition of Blood Products Intended September 11, 1991 Do
Do for Autologous Use That Test Repeatedly Reactive for Anti-HCV Clarification of FDA Recommendations December 12, 1991 Do
Do for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing Revised Recommendations for the
April 23, 1992 Do
Do Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products Use of Fluorognost HIV-1
April 23, 1992 Do
Do Immunofluorescent Assay (IFA) Revised Recommendations for Testing April 23, 1992 Do
Do Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) Exemptions to Permit Persons with a April 23, 1992 Do
Do History of 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 July 21, 1992 Do
Do Blood Donor Samples Nomenclature for Monoclonal Blood August 19, 1993 Do
Do Grouping Reagents Volume Limits for Automated Collection November 4, 1992 Do
Do of Source Plasma Revision of October 7, 1988 Memo
December 16, 1992 Do
Do Concerning Red Blood Cell Immunization Programs Recommendations Regarding License July 22, 1993 Do
Do Amendments and Procedures for Gamma Irradiation of Blood Products Deferral of Blood and Plasma Donors July 28, 1993 Do
Do Based on Medications Revised Recommendations for Testing August 19, 1993 Do
Do Whole 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 Guidance Regarding Post Donation
December 10, 1993 Do
Do Information Reports Donor Suitability Related to
December 22, 1993 Do
Do Laboratory Testing for Viral Hepatitis and a History of Viral Hepatitis Recommendations for the Invalidation January 3, 1994 Do
Do of Test Results When Using Licensed Viral Marker Assays to Screen Donors Recommendations for Deferral of Donors July 26, 1994 Do
Do for Malaria Risk Use of and FDA Cleared or Approved August 5, 1994 Do
Do Sterile Docking Device (STCD) in Blood Bank Practices (transmittal memo 8/12/94) (corrects 7/29/94 Memo) Recommendations to Users of Medical December 20, 1994 Do
Do Devices That Test for Infectious Disease Markers by Enzyme Immunoassay (EIA) Test Systems Timeframe for Licensing Irradiated February 3, 1995 Do
Do Blood Products Revision of 8/27/82 FDA Memo:
March 10, 1995 Do
Do Requirements for Infrequent Plasmapheresis Donors To All Establishments Performing Red March 14, 1995 Do
Do Blood Cell Immunizations: Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma
[[Page 31231]]
Recommendations for the Deferral of June 8, 1995
Do
Do Current and Recent Inmates of Correctional Institutions as Donors of Whole Blood, Blood Components, Source Leukocytes and Source Plasma Disposition of Products Derived from August 8, 1995 Do
Do Donors Diagnosed with, or at Known High Risk for, Creutzfeldt-Jakob Disease Recommendations for Labeling and Use August 8, 1995 Do
Do of Units 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 August 8, 1995 Do
Do Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease by Blood and Blood Products Recommendations for Donor Screening August 8, 1995 Do
Do with a Licensed Test for HIV-1 Antigen Guidance Concerning Conversion to FDA- November 13, 1995 Do
Do Reviewed Software Products Donor Deferral Due to Red Blood Cell December 4, 1995 Do
Do Loss During Collection of Source Plasma by Automated Plasmapheresis Additional Recommendations for Donor March 14, 1996 Do
Do Screening With a Licensed Test for HIV-1 Antigen Additional Recommendations for Testing May 16, 1996
Do
Do Whole Blood, Blood Components, Source Plasma and Source Leucocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) Recommendations and Licensure
May 29, 1996
Do
Do Requirements for Leukocyte-Reduced Blood Products 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) Interim Recommendations for Deferral December 11, 1996 Do
Do of Donors at Increased Risk for HIV-1 Group O Infection Revised Precautionary Measures to December 11, 1996 Do
Do Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) by Blood and Blood Products Interstate Shipment of Interferon for November 21, 1983 Do
Do Investigational Use in Laboratory Research Animals or Tests in Vitro Alternatives to Lot Release
July 20, 1993 Do
Do Application of Current Statutory
October 14, 1993 Do
Do Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products; Notice Home Specimen Collection Kit Systems February 23, 1995 Do
Do Intended for Human Immunodeficiency Virus (HIV-1 and/or HIV-2) Antibody Testing; Revisions to Previous Guidance Interim Definition and Elimination of December 8, 1995 Do
Do Lot-by-Lot Release for Well- Characterized Therapeutic Recombinant DNA-Derived and Monoclonal Antibody Biotechnology Products Draft Public Health Service Guideline September 23, 1996 Do
Do on Infectious Disease Issues in Xenotransplantation; Notice The Food and Drug Administration's February 27, 1997 Do
Do Development, Issuance, and Use of Guidance Documents Preclearance of Promotional Labeling; March 5, 1997 Do
Do Clarification Draft Guidance for Industry:
June 18, 1997 Do
Do Computerized Systems Used in Clinical Trials; Availability Recommended Methods for Short Ragweed November 1, 1985 Do
Do Pollen Extracts Information Relevant to the
August 23, 1989 Do
Do Manufacture of Acellular Pertussis Vaccine Recommended Methods for Blood Grouping March 1, 1992 Do
Do Reagents Evaluation
[[Page 31232]]
Recommended Methods for Evaluating March 1, 1992 Do
Do Potency, Specificity and Reactivity of Anti-Human Globulin Methods of the Allergenic Products October 1, 1993 Do
Do Testing Laboratory Guide to Inspections of Blood Banks, September 1, 1994 FDA personnel
Do Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs Guide to Inspections of Infectious June 1, 1996
Do
Do Disease Marker Testing Facilities Guide to Inspections of Source Plasma June 1, 1997
Do
Do Establishments (Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs) Notification Process for Transfusion October 7, 1997 FDA regulated
Do Related Fatalities and Donation
industry Related Deaths (revised telephone number) Submission Requirements for Requesting October 15, 1997 Do
Do Certificates for Exporting Products to Foreign Countries CBER Refusal to File (RTF) Guidance July 12, 1993 Do
Do for Product and Establishment License Applications OELPS, Advertising and Promotional August 1, 1994 Do
Do Labeling Staff Procedural Guidance Document (Draft) Guidance on Alternatives to Lot
October 27, 1994 Do
Do Release for Licensed Biological Products Content and Format of Investigational November 1, 1995 Do
Do New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products Computer Assisted Product License March 1, 1996 Do
Do Application (CAPLA) Guidance Manual FDA Guidance Concerning Demonstration April 26, 1996 Do
Do of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived Products Guidance for Industry--The Content and May 23, 1996
Do
Do Format for Pediatric Use Supplements Guidance on Applications for Products May 24, 1996
Do
Do Comprised of Living Autologous Cells Manipulated Ex Vivo and Intended for Structural Repair of Reconstruction Guidance for Industry for the
August 15, 1996 Do
Do Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use Draft Guidance for Industry:
September 20, 1996 Do
Do Manufacture, Processing or Holding of Active Pharmaceutical Ingredients Draft Guidance for Industry;
November 4, 1996 Do
Do Submitting Application Archival Copies in Electronic Format Draft Guidance for Industry;
November 4, 1996 Do
Do Electronic Submission of Case Report Forms and Case Report Tabulations Guidance for the Submission of
January 10, 1997 Do
Do Chemistry, Manufacturing, and Controls Information and Establishment Description for Autologous Somatic Cell Therapy Products Proposed Approach to Regulation of February 28, 1997 Do
Do Cellular and Tissue-Based Products Tables 1 and 2 from Proposed Approach March 4, 1997 Do
Do to Regulation of Cellular and Tissue- Based Products Guidance for Industry--Providing
March 13, 1997 Do
Do Clinical Evidence of Effectiveness for Human Drug and Biological Products Guidance for Industry for the
April 10, 1997 Do
Do Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies Guidance for Industry--Changes to an July 24, 1997 Do
Do Approved Application: Biological Products Guidance for Industry--Changes to an July 24, 1997 Do
Do Approved Application for Specified Biotechnology and Specified Synthetic Biological Products
[[Page 31233]]
Guidance for Industry--Screening and July 29, 1997 Do
Do Testing of Donors of Human Tissue Intended for Transplantation Guidance for Industry--Donor Screening August 15, 1997 Do
Do for Antibodies to HTLV-II Draft Guidance for Industry on Testing August 25, 1997 Do
Do Limits in Stability Protocols for Standardized Grass Pollen Extracts Guidance for Industry--Postmarketing August 27, 1997 Do
Do Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report Draft Guidance for Industry Efficacy September 1, 1997 Do
Do Evaluation of Hemoglobin-and Perfluorocarbon-Based Oxygen Carriers Guidance for Industry--The Sourcing October 7, 1997 Do
Do and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA--Regulated Products for Human Use FDA's Policy Statement Concerning November 25, 1992 Do
Do Cooperative Manufacturing Arrangements for Licensed Biologics FDA Guidance Document Concerning Use July 11, 1995 Do
Do of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products; Availability Advertising and Promotion; Guidance; October 8, 1996 Do
Do Notice Interpretative Guidelines of the
October 2, 1973 Do
Do Source Plasma (Human) Standards Guidelines for Reviewing Amendments to July 20, 1976 Do
Do Include Plasmapheresis of Hemophiliacs Package Insert: Immune Serum Globulin March 30, 1978 Do
Do (Human) Guidelines for Interpretation of
April 12, 1979 Do
Do Potency Test Results for All Forms of Adsorbed Diphtheria and Tetanus Toxoids Guidelines for Immunization of Source June 1, 1980
Do
Do Plasma (Human) Donors with Blood Substances Collection of Human Leukocytes for January 28, 1981 Do
Do Further Manufacturing (Source Leukocytes) Platelet Testing Guidelines--Approval July 1, 1981
Do
Do of New Procedures and Equipment Revised Guideline for Adding Heparin August 1, 1981 Do
Do to Empty Containers for Collection of Heparinized Source Plasma (Human) Guidelines for Meningococcal
July 17, 1985 Do
Do Polysaccharide Vaccines Guideline for the Uniform Labeling of August 1, 1985 Do
Do Blood and Blood Components Guideline for Submitting Documentation February 1, 1987 Do
Do for the Stability of Human Drugs and Biologics Guideline for Submitting Documentation February 1, 1987 Do
Do for Packaging for Human Drugs and Biologics Guideline On General Principles of May 1, 1987
Do
Do Process Validation Guideline On Sterile Drug Products June 1, 1987
Do
Do Produced by Aseptic Processing 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 Revised Guideline for the Collection October 7, 1988 Do
Do of Platelets, Pheresis Draft Guideline for the Design of November 1, 1988 Do
Do Clinical Trials for Evaluation of Safety and Efficacy of Allergenic Products for Therapeutic Uses Guidelines for Release of Pneumococcal February 1, 1989 Do
Do Vaccine, Polyvalent FDA Regulated Industries for Drug September 1, 1989 Do
Do Master Files
[[Page 31234]]
FDA Regulated Industries for
October 26, 1989 Do
Do Collection of Blood or Blood Products from Donors With Positive Tests for Infectious Disease Markers (``High Risk'' Donors) Guideline for Determination of
January 1, 1990 Do
Do Residual Moisture in Dried Biological Products Guideline on the Preparation of
March 1, 1991 Do
Do Investigational New Drug Products (Human & Animal) Draft Guideline for the Validation of September 28, 1993 Do
Do Blood Establishment Computer Systems Guideline for Adverse Experience
October 15, 1993 Do
Do Reporting for Licensed Biological Products Guideline for Quality Assurance in July 11, 1995 Do
Do Blood Establishments To In Vitro Diagnostic Reagent
December 6, 1986 Do
Do Manufacturers: Guidance On the Labeling of Human Blood Derived In Vitro Diagnostic Devices In Regard to Labeling for HTLV-III/LAV Antibody Testing To Biologic Product Manufacturers-- May 3, 1991
Do
Do Controlling Materials of Bovine or Ovine Origin To Sponsors of INDs Using Retroviral September 20, 1993 Do
Do Vectors To Manufacturers: Bovine Derived
December 17, 1993 Do
Do Materials (BSE) To Blood Establishment Computer
March 31, 1994 Do
Do Software Manufacturers To Sponsors of INDs for Human
May 23, 1994
Do
Do Immunoglobulin Products To Manufacturers of Licensed Anti-HIV May 26, 1994
Do
Do Test Kits Letter to Manufacturers of Immune October 3, 1994 Do
Do Globulin Intravenous (Human) (IGIV), Aseptic Meningitis Syndrome To Manufacturers of Immune Globulin December 27, 1994 Do
Do Products: Testing for Hepatitis C Virus RNA Immunoglobulin To Blood Establishment Computer
February 10, 1995 Do
Do Software Manufacturers To Manufacturers of Intramuscular March 3, 1995 Do
Do Immune Globulin Products: HCV RNA Testing by PCR To Manufacturers of Intramuscular March 13, 1995 Do
Do Immune Globulin Products: Additional Information Regarding HCV RNA Testing by PCR To Health Professionals:
March 14, 1995 Do
Do Implementation of Testing for HCV RNA by PCR for Immune Globulin Products for Intramuscular Administration Dear Colleague: Regarding Reverse January 4, 1996 Do
Do Transcriptase Activity in Viral Vaccines Produced in Chicken Cells To Manufacturers of FDA-Regulated Drug/ May 9, 1996
Do
Do Biological/Device Products, Bovine Spongiform Encephalopathy (BSE) To Manufacturers: Implementation of June 13, 1996 Do
Do Testing for Hepatitis C Virus RNA by Manufacturers: Implementation of Testing for Hepatitis C Virus RNA by Polymerase Chain Reaction (PCR) of Intramuscular Immune Globulin Preparations To Manufacturers: HIV-1 Group O
July 31, 1996 Do
Do To All Plasma Derivative Manufacturers October 7, 1996 Do
Do and to ABRA: Warning Statement for Plasma Derivative Product Labeling To Biologic Product Manufacturers: December 3, 1996 Do
Do Revised Procedures for Internal Labeling Review Number Assignment To Plasma Fractionators--CBER's View May 29, 1997
Do
Do on Product Recalls Conducted by the Plasma Fractionation Industry PTC in the Manufacture of In Vitro June 20, 1983 Do
Do Monoclonal Antibody Products Subject to Licensure Draft PTC in the Production and
July 28, 1983 Do
Do Testing of Interferon Intended for Investigational Use in Humans (Interferon Test Procedures)
[[Page 31235]]
Draft PTC in the Production and
April 10, 1985 Do
Do Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology Draft PTC in the Manufacture and
August 8, 1989 Do
Do Clinical Evaluation of In Vitro Tests to Detect Antibodies to Human Immunodeficiency Virus Type 1 (1989) PTC in the Collection, Processing and August 22, 1989 Do
Do Testing of Ex Vivo Activated Mononuclear Leukocytes for Administration to Humans Cytokine and Growth Factor Pre-Pivotal April 2, 1990 Do
Do Trial Information Package PTC in the Safety Evaluation of
August 21, 1990 Do
Do Hemoglobin-Based Oxygen Carriers PTC in the Design and Implementation March 1, 1992 Do
Do of Field Trials for Blood Grouping Reagents and Anti-Human Globulin PTC in the Manufacture of In Vitro March 1, 1992 Do
Do Monoclonal Antibody Products for Further Manufacturing into Blood Grouping Reagent and Anti-Human Globulin Supplement to the PTC in the
April 6, 1992 Do
Do Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology: Nucleic Acid Characterization and Genetic Stability Draft PTC in the Characterization of July 12, 1993 Do
Do Cell Lines Used to Produce Biologicals PTC in the Manufacture and Testing of August 22, 1995 Do
Do Therapeutic Products for Human Use Derived from Transgenic Animals PTC on Plasmid DNA Vaccines for
December 22, 1996 Do
Do Preventive Infectious Disease Indications PTC in the Manufacture and Testing of February 28, 1997 Do
Do Monoclonal Antibody Products for Human Use Reviewer Guidance, Computer Software April 26, 1995 FDA Personnel
Do Informed Consent for Plasmapheresis/ October 1, 1995 Do
Do Immunization Draft Reviewers' Guide: Changes in October 1, 1995 Do
Do Personnel Disease Associated Antibody Collection October 1, 1995 Do
Do Program Reviewer Guidance for a Premarket January 13, 1997 Do
Do Notification Submission for Blood Establishment Computer Software Compliance Program Guidance Manual 1994
Do
National Technical (Drugs and Biologics)
Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, 703- 605-6050 (Publication No. 94- 920699) Guidance for Industry: Industry-
November 1997 FDA regulated
Office of Communication, Supported Scientific and Educational
industry
Training, and Manufacturers Activities
Assistance (HFM-40), 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: http://www.fda.gov/ cber To Biologic Product Manufacturers-- December 11, 1997 Do
Do Withdrawal 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 Draft Guidance for Industry: Promoting December 1997 Do
Do Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMS) Dear Doctor Letter--Difficulty in January 28, 1998 Health care providers Do Obtaining Immune Globulin Intravenous (Human) Guidance for Industry: Year 2000 Date January 1998
FDA regulated
Do Change for Computer Systems and
industry Software Applications Used in the Manufacture of Blood Products
[[Page 31236]]
Draft Guidance for Industry: Efficacy January 1998
Do
Do Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use Draft Guidance for Industry: Container January 1998
Do
Do and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products Draft Guidance for Industry: Clinical February 1998 Do
Do Development of Programs for Drugs, Devices and Biological Products Intended for Treatment of Osteoarthritis (OA) Draft Guidance for Industry:
March 1998
Do
Do Manufacturing, Processing or Holding Active Pharmaceutical Ingredients Guidance for Industry: Guidance for March 1998
Do
Do Human Somatic Cell Therapy and Gene Therapy Dear Doctor Letter--Standardized Grass May 11, 1998
Health care providers Do Pollen Extracts Draft Guidance for Industry:
May 1998
FDA regulated
Do Instructions for Submitting
industry Electronic Lot Release Protocols to the Center for Biologics Evaluation and Research Draft Guidance for Industry: Pilot May 1998
Do
Do Program for Electronic Investigational New Drug (eIND) Applications for Biological Products Draft Guidance for Industry:
May 1998
Do
Do Electronic Submissions of Case Report Forms (CRFs), Case Report Tabulations (CRTs) and Data to the Center for Biologics Evaluation and Research Draft Guidance for Industry:
May 1998
Do
Do Electronic Submissions of a Biologics License Application (BLA) or Product License Application (PLA)/ Establishment License Application (ELA) to the Center for Biologics Evaluation and Research Guidance for Industry: Submitting and May 1998
Do
Do Reviewing Complete Responses to Clinical Holds Guidance for Industry: Classifying May 1998
Do
Do Resubmissions in Response to Action Letters Guidance for Industry:
May 1998
Do
Do Pharmacokinetics in Patients with Impaired Renal Function--Study Design, Data Analysis and Impact on Dosing and Labeling Guidance for Industry: Standards for May 1998
Do
Do the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements Guidance for Industry: Providing
May 1998
Do
Do Clinical Evidence of Effectiveness for Human Drugs and Biological Products Draft Guidance for Industry: Stability June 1998
Do
Do Testing of Drug Substances and Drug Products ICH Draft Guidance on Specifications: June 9, 1998
Do
Do Test Procedures and Acceptance Criteria for Biotechnological/ Biological Products ICH Guidance on Ethnic Factors in the June 10, 1998 Do
Do Acceptability of Foreign Clinical Data Draft Guidance for Industry: Exports June 12, 1998 Do
Do and Imports Under the FDA Export Reform and Enhancement Act of 1996 Guidance for Industry: Qualifying for June 1998
Do
Do Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry: Errors and June 1998
Do
Do Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing Draft Guidance for Industry: In the July 1998
Do
Do Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Virus Type 1
[[Page 31237]]
Draft Guidance for Industry: For the July 1998
Do
