[Federal Register Volume 70, Number 3 (Wednesday, January 5, 2005)]
[Notices]
[Pages 824-913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-155]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1998N-0046]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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been added or withdrawn in the past year.

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

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

FOR FURTHER INFORMATION CONTACT: Regarding GGPs: Lisa Helmanis, Office 
of Policy (HF-26), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-3480.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA's GGPs were published in the Federal Register of September 19, 
2000 (65 FR 56468), and became effective October 19, 2000. GGPs are 
intended to ensure involvement of the public in the development of 
guidance documents, and to enhance understanding of the availability, 
nature, and legal effect of such guidance (Sec.  10.115 (21 CFR 
10.115)). In Sec.  10.115(n)(2), FDA stated that it intended to publish 
an annual comprehensive list of guidance documents. The list in this 
document updates a comprehensive list that published October 24, 2001 
(66 FR 53836).
    The following comprehensive list identifies all guidances that have 
been issued and are in use, and all draft guidances that have been 
distributed for comment and not for implementation. Any guidances that 
have been withdrawn since the last publication of this comprehensive 
list are also identified. These withdrawn guidances include some final 
and draft guidances that had been withdrawn prior to the date of 
publication of this list, and some that are being withdrawn as of this 
date. In accordance with the agency's general policy on guidances, you 
may comment on this list and on any FDA guidance document at any time. 
Please note that although we have stated that the ``Guidance for 
Industry on Qualified Health Claims in Labeling of Conventional Foods 
and Dietary Supplements'' (December 2002) has been ``replaced'' by 
subsequent guidance, the agency has not abandoned the position in the 
2002 guidance regarding reasonable consumer standard.
    We have organized the documents by the issuing center or office 
within FDA, and have identified the pertinent intended users or 
regulatory activities. The dates in the list refer to the date we 
issued the guidances or, where applicable, the last date we revised a 
document. Because each issuing center or office maintains its own 
database, there are slight variations in the way in which they provide 
information in the tables in this document.
    The following most frequently used Internet sites for agency 
guidances are provided for future reference:
     Center for Biologics Evaluation and Research (CBER): 
http://www.fda.gov/cber/guidelines.htm
     Center for Drug Evaluation and Research (CDER): http://www.fda.gov/cder/guidance/index.htm
     Center for Devices and Radiological Health (CDRH): http://www.fda.gov/cdrh/guidance.html
     Center for Food Safety and Applied Nutrition (CFSAN): 
http://www.cfsan.fda.gov/dms/guidance.html
     Center for Veterinary Medicine (CVM): http://www.fda.gov/cvm/guidance/published.htm
     Office of Regulatory Affairs (ORA) and Office of the 
Commissioner: http:/

[[Page 825]]

/www.fda.gov/opacom/morechoices/industry/guidance.htm

                    Guidance Documents Issued by