Do Submission of 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 FDA Form 356h ``Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use'' Guidance for Industry: Implementation July 1998
Do
Do of Section 126 of the Food and Drug Administration Modernization Act of 1997--Elimination of Certain Labeling Requirements Guidance for Industry: Environmental July 1998
Do
Do Assessment of Human Drug and Biologics Applications Draft Guidance for Industry:
July 1998
Do
Do Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods Dear Colleague Letter--Use of
August 12, 1998 Health care providers Do Haemophilus influenzae Conjugate Vaccines in Combination With DTaP in Infants Dear Doctor Letter--Albumin Use in August 19, 1998 Do
Do Seriously Ill Patients Draft Guidance for Industry: Content August 1998
FDA regulated
Do and Format of Chemistry,
industry Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test Draft Guidance for Industry:
August 1998
Do
Do Submission of Abbreviated Reports and Synopses in Support of Marketing Applications ICH Guidance on Statistical Principles September 16, 1998 Do
Do for Clinical Trials ICH Guidance on Quality of
September 21, 1998 Do
Do Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products ICH Guidance on Viral Safety
September 24, 1998 Do
Do Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin Change to the Guidance Entitled
September 8, 1998 Do
Do ``Revised Precautionary Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) by Blood and Blood Products''--Information Sheet 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:
September 1998 Do
Do Submitting Debarment Certification Statements Guidance for Industry: How to Complete September 1998 Do
Do the Vaccine Adverse Reporting System Form (VAERS-1) Guidance for Industry: Fast Track Drug September 1998 Do
Do Development Programs--Designation, Development, and Application Review CBER's Year 2000 Letter
October 27, 1998 Do
Do Draft Guidance for Industry:
October 1998
Do
Do Developing Medical Imaging Drugs and Biologics Dear Blood Bank/Transfusion Service November 3, 1998 Do
Do Director Letter: Hepatitis C Virus Risk Dear Doctor Letter--Important Drug November 13, 1998 Health care providers Do Warning: Immune Globulin Intravenous (Human) Draft Guidance for Industry: Content November 1998 FDA regulated
Do and Format of Chemistry,
industry Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product
[[Page 31238]]
Draft Guidance for Industry: In Vivo November 1998 Do
Do Drug Metabolism/Drug Interaction Studies--Study Design, Data Analysis and Recommendations for Dosing and Labeling Draft Document: United States Industry December 1997 Do
Do Consensus Standard for the Uniform (released Labeling of Blood and Blood
November 1998) 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 December 18, 1998 Do
Do PCR-Based Reverse Transcriptase Assay Guidance for Industry: FDA Approval of December 1998 Do
Do New Cancer Treatment Uses for Marketed Drug and Biological Products Draft Guidance for Industry: Gamma December 1998 Do
Do Irradiation of Blood and Blood Components: A Pilot Program for Licensing Draft Guidance for Industry: Content December 1998 Do
Do and Format of Geriatric Labeling Dear Healthcare Provider: Important January 25, 1999 Health care providers Do Drug Warning: Safety Information Regarding the use of Abbokinase (Urokinase) Guidance for Industry: Content and January 1999
FDA regulated
Do Format of Chemistry, Manufacturing
industry and Controls Information and Establishment Description Information for a Vaccine or Related Product Guidance on Amended Procedures for January 1999
Do
Do Advisory Panel Meetings Guidance for Industry: Providing
January 1999
Do
Do Regulatory Submissions in Electronic Format--General Considerations Guidance for Industry: Population February 1999 Do
Do Pharmacokinetics Guidance for Industry: For the
February 1999 Do
Do Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum- Derived Products Guidance for Industry: Clinical
February 1999 Do
Do Development Programs for Drugs, Devices and Biological Products for the Treatment of Rheumatoid Arthritis (RA) Dear Colleague Letter: Voluntary
February 4, 1999 Health care providers Do Recall of Tripedia, DTaP Vaccine
-
Guidance Documents Issued by the Center for Devices and Radiological Health (CDRH)
How to Obtain a Hard Copy of Grouped by Intended the Document (Name and Name of Document
Date of Issuance User or Regulatory Address, Phone, FAX, E-mail Activity
or Internet)
Guidance on Medical Device Tracking February 19, 1998 Office of Compliance Division of Small (Docket No. 98D-0132)
(OC)
Manufacturers Assistance, CDRH, Food and Drug Administration, 1-800-638- 2041 or 301-827-0111 or (FAX) Facts on Demand at 1- 800-899-0381 or Internet at http://www.fda.gov/cdrh Guidance on Lead Wires and Patient March 9, 1998 OC
Do Cables Global Harmonization Task Force: Draft October 28, 1998 OC
Do Document on the Essentials Principles of Safety and Performance of Medical Devices on a Global Basis Medical Devices: Draft Global
July 16, 1998 OC
Do Harmonization Task Force Study Group 3 Process Validation Guidance (Draft)
[[Page 31239]]
Letter to Medical Device Manufacturer February 14, 1995 OC
Do on Pentium Processors Guideline for Preparing Notices of November 1, 1985 OC/Bioresearch
Do Availability of Investigational
Monitoring (BIMO) Medical Devices All Diagnostic Ultrasound
February 24, 1986 OC/Division of
Do Manufacturers and Importers-Exemption
Enforcement I (DOEI) from Reporting Under 21 CFR 1002 General Principles of Software
June 9, 1997
OC/DOEI
Do Validation; Draft Guidance Exemption from Reporting and
September 16, 1981 OC/DOEI
Do Recordkeeping Requirements for Certain Sunlamp Product Manufacturers Clarification of Radiation Control March 1, 1989 OC/DOEI
Do Regulations for Diagnostic X-ray Equipment (FDA 89-8221) A Guide for the Submission of
March 1, 1996 OC/DOEI
Do Abbreviated Radiation Safety Reports on Cephalometric X-ray Devices: Defined as Dental Units with an Attachment for Mandible Work that Holds a Cassette and Beam Limiting Device A Guide for the Submission of
March 1, 1996 OC/DOEI
Do Abbreviated Radiation Safety Reports on Image Receptor Support Devices for Mammographic X-ray Systems A Guide for the Submission of an
March 1, 1996 OC/DOEI
Do Abbreviated Radiation Safety Report on X-ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use Guide for the Submission of Initial January 1, 1982 OC/DOEI
Do Reports on Diagnostic X-Ray Systems and their Major Components Guideline for the Manufacture of In January 10, 1994 OC/DOEI
Do Vitro Diagnostic Products Letter to Medical Device Industry on May 17, 1993
OC/DOEI
Do Endoscopy and Laparoscopy Accessories (Galdi) Manufacturers/Assemblers of Diagnostic October 13, 1993 OC/DOEI
Do X-ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g) Retention of Records Required by 21 August 24, 1981 OC/DOEI
Do CFR 1002 All U.S. Condom Manufacturers,
April 7, 1987 OC/Division of
Do Importers and Repackagers
Enforcement II (DOEII) Letter to Ophthalmologists about
June 27, 1997 OC/DOEII
Do Lasers for Refractive Surgery Manufacturers and Initial Distributors May 23, 1996
OC/DOEII
Do of Hemodialyzers Manufacturers and Users of Lasers for October 10, 1996 OC/DOEII
Do Refractive Surgery Shielded Trocars and Needles Used for August 23, 1996 OC/DOEII
Do Abdominal Access During Laparoscopy Prospective Manufacturers of Barrier October 31, 1996 OC/DOEII
Do Devices Used During Oral Sex for STD Protection Condoms: Inspection and Sampling at April 8, 1987 OC/DOEII
Do Domestic Manufacturers and of all Repackers; Sampling from all Importers (Damaska Memo to Field on 4/ 8/87) Guide for Preparing Product Reports September 1, 1995 OC/DOEII
Do for Lasers and Products Containing Lasers Hazards of Volume Ventilators and September 15, 1993 OC/DOEII
Do Heated Humidifiers Latex Labeling Letter (Johnson)
March 18, 1993 OC/DOEII
Do Letter--Condom Manufacturers and
April 5, 1994 OC/DOEII
Do Distributors (included in Condom Packet #398) Letter to Industry, Powered Wheelchair May 10, 1993
OC/DOEII
Do Manufacturers from R. M. Johnson Letter to Manufacturers/Repackers April 22, 1994 OC/DOEII
Do Using Cotton Manufacturers and Initial Distributors February 3, 1994 OC/DOEII
Do of Sharps Containers and Destroyers Used by Health Care Professionals Compliance Guide for Laser Products September 1, 1985 OC/DOEII
Do (FDA 86-8260) Dental Handpiece Sterilization (Dear September 28, 1992 OC/DOEII
Do Doctor Letter)
[[Page 31240]]
Ethylene Oxide; Ethylene Chlorohydrin; June 23, 1978 OC/DOEII
Do and Ethylene Glycol; Proposed Maximum Residue Limits and Maximum Levels of Exposure Letter--Manufacturers, Distributors February 23, 1994 OC/DOEII
Do and Importers of Condom Products (included in Condom Packet #‹greek- K›398) Letter--Manufacturers, Importers, and February 13, 1989 OC/DOEII
Do Repackagers of Condoms for Contraception or Sexually-Transmitted Disease Prevention (Holt) (included in Condom Packet #398) Regulatory Requirements for Medical September 1, 1996 OC/DOEII
Do Gloves--A Workshop Manual FDA Publication No. 96-4257 Standard Specification for Rubber October 28, 1983 OC/DOEII
Do Contraceptives (Condoms) (included in Condom Packet #398) Pesticide Regulation Notice 94-4
June 30, 1994 OC/DOEII
Do Interim Measures for the Registration of Antimicrobial Products/Liquid Chemical Germicides with Medical Device Use Claims Open Door Operation of Microwave Ovens March 28, 1980 OC/Division of
Do as a Result of Oven Miswiring
Enforcement III (DOEIII) Guide for Preparing Abbreviated
September 1, 1996 OC/DOEIII
Do Reports of Microwave and RF Emitting Electronic Products Intended for Medical Use Final Design Control Inspectional March 1, 1997 OC/DOEIII
Do Strategy Abbreviated Reports on Radiation
August 1, 1995 OC/DOEIII
Do Safety for Microwave Products (Other Than Microwave Ovens)--E.G. Microwave Heating, Microwave Diathermy, RF Sealers, Induction, Dielectric Heaters, Security Systems Design Control Guidance for Medical March 11, 1997 OC/DOEIII
Do Device Manufacturers Abbreviated Reports on Radiation
August 1, 1995 OC/DOEIII
Do Safety of Non-Medical Ultrasonic Products Application for a Variance from 21 CFR March 1, 1987 OC/DOEIII
Do 1040.11(c) for a Laser Light Show, Display, or Device Computerized Devices/Processes
May 1, 1992
OC/DOEIII
Do Guidance--Application of the Medical Device GMP to Computerized Devices and Manufacturing Processes Guidance for the Submission of Cabinet February 1, 1975 OC/DOEIII
Do X-Ray System Reports Pursuant to 21 CFR 1020.40 Guide for Preparing Annual Reports on October 1, 1987 OC/DOEIII
Do Radiation Safety Testing of Electronic Products (General) Guide for Preparing Annual Reports on September 1, 1995 OC/DOEIII
Do Radiation Safety Testing of Mercury Vapor Lamps (replaces FDA 82-8127) Guide for Preparing Annual Reports on September 1, 1995 OC/DOEIII
Do Radiation Safety Testing of Sunlamps and Sunlamp Products (replaces FDA 82- 8127) Guide for Preparing Product Reports on September 1, 1995 OC/DOEIII
Do Sunlamps and Sunlamp Products (21 CFR 1002) Guide for Preparing Reports on
March 1, 1985 OC/DOEIII
Do Radiation Safety of Microwave Ovens Guide for Submission of Information on April 1, 1971 OC/DOEIII
Do Accelerators Intended to Emit X- Radiation Required Pursuant to 21 CFR 1002.10 Guide for Submission of Information on April 30, 1974 OC/DOEIII
Do Analytical X-Ray Equipment Required Pursuant to 21 CFR 1002.10 Guide for Submission of Information on September 1, 1980 OC/DOEIII
Do Industrial Radiofrequency Dielectric Heater and Sealer Equipment Pursuant to 21 CFR 1002.10 and 1002.12 (FDA 81- 8137) Guide for Submission of Information on March 1, 1973 OC/DOEIII
Do Industrial X-Ray Equipment Required Pursuant to 21 CFR 1002.10 Guide for the filing of Annual Reports July 1, 1980
OC/DOEIII
Do for X-Ray Components and Systems Guide for the Submission of Initial September 1, 1984 OC/DOEIII
Do Reports on Computed Tomography X-Ray Systems
[[Page 31241]]
Impact Resistant Lenses: Questions and September 1, 1987 OC/DOEIII
Do Answers (FDA 87-4002) (see shelf # 460) Imports Radiation-Producing Electronic November 1, 1988 OC/DOEIII
Do Products (FDA 89-8008) Information Requirements for Cookbooks October 31, 1988 OC/DOEIII
Do and User and Service Manuals Keeping Medical Devices Safe from July 1, 1995
OC/DOEIII
Do Electromagnetic Interference Keeping Up With the Microwave
March 1, 1990 OC/DOEIII
Do Revolution (FDA Pub No. 91-4160) Laser Light Show Safety--Who's
May 1, 1986
OC/DOEIII
Do Responsibility (FDA 86-8262) Letter to All Foreign Manufacturers May 28, 1981
OC/DOEIII
Do and Importers of Electronic Products for Which Applicable FDA Performance Standards Exist Letter to Trade Association: ReUse of December 27, 1995 OC/DOEIII
Do Single-use or Disposable Medical Devices Letter: Changes in Regulations
October 27, 1995 OC/DOEIII
Do Concerning Records and Reports on Radiation-Emitting Electronic Products Medical Device Electromagnetic
OC/DOEIII
Do Interference Issues, Problem Reports, Standards, and Recommendations Medical Devices and EMI: The FDA
January 1, 1995 OC/DOEIII
Do Perspective Policy on Lamp Compatibility
September 2, 1986 OC/DOEIII
Do (sunlamps) Policy on Maximum Timer Interval and August 21, 1986 OC/DOEIII
Do Exposure Schedule for Sunlamp Products Policy on Warning Label Required on June 25, 1985 OC/DOEIII
Do Sunlamp Products Quality Assurance Guidelines for
February 1, 1991 OC/DOEIII
Do Hemodialysis Devices Quality Control Guide for Sunlamp March 1, 1988 OC/DOEIII
Do Products (FDA 88-8234) Quality Control Practices for
May 1, 1980
OC/DOEIII
Do Compliance with the Federal Mercury Vapor Lamp Performance Standard Reporting and Compliance Guide for October 1, 1995 OC/DOEIII
Do Television Products including Product Report, Supplemental Report, Radiation Safety Abbreviated Report, Annual Report, Information and Guidance Reporting Guide for Laser Light Shows September 1, 1995 OC/DOEIII
Do and Displays (21 CFR 1002) (FDA 88- 8140) Reporting Guide for Product Reports on September 1, 1995 OC/DOEIII
Do High Intensity Mercury Vapor Discharge Lamps (21 CFR 1002) Reporting of New Model Numbers to June 14, 1983 OC/DOEIII
Do Existing Model Families Revised Guide for Preparing Annual September 1, 1995 OC/DOEIII
Do Reports on Radiation Safety Testing of Laser and Laser Light Show Products (replaces FDA 82-8127) Safety of Electrically Powered
September 18, 1996 OC/DOEIII
Do Products: Letter To Medical Device and Electronic Product Manufacturers From Lillian Gill & BHB correction memo Suggested State Regulations for
January 1, 1982 OC/DOEIII
Do Control of Radiation--Volume II Nonionizing Radiation--Lasers (FDA Pub No. 83-8220) Unsafe Patient Lead Wires and Cables September 3, 1993 OC/DOEIII
Do Guide for Preparing Annual Reports for September 1, 1996 OC/DOEIII
Do Ultrasonic Therapy Products Guide for Preparing Product Reports September 1, 1996 OC/DOEIII
Do for Medical Ultrasound Products Guide for Preparing Product Reports August 1, 1996 OC/DOEIII
Do for Ultrasonic Therapy Products (physical therapy only) Guide for Establishing and Maintaining March 1, 1988 OC/DOEI & III
Do a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264) The FDA Export Reform and Enhancement October 1, 1996 OC/Division of
Do Act of 1996/Export Certification
Program Operations (DPO)
[[Page 31242]]
Sec. 300.600 Commercial Distribution September 24, 1987 OC/Office of the Do with Regard to Premarket Notification
Director (OD) (Section 510(k)) (CPG 7124.19) Global Harmonization Task Force:
August 31, 1998 OC/Office of
Do Availability of Draft Documents on
Surveillance and Adverse Event and Vigilance Reporting
Biometrics (OSB) of Medical Device Events Commercial Distribution/Exhibit Letter April 10, 1992 OC/Other (OT)
Do (Use instead of Hile letter) (Display) Working Draft of the Current Good July 1, 1995
OC/OT
Do Manufacturing Practice (CGMP) Final Rule Guidance for the Medical Device
November 6, 1998 ODE
Do Industry on PMA Shell Development and Modular Review Medical Devices Containing Materials November 6, 1998 ODE
Do Derived from Animal Sources (Except In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry Frequently Asked Questions on the New October 22, 1998 ODE
Do 510(k) Pardigm Guidance to Industry Supplements to May 20, 1998
ODE
Do Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Material, and Priority Review Convenience Kits Interim Regulatory May 20, 1997
ODE
Do Guidance Kit Certification for 510(k)s
July 1997
ODE
Do Guidance for Industry--Contents of a July 27, 1998 ODE
Do Product Development Protocol Guidance for the Content of Premarket May 28, 1998
ODE
Do Submissions for Software Contained in Medical Devices (replaces Reviewer Guidance for Computer-Controlled Medical Devices Undergoing 510(k) Review 8/29/91) New Model Medical Device Development June 3, 1998
ODE
Do Process Modifications to Devices Subject to August 6, 1998 ODE
Do Premarket Approval--the PMA Supplement Decision Making Process Guidance for Off-the-Shelf Software August 17, 1998 ODE
Do Use in Medical Devices PMA/510(k) Expedited Review--Guidance March 20, 1998 ODE
Do for Industry and CDRH Staff Guidance on Amended Procedures for March 30, 1998 ODE
Do Advisory Panel Meetings `Real-Time' Review Program for
April 22, 1997 ODE
Do Premarket Approval Application (PMA) Supplements A New 510(k) Paradigm--Alternate
March 30, 1998 ODE
Do Approaches to Demonstrating Substantial Equivalence in Premarket Notifications Freedom of Information/510(K) Process May 15, 1997
ODE
Do Changes Guidance for Submitting
January 1, 2000 ODE
Do Reclassification Petition Product Development Protocol
October 1, 1997 ODE
Do Guidance on PMA Interactive Procedures February 19, 1998 ODE
Do for Day-100 Meetings and Subsequent Deficiencies--for Use by CDRH and Industry (Docket No. 98D-0079) Procedures for Class II Device
February 25, 1998 ODE
Do Exemptions from Premarket Notification Guidance for Industry and CDRH Staff (Docket No. 98D-0083) New section 513(f)(2)--Evaluation of February 19, 1998 ODE
Do Automatic Class III Designation: Guidance for Industry and CDRH Staff (Docket No. 98D-0082) SMDA Changes--Premarket Notification; April 17, 1992 ODE
Do Regulatory Requirements for Medical Devices (510k) Manual Insert #D95-2, Attachment A (Interagency September 15, 1995 ODE
Do Agreement between FDA & HCFA) #D95-2, Attachment B (Criteria for September 15, 1995 ODE
Do Categorization of Investigational Devices (HCFA) 30-Day Notices and 135-Day PMA
February 19, 1998 ODE
Do Supplements for Manufacturing Method or Process Changes, Guidance for Industry and CDRH (Docket No. 98D- 0080) 510(k) Quality Review Program (blue March 29, 1996 ODE
Do book memo)
[[Page 31243]]
Distribution and Public Availability October 10, 1997 ODE
Do of PMA Summary of Safety and Effectiveness Data Packages Document Review by the Office of the June 6, 1996
ODE
Do Chief Counsel (Blue Book Memo G96-1)) HCFA Reimbursement Categorization September 15, 1995 ODE
Do Determinations for FDA-approved IDEs ODE Executive Secretary Guidance
August 7, 1987 ODE
Do Manual Determination of Intended Use for February 19, 1998 ODE
Do 510(k) Devices: Final Document (Docket No. 98D-0081) Letter--Vascular Graft Industry
November 22, 1995 ODE
Do (Philip Phillips) Letter to Industry, Powered Wheelchair/ May 26, 1994
ODE
Do Scooter or Accessory/Component Manufacturer from Susan Alpert, Ph.D., M.D. Preamendments Class III Strategy; April 19, 1994 ODE
Do SXAlpert 4-of-A-Kind PMA's
October 1, 1991 ODE
Do Application of the Device Good
December 1, 1983 ODE
Do Manufacturing Practice (GMP) Regulation to the Manufacture of Sterile Devices CDRH's 510(k)/IDE/PMA Refuse to Accept/ June 30, 1993 ODE
Do Accept/File Policies (see #D94-1, #K94-1, & #P94-1) Classified Convenience Kits
April 30, 1993 ODE
Do Color Additive Petitions (p. II-19 of June 1, 1987
ODE
Do PMA Manual) Color Additive Status List (Inspection February 1, 1989 ODE
Do Operations Manual) Early Collaboration Meetings Under the February 19, 1998 ODE
Do FDA Modernization Act (FDAMA), Guidance for Industry and CDRH Staff, Final Document (Docket No. 98D-0078) Color Additives for Medical Devices November 15, 1995 ODE
Do (Snesko) Deciding When to Submit a 510(k) for a January 10, 1997 ODE
Do Change to an Existing Device (see CDRH F-O-D #1935) Device Specific Guidance Documents May 11, 1993
ODE
Do (List) FDA Clinical Investigator Information May 1, 1989
ODE
Do Sheets FDA Guide for Validation of Biological January 1, 1986 ODE
Do Indicator Incubation Time (Source: Sterilization Committee; through Virginia Ross; HFZ-332) FDA Policy For The Regulation Of
November 13, 1989 ODE
Do Computer Products (DRAFT) (See 2099) Format for IDE Progress Reports
January 1, 2000 ODE
Do Guidance for Preparation of PMA
August 1, 1992 ODE
Do Manufacturing Information Guideline for the Monitoring of
January 1, 1988 OC/BIMO
Do Clinical Investigations Guideline on General Principles of May 1, 1987
ODE
Do Process Validation Guideline on Sterile Drug Products June 1, 1987
ODE
Do Produced by Aseptic Processing Guideline on Validation of the Limulus December 1, 1987 ODE
Do Amebocyte Lysate (LAL) Test as an End- Product Endotoxin Test Indications for Use Statement
January 2, 1996 ODE
Do Industry Representatives on Scientific March 27, 1987 ODE
Do Panels Labeling Reusable Medical Devices for April 1, 1996 ODE
Do Reprocessing in Health Care Facilities: FDA Reviewer Guidance (see 1198) Limulus Amebocute Lysate; Reduction of October 23, 1987 ODE
Do Samples for Testing Master Files Part III; Guidance on June 1, 1987
ODE
Do Scientific and Technical Information Memorandum: Electromagnetic
June 13, 1995 ODE
Do Compatibility for Medical Devices: Issues and Solutions Methods for Conducting Recall
June 16, 1978 ODE
Do Effectiveness Checks Necessary Information for Diagnostic November 24, 1987 ODE
Do Ultrasound 510(k) (Draft) Perspectives on Clinical Studies for January 1, 2000 ODE
Do Medical Device Submissions (Statistical) PMA Review Statistical Checklist
January 1, 2000 ODE
Do
[[Page 31244]]
Points to Consider in the
June 1, 1984
ODE
Do Characterization of Cell Lines Used to Produce Biological Products (from John C. Petricciani, M.D.) Preamendment Class III Devices
March 11, 1992 ODE
Do Premarket Notification [510(k)] Status March 7, 1994 ODE
Do Request Form, revised Premarket Submission Coversheet,
January 19, 1995 ODE
Do Instructions, and Survey Preproduction Quality Assurance
September 1, 1989 ODE
Do Planning: Recommendations for Medical Device Manufacturers (FDA 90-4236) Proposal for Establishing Mechanisms June 30, 1993 ODE
Do for Setting Review Priorities Using Risk Assessment and Allocating Review Resources (include with 926-930) Questions and Answers for the FDA September 3, 1996 ODE
Do Reviewer Guidance: Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities (see 198) Shelf Life of Medical Devices
March 1, 1991 ODE
Do Substantial Equivalence (SE) Decision January 1, 1990 ODE
Do Making Documentation ATTACHED: `SE' Decision Making Process (Detailed) i.e. the decision making tree Suggested Content for Original IDE February 27, 1996 ODE
Do Application Cover Letter--Version 4 Suggestions for Submitting a Premarket April 1, 1993
ODE
Do Approval (PMA) Application Threshold Assessment of the Impact of January 1, 1990 ODE
Do Requirements for Submission of PMAs for 31 Medical Devices Marketed Prior to May 28, 1976 Guidance on IDE Policies and
January 20, 1998 ODE
Do Procedures Viable Bacteriophage in Co2 Laser January 1, 2000 ODE
Do Plume: Aerodynamic Size Distribution Deciding When to Submit a 510(k) for a January 10, 1997 ODE/blue
Do Change to an Existing Device (blue book memo #K97-1) (see CDRH F-O-D #935) Memorandum of Understanding Regarding August 9, 1996 ODE/blue
Do Patient Labeling Review (blue book memo #G96-3)) Continued Access to Investigational July 15, 1996 ODE/blue
Do Devices During PMA Preparation and Review (blue book memo) 510(k) Additional Information
July 23, 1993 ODE/blue/510k
Do Procedures (blue book memo #K93-1) 510(k) Refuse to Accept Procedures May 20, 1994
ODE/blue/510k
Do (blue book memo #K94-1) 510(k) Sign-Off Procedures (blue book June 3, 1994
ODE/blue/510k
Do memo #K94-2) 510(k) Sterility Review Guidance and February 12, 1990 ODE/blue/510k
Do Revision of 11/18/1994 (blue book memo #K90-1) Cover Letter: 510(k) Requirements November 21, 1995 ODE/blue/510k
Do During Firm-Initiated Recalls; Attachment A: Guidance on Recall and Premarket Notification Review Procedures During Firm-Initiated Recalls of Legally Marketed Devices (blue book memo #‹greek-K›95-1) Guidance on the Center for Devices and June 30, 1986 ODE/blue/510k
Do Radiological Health's Premarket Notification Review Program (blue book memo #K86-3) Premarket Notification--Consistency of February 28, 1989 ODE/blue/510k
Do Reviews (blue book memo #K89-1) Review of 510(k)s for Computer
August 29, 1991 ODE/blue/510k
Do Controlled Medical Devices (blue book memo #K91-1) Executive Secretaries Guidance Manual August 7, 1987 ODE/blue/gnrl
Do ‹greek-i›G87-3 Consolidated Review of Submissions for October 19, 1990 ODE/blue/gnrl
Do Diagnostic Ultrasound Equipment, Accessories and Related Measurement Devices (blue book memo #G90-2) Consolidated Review of Submissions for October 19, 1990 ODE/blue/gnrl
Do Lasers and Accessories (blue book memo #G90-1) Device Labeling Guidance (blue book March 8, 1991 ODE/blue/gnrl
Do memo ‹greek-G›91-1 ) Documentation and Resolution of
December 23, 1993 ODE/blue/gnrl
Do Differences of Opinion on Product Evaluations (blue book memo #G93-1)
[[Page 31245]]
ODE Regulatory Information for the May 15, 1987
ODE/blue/gnrl
Do Office of Compliance--Information Sharing Procedures (blue book memo #G87-2) PMA/510(k) Expedited Review (blue book May 20, 1994
ODE/blue/gnrl
Do memoG94-2) PMA/510(k) Triage Review Procedures May 20, 1994
ODE/blue/gnrl
Do (blue book memo #G94-1) Review of Laser Submissions (blue book April 15, 1988 ODE/blue/gnrl
Do memo #G88-1) Toxicology Risk Assessment Committee August 9, 1989 ODE/blue/gnrl
Do (blue book memo #G89-1) Use of International Standard ISO- May 1, 1995
ODE/blue/gnrl
Do 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (blue book memo) (Replaces #G87-1 #8294) Delegation of IDE Actions (blue book April 26, 1988 ODE/blue/ide
Do memo #D88-1) Goals and Initiatives for the IDE July 12, 1995 ODE/blue/ide
Do Program (blue book memo #D95-1) IDE Refuse to Accept Procedures (blue May 20, 1994
ODE/blue/ide
Do book memo #D94-1) Implementation of the FDA/HCFA
September 15, 1995 ODE/blue/ide
Do Interagency Agreement Regarding Reimbursement Categorization of Investigational Devices, Att. A Interagency Agreement, Att. B Criteria for Catergorization of Investigational Devices, & Att. C- List (blue book memo #D95-2) Overdue IDE Annual Progress Report July 23, 1993 ODE/blue/ide
Do Procedures (blue book memo) #D93-1 Review of IDEs for Feasibility Studies May 17, 1989
ODE/blue/ide
Do (blue book memo #D89-1) Assignment of Review Documents (blue August 24, 1990 ODE/blue/integ
Do book memo #I90-2) Document Review Processing (blue book February 12, 1992 ODE/blue/integ
Do memo #I91-1) Integrity of Data and Information May 29, 1991
ODE/blue/integ
Do Submitted to ODE (blue book memo #I91- 2) Meetings with the Regulated Industry November 20, 1989 ODE/blue/integ
Do (blue book memo #I89-3) Nondisclosure of Financially Sensitive March 5, 1992 ODE/blue/integ
Do Information (blue book memo #I92-1) Policy Development and Review
February 15, 1990 ODE/blue/integ
Do Procedures (blue book memo #I90-1) Telephone Communications Between ODE January 29, 1993 ODE/blue/integ
Do Staff and Manufacturers (blue book memo #I93-1) Clinical Utility and Premarket
May 3, 1991
ODE/blue/pma
Do Approval (blue book memo #P91-1) Criteria for Panel Review of PMA
January 30, 1986 ODE/blue/pma
Do Supplements (blue book memo #P86-3) Panel Report and Recommendations on April 18, 1986 ODE/blue/pma
Do PMA Approvals (blue book memo #P86-5) Panel Review of 'Me-Too' Devices July 1, 1986
ODE/blue/pma
Do (blue book memo #P86-6) Panel Review of Premarket Approval May 3, 1991
ODE/blue/pma
Do Applications (blue book memo #P91-2) PMA Compliance Program (blue book memo May 3, 1991
ODE/blue/pma
Do #P91-3) PMA Filing Decisions (blue book memo May 18, 1990
ODE/blue/pma
Do #P90-2) PMA Refuse to File Procedures (blue May 20, 1994
ODE/blue/pma
Do book memo #P94-1) PMA Supplements: ODE's letter to
April 24, 1990 ODE/blue/pma
Do manufacturers; identifies situations which may require the submission of a PMA supplement (when PMA Supplements are required) (blue book memo) #P90-1 PMAs Early Review and Preparation of January 27, 1986 ODE/blue/pma
Do Summaries of Safety and Effectiveness (blue book memo #P86-1) Premarket Approval Application (PMA) July 8, 1994
ODE/blue/pma
Do Closure (blue book memo #P94-1)
[[Page 31246]]
Review and Approval of PMAs of
October 22, 1990 ODE/blue/pma
Do Licensees (blue book memo #P86-4) Review of Final Draft Medical Device August 29, 1991 ODE/blue/pma
Do Labeling (blue book memo #P91-4) Distribution and Public Availability October 10, 1997 ODE/blue/pma
Do of Premarket Approval Application Summary of Safety and Effectiveness Data Packages (P98-1) PMA Summaries of Safety and
June 11, 1993 ODE/blue/pma
Do Effectiveness and Federal Register Notices of PMA Approvals--Review by the Office of General Counsel (Revised) (P98-1) PMA Review Schedules (P87-1)
March 31, 1988 ODE/blue/pma
Do Points to Consider Guidance Document February 3, 1999 ODE/Division of
Do on Assayed and Unassayed Quality
Clinical Laboratory Control Material
Devices (DCLD) Review Criteria for Assessment of October 30, 1996 ODE/DCLD
Do Antimicrobial Susceptibility Test Discs Guidance for Submission of
June 3, 1998
ODE/DCLD
Do Immunohistochemistry Applications to the FDA In Vitro Diagnostic Creatinine Test July 2, 1998
ODE/DCLD
Do System In Vitro Diagnostic Bicarbonate/Carbon July 6, 1998
ODE/DCLD
Do Dioxide Test System In Vitro Diagnostic Chloride Test July 6, 1998
ODE/DCLD
Do System In Vitro Diagnostic Glucose Test
July 6, 1998
ODE/DCLD
Do System In Vitro Diagnostic Potassium Test July 6, 1998
ODE/DCLD
Do System In Vitro Diagnostic Sodium Test System July 6, 1998
ODE/DCLD
Do In Vitro Diagnostic Urea Nitrogen Test July 6, 1998
ODE/DCLD
Do System In Vitro Diagnostic C-Reactive
July 20, 1998 ODE/DCLD
Do Immunological Test System In Vitro Diagnostic Calibrators
July 20, 1998 ODE/DCLD
Do Points To Consider For Hematology September 30, 1997 ODE/DCLD
Do Quality Control Materials Guidance for Premarket Submissions for December 30, 1998 ODE/DCLD
Do Kits for Screening Drugs of Abuse to be Used by the Consumer Review Criteria for Assessment of November 6, 1996 ODE/DCLD
Do Professional Use Human Chorionic Gonadotropin (hCG) in Vitro Diagnostic Devices (IVDs) Letter to IVD Manufacturers on
December 22, 1997 ODE/DCLD
Do Streamlined PMA Guidance Document for the Submission September 19, 1996 ODE/DCLD
Do of Tumor Associated Antigen Premarket Notification [510(k)] to FDA Review Criteria for Assessment of February 21, 1997 ODE/DCLD
Do Rheumatoid Factor (RF) In Vitro Diagnostic Devices Using Enzyme- Linked Immunoassay (EIA), Enzyme Linked Immunosorbent Assay (ELISA), Particle Agglutination Tests, and Laser and Rate Nephgelometry Guidance for 510(k)s on Cholesterol July 14, 1995 ODE/DCLD
Do Tests for Clinical Laboratory, Physicians' Office Laboratory, and Home Use Assessing the Safety/Effectiveness of October 1, 1988 ODE/DCLD
Do Home-use In Vitro Diagnostic Devices (IVDs): Draft Points to Consider Regarding Labeling and Premarket Submissions Data for Commercialization of Original June 10, 1996 ODE/DCLD
Do Equipment Manufacturer, Secondary and Generic Reagents for Automated Analyzers DCLD Tier/Triage lists (include 931) May 31, 1996
ODE/DCLD
Do Draft Criteria for Assessment of In August 31, 1995 ODE/DCLD
Do Vitro Diagnostic Devices for Drugs of Abuse Assays Using Various Methodologies Draft Guidance Document for 510(k) July 29, 1992 ODE/DCLD
Do Submission of Fecal Occult Blood Tests Draft Guidance Document for 510(k) September 30, 1991 ODE/DCLD
Do Submission of Glycohemoglobin (Glycated or Glycosylated) Hemoglobin for IVDs Draft Guidance Document for 510(k) September 1, 1992 ODE/DCLD
Do Submission of Immunoglobulins A, G, M, D and E Immunoglobulin System In Vitro Devices
[[Page 31247]]
Draft Guidance for 510(k) Submission September 26, 1991 ODE/DCLD
Do of Lymphocyte Immunophenotyping IVDs using Monoclonal Antibodies Draft Review Criteria for Nucleic Acid June 14, 1993 ODE/DCLD
Do Amplification Based In Vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms Guidance Criteria for Cyclosporine January 24, 1992 ODE/DCLD
Do PMAs Draft: Premarketing Approval Review September 10, 1992 ODE/DCLD
Do Criteria for Premarket Approval of Estrogen (ER) or Progesterone (PGR) Receptors In Vitro Diagnostic Devices Using Steroid Hormone Points to Consider for Cervical
July 25, 1994 ODE/DCLD
Do Cytology Devices Points to Consider for Collection of September 26, 1994 ODE/DCLD
Do Data in Support of In-Vitro Device Submissions for 510(k) Clearance Points to Consider for Portable Blood February 20, 1996 ODE/DCLD
Do Glucose Monitoring Devices Intended for Bedside Use in the Neonate Nursery Points to Consider for Review of
February 1, 1996 ODE/DCLD
Do Calibration and Quality Control Labeling for In Vitro Diagnostic Devices/Cover Letter dated 3/14/1996 Review Criteria for In Vitro
February 1, 1994 ODE/DCLD
Do Diagnostic Devices for the Assessment of Thyroid Autoantibodies Using Indirect Immunofluorescence Assay (IFA), Indirect Hemagglutination Assay (IHA), Radioimmunoasay (RIA), and Enzyme Linked Immunosorbent Assay (ELISA) Review Criteria for Assessment of July 15, 1994 ODE/DCLD
Do Alpha-Fetoprotein (AFP) In Vitro Diagnostic Devices for Fetal Open Neural Tube Defects Using Immunological Test Methodologies Review Criteria for Assessment of May 31, 1991
ODE/DCLD
Do Antimicrobial Susceptibility Devices Review Criteria for Assessment of July 15, 1991 ODE/DCLD
Do Cytogenetic Analysis Using Automated and Semi-Automated Chromosome Analyzers Review Criteria for Assessment of September 27, 1995 ODE/DCLD
Do Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs) Review Criteria for Assessment of In January 1, 1992 ODE/DCLD
Do Vitro Diagnostic Devices for Direct Detection of Chlamydiae in Clinical Specimens Review Criteria for Assessment of In July 6, 1993
ODE/DCLD
Do Vitro Diagnostic Devices for Direct Detection of Mycobacterium Spp. (Tuberculosis (TB)) Review Criteria for Assessment of September 17, 1992 ODE/DCLD
Do Laboratory Tests for the Detection of Antibodies to Helicobacter pylori Review Criteria for Assessment of February 14, 1996 ODE/DCLD
Do Portable Blood Glucose In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase, or Hexokinase Methodology Review Criteria for Blood Culture August 12, 1991 ODE/DCLD
Do Systems Review Criteria for Devices Assisting May 31, 1990
ODE/DCLD
Do in the Diagnosis of C. Difficile Associated Diseases Review Criteria for Devices Intended December 30, 1991 ODE/DCLD
Do for the Detection of Hepatitis B 'e' Antigen and Antibody to HBe Review Criteria for In Vitro
August 1, 1992 ODE/DCLD
Do Diagnostic Devices for Detection of IGM Antibodies to Viral Agents Review Criteria for In Vitro
February 15, 1996 ODE/DCLD
Do Diagnostic Devices that Utilize Cytogenetic In Situ Hybridization Technology for the Detection of Human Genetic Mutations (Germ Line and Somatic) Review Criteria For Premarket Approval May 15, 1992
ODE/DCLD
Do of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19 Review Criteria for the Assessment of March 2, 1993 ODE/DCLD
Do Allergen-Specific Immunoglobulin E (IGE) In-Vitro Diagnostic Devices Using Immunological Test Methodologies
[[Page 31248]]
Review Criteria for the Assessment of September 1, 1992 ODE/DCLD
Do Anti-nuclear Antibodies (ANA) In- Vitro Diagnostic Devices Using Indirect Immunofluorescence Assay (IFA), Immunodiffusion (IMD) and Enzyme Linked Immunosorbant Assay (ELISA) Non-Automated Sphygmomanometer (Blood November 19, 1998 ODE/DCRND
Do Pressure Cuff) Guidance Cardiac Monitor Guidance (including November 5, 1998 ODE/Division of
Do Cardiotachometer and Rate Alarm)
Cardiovascular, Respiratory and Neurological Devices (DCRND) Diagnostic ECG Guidance (Including Non- November 5, 1998 ODE/DCRND
Do Alarming ST Segment measurement) Carotid Stent--Suggestions for Content October 26, 1996 ODE/DCRND
Do of Submissions to the Food and Drug Administration in Support of Investigational Devices Exemption (IDE) Applications Non-Invasive Blood Pressure (NIBP) March 10, 1997 ODE/DCRND
Do Monitor Guidance Guidance for Off-the-Shelf Software June 4, 1997
ODE/DCRND
Do Use in Medical Devices; Draft Document Draft Percutaneous Transluminal
February 7, 1995 ODE/DCRND
Do Coronary Angioplasty Package Insert Template Medical Device Labeling--Suggested August 12, 1997 ODE/DCRND
Do Format and Content; Draft Document Draft Intravascular Brachytherapy-- May 24, 1996
ODE/DCRND
Do Guidance for Data to be Submitted to the Food and Drug Administration in Support of Investigational Device Exemption (IDE) Applications 510(k) Reviewer Guidelines--
January 1, 2000 ODE/DCRND
Do Tracheostomy Tubes 868.5800 Balloon Valvuloplasty Guidance For The January 1, 1989 ODE/DCRND
Do Submission Of an IDE Application and a PMA Application Rechargeable Battery Preliminary
July 12, 1993 ODE/DCRND
Do Guidance for Data to be Submitted to FDA in Support of Premarket Notification Applications Review Guidance for Anesthesia
May 15, 1991
ODE/DCRND
Do Conduction Catheter Coronary and Cerebrovascular Guidewire January 1, 1995 ODE/DCRND
Do Guidance Draft Guidance: Human Heart Valve June 21, 1991 ODE/DCRND
Do Allografts Draft Replacement Heart Valve Guidance October 14, 1994 ODE/DCRND
Do Draft Reviewer Guidance for
July 1, 1995
ODE/DCRND
Do Ventilators Draft Reviewer Guidance on Face Masks March 16, 1996 ODE/DCRND
Do and Shield for CPR Draft Version Cardiac Ablation
March 1, 1995 ODE/DCRND
Do Preliminary Guidance (Data to be Submitted to FDA in Support Investigation Device Exemption Application Draft Version Electrode Recording March 1, 1995 ODE/DCRND
Do Catheter Preliminary Guidance (Data to be Submitted to FDA in Support of Premarket Notifications Excerpts Related to EMI from November November 1, 1993 ODE/DCRND
Do 1993 Anesthesiology and Respiratory Devices Branch (to be used with EMI standard) General Guidance Document: Non-
September 7, 1992 ODE/DCRND
Do Invasive Pulse Oximeter Guidance for Oxygen Conserving Device February 1, 1989 ODE/DCRND
Do 510(k) Review 73 BZD 868.5905 Non- continuous Ventilator Class II Reviewer Guidance for Premarket
July 19, 1995 ODE/DCRND
Do Notification (510(k)) Submissions-- Labeling, Performance and Environmental Testing for Electronic Devices Guidance for Peak Flow Meters for Over- June 1, 1993
ODE/DCRND
Do the-Counter Sale Guidance for the Preparation of the April 1, 1990 ODE/DCRND
Do Annual Report to the PMA Approved Heart Valve Prostheses Heated Humidifier Review Guidance August 30, 1991 ODE/DCRND
Do Implantable Pacemaker Lead Testing September 1, 1989 ODE/DCRND
Do Guidance For The Submission of a Section 510(k) Notification Implantable Pacemaker Testing Guidance January 12, 1990 ODE/DCRND
Do Policy for Expiration Dating (DCRND October 30, 1992 ODE/DCRND
Do RB92-G)
[[Page 31249]]
Review Guidelines for Oxygen
Undated
ODE/DCRND
Do Generators and Oxygen Equipment Reviewer Guidance for Nebulizers, November 9, 1990 ODE/DCRND
Do Metered Dose Inhalers, Spacers and Actuators Reviewer's Guidance for Oxygen
August 30, 1991 ODE/DCRND
Do Concentrator Electrocardiograph (ECG) Electrode February 11, 1997 ODE/DCRND
Do Electrocardiograph (ECG) Lead
February 11, 1997 ODE/DCRND
Do Switching Adapter Electrocardiograph (ECG) Surface
February 11, 1997 ODE/DCRND
Do Electrode Tester Guidance on the Content of Premarket December 1, 1995 ODE/Division of
Do Notification [510(k)] Submissions for
Dental Infection Protective Restraints
Control and General Hospital Devices (DDIGD) Guidance for the Preparation of
November 27, 1998 ODE/DDIGD
Do Premarket Notifications for Dental Composites Neonatal and Neonatal Transport
September 18, 1998 ODE/DDIGD
Do Incubators Premarket Notifications Reexamination of the Evaluation
May 19, 1997
ODE/DDIGD
Do Process for Liquid Chemical Sterilant and High Level Disinfectants Further Information on the Regulation August 5, 1997 ODE/DDIGD
Do of Liquid Chemical Sterilants and High Level Disinfectants Guidance on the Content and Format of December 18, 1997 ODE/DDIGD
Do Premarket Notifications [510(k)] Submissions for Liquid Chemical Sterilants and High Level Disinfectants Guidance on the Content and Format of January 16, 1998 ODE/DDIGD
Do Premarket Notification [510(k)] Submissions for Surgical Masks Premarket Notification [510(k)]
January 13, 1999 ODE/DDIGD
Do Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products (Replaces: Guidance on the Content and Format of Premarket Notifications [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products--2/13/98) Guidance on the Content and Format of August 4, 1998 ODE/DDIGD
Do Premarket Notification [510(k)] Submissions of Washers and Washer- Disinfectors Devices for the Treatment and/or
June 10, 1998 ODE/DDIGD
Do Diagnosis of Temporomandibular Joint Dysfunction and/or Orofacial Pain Dental Impression Materials--Premarket August 17, 1998 ODE/DDIGD
Do Notification OTC Denture Cushions, Pads, Reliners, August 18, 1998 ODE/DDIGD
Do Repair Kits, and Partially Fabricated Denture Kits Dental Cements--Premarket Notification August 18, 1998 ODE/DDIGD
Do Groups Capable of Testing for Latex July 28, 1997 ODE/DDIGD
Do Skin Sensitization (Addendum to #944) Addendum to: Guidance on Premarket September 19, 1995 ODE/DDIGD
Do Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities Guidance Document on Dental Handpieces July 1, 1995
ODE/DDIGD/Dental Do Devices Branch (DDB) 510(k) Guidance for Screw Type
August 11, 1992 ODE/DDIGD/DDB
Do Endosseous Implants for Prosthetic Attachment 510(k) Information Needed for
July 6, 1993
ODE/DDIGD/DDB
Do Hydroxyapatite Coated Titanium Endosseous Implants 510(k) Information Needed for
August 12, 1993 ODE/DDIGD/DDB
Do Metallurgical Endosseous Implants 510(k) Information Needed for Ti- July 13, 1993 ODE/DDIGD/DDB
Do Powder Coated Titanium Endosseous Implants Draft Guidance Document for the
March 3, 1997 ODE/DDIGD/DDB
Do Preparation of Premarket Notification [510(k)'s] for Dental Alloys Guidance Document for the Preparation January 23, 1995 ODE/DDIGD/DDB
Do of Premarket Notifications (510(k)'s) for Temporomandibular Joint Implants Guidance for the Arrangement and
May 16, 1989
ODE/DDIGD/DDB
Do Content of a Premarket Approval (PMA) Application For An Endosseous Implant For Prosthetic Attachment Guidance for the Preparation of
January 1, 2000 ODE/DDIGD/DDB
Do Premarket Notification [510(k)] for Resorbable Periodontal Barriers
[[Page 31250]]
Information Necessary for Premarket December 9, 1996 ODE/DDIGD/DDB
Do Notification Submissions for Screw- Type Endossesous Implants Outline of Recommended Procedures for January 1, 2000 ODE/DDIGD/DDB
Do a Clinical Investigation of Endosseous Implants Under a 510(k) Outline of Recommended Procedures for January 1, 2000 ODE/DDIGD/DDB
Do Animal Laboratory Studies of Endosseous Implants Guidance on the Content of Premarket April 1, 1993 ODE/DDIGD/General Do Notification [510(k)] Submissions for
Hospital Devices Piston Syringes
Branch (GHDB) Draft Supplementary Guidance on the March 1, 1995 ODE/DDIGD/GHDB
Do Content of Premarket Notification [510(k)] Submissions for Medical Devices with Sharps Injury Prevention Features (Antistick) Guidance on 510(k) Submissions for October 1, 1990 ODE/DDIGD/GHDB
Do Implanted Infusion Ports Guidance on Premarket Notification March 16, 1995 ODE/DDIGD/GHDB
Do [510(k)] Submissions for Short-Term and Long-Term Intravascular Catheters Guidance on the Content of Premarket March 1, 1993 ODE/DDIGD/GHDB
Do Notification [510(k)] Submissions for Clinical Electronic Thermometers Guidance on the Content of Premarket March 1, 1993 ODE/DDIGD/GHDB
Do Notification [510(k)] Submissions for External Infusion Pumps Guidance on the Content of Premarket April 1, 1993 ODE/DDIGD/GHDB
Do Notification [510(k)] Submissions for Hypodermic Single Lumen Needles Guidance on Premarket Notification August 1, 1993 ODE/DDIGD/Infection Do [510(k)] Submissions for Automated
Control Devices Endoscope Washers, Washer/
Branch (ICDB) Disinfectors, and Disinfectors Intended for Use in Health Care Facilities Guidance on Premarket Notification August 1, 1993 ODE/DDIGD/ICDB
Do [510(k)] Submissions for Surgical Gowns and Surgical Drapes Guidance on the Content and Format of December 6, 1996 ODE/DDIG/ICDB
Do Premarket Notification 510(k) Submissions for Liquid Chemical Germicides Guidance on the Content and Format of October 1, 1993 ODE/DDIGD/ICDB
Do Premarket Notification [510(k)] Submissions for General Purpose Disinfectants (and 3/9/94 Addendum) Guidance on the Content and Format of October 1, 1993 ODE/DDIGD/ICDB
Do Premarket Notification [510(k)] Submissions for Sharps Containers Addendum to Guidance on the Content March 9, 1994 ODE/DDIGD/ICDB
Do and Format of Premarket Notification [510(k)] Submissions for General Purpose Disinfectants Guidance on Premarket Notification March 3, 1993 ODE/Division of
Do 510(k) for Sterilizers Intended for
General and Use in Health Care Facilities
Restorative Devices (DGRD) Guidance Document for Powered Suction September 30, 1998 ODE/DGRD
Do Pump 510(k)s Guidance Document for Industry and March 18, 1998 ODE/DGRD
Do CDRH Staff for the Preparation of Investigational Device Exemptions and Premarket Approval Applications for Bone Growth Stimulator Devices (Replaces: Guidance Document for the Preparation of Investigatinal Device Exemptions and Premarket Approval Applications for Bone Growth Stimulator Devices--8/12/88) Guidance for Content of Premarket April 28, 1998 ODE/DGRD
Do Notifications for Esophageal and Tracheal Prostheses Guidance Document for Surgical Lamp July 13, 1998 ODE/DGRD
Do 510ks Protocol for Dermal Toxicity Testing January 1, 2000 ODE/DGRD
Do for Devices in Contact with Skin (Draft) Guide for 510(k) Review of Processed June 26, 1990 ODE/DGRD
Do Human Dura Mater Guide for TENS 510(k) Content (Draft) August 1, 1994 ODE/DGRD
Do Guidelines for Reviewing Premarket January 1, 2000 ODE/DGRD
Do Notifications that Claim Substantial Equivalence to Evoked Response Stimulators
[[Page 31251]]
Guidance for Studies for Pain Therapy May 12, 1988
ODE/DGRD
Do Devices--General Considerations in the Design of Clinical Studies for Pain-Alleviating Devices Galvanic Skin Response Measurement August 23, 1994 ODE/DGRD
Do Devices--Draft Guidance for 510(k) Content Draft Version Guide for Cortical
August 10, 1992 ODE/DGRD
Do Electrode 510(k) Content Draft Version Neuro Endoscope Guidance July 7, 1994
ODE/DGRD
Do Draft Version Guidance for Clinical August 20, 1992 ODE/DGRD
Do Data to be Submitted for Premarket Approval Application for Cranial Electrotherapy Stimulators Draft Version 1--Biofeedback Devices-- August 1, 1994 ODE/DGRD
Do Draft Guidance for 510(k) Content Draft Version--Guidance on
September 12, 1994 ODE/DGRD
Do Biocompatibility Requirements for Long Term Neurological Implants: Part 3--Implant Model Draft Premarket Notification Review June 1, 1994
ODE/DGRD
Do Guidance for Evoked Response Somatosensory Stimulators Draft Version Cranial Perforator
July 13, 1994 ODE/DGRD
Do Guidance ORDB 510(k) Sterility Review Guidance July 3, 1997
ODE/DGRD
Do Draft Guidance for Testing MR
May 22, 1996
ODE/DGRD
Do Interaction with Aneurysm Clips Draft 510(k) Guideline for General May 10, 1995
ODE/DGRD/General Do Surgical Electrosurgical Devices
Surgery Devices Brancch (GSDB) Draft Guidance for Arthroscope and May 1994
ODE/DGRD/GSDB
Do Accessory 510(k)s Guidance for the Preparation of a August 30, 1994 ODE/DGRD/GSDB
Do Premarket Notification for Extended Laparoscopy Devices Guidance on the Content and
June 1, 1995
ODE/DGRD/GSDB
Do Organization of a Premarket Notification for a Medical Laser Guidance Document for Testing Bone April 20, 1996 ODE/DGRD/Orthopedic Do Anchor Devices
Devices Branch (ORDB) 510(k) Information Needed for
February 20, 1997 ODE/DGRD/ORDB
Do Hydroxyapatite Coated Orthopedic Implants Calcium Phosphate (Ca-P) Coating Draft February 21, 1997 ODE/DGRD/ORDB
Do Guidance for Preparation of FDA Submissions for Orthopedic and Dental Endosseous Implants Draft Data Requirements for Ultrahigh March 28, 1995 ODE/DGRD/ORDB
Do Molecular Weight Polyethylene (Uhmupe) Used in Orthopedic Devices Draft Guidance Document for Femoral August 1, 1995 ODE/DGRD/ORDB
Do Stem Prostheses Draft Guidance Document for Testing May 1, 1995
ODE/DGRD/ORDB
Do Acetabular Cup Prostheses Draft Guidance Document for the
July 16, 1997 ODE/DGRD/ORDB
Do Preparation of Premarket Notification [510(k)] Applications for Orthopedic Devices-The Basic Elements Draft Guidance for the Preparation of April 1, 1993 ODE/DGRD/ORDB
Do Premarket Notifications [510(k)s] for Cemented, Semi-Constrained Total Knee Prostheses Draft Guideline for Reviewing Spinal January 9, 1997 ODE/DGRD/ORDB
Do Fixation Device Systems Draft of Guidance Document for Testing October 25, 1995 ODE/DGRD/ORDB
Do of Orthopedic Implants with Metallic Plasma Sprayed Porous Coatings Subject to Required Post Market Surveillance Draft Outline for a Guidance Document November 1, 1993 ODE/DGRD/ORDB
Do for Testing Orthopedic Bone Cement, request for comments by December 10, 1993 Guidance Document for Testing
April 20, 1996 ODE/DGRD/ORDB
Do Biodegradable Polymer Implant Devices Guidance Document for Testing Non- May 1, 1995
ODE/DGRD/ORDB
Do Articulating, ``Mechanically Locked'', Modular Implant Components Guidance Document for Testing
April 28, 1994 ODE/DGRD/ORDB
Do Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement
[[Page 31252]]
Guidance Document for the Preparation February 18, 1993 ODE/DGRD/ORDB
Do of IDE and PMA Applications for Intra- Articular Prosthetic Knee Ligament Devices Guidance Document for the Preparation January 10, 1995 ODE/DGRD/ORDB
Do of Premarket Notification for Ceramic Ball Hip Systems Reviewers Guidance Checklist for
February 21, 1997 ODE/DGRD/ORDB
Do Intramedullary Rods Reviewers Guidance Checklist for
February 21, 1997 ODE/DGRD/ORDB
Do Orthopedic External Fixation Devices Electroencephalograph Device Draft June 25, 1997 ODE/DGRD/Plastic and Do Guidance for 510(k) Content
Reconstructive Surgery Devices Branch (PRSB) Alternate Suture Labeling Resulting January 11, 1993 ODE/DGRD/PRSB
Do from the January 11, 1993, Meeting with HIMA Copy of October 9, 1992 Letter and
ODE/DGRD/PRSB
Do Original Suture Labeling Guidance Draft Guidance for Preparation of PMA January 18, 1995 ODE/DGRD/PRSB
Do Applications for Silicone Inflatable (Saline) Breast Prostheses Draft Guidance for Preparations of FDA May 11, 1992
ODE/DGRD/PRSB
Do Submissions of Silicone Gel-Filled Breast Prostheses Draft Guidance for Testing of
September 1, 1994 ODE/DGRD/PRSB
Do Alternative Breast Prostheses (nonsilicone gel-filled) Draft Guidance for the Preparation of March 31, 1995 ODE/DGRD/PRSB
Do a Premarket Notification for a Non- Interactive Wound and Burn Dressing [510(k)] Draft Guidance for the Preparation of April 1, 1995 ODE/DGRD/PRSB
Do IDE Submission for Interactive Wound and Burn Dressing Letter: Core Study for Silicone Breast January 11, 1996 ODE/DGRD/PRSB
Do Implants Electrical Muscle Stimulator (EMS) July 11, 1985 ODE/DGRD/Restorative Do Labeling Indications,
Devices Branch Contraindications, Warnings, etc.
(REDB) Technological Reporting for Powered January 1, 1992 ODE/DGRD/REDB
Do Muscle Stimulator 510k Submissions Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB
Do of Notification (510(k)) Applications for Therapeutic Massagers and Vibrators Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB
Do of Premarket Notification [510(k)] Applications for Beds Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB
Do of Premarket Notification [510(k)] Applications for Communications Systems (Powered and Non-Powered) and Powered Environmental Control Systems Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB
Do of Premarket Notification [510(k)] Applications for Electromyograph Needle Electrodes Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB
Do of Premarket Notification [510(k)] Applications for Exercise Equipment Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB
Do of Premarket Notification [510(k)] Applications for Heating and Cooling Devices Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB
Do of Premarket Notification [510(k)] Applications for Immersion Hyudrobaths Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB
Do of Premarket Notification [510(k)] Applications for Powered Muscle Stimulators, and Ultrasound Diathermy and Muscle Stimulators Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB
Do of Premarket Notification [510(k)] Applications for Powered Tables and Multifunctional Physical Therapy Tables Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB
Do of Premarket Notification [510(k)] Applications for Submerged (Underwater) Exercise Equipment
[[Page 31253]]
Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB
Do of Premarket Notification [510k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles Aqueous Shunts--510(k) Submissions November 16, 1998 ODE/Division of
Do Opthalmics Devices (DOD) Guidance for Industry--Guidance
October 9, 1998 ODE/DOD
Do Document for Nonprescription Sunglasses Third Party Review Guidance for
January 31, 1997 ODE/DOD
Do Vitreous Aspiration and Cutting Device Premarket Notification (510k) Dear Sponsor Letter Concerning the May 20, 1997
ODE/DOD
Do Revocation of 21 CFR Part 813 IOL IDE Regulations Retinoscope Guidance
July 8, 1998
ODE/DOD
Do Opthalmoscope Guidance
July 8, 1998
ODE/DOD
Do Slit Lamp Guidance
July 8, 1998
ODE/DOD
Do Revised Procedures for Adding Lens August 11, 1998 ODE/DOD
Do Finishing Laboratories to Approved Premarket Approval Applications for Class III Rigid Gas Permeable Contact Lens for Extended Wear Announcement by Dr. Alpert at 7/26/96 August 26, 1996 ODE/DOD
Do Ophthalmic Panel Meeting Concerning Manufacturers & Users of Lasers for Refractive Surgery [excimer Announcement: Information for
September 22, 1997 ODE/DOD
Do Manufacturers & Users of Lasers for Refractive Surgery [excimer] Intraocular Lens (IOL) Guidance
October 10, 1997 ODE/DOD
Do Document FDA Guidelines for Multifocal
May 29, 1997
ODE/DOD
Do Intraocular Lens IDE Studies and PMAs Premarket Notification [510(k)]
May 12, 1994
ODE/DOD
Do Guidance Document for Class II Daily Wear Contact Lenses Contact Lenses: The Better the Care April 1, 1991 ODE/DOD
Do the Safer the Wear--FDA Publication No. (FDA) (91-4220) An FDA Survey of U.S. Contact Lens July 1, 1987
ODE/DOD
Do Wearers (Carol L. Herman) Reprinted from Contact Lens Spectrum Facts for Consumers from the Federal April 1, 1986 ODE/DOD
Do Trade Commission--Eyeglasses Important Information About Rophae August 20, 1992 ODE/DOD
Do Intraocular Lenses Checklist of Information Usually
October 10, 1996 ODE/DOD
Do Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers [excimer] Ophthalmic Device Triage List
March 19, 1998 ODE/DOD
Do Discussion Points for Expansion of the September 5, 1997 ODE/DOD
Do 'Checklist of Information Usually Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers' Draft Document Letter to Manufacturers and Users of October 10, 1996 ODE/DOD
Do Lasers for Refractive Surgery [excimer] Owners Certification of Lasers as PMA September 26, 1996 ODE/DOD
Do Approved Devices [excimer] Update on Excimer Lasers for
May 20, 1996
ODE/DOD
Do Nearsightedness Amendment 1: Premarket Notification June 28, 1994 ODE/DOD
Do [510(k)] Guidance Document for Class II Daily Wear Contact Lenses Certification Statement for the Impact February 3, 1995 ODE/DOD
Do Resistance Test Premarket Notification 510(k) Guidance May 1, 1997
ODE/DOD
Do for Contact Lens Care Products Eye Valve Implant (and all glaucoma November 16, 1995 ODE/DOD
Do drainage devices) manufacturers letter from N. C. Brogdon New FDA Recommendations & Results of May 30, 1989
ODE/DOD
Do Contact Lens Study (7-day letter) Sunglass Letter including 510(k)
October 8, 1996 ODE/DOD
Do format Sunglass Package
February 3, 1995 ODE/DOD
Do Guidance for Industry; Noise Claims in October 21, 1998 ODE/Division of
Do Hearing Aid Labeling
Reproductive, Abdominal, ENT, and Radiological Devices (DRAERD)
[[Page 31254]]
Guidance for the Submission of
November 14, 1998 ODE/DRAERD
Do Premarket Notification for Magnetic Resonance Diagnostic Devices Guidance for the Content of Premarket November 30, 1998 ODE/DRAERD
Do Notifications for Intracorporeal Lithotripters Guidance for the Submission of
November 20, 1998 ODE/DRAERD
Do Premarket Notifications for Radionuclide Dose Calibrators Guidance for the Submission of
December 3, 1998 ODE/DRAERD
Do Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems Information for Manufacturers Seeking February 4, 1999 ODE/-DRAERD
Do Marketing Clearance of Digital Mammography Systems Harmonic Imaging with/without
November 16, 1998 ODE/DRAERD
Do Contrast--Premarket Notification Requirements Guidance for the Content of Premarket February 5, 1998 ODE/DRAERD
Do Notifications for Metal Expandable Biliary Stents Guidance for the Submission of 510(k) February 11, 1997 ODE/DRAERD
Do Premarket Notifications for Cardiovascular Intravascular Filters Tympanostomy Tubes, Submission
January 14, 1998 ODE/DRAERD
Do Guidance for a 510(k) Premarket Notification Letter to Manufacturers of
September 5, 1996 ODE/DRAERD
Do Falloposcopes Letter to Manufacturers of
September 6, 1996 ODE/DRAERD
Do Prescription Home Monitors for Non- Stress Tests Latex Condoms for Men--Information for July 23, 1998 ODE/DRAERD
Do 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions Uniform Contraceptive Labeling
July 23, 1998 ODE/DRAERD
Do Guidance to Industry and CDRH
August 7, 1998 ODE/DRAERD
Do Reviewers--Guidance for the Content of Premarket Notifications for Conventional and Permeability Hemodialyzers (Replaces: Guidelines for Premarket Testing of New Conventional Hemodialyers, High Premeability Hemodialyzers and Hemofilters) Devices Used for In Vitro
September 10, 1998 ODE/DRAERD
Do Fertilization and Related Assisted Reproduction Procedures Guidance for the Technical Content of April 1, 1990 ODE/DRAERD
Do a Premarket Approval (PMA) Application for an Endolymphatic Shunt Tube with Valve Letter: Notice to Manufacturers of September 25, 1997 ODE/DRAERD
Do Bone Mineral Densitometers Draft Guidance to Hearing Aid
August 5, 1994 ODE/DRAERD/Ear, Nose, Do Manufacturers for Substantiation of
and Throat Devices Claims
Branch (ENTB) Guidance for Submission of a 510(k) April 1, 1991 ODE/DRAERD/ENTB
Do Premarket Notification for an Air Conduction Hearing Aid Guidance For The Arrangement and
May 1, 1990
ODE/DRAERD/ENTB
Do Content of a Premarket Approval (PMA) Application For a Cochlear Implant in Children Ages 2 through to 17 Years Guidance for the Content of Premarket October 21, 1996 ODE/DRAERD/ENTB
Do Notification for Disposable, Sterile, Ear, Nose and Throat Endoscope Sheaths with Protective Barrier Claims Guideline for the Arrangement and May 1, 1990
ODE/DRAERD/ENTB
Do Content of a Premarket Approval (PMA) Application for a Cochlear Implant in Adults at Least 18 Years of Age Draft Guidance for Hemodialyzer Reuse October 6, 1995 ODE/DRAERD/
Do Labeling
Gastroenterology and Renal Devices Branch (GRDB) Draft Guidance for the Content of May 30, 1997
ODE/DRAERD/GRDB
Do Premarket Notifications for Water Purification Components and Systems for Hemodialysis Condom Packet: 4/13/94 R. J. Rivera April 13, 1994 ODE/DRAERD/Obstetrics/ Do Letter, Condom Guidance & 7 Tabs,
Gynecology Devices General Guidance for Modifying Condom
Branch (OGDB) Labeling to Include Shelf Life
[[Page 31255]]
Draft Guidance for the Content of July 29, 1991 ODE/DRAERD/OGDB
Do Premarket Notifications for Loop and Rollerball Electrodes for GYN Electrosurgical Excisions Draft Guidance for the Content of May 25, 1995
ODE/DRAERD/OGDB
Do Premarket Notifications for Menstrual Tampons Draft Thermal Endometrial Ablation March 14, 1996 ODE/DRAERD/OGDB
Do Devices (Submission Guidance for an IDE) Guidance (`Guidelines') for Evaluation March 8, 1977 ODE/DRAERD/OGDB
Do of Fetal Clip Electrode Guidance (`Guidelines') for Evaluation May 10, 1978
ODE/DRAERD/OGDB
Do of Hysteroscopic Sterilization Devices Guidance (`Guidelines') for Evaluation January 1, 2000 ODE/DRAERD/OGDB
Do of Laparoscopic Bipolar and Thermal Coagulators (and Accessories) Guidance (`Guidelines') for Evaluation November 22, 1977 ODE/DRAERD/OGDB
Do of Tubal Occlusion Devices Guidelines for Evaluation of Non-Drug September 28, 1976 ODE/DRAERD/OGDB
Do IUDs Hysteroscopes and Gynecology
March 27, 1996 ODE/DRAERD/OGDB
Do Laparoscopes--Submission Guidance for a 510(k) --includes 00192 Hysteroscopes and Laparoscopic
August 1, 1995 ODE/DRAERD/OGDB
Do Insufflators: Submission Guidance for a 510(k) In-vivo Devices for the Detection of June 14, 1997 ODE/DRAERD/OGDB
Do Cervical Cancer and its Precursors: Submission Guidance for an IDE Draft Document Intrapartum Continuous Monitors for June 14, 1997 ODE/DRAERD/OGDB
Do Fetal Oxygen Saturation and Fetal pH; Submission Guidance for a PMA; Draft Document Premarket Testing Guidelines for
November 20, 1992 ODE/DRAERD/OGDB
Do Falloposcopes Premarket Testing Guidelines for
April 4, 1990 ODE/DRAERD/OGDB
Do Female Barrier Contraceptive Devices also Intended to Prevent Sexually Transmitted Diseases Premarket Testing Guidelines for Home March 31, 1993 ODE/DRAERD/OGDB
Do Uterine Activity Monitors Information for a Latex Condom 510(k) March 1994
ODE/DRAERD/OGDB
Do Submission for Obstetrics-Gynecology Branch (draft) Testing Guidance for Male Condoms Made June 29, 1995 ODE/DRAERD/OGDB
Do from New Material (Non-Latex) Draft Guidance for Review of Bone November 9, 1992 ODE/DRAERD/Radiology Do Densitometer 510(k) Submissions
Devices Branch (RDB) Guidance for Content and Review of a August 2, 1988 ODE/DRAERD/RDB
Do Magnetic Resonance Diagnostic Device 510(k) Application and 10/11/95 MRI Guidance Update for dB/dt Guidance for Magnetic Resonance
September 29, 1997 ODE/DRAERD/RDB
Do Diagnostic Devices--Criteria for Significant Risk Investigations Guidance for the Comment and Review of August 1, 1993 ODE/DRAERD/RDB
Do 510(k) Notifications for Picture Archiving and Communications Systems (PACS) and Related Devices [See 2099] Guidance for the Submission of 510(k)s June 1, 1997
ODE/DRAERD/RDB
Do for Solid State X-ray Imaging Devices Information for Manufacturers Seeking September 30, 1997 ODE/DRAERD/RDB
Do Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Information for Manufacturers Seeking June 19, 1996 ODE/DRAERD/RDB
Do Marketing Clearance of Digital Mammography Systems Reviewer Guidance for Automatic X-Ray February 1, 1990 ODE/DRAERD/RDB
Do Film Processor 510(k) Simplified 510(k) procedures for
December 21, 1993 ODE/DRAERD/RDB
Do certain radiology devices: 12/21/93 letter from L. Yin, ODE/DRAERD, to NEMA 510(k) Checklist for Sterile
September 19, 1994 ODE/DRAERD/Urology Do Lubricating Jelly Used With
and Lithrotripsy Transurethral Surgical Instruments
Devices Branch (ULDB) Draft Guidance to Firms on Biliary August 2, 1990 ODE/DRAERD/ULDB
Do Lithotripsy Studies CDRH Interim Regulatory Policy for September 10, 1997 ODE/DRAERD/ULDB
Do External Penile Rigidity Devices Checklist for Mechanical Lithotripters November 1, 1994 ODE/DRAERD/ULDB
Do and Stone Dislodgers Used in Gastroenterology and Urology
[[Page 31256]]
Draft--510(k) Checklist for
November 23, 1994 ODE/DRAERD/ULDB
Do Conditioned Response Enuresis Alarms Draft 510(k) Checklist for Condom February 23, 1995 ODE/DRAERD/ULDB
Do Catheters Draft 510(k) Checklist for Endoscopic August 16, 1995 ODE/DRAERD/ULDB
Do Electrosurgical Unit (ESU) and Accessories Used in Gastroenterology and Urology Draft 510(k) Checklist for Endoscopic June 22, 1995 ODE/DRAERD/ULDB
Do Light Sources Used in Gastroenterology and Urology Draft 510(k) Checklist for Non-
June 6, 1995
ODE/DRAERD/ULDB
Do Implanted Electrical Stimulators Used for the Treatment of Urinary Incontinence Draft 510(k) Checklist for Urological August 1, 1995 ODE/DRAERD/ULDB
Do Irrigation System and Tubing Set Draft Guidance for Clinical
November 11, 1994 ODE/DRAERD/ULDB
Do Investigations of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH) Draft Guidance for Information on February 5, 1992 ODE/DRAERD/ULDB
Do Clinical Safety and Effectiveness Data for Extracorporeal Shock Wave Lithotripsy of Upper Urinary Tract (Renal Pelvis, Renal Calyx and Upper Ureteral) Calculi Draft Guidance for Preclinical and November 29, 1995 ODE/DRAERD/ULDB
Do Clinical Investigations of Urethral Bulking Agents Used in the Treatment of Urinary Incontinence Draft Guidance for Preparation of PMA March 16, 1993 OD/DRAERD/ULDB
Do Applications for Penile Inflatable Implants Draft Guidance for Preparation of PMA March 16, 1993 ODE/DRAERD/ULDB
Do Applications for Testicular Prostheses Draft Guidance for Preparation of PMA May 1, 1995
ODE/DRAERD/ULDB
Do Applications for the Implanted Mechanical/Hydraulic Urinary Continence Device (Artificial Urinary Sphincter) Draft Guidance for the Clinical
November 2, 1995 ODE/DRAERD/ULDB
Do Investigation of Urethral Stents Draft Guidance for the Content of March 17, 1995 ODE/DRAERD/ULDB
Do Premarket Notifications for Endoscopes Used in Gastroenterology and Urology Draft Guidance for the Content of May 30, 1995
ODE/DRAERD/ULDB
Do Premarket Notifications for Penile Rigidity Implants Draft Guidance for the Content of January 24, 1992 ODE/DRAERD/ULDB
Do Premarket Notifications for Urological Balloon Dilatation Catheters Draft Guidance Outline--Points to November 30, 1993 ODE/DRAERD/ULDB
Do Consider for Clinical Studies for Vasovasostomy Devices Draft of Suggested Information for January 18, 1991 ODE/DRAERD/ULDB
Do Reporting Extracorporeal Shock Wave Lithotripsy Device Shock Wave Measurements Guidance for the Content of Premarket February 10, 1993 ODE/DRAERD/ULDBDo Notifications for Biopsy Devices Used in Gastroenterology and Urology Guidance for the Content of Premarket September 12, 1994 ODE/DRAERD/ULDB
Do Notifications for Conventional and Antimicrobial Foley Catheters Guidance for the Content of Premarket February 10, 1993 ODE/DRAERD/ULDB
Do Notifications for Ureteral Stents Guidance for the Content of Premarket June 7, 1994
ODE/DRAERD/ULDB
Do Notifications for Urine Drainage Bags Guidance for the Content of Premarket July 29, 1994 ODE/DRAERD/ULDB
Do Notifications for Urodynamic/ Uroflowmetry Systems Guidance to Manufacturers on the
January 1, 2000 ODE/DRAERD/ULDB
Do Development of Required Postapproval Epidemiologic Study Protocols for Testicular Implants Center for Devices and Radiological June 30, 1993 ODE/IDE/blue/
Do Health's Investigational Device Exemption (IDE) Refuse to Accept Policy Center for Devices and Radiological June 30, 1993 ODE/510k/blue/
Do Health's Premarket Notification [510(k)] Refuse to Accept Policy-- (updated Checklist 3/14/95)
[[Page 31257]]
Guidance For Request and Issuance of October 21, 1998 Office of Health and Do Interim Notice Letters for
Industry Programs Mammography Facilities Under the MQSA
(OHIP)/Division of Mammography Quality and Radiation Programs (DMQRP) Continuing Education Credits for
March 17, 1998 OHIP/DMQRP
Do Reading/ Writing Articles/Papers and Presenting Courses/Lectures Accidental Radioactive Contamination August 13, 1998 OHIP/DMQRP
Do of Human Food and Animal Feeds: Recommendations for State and Local Agencies Additional Mammography Review Policy March 26, 1998 OHIP/DMQRP
Do Guidance For Review of Cases of
March 26, 1998 OHIP/DMQRP
Do Possible Suspension or Revocation of Mammography Facility Certificates Under the Mammography Quality Standards Act (42 U.S.C. 263(b)) Guidance for Review of Requests for March 26, 1998 OHIP/DMQRP
Do Reconsideration of Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Act (42 U.S.C. 263(b)) Guidance for Submission of Requests March 26, 1998 OHIP/DMQRP
Do for Reconsideration of Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Act, 42 U.S.C. 263(b) Supplement to The Physician's
April 9, 1998 OHIP/DMQRP
Do Continuing Experience Requirement Requalification for Interpreting
May 28, 1998
OHIP/DMQRP
Do Physician's Continuing Experience MQSA Policy Statements in a Question June 2, 1998
OHIP/DMQRP
Do and Answer Compliance Guidance: The Mammography August 27, 1998 OHIP/DMQRP
Do Quality Standards Act Final Regulations MQSA Policy Statements for the Interim August 6, 1998 OHIP/DMQRP
Do Regulations Policy for Facilities Changing
April 15, 1998 OHIP/DMQRP
Do Accreditation Bodies Addendum to What a Mammography
July 31, 1996 OHIP/DMQRP
Do Facility Should do to Prepare for an MQSA Inspection Handbook of Selected Tissue Doses for September 1, 1995 OHIP/DMQRP
Do Fluoroscopic and Cineangiographic Examination of the Coronary Arteries (in SI Units) FDA 95-8289, (Units of milliray (mmmGy) tissue dose and gray (Gy) air kerma) What a Mammography Facility Should Do June 30, 1995 OHIP/DMQRP
Do to Prepare for an MQSA Inspection Policy Notebook in a Q/A Format
January 23, 1998 OHIP/DMQRP
Do (update to existing document) Guidance for Staff, Industry, and October 30, 1998 OHIP/Division of Do Third Parties Implementation of Third
Small Manufacturer's Party Programs Under the FDA
Assistance (DSMA) Modernization Act of 1997 Pages 39.html Exporting Medical
June 30, 1998 OHIP/DSMA
Do Devices and 391.html Foreign Liaison List Guidance for Staff, Industry and Third January 6, 1999 OHIP/DSMA
Do Parties: Third Party Programs Under the Sectoral Annex on Medical Devices to the Agreement on Mutual Recognition Between the United States of America and the European Community (MRA) A Pocket Guide to Device GMP
November 1, 1991 OHIP/DSMA
Do Inspections--Inspections of Medical Device Manufacturers and GMP Regulation Requirements Medical Device Reporting for
March 1997
OHIP/DSMA
Do Manufacturers Regulatory Requirement for Devices for August 1, 1987 OHIP/DSMA
Do the Handicapped (FDA 87-4221) Comparison Chart: 1996 Quality System January 1, 2000 OHIP/DSMA
Do Reg vs. 1978 Good Manufacturing Practices Reg vs. ANSI/ISO/ASQC Q9001 and ISO/DI 13485:1996 (include 126) Small Business Guide to FDA (FDA 96- January 1, 1996 OHIP/DSMA
Do 1092) Investigational Device Exemptions July 1, 1996
OHIP/DSMA
Do [IDE] Manual (FDA 96-4159)/DSMA An Introduction to Medical Device January 1, 1992 OHIP/DSMA
Do Regulations (FDA 92-4222)
[[Page 31258]]
In Vitro Diagnostic Devices: Guidance January 1, 1997 OHIP/DSMA
Do for the Preparation of 510(k) Submissions (supersedes FDA 87-4224) Instructions for Completion of Medical July 1, 1997
OHIP/DSMA
Do Device Registration and Listing Forms FDA 2891, 2891a and 2892 Additional Guidance for Testing
September 1, 1993 OHIP/DSMA
Do Immunity to Radiated Electromagnetic Fields--Infant Apnea Monitor Standard Classification Names for Medical
March 1, 1995 OHIP/DSMA
Do Devices and In Vitro Diagnostic Products (FDA Pub No. 95-4246) Labeling--Regulatory Requirements for September 1, 1989 OHIP/DSMA
Do Medical Devices (FDA 89-4203) List of Current CDRH Addresses for July 30, 1996 OHIP/DSMA
Do Report Submission and Ordering of CDRH Forms Obtaining CDRH Guidance Documents May 13, 1998
OHIP/DSMA
Do Premarket Approval (PMA) Manual (FDA July 1, 1997
OHIP/DSMA
Do 97-4214) Premarket Notification: 510(k)--
August 1, 1995 OHIP/DSMA
Do Regulatory Requirements for Medical Devices (FDA 95-4158) Procedures for Laboratory Compliance May 1, 1986
OHIP/DSMA
Do Testing of Television Receivers--Part of TV Packet Regulation of Medical Devices
May 1, 1996
OHIP/DSMA
Do Background Information for Foreign Officials MDR Documents Access Information
May 10, 1996
OHIP/DSMA
Do MDR Documents Access Information for February 29, 1996 OHIP/DSMA
Do CDRH Electronic Docket (ED) MDR Documents Access Information for February 29, 1996 OHIP/DSMA
Do CDRH Facts-On-Demand (FOD) MDR Documents Access Information for May 8, 1996
OHIP/DSMA
Do Industry Organizations MDR Documents Access Information for May 10, 1996
OHIP/DSMA
Do National Technical Information Service (NTIS) MDR Documents Access Information for February 29, 1996 OHIP/DSMA
Do World Wide Web (WWW) Medical Device Quality Systems Manual: December 1, 1996 OHIP/DSMA
Do A Small Entity Compliance Guide Overview of FDA Modernization Act of February 19, 1998 OHIP/DSMA
Do 1997, Medical Device Provisions Medical Device Appeals and Complaints-- February 1, 1998 OHIP/DSMA/Office of Do Guidance on Dispute Resolutions
the Center Director (OCD) Medical Device Reporting for User April 1996
OHIP/Division of Do Facilities
Device User Programs and Systems Analysis (DUPSA) Human Factors Points to Consider for January 17, 1997 OHIP/DUPSA
Do IDE Devices Human Factors Principles for Medical September 1, 1993 OHIP/DUPSA
Do Device Labeling Write it Right
August 1, 1993 OHIP/DUPSA
Do Do It By Design--An Introduction to December 1, 1996 OHIP/DUPSA
Do Human Factors in Medical Devices FDA Modernization Act of 1997:
February 6, 1998 OHIP/Regs
Do Guidance for the Device Industry on Implementation of Highest Priority Provisions: Availability Statistical Aspects of Submissions to June 1, 1984
OSB/Division of
Do FDA: A Medical Device Perspective
Biostatistics (DB) (also includes as Appendix the Article Observed Uses and Abuses of Statistical Procedures in Medical Device Submissions Statistical Guidance for Clinical January 1, 1996 OSB/DB
Do Trials of Non Diagnostic Medical Devices (Replaces Clincal Study Guidance, formerly 891) Amendment to Guidance on Discretionary March 30, 1994 OSB/Division of
Do Postmarket Surveillance on Pacemaker
Postmarket Leads
Surveillance (DPS) Guidance on Procedures to Determine February 19, 1998 OSB/DPS
Do Application of Postmarket Surveillance Strategies Guidance on Procedures for Review of February 19, 1998 OSB/DPS
Do Postmarket Surveillance Submissions SMDA to FDAMA: Guidance on FDA's
February 19, 1998 OSB/DPS
Do Transition Plan for Existing Postmarket Surveillance
[[Page 31259]]
Proposed Draft Guidance to Sponsors October 7, 1994 OSB/DPS
Do Regarding Required Postmarket Surveillance Studies of Plasma- Sprayed Porous-Coated Hip Prostheses Guidance to Sponsors on the
June 9, 1993
OSB/DPS
Do Development of a Discretionary Postmarket Surveillance Study for Permanent Implantable Cardiac Pacemaker Electrodes (Leads) Medical Device Reporting for
April 1996
OSB/Division of
Do Distributors
Surveillance Systems (DSS) Medical Device Reporting: An Overview April 1996
OSB/DSS
Do MDR Internet List Server (listserv) August 29, 1996 OSB/DSS
Do Instruction Sheet MEDWATCH FDA Form 3500A For Use By June 1, 1993
OSB/DSS
Do User Facilities, Distributors and Manufacturers for Mandatory Reporting Instructions for Completing FDA Form December 15, 1995 OSB/DSS
Do 3500A with Coding Manual for Form 3500A (MEDWATCH) MDR Policy/Guidance for Endosseus December 1992 OSB/DSS
Do Implant Devices MDR Guidance--Blood Loss Policy
December 1995 OSB/DSS
Do Summary Reporting Approval for Adverse July 31, 1997 OSB/DSS
Do Events Common Problems: Baseline Reports and
OSB/DSS
Do MedWatch Form 3500A (letter to manufacturer--undated) MDR Guidance Document: Remedial Action July 30, 1996 OSB/DSS
Do Exemption--E1996001 Variance from Manufacturer Report July 16, 1996 OSB/DSS
Do Number Format [MDR letter] Instructions for Completing Form 3417: March 31, 1997 OSB/DSS
Do Medical Device Reporting Baseline Report [MDR] MDR Guidance Document No. 1--IOL-- August 7, 1996 OSB/DSS
Do E1996004 MDR Guidance Document No. 3--
August 9, 1996 OSB/DSS
Do Needlestick & Blood Exposure-- E1996003 MDR Reporting Guidance For Breast August 7, 1996 OSB/DSS
Do Implants--E1996002 Instructions for Completing Semi- September 24, 1996 OSB/DSS
Do Annual Report, Form 3419 (MDR) Guidance on FDA's Expectations of May 15, 1998
Office of Standards Do Medical Device Manufacturers
and Technology (OST)/ Concerning the Year 2000 Date
Division of Electronics and Computer Science (DECS) Draft Document--A Primer on Medical February 7, 1997 OST/Division of
Do Device Interactions with Magnetic
Postmarket Resonance Imaging Systems
Surveillance (DPS) Frequently Asked Questions on
February 19, 1998 OST/OD
Do Recognition of Consensus Standards Guidance on the Recognition and Use of February 19, 1998 OST/OD
Do Consensus Standards
-
Guidance Documents Issued by the Center for Drug Evaluation and Research (CDER)
How to Obtain a Hard Copy of Grouped by Intended the Document (Name and Name of Document
Date of Issuance User or Regulatory Address, Phone, FAX, E-mail, Activity
or Internet)
Aerosol Steroid Product Safety
January 12, 1998 Advertising
Drug Information Branch (HFD- Information in Prescription Drug
210), CDER, Food and Drug Advertising and Promotional Labeling
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573, or via Internet at http:// www.fda.gov/cder/guidance/ index.htm Dissemination of Reprints of Certain October 8, 1996 Do
Do Published, Original Data Funded Dissemination of Reference October 8, 1996 Do
Do Texts
[[Page 31260]]
Consumer-Directed Broadcast
August 12, 1997 Advertising draft Do Advertisements Promoting Medical Products in a
January 5, 1998 Do
Do Changing Healthcare Environment; Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs) Alprazolam Tablets In Vivo
November 27, 1992 Biopharmaceutic
Do Bioequivalence and In Vitro Dissolution Testing Bioavailability Policies and
Do
Do Guidelines Bumetanide Tablets In Vivo
April 23, 1993 Do
Do Bioequivalence and In Vitro Dissolution Testing Buspirone Hydrochloride Tablets In May 15, 1998
Do
Do Vivo Bioequivalence and In Vitro Dissolution Testing Captopril Tablets In Vivo
May 13, 1993
Do
Do Bioequivalence and In Vitro Dissolution Testing Carbidopa and Levodopa Tablets In Vivo June 19, 1992 Do
Do Bioequivalence and In Vitro Dissolution Testing Cefactor Capsules and Suspension In April 23, 1993 Do
Do Vivo Bioequivalence and In Vitro Dissolution Testing Cholestyramine Powder In Vitro
July 15, 1993 Do
Do Bioequivalence Cimetidine Tablets In Vivo
June 12, 1992 Do
Do Bioequivalence and In Vitro Dissolution Testing Clozapine (Tablets) In Vivo
November 15, 1996 Do
Do Bioequivalence and In Vitro Dissolution Testing Corticosteroids, Dermatologic
June 2, 1995
Do
Do (topical) In Vivo Diclofenac Sodium (tablets) In Vivo October 6, 1994 Do
Do Bioequivalence and In Vitro Dissolution Testing Diflunisal Tablets In Vivo
May 16, 1992
Do
Do Bioequivalence and In Vitro Dissolution Testing Diltiazen Hydrochloride Tablets In May 16, 1992
Do
Do Vivo Bioequivalence and In Vitro Dissolution Testing Dissolution Testing of Immediate
August 25, 1997 Do
Do Release Solid Oral Dosage Forms Extended Release Oral Dosage Forms: September 26, 1997 Do
Do Development, Evaluation, and Application of In Vitro/In Vivo Correlations Flurbiprofen (tablets) In Vivo
June 8, 1995
Do
Do Bioequivalence and In Vitro Dissolution Testing Gemfibrozil Capsules or Tablets In June 15, 1992 Do
Do Vivo Bioequivalence and In Vitro Dissolution Testing Glipizide (Tablets) In Vivo
April 23, 1993 Do
Do Bioequivalence and In Vitro Dissolution Testing Guanabenz Acetate Tablets In Vivo April 23, 1993 Do
Do Bioequivalence and In Vitro Dissolution Testing Hydroxchloroquine Sulfate (tablets) In December 28, 1995 Do
Do Vivo Bioequivalence and In Vitro Dissolution Testing Indapamide (tablets) In Vivo
April 23, 1993 Do
Do Bioequivalence and In Vitro Dissolution Testing Ketoprofen (capsules) In Vivo
April 23, 1993 Do
Do Bioequivalence and In Vitro Dissolution Testing Leucovorin Calcium (tablets) In Vivo August 4, 1988 Do
Do Bioequivalence and In Vitro Dissolution Testing Medroxyprogesterone Acetate (tablets) September 17, 1987 Do
Do In Vivo Bioequivalence and In Vitro Dissolution Testing Metaproferenol Sulfate and Albuterol June 27, 1989 Do
Do Metered Dose Inhalers In Vitro Metoprolol Tartrate (tablets) In Vivo June 12, 1992 Do
Do Bioequivalence and In Vitro Dissolution Testing Nadolol (tablets) In Vivo
May 16, 1992
Do
Do Bioequivalence and In Vitro Dissolution Testing Naproxen (tablets) In Vivo
June 8, 1995
Do
Do Bioequivalence and In Vitro Dissolution Testing Nortriptyline Hydrochloride (capsules) June 12, 1992 Do
Do In Vivo Bioequivalence and In Vitro Dissolution Testing Oral Extended (controlled) Release In September 9, 1993 Do
Do Vivo Bioequivalence and In Vitro Dissolution Testing Pentoxifyline (extended-release
December 22, 1995 Do
Do tablets) In Vivo Bioequivalence and In Vitro Dissolution Testing Phenytoin/Phenytoin Sodium (capsules, March 4, 1994 Do
Do tablets, suspension) In Vivo Bioequivalence and In Vitro Dissolution Testing
[[Page 31261]]
Pindolol (tablets) In Vivo
April 23, 1993 Do
Do Bioequivalence and In Vitro Dissolution Testing Piroxicam (capsules) In Vivo
June 15, 1992 Do
Do Bioequivalence and In Vitro Dissolution Testing Potassium Chloride (slow-release
June 6, 1994
Do
Do tablets and capsules) In Vivo Bioequivalence and In Vitro Dissolution Testing Rantidine Hydrochloride (tablets) In April 23, 1993 Do
Do Vivo Bioequivalence and In Vitro Dissolution Testing Selegiline Hydrochloride (tablets) In December 22, 1995 Do
Do Vivo Bioequivalence and In Vitro Dissolution Testing Statistical Procedure for
July 1, 1992
Do
Do Bioequivalence Studies Using a Standard Two-Treatment Crossover Design Trazodone Hydrochloride (tablets) In April 30, 1988 Do
Do Vivo Bioequivalence and In Vitro Dissolution Testing Antifungal (topical)
February 24, 1990 Biopharmaceutic draft Do Antifungal (vaginal)
February 24, 1990 Do
Do Bioanalytical Methods Validations for January 5, 1999 Do
Do Human Studies Food-Effect Bioavailability and
December 30, 1997 Do
Do Bioequivalence Studies In Vivo Bioequivalence Studies Based December 30, 1997 Do
Do on Population and Individual Bioequivalence Approaches Topical Dermatological Drug Product June 18, 1998 Do
Do NDAs and ANDAs--In Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated Studies Waiver Policy
March 29, 1993 Do
Do Glyburide Tablets In Vivo
April 23, 1993 Biopharmaceutic
Do Bioequivalence and In Vitro
testing Dissolution Testing Drug Master Files
September 1, 1989 Chemistry
Do Environmental Assessment of Human July 27, 1998 Do
Do Drugs and Biologics Applications FDA's Policy Statement for the
May 1, 1992
Do
Do Development of New Stereoisomeric Drugs Format and Content for the CMC Section September 1, 1994 Do
Do of an Annual Report Format and Content of the Chemistry, February 1, 1987 Do
Do Manufacturing and Controls Section of an Application Format and Content of the Microbiology February 1, 1987 Do
Do Section of an Application PAC-ALTS: Postapproval Changes--
April 28, 1998 Do
Do Analytical Testing Laboratory Sites Reviewer Guidance: Validation of
November 1, 1994 Do
Do Chromatographic Methods Submission of Chemistry, Manufacturing November 1, 1994 Do
Do and Controls Information for Synthetic Peptide Substances Submission of Documentation for
November 1, 1994 Do
Do Sterilization Process Validation Applications for Human and Veterinary Drug Products Submitting Documentation for Packaging February 1, 1987 Do
Do for Human Drugs and Biologics Submitting Documentation for the
February 1, 1987 Do
Do Manufacturing of and Controls for Drug Products Submitting Documentation for the
February 1, 1987 Do
Do Stability of Human Drugs and Biologics Submitting Supporting Documentation in February 1, 1987 Do
Do Testing Drug Applications for the Manufacture of Drug Substances Submitting Samples and Analytical Data February 1, 1987 Do
Do for Methods Validation SUPAC-IR--Immediate-Release Solid Oral November 30, 1995 Do
Do Dosage Forms: Scale-Up and Post- Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation SUPAC-IR: Immediate Release Solid Oral October 21, 1997 Do
Do Dosage Forms; Manufacturing Equipment Addendum SUPAC-IR Questions and Answers
February 18, 1997 Do
Do
[[Page 31262]]
SUPAC-MR: Modified Release Solid Oral October 6, 1997 Do
Do Dosage Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation SUPAC-SS--Nonsterile Semisolid Dosage June 13, 1997 Do
Do Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation BACPAC I: Intermediates in Drug
November 30, 1998 Chemistry draft
Do Substance Synthesis (Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation) Content and Format of Investigational December 10, 1997 Do
Do New Drug Applications (INDs) for Phases 2 and 3 Studies of Drugs, Including Specific Therapeutic Biotechnology-Derived Products-- Preliminary Draft Metered Dose Inhalers (MDI) and Dry November 19, 1998 Do
Do Powder Inhalers (DPI) Drug Products; Chemistry, Manufacturing, and Controls Documentation NDAs: Impurities in Drug Substances January 21, 1999 Do
Do Stability Testing of Drug Substances June 8, 1998
Do
Do and Drug Products Submission of Documentation in Drug July 15, 1997 Do
Do Applications for Container Closure Systems Used for the Packaging of Human Drugs and Biologics Submitting Supporting Chemistry
November 1, 1991 Do
Do Documentation in Radiopharmaceutical Drug Applications SUPAC-IR/MR: Immediate Release and April 28, 1998 Do
Do Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum SUPAC-SS: Nonsterile Semisolid Dosage January 5, 1999 Do
Do Forms Tracking of NDA and ANDA
Do
Do Reformulations for Solid, Oral, Immediate Release Drug Products Acute Bacterial Exacerbation of
July 22, 1998 Clinical
Do Chronic Bronchitis; Developing
antimicrobial draft Antimicrobial Drugs for 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 or Chronic Bacterial
July 22, 1998 Do
Do Prostatitis; Developing Antimicrobial Drugs for Treatment Acute Otitis Media; Developing
July 22, 1998 Do
Do Antimicrobial Drugs for Treatment Bacterial Vaginosis; Developing
July 22, 1998 Do
Do Antimicrobial Drugs for Treatment Community Acquired Pneumonia;
July 22, 1998 Do
Do Developing Antimicrobial Drugs for Treatment Complicated Urinary Tract Infections July 22, 1998 Do
Do and Pylonephritis; Developing Antimicrobial Drugs for Treatment Empiric Therapy of Febrile
July 22, 1998 Do
Do Neutropenia; Developing Antimicrobial Drugs for Treatment General Considerations for Clinical July 22, 1998 Do
Do Trials; Developing Antimicrobial Drugs for Treatment Lyme Disease; Developing Antimicrobial July 22, 1998 Do
Do Drugs for Treatment Nosocomial Pneumonia; Developing
July 22, 1998 Do
Do Antimicrobial Drugs for Treatment Secondary Bacterial Infections of July 22, 1998 Do
Do Acute Bronchitis; Developing Antimicrobial Drugs for Treatment Streptococcal Pharyngitis and
July 22, 1998 Do
Do Tonsillitis; Developing Antimicrobial Drugs for Treatment Uncomplicated Gonorrhea--Cervical, July 22, 1998 Do
Do Urethral, Rectal, and/or Pharyngeal; Developing Antimicrobial Drugs for Treatment Uncomplicated Urinary Tract
July 22, 1998 Do
Do Infections; Developing Antimicrobial Drugs for Treatment
[[Page 31263]]
Uncomplicated and Complicated Skin and July 22, 1998 Do
Do Skin Structure Infections; Developing Antimicrobial Drugs for Treatment Vuvlovaginal Candidiasis; Developing July 22, 1998 Do
Do Antimicrobial Drugs for Treatment Clinical Evaluation of Antidepressant September 1, 1977 Clinical medical Do Drugs Clinical Evaluation of Antidiarrheal September 1, 1977 Do
Do Drugs Clinical Evaluation of Antiepileptic January 1, 1981 Do
Do Drugs (adults and children) Clinical Evaluation of Combination March 20, 1995 Do
Do Estrogen/Progestin-Containing Drug Products Used for Hormone Replacement Therapy of Postmenopausal Women Clinical Evaluation of
October 1, 1981 Do
Do Radiopharmaceutical Drugs Clinical Evaluation of Analgesic Drugs December 1, 1992 Do
Do Clinical Evaluation of Antacid Drugs April 1, 1978 Do
Do Clinical Evaluation of Anti-
April 1, 1988 Do
Do Inflammatory and Antirheumatic Drugs (adults and children) Clinical Evaluation of Anti-Anxiety September 1, 1977 Do
Do Drugs Clinical Evaluation of Anti-Infective September 1, 1977 Do
Do Drugs (Systemic) Clinical Evaluation of Drugs to
November 1, 1978 Do
Do Prevent, Control and/or Treat Periodontal Disease Clinical Evaluation of Gastric
September 1, 1977 Do
Do Secretory Depressant (GSD) Drugs Clinical Evaluation of General
May 1, 1982
Do
Do Anesthetics Clinical Evaluation of Hypnotic Drugs September 1, 1977 Do
Do Clinical Evaluation of Laxative Drugs April 1, 1978 Do
Do Clinical Evaluation of Local
May 1, 1982
Do
Do Anesthetics Clinical Evaluation of Psychoactive July 1, 1979
Do
Do Drugs in Infants and Children Content and Format for Pediatric Use May 24, 1996
Do
Do Supplements Content and Format of Investigational November 20, 1995 Do
Do New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products Development of Vaginal Contraceptive April 19, 1995 Do
Do Drugs (NDA) FDA Approval of New Cancer Treatment February 2, 1999 Do
Do Uses for Marketed Drug and Biological Products FDA Requirements for Approval of Drugs June 20, 1989 Do
Do to Treat Superficial Bladder Cancer FDA Requirements for Approval of Drugs January 29, 1991 Do
Do to Treat Non-Small Cell Lung Cancer Format and Content of the Clinical and July 1, 1988
Do
Do Statistical Sections of an Application Format and Content of the Summary for February 1, 1987 Do
Do New Drug and Antibiotic Applications Formatting, Assembling and Submitting February 1, 1987 Do
Do New Drug and Antibiotic Applications General Considerations for the
September 1, 1977 Do
Do Clinical Evaluation of Drugs in Infants and Children General Considerations for the
December 1, 1978 Do
Do Clinical Evaluation of Drugs Oncologic Drugs Advisory Committee April 13, 1988 Do
Do Discussion on FDA Requirements for Approval of New Drugs for Treatment of Ovarian Cancer Oncologic Drugs Advisory Committee April 19, 1988 Do
Do Discussion on FDA Requirements for Approval of New Drugs for Treatment of Colon and Rectal Cancer OTC Treatment of Hypercholesterolemia October 27, 1997 Do
Do Points to Consider: Clinical
September 19, 1994 Do
Do Development Programs for MDI and DPI Drug Products Points to Consider in the Clinical October 26, 1992 Do
Do Development and Labeling of Anti- Infective Drug Products Points to Consider in the Preclinical May 1, 1993
Do
Do Development of Immunomodulatory Drugs for the Treatment of HIV Infection and Associated Disorders Points to Consider in the Preclinical November 1, 1990 Do
Do Development of Antiviral Drugs
[[Page 31264]]
Postmarketing Adverse Experience
August 27, 1997 Do
Do Reporting for Human Drugs and Licensed Biological Products; Clarification of What to Report Postmarketing Reporting of Adverse March 1, 1992 Do
Do Drug Experiences Preparation of Investigational New November 1, 1992 Do
Do Drug Products (Human and Animal) Providing Clinical Evidence of
May 15, 1998
Do
Do Effectiveness for Human Drug and Biological Products Study and Evaluation of Gender
July 22, 1993 Do
Do Differences in the Clinical Evaluation of Drugs Study of Drugs Likely to be Used in November 1, 1989 Do
Do the Elderly Abuse Liability Assessment
July 1, 1990
Clinical medical Do draft Clinical Development Programs for February 18, 1998 Do
Do Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA) Clinical Development Programs for March 18, 1998 Do
Do Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) Clinical Evaluation of
May 1, 1988
Do
Do Antihypertensive Drugs Clinical Evaluation of Anti-Anginal January 1, 1989 Do
Do Drugs Clinical Evaluation of Anti-Arrhythmic July 1, 1985
Do
Do Drugs Clinical Evaluation of Drugs for the December 1, 1987 Do
Do Treatment of Congestive Heart Failure Clinical Evaluation of Drugs for
Do
Do Ulcerative Colitis (3rd draft) Clinical Evaluation of Lipid-Altering September 1, 1990 Do
Do Agents in Adults and Children Clinical Evaluation of Motility-
Do
Do Modifying Drugs Clinical Evaluation of Weight-Control October 1, 1997 Do
Do Drugs Conducting a Clinical Safety Review of November 22, 1996 Do
Do a New Product Application and Preparing a Report on the Review Developing Medical Imaging Drugs and October 13, 1998 Do
Do Biologics Development and Evaluation of Drugs February 12, 1992 Do
Do for the Treatment of Psychoactive Substance Use Disorders Evaluating Clinical Studies of
February 18, 1997 Do
Do Antimicrobials in the Division of Anti-Infective Drug Products Points to Consider for System
Do
Do Inflammatory Response Syndrome (SIRS) 1st Draft Points to Consider in the Preparation September 1, 1991 Do
Do of IND Applications for New Drugs Intended for the Treatment of HIV- Infected Individuals Preclinical and Clinical Evaluation of April 1, 1994 Do
Do Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis Submission of Abbreviated Reports and September 21, 1998 Do
Do Synopses in Support of Marketing Applications Drug Metabolism/Drug Interaction
April 7, 1997 Clinical pharmacology Do Studies in the Drug Development Process: Studies In Vitro Format and Content of the Human
February 1, 1987 Do
Do Pharmacokinetics and Bioavailability Section of an Application Pharmacokinetics and Pharmacodynamics May 15, 1998
Do
Do in Patients with Impaired Renal Function: Study Design, Data Analysis, and Impact on Dosing and Labeling Population Pharmacokinetics
February 10, 1999 Do
Do General Considerations for Pediatric November 30, 1998 Clinical pharmacology o Pharmacokinetic Studies for Drugs and
draft Biological Products In Vivo Metabolism/Drug Interaction November 19, 1998 Do
Do Studies--Study Design, Data Analysis, and Recommendations for Dosing and Labeling A Review of FDA's Implementation of
Compliance
Do the Drug Export Amendments of 1986 Compressed Medical Gases
December 1, 1989 Do
Do Expiration Dating and Stability
June 27, 1997 Do
Do Testing of Solid Oral Dosage Form Drugs Containing Iron General Principles of Process
May 1, 1987
Do
Do Validation
[[Page 31265]]
Good Laboratory Practice Regulations
Do
Do Questions and Answers Monitoring of Clinical Investigations January 1, 1988 Do
Do Nuclear Pharmacy Guideline Criteria May 1, 1984
Do
Do for Determining When to Register as a Drug Establishment Sterile Drug Products Produced by May 1, 1987
Do
Do Aseptic Processing Validation of Limulus Amebocyte Lysate December 1, 1987 Do
Do Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices Computerized Systems Used in Clinical June 18, 1997 Compliance draft Do Trials Investigating Out of Specification September 30, 1998 Do
Do (OOS) Test Results for Pharmaceutical Production Manufacture, Processing or Holding of April 17, 1998 Do
Do Active Pharmaceutical Ingredients Repackaging of Solid Oral Dosage Form February 1, 1992 Do
Do Drug Products ANDAs: Impurities in Drug Products January 5, 1999 Generic drug draft Do ANDAs: Impurities in Drug Substances July 24, 1998 Do
Do Content and Format of an Abbreviated April 18, 1997 Do
Do New Drug Application (ANDA)--Positron Emission Tomography (PET) Drug Products--With Specific Information for ANDAs for Fludeoxyglucose F18 Injection Letter announcing that the OGD will August 18, 1995 Generic drug
Do now accept the ICH long-term storage conditions as well as the stability studies conducted in the past Letter describing efforts of CDER & October 14, 1994 Do
Do ORA to clarify the responsibilities of CDER chemistry review scientists and ORA field investigators in the new and abbreviated drug approval process in order to reduce duplication or redundancy in the process Letter on incomplete Abbreviated
April 8, 1994 Do
Do Applications, 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 request for cooperation November 8, 1991 Do
Do of regulated industry to improve the efficiency and effectiveness of the generic drug review process, by assuring the completeness and accuracy of required information and data submissions Letter on the provision of new
July 1, 1992
Do
Do information pertaining to new bioequivalence guidelines and refuse- to-file letters Letter on the provision of new
March 15, 1989 Do
Do procedures and policies affecting the generic drug review process Letter on the response to 12/20/84 March 26, 1985 Do
Do letter from the Pharmaceutical Manufacturers Association about the Drug Price Competition and Patent Term Restoration Act Letter to all ANDA and AADA applicants January 15, 1993 Do
Do about the Generic Drug Enforcement Act of 1992 (GDEA), and the Office of Generic Drugs intention to refuse-to- file incomplete submissions as required by the new law Letter to regulated industry notifying August 4, 1993 Do
Do interested parties about important detailed information regarding labeling scale-up, packaging, minor/ major amendment criteria, and bioequivalence requirements Organization of an Abbreviated New April 7, 1997 Do
Do Drug Application and an Abbreviated Antibiotic Application Variations in Drug Products that May January 27, 1999 Do
Do Be Included in a Single ANDA E5 Ethnic Factors in the Acceptability June 10, 1998 ICH draft guidances Do of Foreign Clinical Data
efficacy
[[Page 31266]]
Q6A Specifications: Test Procedures November 25, 1997 ICH draft guidances-- Do and Acceptance Criteria for New Drug
quality Substances and New Drug Products: Chemical Substances Q6B Specifications: Test Procedures June 9, 1998
Do
Do and Acceptance Criteria for Biotechnological/Biological Products S4A Duration of Chronic Toxicity
November 18, 1997 ICH draft guidances Do Testing in Animals (Rodent and
safety Nonrodent Toxicity Testing) E1A The Extent of Population Exposure March 1, 1995 ICH guidances--
Do to Assess Clinical Safety: for Drugs
efficacy Intended for Long-Term Treatment of Non-Life-Threatening Conditions E2A Clinical Safety Data Management: March 1, 1995 Do
Do Definitions and Standards for Expedited Reporting E2B Data Elements for Transmission of January 15, 1998 Do
Do Individual Case Reports E2C Clinical Safety Data Management: May 19, 1997
Do
Do Periodic Safety Update Reports for Marketed Drugs E4 Dose-Response Information to
November 9, 1994 Do
Do Support Drug Registration E6 Good Clinical Practice:
May 9, 1997
Do
Do Consolidated Guideline E7 Studies in Support of Special
August 2, 1994 Do
Do Populations: Geriatrics E8 General Considerations for Clinical December 24, 1997 Do
Do Trials E9 Statistical Principles for Clinical September 16, 1998 Do
Do Trials M3 Nonclinical Safety Studies for the November 25, 1997 ICH guidances--joint Do Conduct of Human Clinical Trials for
safety/efficacy Pharmaceuticals
(multidisciplinary) Q1A Stability Testing of New Drug September 22, 1994 ICH guidances--
Do Substances and Products
quality Q1B Photostability Testing of New Drug May 16, 1997
Do
Do Substances and Products Q1C Stability Testing for New Dosage May 9, 1997
Do
Do Forms Q2A Text on Validation of Analytical March 1, 1995 Do
Do Procedures Q2B Validation of Analytical
May 19, 1997
Do
Do Procedures: 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 Biotechnological/Biological
September 24, 1998 Do
Do Pharmaceutical Products, Viral Safety Evaluation Q5B Quality of Biotechnology Products: February 23, 1996 Do
Do Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products Q5C Quality of Biotechnological
July 10, 1996 Do
Do Products: Stability Testing of Biotechnology/Biological Products Q5D Quality of Biotechnological/
September 21, 1998 Do
Do Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products S1A The Need for Long-Term Rodent March 1, 1996 ICH guidances--safety Do Carcinogenicity Studies of Pharmaceuticals S1B Testing for Carcinogenicity in February 23, 1998 Do
Do Pharmaceuticals S1C Dose Selection for Carcinogenicity March 1, 1995 Do
Do Studies of Pharmaceuticals S1C(R) Dose Selection for
December 4, 1997 Do
Do Carcinogenicity Studies of Pharmaceuticals: Addendum on a Limit Dose and Related Notes S2A Specific Aspects of Regulatory April 24, 1996 Do
Do Genotoxicity Tests for Pharmaceuticals S2B Genotoxicity: Standard Battery November 21, 1997 Do
Do Testing S3A Toxicokinetics: The Assessment of March 1, 1995 Do
Do Systemic Exposure in Toxicity Studies S3B Pharmacokinetics: Guidance for March 1, 1995 Do
Do Repeated Dose Tissue Distribution Studies S5A Detection of Toxicity to
September 22, 1994 Do
Do Reproduction for Medicinal Products S5B Detection of Toxicity to
April 5, 1996 Do
Do Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility
[[Page 31267]]
S6 Preclinical Safety Evaluation of November 18, 1997 Do
Do Biotechnology-Derived Pharmaceuticals E3 Structure and Content of Clinical July 17, 1996 IHC guidances--
Do Study Reports
efficacy A Revision in Sample Collection Under July 15, 1996 Industry letters Do the Compliance Program Pertaining to Pre-Approval Inspections Certification Requirements for
July 27, 1992 Do
Do Debarred Individuals in Drug Applications Continuation of a series of letters June 1, 1990
Do
Do communicating 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 April 10, 1987 Do
Do informal notice about the Act, discussing the statutory mechanisms by which ANDA applicants may make modifications in approved drugs where clinical data is required Fourth of a series of letters
October 31, 1986 Do
Do providing informal notice to all affected parties about policy developments and interpretations regarding the Act. Three year exclusivity provisions of Title I Implementation of the Drug Price
October 11, 1984 Do
Do Competition and Patent Term Restoration Act. Preliminary Guidance Implementation Plan USP injection October 2, 1995 Do
Do nomenclature Instructions for Filing Supplements April 11, 1996 Do
Do Under the Provisions of SUPAC-IR Seventh of a series of letters about July 29, 1988 Do
Do the act providing guidance on the ``180-day exclusivity'' provision of section 505(j)(4)(B)(iv) of the FD&C Act Sixth of a series of informal notice April 28, 1988 Do
Do letters about the Act discussing the 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 November 16, 1984 Do
Do policies, procedures and implementation of the Act (Q & A format) Third of a series of letters regarding May 1, 1985
Do
Do the implementation of the Act Regulatory Submissions in Electronic January 28, 1999 Information
Do Format; General Considerations
technology Regulatory Submissions in Electronic January 28, 1999 Do
Do Format; New Drug Applications Acetaminophen, Aspirin and Codeine December 1, 1993 Labeling
Do Phosphate Tablets/Capsules Acetaminophen and Codeine Phosphate December 1, 1993 Do
Do Oral Solution/Suspension Acetaminophen and Codeine Phosphate December 1, 1993 Do
Do Tablets/Capsules Alprazolam Tablets USP
August 1, 1996 Do
Do Amiloride Hydrochloride and
September 1, 1997 Do
Do Hydrochlorothiazide 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 Barbituate, Single Entity-Class
March 1, 1981 Do
Do Labeling Butalbital, Acetaminophen, Caffeine September 21, 1997 Do
Do and Hydocodone Bitartrate Tablets Butalbital, Acetaminophen and Caffeine September 1, 1997 Do
Do Capsules/Tablets USP Butorphanol Tartrate Injection USP October 1, 1992 Do
Do Captopril and Hydrochlorothiazide April 1, 1995 Do
Do Tablets USP Captopril Tablets
February 1, 1995 Do
Do Carbidopa and Levodopa Tablets USP February 1, 1992 Do
Do Chlordiazepoxide Hydrochloride
January 1, 1988 Do
Do Capsules Cimetidine Hydrochloride Injection September 1, 1995 Do
Do Cimetidine Tablets
September 1, 1995 Do
Do Cisapride Oral Suspension
September 1, 1997 Do
Do
[[Page 31268]]
Cisapride Tablets
September 1, 1997 Do
Do Clindamycin Phosphate Injection USP September 1, 1998 Do
Do Clorazepate Dipotassium Capsules/ March 1, 1993 Do
Do Tablets Combination Oral Contraceptives-- January 1, 1994 Do
Do Physician and Patient Labeling Cyproheptadine Hydrochloride Tablets/ December 1, 1986 Do
Do Syrup Diclofenac Sodium Delayed-Release January 1, 1997 Do
Do Tablets Diltiazem Hydrochloride Extended- September 1, 1995 Do
Do Release Capsules Diphenoxylate Hydrochloride and
April 1, 1995 Do
Do Atropine Sulphate Tablets USP Diphenoxylate Hydrochloride and
April 1, 1995 Do
Do Atropine Sulfate Oral Solution USP Dipivefrin Hydrochloride Ophthalmic October 1, 1998 Do
Do Solution USP Dipivefrin Hydrochloride Ophthalmic November 2, 1998 Do
Do Solution, 0.1% 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 April 1, 1992 Do
Do and Solution USP Heparin Sodium Injection USP
March 1, 1991 Do
Do Hydrocodone Bitartrate and
April 1, 1994 Do
Do Acetaminophen Tablets USP Hydroxyzine Hydrochloride Injection December 1, 1989 Do
Do Hypoglycemic Oral Agents--Federal April 1, 1984 Do
Do Register Indomethacin Capsules USP
September 1, 1995 Do
Do Informal Labeling Guidance Texts for August 1, 1992 Do
Do Estrogen Drug Products--Patient Labeling Informal Labeling Guidance Texts for August 1, 1992 Do
Do Estrogen Drug 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 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, September 1, 1998 Do
Do USP Metaproterenol Sulfate Inhalation May 1, 1992
Do
Do Solution USP Metaproterenol Sulfate Syrup, USP May 1, 1992
Do
Do Metaproterenol Sulfate Tablets
May 1, 1992
Do
Do Metoclopramide Tablets/ Oral Solution, February 1, 1995 Do
Do USP Naphazoline Hydrochloride Ophthalmic March 1, 1989 Do
Do Solution 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
September 1, 1997 Do
Do Phendimetrazine Tartrate Capsules/ February 1, 1991 Do
Do Tablets, and Extended-Release Capsules Phentermine Hydrochloride Capsules/ August 1, 1988 Do
Do Tablets 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
November 1, 1993 Do
Do Risperidone Oral Solution
September 1, 1997 Do
Do Risperidone Tablets
September 1, 1997 Do
Do Sulfacetamide Sodium Ophthalmic
August 1, 1992 Do
Do Solution/Ointment Sulfacetamide Sodium and Prednisolone January 1, 1995 Do
Do Acetate Ophthalmic Suspension and Ointment Sulfamethoxazole and Phenazopyridine February 1, 1992 Do
Do Hydrochloride Tablets Sulfamethoxazole and Trimethoprim August 1, 1993 Do
Do Tablets and Oral Suspension Theophylline Immediate-Release Dosage February 1, 1995 Do
Do Forms 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
[[Page 31269]]
Verapamil Hydrochloride Tablets
October 1, 1991 Do
Do Vitamin A Capsules
February 1, 1992 Do
Do Zolpidem Tartrate Tablets
September 1, 1997 Do
Do Content and Format for Geriatric
January 21, 1999 Labeling draft
Do Labeling Non-Contraceptive Estrogen Class
October 15, 1998 Do
Do Labeling Non-Contraceptive Estrogen Drug
January 8, 1999 Do
Do Products--Physician and Patient Labeling OTC Topical Drug Products for the July 16, 1998 Do
Do Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis) Therapeutic Equivalence Code Placement January 28, 1999 Do
Do on Prescription Drug Labels and Labeling Enforcement Policy on Marketing OTC
OTC
Do Combination Products General Guidelines for OTC Combination
Do
Do Products Upgrading Category III Antiperspirants
Do
Do to Category I OTC Nicotine Substitutes
March 1, 1994 OTC draft
Do Points to Consider for OTC Actual Use July 22, 1994 Do
Do Studies Format and Content of the Nonclinical February 1, 1987 Pharmacology/
Do Pharmacology/Toxicology Section of an
toxicology Application Points to Consider in the Nonclinical
Do
Do Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal Contraceptives Reference Guide for the Nonclinical February 1, 1989 Do
Do Toxicity Studies of Antiviral Drugs Indicated for the Treatment of Non- Life Threatening Disease: Evaluation of Drug Toxicity Prior to Phase I Clinical Studies Single Dose Acute Toxicity Testing for August 26, 1996 Do
Do Pharmaceuticals 180-Day Generic Drug Exclusivity Under July 14, 1998 Procedural
Do the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act Advisory Committees: Implementing November 2, 1998 Do
Do Section 120 of the Food and Drug Modernization Act of 1997 Enforcement Policy During
November 23, 1998 Do
Do Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act Fast Track Drug Development Programs: November 18, 1998 Do
Do Designation, Development, and Application Review Implementation of Section 126,
July 21, 1998 Do
Do Elimination of Certain Labeling Requirements, of the FDA Modernization Act of 1997 National Uniformity for
April 9, 1998 Do
Do Nonprescription Drugs Ingredient Labeling for OTC Drugs Qualifying for Pediatric Exclusivity June 29, 1998 Do
Do Under Section 505A of the Federal Food, Drug, and Cosmetic Act Repeal of Section 507 of the Federal June 15, 1998 Do
Do Food, Drug, and Cosmetic Act Standards for the Prompt Review of May 15, 1998
Do
Do Efficacy Supplements, Including Priority Efficacy Supplements Submitting Debarment Certification October 2, 1998 Procedural draft Do Statements Classifying Resubmissions in Response May 14, 1998
User fee
Do to Action Letters Submitting and Reviewing Complete May 14, 1998
Do
Do Responses to Clinical Holds
-
Guidance Documents Issued by the Center for Food Safety and Applied Nutrition (CFSAN)
[[Page 31270]]
How to Obtain a Hard Copy of Grouped by Intended the Document (Name and Name of Document
Date of Issuance User or Regulatory Address, Phone, FAX, E-mail Activity
or Internet)
Compliance Policy Guides Manual
1996
FDA regulated
National Technical industries
Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161 (Order No. PB96-920500) Compliance Programs Guidance Manual 1995
Do
NTIS (Order No. PB95-915499) Inspection Operations Manual
October 1994
Do
NTIS (Order No. PB95-913399) Regulatory Procedures Manual
August 1995
Do
NTIS (Order No. PB95-265534) Requirements of Laws and Regulations 1997
Do
Superintendent of Documents, Enforced by the U.S. Food and Drug
Government Printing Office, Administration ``Blue Book''
Washington, DC 20402 FDA Recall Policy
1995
Do
Industry Activities Staff (HFS-565), CFSAN, Food and Drug Administration, 200 C St. SW., Washington, DC 20204 Action Levels for Poisonous or
1995
Food and animal feed Do Deleterious Substances in Human Food
industries and Animal Feed Pesticides Analytical Manual
1994
Food Industry
NTIS (Order No. PB94-911899) FDA Advisory for Deoxynivanol (DON) in September 16, 1993 Food and animal feed Office of Plant & Dairy Foods Finished Wheat Products Intended for
industries
& Beverages (HFS-306), Human Consumption and in Grain and
CFSAN, Food and Drug Grain By-Products for Animal Feed
Administration, 200 C St. SW., Washington, DC 20204, 202-205-4681 FDA's Cosmetic Labeling Manual
October 1991
Cosmetic industry Office of Colors and Cosmetics (HFS-105), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4493 Statement of Policy: Foods Derived May 29, 1992
Developers of new Office of Premarket Approval from New Plant Varieties
plant food varieties (HFS-200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3100 A Food Labeling Guide
September 1994 Food industry
Superintendent of Documents, Government Printing Office, Washington, DC 20402, 202- 512-1800 Appendix I--Model Small Business Food August 7, 1993 Do
Industry Activities Staff Labeling Exemption Notice
(HFS-565), CFSAN, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-5251 Food Labeling: Questions and Answers August 1993
Do
Do Food Labeling: Questions and Answers: August 1995
Do
Superintendent of Documents, Volume II
Government Printing Office, Washington, DC 20420, 202- 512-1800 Fair Packaging and Labeling Act
June 1978
Do
NTIS (Order No. PB83-222117) Requirements and Interpretations Bacteriological Analytical Manual 7th 1992
FDA regulated
AOAC International, 481 North Edition
industries
Frederick Ave., suite 500, Gaithersburg, MD 20877-2417, 301-924-7077 FDA Food Importer's Guide for Low-Acid 1995
Food industry
Industry Activities Staff Canned and Acidified Foods
(HFS-565), CFSAN, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-5251 Fabrication of Single Service
1995
States
Milk Safety Branch (HFS-626), Containers and Closures for Milk and
CFSAN, Food and Drug Milk Products
Administration, 200 C St. SW., Washington, DC 20204, 202-205-9175 Evaluation of Milk Laboratories
1995
Do
Do Methods of Making Sanitation Ratings 1995
Do
Do Of Milk Supplies Dry Milk Ordinance
1995
Do
Do Procedures Governing the Cooperative 1995
Dairy industry
Do State-Public Health Service/Food and Drug Administration Program for Certification of Interstate Milk Shippers Frozen Dessert Processing Guidelines 1989
Do
Office of Plant and Dairy Foods and Beverages (HFS- 302), CFSAN, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-9175 Pasteurized Milk Ordinance
1995
States
Milk Safety Branch (HFS-626), CFSAN, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-9175
[[Page 31271]]
FDA Nutrition Labeling Manual: A Guide 1993
Food industry
Office of Food Labeling (HFS- for Developing and Using Databases
150), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4561 Guidelines for Determining Metric October 1, 1993 Do
Do Equivalents of Household Measures List of Food Defect Action Levels 1995
Food and Animal Feed (DALS)
Industries Industry Activities Staff (HFS-565), CFSAN, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-5251 Action Levels for Poisonous or
1995
Do
Do Deleterious Substances in Human Food and Feed (Also Found in CPG's) 1997 FDA Food Code
1997
States
NTIS Seafood List
1993
Seafood industry Superintendent of Documents, Government Printing Office, Washington, DC 20402, 202- 512-1800 Manual of Operations National
1992
States
Office of Seafood (HFS-407), Shellfish Sanitation
Shellfish Sanitation Branch, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3150 Fish and Fisheries Products Hazards 1996
Seafood industry Office of Seafood (HFS-400), and Controls Guide
Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3150 Guidance for Submitting Requests Under 1996
Food packaging
Office of Premarket Approval 21 CFR 170.39, Threshold of
industry
(HFS-200), Food and Drug Regulation for Substances Used in
Administration, 200 C St. Food Articles
SW., Washington, DC 20204, 202-418-3100 Guidelines for the Preparation of 1996
Do
Do Petition Submissions Guidelines for Approval of Color
1996
Color or contact lens Do Additives in Contact Lenses Intended
industry as Colors Recommendations for Submission of February 1993 Color additives
Do Chemical and Technological Data on
industry Color Additives for Food, Drugs or Cosmetics Use Points to Consider for the Use of December 1992 Food packaging
Do Recycled Plastics in Food Packaging:
industry Chemistry Considerations Recommendations for Submission of May 1993
Do
Do Chemical and Technological Data for Direct Food Additive and GRAS Food Ingredient Petitions Recommendations for Chemistry Data for June 1995
Do
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 September 1995 Food and food
Do Additive and Chemical Contaminants in
ingredient industry the Diet Toxicological Principles for the
1982
Petitioners for food NTIS (Order No. PR-83-170696) Safety Assessment of Direct Food
or color additives Additives and Color Additives Used in Food (also known as Redbook I) Environmental Assessment Technical March 1987
Do
NTIS (Order No. PB87-175345- Handbook
AS, A-01) Preparing Environmental Assessments: August 1990
Do
Office of Premarket Approval General Suggestions
(HFS-200), Food and Drug Administration, 200 C St. SW, Washington, DC 20204, 202-418-3100 Step-by-Step Guidance for Preparing March 1987
Do
Do Environmental Assessments Environmental Assessment of Food- February 1994 Do
Do Packaging Materials with Enhanced Degradation Characteristics Color Additive Petitions Information 1996
Do
Do and Guidance Toxological Testing of Food Additives 1983
Do
Do
[[Page 31272]]
List of Products for Each Product October 8, 1992 Food industry
Office of Food Labeling (HFS- Category
150), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4561 Label Declaration of Allergenic
June 10, 1996 Do
Do Substances in Foods; Notice to Manufacturers Guidance on Labeling of Foods that February 24, 1997 Do
Do Need Refrigeration by Consumers Interim Guidance on the Voluntary February 10, 1994 Do
Do Labeling of Milk and Milk Products that Have Not Been Treated With Recombinant Bovine Somatropin Guidelines Concerning Notification and 1985
Infant formula
Office of Special Testing of Infant Formula
manufacturers
Nutritionals (HFS-450), Food and Drug Administration, 200 C St. SW, Washington, DC 20204 202-205-4168 Clinical Testing of Infant Formulas 1985
Do
Do with Respect to Nutritional Suitability for Term Infants Guidelines for the Evaluation of the Infants with
1988
Do Safety and Suitability of New Infant Allergic Diseases Formulas for Feeding Guidelines for the Evaluation of the 1990
Do
Do Safety and Suitability of Infant Formulas for Feeding Infants with Allergic Diseases Guidelines for the Clinical Evaluation 1987
Do
Do of New Products Used in the Dietary Management of Infants, Children and Pregnant Women with Metabolic Disorders Guidance Document for Arsenic (Trace January 1993
States
Office of Seafood (HFS-400), Elements in Seafood)
Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3150 or via Internet: FDA Home Page http://vm.cfsan.fda.gov/ list.html Guidance Document for Cadmium (Trace January 1993
Do
Do Elements in Seafood) Guidance Document for Chromium (Trace January 1993
Do
Do Elements in Seafood) Guidance Document for Lead (Trace August 1993
Do
Do Elements in Seafood) Guidance Document for Nickel (Trace January 1993
Do
Do Elements in Seafood) FDA's Policy for Foods Developed by 1995
Food industry
Internet: FDA Home Page http:/ Biotechnology
/vm.cfsan.fda.gov Bovine Spongiform Encephalopathy (BSE) 1997
Do
Office of Plant and Dairy In Products for Human Use
Foods and Beverages (HFS- 302), CFSAN, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-9175 or via Internet: FDA Home Page http://www.fda.gov/opacom/ morechoices/industry/ guidance/gelguide.htm Shellfish Sanitation Model Ordinance 1995
States
Shellfish Program Implementation Branch, Office of Field Programs (HFS-628), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-8137 Draft Working Guide to Minimize
1998
Farmers and food Food Safety Initiative (HFS- Microbial Hazards for Fresh Fruits
packers
3), Food and Drug and Vegetables
Administration, 200 C. St. SW, Washington, DC 20204 or jsaltsman@bangate.fda.gov Iron-Containing Supplements and Drugs: 1997
Dietary supplement Office of Special Label Warning and Unit Dose
manufacturers: small Nutritionals (HFS-450), Food Packaging; Small Entity Compliance
entities
and Drug Administration, 200 Guide
C St. SW., Washington, DC 20204 Partial List of Enzyme Preparations 1998
FDA regulated
Office of Premarket Approval That are Used in Foods
industry
(HFS-200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204 Partial List of Microorganisms and 1998
Do
Do Microbial-Derived Ingredients That Are Used in Food
[[Page 31273]]
Fish and Fishery Products Hazards and January 1998
Do
Office of Seafood (HFS-400), Controls Guide, 2nd Edition
Food and Drug Administration, 200 C St. SW., Washington, DC 20204 HACCP Regulations for Fish and Fishery 1997
Do
Do Products: Questions and Answers Notification of a Health Claim or 1998
Do
Office of Food Labeling (HFS- Nutrient Content Claim Based on an
150), Food and Drug Authoritative Statement of a
Administration, 200 C St. Scientific Body
SW., Washington, DC 20204, 202-205-5099 Small Business Juice Labeling:
1998
Do
Do Questions and Answers FDA Nutrition Labeling Manual, A Guide March 1998
Do
Do for Developing and Using Data Bases HACCP Regulation for Fish and Fishery January 1999
Seafood processors Office of Seafood (HFS-400), Products: Questions and Answers,
Food and Drug Issue Three, Revised
Administration, 200 C St. SW., Washington, DC 20204, 202-418-3150 Foods--Adulteration Involving Hard or February 1999 FDA field offices Office of Plant and Dairy Sharp Foreign Objects (CPG)
Foods and Beverages (HFS- 300), Food and Drug Administration, 200 C St. SW., Washington, DC 20204 Food Additive Petition Expedited
January 1999
FDA personnel and Office of Premarket Approval, Review
regulated industry Food and Drug Administration, 200 C St. SW., 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 September 1998 FDA regulated
Do--premarkt@cfsan.fda.gov OR Genes in Transgenic Plants
industry
http://vm.cfsan.fda.gov//dms/ opa-armg.html Changes to the ``Pesticides and
December 30, 1998 FDA districts
FOI/Domestic Programs Branch Industrial Chemicals in Domestic
(HFS-636), Office of Field Foods'' Compliance Program for FY 99Programs, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4771 FY 99Mycotoxin Collection and Sample November 13, 1998 Do
Do Analysis Schedule Revisions to the EHEC Method
November 23, 1998 Do
Do Vibrio Vulnificus and Vibrio
June 17, 1998 Do
Do parahaemolyticus in Retail Shell Oysters CFSAN Assignment 98-7 Revisions to Att F ``Special Survey September 30, 1998 Do
Do Obligations--Dioxins and Furans in Food'' of the Pesticides and Industrial Chemicals Domestic Food Compliance Program for FY99 Collection and Analyses of Physical November 30, 1998 Do
Do Sample to Support Undeclared Allergen Cases: NLEA and General Labeling Requirements; Domestic Compliance Program Assignment to Assure Unpasteurized September 21, 1998 Do
Do Juice Manufacturers and Imported Juice Products Provide Required Label Warnings, Placards, and/or meet the 5 log Pathogen Reduction Requirement Assignment to Assure Unpasteurized November 3, 1998 Do
Do Juice Manufacturers and Imported Juice Products Provide Required Label Warnings, Placards, and/or meet the 5 log Pathogen Reduction Requirement Pesticides in Imported Ginseng (Field September 17, 1998 FDA districts
FOI/Imports Branch (HFS-606), Assignment)
Office of Field Programs, Food and Drug Administration, 200 C St. SW., Washington, DC 20204 Radionuclides in Foods
October 2, 1998 Do
Do Letters to Manufacturers of Prepared August 21, 1998 Manufacturers of Office of Field Programs (HFS- Sandwiches
prepared sandwiches 600), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-5194 or JohnThomas@OFP@FDA.CFSAN, FAX 292-260-0133
[[Page 31274]]
-
Guidance Documents Issued by the Center for Veterinary Medicine (CVM)
How to Obtain a Hard Copy of Grouped by Intended the Document (Name and Name of Document
Date of Issuance User or Regulatory Address, Phone, FAX, E-mail Activity
or Internet)
Guideline 3--General Principles for July 1994
Animal drug industry Internet via: http:// Evaluating the Safety of Compounds
www.fda.gov/cvm or Used in Food-Producing Animals
Communications Staff (HFV- 12), CVM, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1755, FAX 301- 594-1831 Guideline 4--Guidelines for Efficacy
Do
Do Studies for Systemic Sustained Release Sulfonamide Boluses for Cattle Guideline 5--Stability Guidelines December 1990 Do
Do Guideline 6--Guidelines for Submitting
Do
Do NADA's for Generic Drugs Reviewed by NAS/NRC Guideline 9--Preclearance Guidelines October 1975
Do
Do for Production Drugs Guideline 10--Amendment of Section October 1975
Do
Do II(G)(1)(b)(4) of the Preclearance Guidelines Guideline 13--Guidelines for
January 1985
Do
Do Evaluation of Effectiveness of New Animal Drugs for Use in Free-Choice Feeds Guideline 14--Guideline and Format for
Do
Do Reporting the Details of Clinical Trials Using An Investigational New Animal Drug in FOOD Producing Animals Guideline 15--Guideline and Format for February 1977 Do
Do Reporting the 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
Do
Do Animal Feeds: Human Health Safety Criteria Guideline 19--Antibacterial Drugs in
Do
Do Animal Feeds: Animal Health Safety Criteria Guideline 20--Antibacterial Drugs in
Do
Do Animal Feeds: Antibacterial Effectiveness Criteria Guideline 22--Guideline Labeling of
Do
Do Arecoline Base Drugs Intended for Animal Use Guideline 23--Medicated Free Choice July 1985
Do
Do Feeds--Manufacturing Control Guideline 24--Guidelines for Drug October 1983
Do
Do Combinations for Use in Animals Guideline 25--Guidelines for the
January 1979
Do
Do Efficacy Evaluation of Equine Anthelmintics Guideline 29--Guidelines for the
September 1980 Do
Do Effectiveness Evaluation of Swine Anthelmintics Guideline 31--Guidelines for the
July 1981
Do
Do Evaluation of Bovine Anthelmintics Guideline 33--Target Animal Safety June 1989
Do
Do Guidelines for New Animal Drugs Guideline 35--Bioequivalence
1996
Do
Do Guideline--Final Guideline 36--Guidelines for Efficacy July 1985
Do
Do Evaluation of Canine/Feline Anthelmintics Guideline 37--Guidelines for
March 1984
Do
Do Evaluation of Effectiveness of New Animal Drugs for Use in Poultry Feed for Pigmentation Guideline 38--Guideline for
August 1984
Do
Do Effectiveness Evaluation of Topical/ Otic Animal Drugs Guideline 40--Draft Guideline for the April 1992
Do
Do Evaluation of the Efficacy of Anticoccidial Drugs and Anticoccidial Drug Combinations in Poultry Guideline 41--Draft Guideline:
June 1992
Do
Do Formatting, Assembling, and Submitting New Animal Drug Applications Guideline 42--Animal Drug
1994
Do
Do Manufacturing Guidelines, 1994 Guideline 43--Guidance on Generic October 1995
Do
Do Animal Drug Products Containing Fermentation-Derived Drug Substances
[[Page 31275]]
Guideline 45--Guideline for Uniform August 1993
Do
Do Labeling of Drugs for Dairy and Beef Cattle Guideline 48--Guidance for Industry November 1994 Do
Do for the Submission of Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products Guideline 49--Guidance Document for April 1996
Do
Do Target Animal Safety and Drug Effectiveness Studies for Anti- Microbial Bovine Mastitis Products Guideline 50--Draft Guideline for February 1993 Do
Do Target Animal and Human Food Safety, Drug Efficacy, Environmental and Manufacturing Studies for Teat Antiseptic Products Guideline 52--Guidance--
January 1996
Do
Do Microbiological Testing of Antimicrobial Drug Residues in Food Guideline 53--Guideline for the
May 1994
Do
Do Evaluation of the Utility of Food Additives in Diets Fed to Aquatic Animals Guideline 54--Draft Guideline for June 1994
Do
Do Utility Studies for Anti-Salmonella Chemical Food Additives in Animal Feeds Guideline 55--Supportive Data for Cat June 1994
Do
Do Food Labels Bearing ``Reduces Urinary pH Claims: Guideline in Protocol Development'' Guideline 56--Protocol Development November 1994 Do
Do Guideline for Clinical Effectiveness and Target Animal Safety Trials Guideline 57--Master Files--Guidance July 1995
Do
Do for Industry for the Preparation and Submission of Veterinary Master Files Guideline 58--Guidance for Industry May 1997
Do
Do for Good Target Animal Study Practices: Clinical Investigators and Monitors Guideline 59--Guidance for Industry: January 1999
Do
Do Submitting a Notice of Claimed Investigational Exemption in Electronic Format to CVM via E-Mail Guidance 61--Guidance for Industry-- January 1999
Do
Do FDA Approval of Animal Drugs for Minor Uses and for Minor Species Guideline 62--Guidance for Industry-- August 1997
Do
Do Consumer-Directed Broadcast Advertisements Guideline 63--Guidance for Industry-- December 1997 Do
Do Validation of Analytical Procedures: Definition and Terminology--Draft Guidance Guideline 64--Guidance for Industry-- December 1997 Do
Do Validation of Analytical Procedures: Methodology--Draft Guidance Guideline 65--Guidance for Industry-- November 1997 Do
Do Industry-Supported Scientific and Educational Activities Guideline 66--Guidance for Industry-- January 1998
Do
Do Professional Flexible Labeling of Antimicrobial Drugs--Draft Guidance Guideline 67--Guidance for Industry-- February 1998 Do
Do Small Entities Compliance Guide for Renderers Guideline 68--Guidance for Industry-- February 1998 Do
Do Small Entities Compliance Guide for Protein Blenders, Feed Manufacturers, and Distributors Guideline 69--Guidance for Industry-- February 1998 Do
Do Small Entities Compliance Guide for Feeders of Ruminant Animals With On- Farm Feed Mixing Operations Guideline 70--Guidance for Industry-- February 1998 Do
Do Small Entities Compliance Guide for Feeders of Ruminant Animals Without On-Farm Feed Mixing Operations Guideline 71--Guidance for Industry-- April 1998
Do
Do Use of Human Chorionic Gonadotropic (HCG) as a Spawning Aid for Fish Guideline 72--Guidance for Industry-- May 1998
Do
Do GMP's for Medicated Feed Manufacturers Not Required to Register and Be Licensed With FDA
[[Page 31276]]
Guideline 73--Draft Guidance for
July 1998
Do
Do Industry--Stability Testing of New Animal Drug Substances and Products Guideline 74--Draft Guidance for
July 1998
Do
Do Industry--Stability Testing for New Dosage Forms of New Animal Drugs Guideline 75--Guidance for Industry-- July 1998
Do
Do Stability Testing: Photostability Testing of New Animal Drug Substances and Products: Draft Guidance Guideline 76--Guidance for Industry-- July 1998
Do
Do Questions and Answers--BSE Feed Regulation Guideline 77--Guidance for Industry-- August 1998
Do
Do Interpretation of On-Farm Feed Manufacturing and Mixing Operations-- Draft Guidance Guideline 78--Guidance for Industry-- November 1998 Do
Do Evaluation of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals--Draft Guidance
-
Guidance Documents Issued by the Office of Regulatory Affairs
How To Obtain A Hard Copy of Grouped by Intended The Document (Name and Name of Document
Date of Issuance User or Regulatory Address, Phone, FAX, E-mail, Activity
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 Medical Device August 27, 1998 Do
Division of Compliance Policy Warning Letter Draft Pilot
(HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420 or via Internet www.fda.gov/ora/compliance-- ref/dev--pl.pdf Compliance Policy Guide-DRAFT
January 5, 1998 Do
Division of Compliance Policy Commercialization of In Vitro
or via Internet at Diagnostic Devices (IVD's) Labeled
www.fda.gov/cdrh/comp/ for Research Use Only or
ivddrfg.html Investigational Use Only Compliance Policy Guide 675.400 (CPG November 13, 1998 Do
Division of Compliance Policy 7126.24) REVISION Rendered Animal
or via Internet at Feed Ingredients
www.fda.gov/ora/compliance-- ref/cpg/cpgvet/ cpg675.400.html Compliance Policy Guide--DRAFT
August 28, 1998 Do
Division of Compliance Policy Distributor Medical Device Reporting
or via Internet at www.fda.gov/ora/compliance-- ref/cpg--mdr3.txt Compliance Policy Guide 257.100 NEW December 21, 1998 Do
Division of Compliance Policy Deferral of Source Plasma Donors Due
or via Internet at to Red Cell Loss During Collection of
www.fda.gov/ora/compliance-- Source Plasma by Automated
ref/cpg/default.html Plasmapheresis FDA/ORA International Inspection
May 1997
Do
Division of Emergency & Manual and Travel Guide
Investigational Operations (HFC-130), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 29857 or via Internet www.fda.gov/ora/ inspect--ref/itob/itob.html Glossary of Computerized System and August 1995
Do
NTIS (Order No. PB96-127352) Software Development Terminology
or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html
[[Page 31277]]
Import Alerts
continuously
Do
Freedom of Information Staff (HFI-35), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 or via Internet www.fda.gov/ora/ fiars/ora--import-- alerts.html Investigations Operations Manual
January 1999
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 or via Internet www.fda.gov/ora/inspect--ref/ iom/iomtc.html Investigations Operations Manual- July 1998
Do
Do REVISION: Chapter 4--Sampling Investigations Operations Manual- July 1998
Do
Do REVISION: Chapter 5--Establishment Inspection 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 Regulatory Procedures Manual
August 1997
Do
NTIS (Order No. PB97-196182) or via Internet www.fda.gov/ ora/compliance--ref/rpm/ rpmtc.html Regulatory Procedures Manual: UPDATE/ March 1998
Do
Division of Compliance New Subchapter/ Application Integrity
Policy, or via Internet Policy
www.fda.gov/ora/compliance-- ref/rpm/rpmtc.html Regulatory Procedures Manual: UPDATE March 1998
Do
Do Subchapter/Warning Letters Regulatory Procedures Manual: UPDATE/ April 1998
Do
Do REVISION Subchapter/Import Procedures Regulatory Procedures Manual; UPDATE/ April 1998
Do
Do REVISION Subchapter/Priority Enforcement Strategy for Problem Importers Regulatory Procedures Manual: UPDATE/ April 1998
Do
Do REVISION Subchapter/Import Procedures Regulatory Procedures Manual: UPDATE/ April 1998
Do
Do REVISION Subchapter/Notice of Sampling Regulatory Procedures Manual: UPDATE/ May 1998
Do
Do NEW Subchapter/Granting and Denying Transportation and Exportation (T&E) Entries Regulatory Procedures Manual: UPDATE/ June 1998
Do
Division of Compliance Policy REVISION Subchapter/Seizure
or via Internet at www.fda.gov/ora/compliance-- ref/rpm--new2/ch6.html Regulatory Procedures Manual: UPDATE/ June 1998
Do
Division of Compliance Policy REVISION Subchapter/Supervisory
or via Internet at Charges
www.fda.gov/ora/compliance-- ref/rpm--new2/ch9chgs.html Regulatory Procedures Manual: NEW July 1998
Do
Division of Compliance Policy Subchapter/Civil Penalties--
or via Internet at Electronic Product Radiation Control
www.fda.gov/ora/compliance-- ref/ch6civpen.html Guide to Inspections of Bulk
May 1994
Do
NTIS (Order No. PB96-127154) Pharmaceutical Chemicals
or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Pharmaceutical July 1993
Do
NTIS (Order No. PB96-127279) Quality Control Laboratories
or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of
July 1993
Do
NTIS (Order No. PB96-127287) Microbiological Pharmaceutical
or via Internet www.fda.gov/ Quality Control Laboratories
ora/inspect--ref/igs/ iglist.html Guide to Inspections of Validation of July 1993
Do
NTIS (Order No. PB96-127246) Cleaning Processes
or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Lyophilization July 1993
Do
NTIS (Order No. PB96-127253) of Parenterals
or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of High Purity July 1993
Do
NTIS (Order No. PB96-127261) Water Systems
or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html
[[Page 31278]]
Guide to Inspections of Dosage Form October 1993
Do
NTIS (Order No. PB96-127212) Drug Manufacturers-CGMPs
or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Oral Solid January 1994
Do
NTIS (Order No. PB96-127345) Dosage Forms Pre/Post Approval Issues
or via Internet www.fda.gov/ for Development and Validation
ora/inspect--ref/igs/ iglist.html Guide to Inspections of Topical Drug July 1994
Do
NTIS (Order No. PB96-127394) Products
or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Sterile Drug July 1994
Do
NTIS (Order No. PB96-127295) Substance Manufacturers
or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Oral Solutions August 1994
Do
NTIS (Order No. PB96-127147) and Suspensions
or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Nutritional February 1995 Do
NTIS (Order No. PB96-127378) Labeling and Education Act (NLEA)
or via Internet www.fda.gov/ Requirements
ora/inspect--ref/igs/ iglist.html Guide to Inspections of Interstate April 1995
Do
NTIS (Order No. PB96-127386) Carriers and Support Facilities
or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Dairy Product April 1995
Do
NTIS (Order No. PB96-127329) Manufacturers
or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Miscellaneous May 1995
Do
NTIS (Order No. PB96-127220) Foods Vol. I
or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Miscellaneous September 1996 Do
NTIS (Order No. PB97-196133) Foods Vol. II
or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Low Acid
November 1996 Do
NTIS (Order No. PB97-196141) Canned Foods Manufacturers, Part 1 -
or via Internet www.fda.gov/ Administrative Procedures/Scheduled
ora/inspect--ref/igs/ Processes
iglist.html Guide to Inspections of Low Acid
April 1997
Do
NTIS (Order No. PB97-196158) Canned Foods Manufacturers, Part 2-
or via Internet www.fda.gov/ Processes/Procedures
ora/inspect--ref/igs/ iglist.html Guide to Inspections of Cosmetic
February 1995 Do
NTIS (Order No. PB96-127238) Product Manufacturers
or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Blood Banks September 1994 Do
NTIS (Order No. PB96-127303) or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Source Plasma December 1994 Do
NTIS (Order No. PB96-127360) Establishments
or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Infectious June 1996
Do
NTIS (Order No. PB96-199476) Disease Marker Testing Facilities
or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Biotechnology Inspections Guide
November 1991 Do
NTIS (Order No. PB96-127402) or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Computerized February 1983 Do
NTIS (Order No. PB96-127337) Systems in Drug Processing
or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Foreign
September 1995 Do
NTIS (Order No. PB96-127311) Medical Device Manufacturers
or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Foreign
May 1996
Do
NTIS (Order No. PB96-199468) Pharmaceutical Manufacturers
or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Mammography Quality Standards Act January 1998
Do
NTIS (Order No. PB98-127178) (MQSA) Auditors Guide
or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of
December 1997 Do
NTIS (Order No. PB98-127152) Electromagnetic Compatibility Aspects
or via Internet www.fda.gov/ of Medical Device Quality Systems
ora/inspect--ref/igs/ iglist.html
[[Page 31279]]
Guide to Inspections of Grain Product March 1998
Do
Division of Emergency and Manufacturers
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
February 1998 Do
Do Inspections of In Vitro Devices Guide to Inspections of Viral
March 1998
Do
Do Clearance Processes for Plasma Derivatives Guide to Traceback of Fresh Fruits and August 1998
Do
Do Vegetables Implicated in Epidemiological Investigations Guide to Inspections of Computerized August 1998
Do
Do--Internet at www.fda.gov/ Systems in the Food Processing
ora/inspect--ref/igf/ Industry
iglist.html Guideline for the Monitoring of
January 1988
FDA regulated
Division of Compliance Policy Clinical Investigators
industry
(HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420 Computerized Systems Used in Clinical June 18, 1997 Do
Do Trials-DRAFT Compliance Program 7348.808:
Revised August 17, FDA staff personnel Do--Internet http:// Bioresearch Monitoring; Good
1998
www.fda.gov/ora/compliance-- Laboratory Practices (Nonclinical)
ref/bimo/default.html Compliance Program 7348.810: Sponsors, Revised October Do
Do Contract Research Organizations and 30, 1998 Monitors Compliance Program 7348.811:
Revised September Do
Do Bioresearch Monitoring; Clinical
2, 1998 Investigations Food Laboratory Practice Program
October 1, 1991 Do
Division of Compliance Policy (Nonclinical Laboratories) 7348.808A; EPA Data Audit Inspections Compliance Program 7348.809;
August 18, 1994 Do
Do Bioresearch Monitoring; Institutional Review Board Good Laboratory Practice Regulations August 1979
Do
Do--Internet at www.fda.gov/ Management Briefings
ora/compliance--ref/bimo/ default.html
-
Guidance Documents Issued by the Office of the Commissioner and Office of Policy
How to Obtain a Hard Copy of Grouped by Intended the Document (Name and Name of Document
Date of Issuance User or Regulatory Address, Phone, Fax, E-mail Activity
or Internet
Draft Guidance for Industry; Exports June 1998
Regulated industry Internet via www.fda.gov/ and Imports under the FDA Export
opacom/fedregister/ Reform and Enhancement Act of 1996
frexport.html FDA's Development, Issuance and Use of February 1997 FDA personnel and Internet via www.fda.gov/ Guidance Documents
regulated industry opacom/morechoices/ moreindu.html or Office of Policy (301-827-3360) Industry Supported Scientific and December 1997 Regulated industry Internet via www.fda.gov/cder/ Educational Activities
guidance/index.htm or Office of Policy (301-827-3360) Draft Guidance on Broadcast
February 1997 Do
Do Advertisements Direct Final Rule Guidance
November 1997 FDA personnel
Internet via www.fda.gov/ opacom/morechoices/industry/ guidedc.htm or Lisa Helmanis (301-443-3480) Small Entities Compliance Guide:
February 1997 Regulated industry Internet via www.fda.gov/ Regulations to Restrict the Sale and
opacom/campaigns/tobacco/ Distribution of Cigarettes and
tobret.htm or 1-888-FDA- Smokeless Tobacco in Order to Protect
4KIDS Children and Adolescents (21 CFR Part 897) Children & Tobacco--Frequently Asked July 1997
Do
Do Questions about the New Regulations (Draft) Children & Tobacco--A Retailer's Guide October 1997
Do
Do to the New Federal Regulations Children & Tobacco--A Guide to the the October 1997
Do
Do New Federal Regulations
[[Page 31280]]
FDA's Standards Policy
October 1995
FDA personnel and 60 FR 53078, October 11, 1995 regulated industry or Office of Policy (301-827- 3360) Policy & Guidance Handbook for FDA 1994
FDA personnel
National Technical Advisory Committees
Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, 703- 487-4650 (Order No. PB94- 158854)
Dated: June 4, 1999. William K. Hubbard, Associate Commissioner for Policy Coordination.
[FR Doc. 99-14752Filed6-9-99; 8:45 am]
BILLING CODE 4160-01-F
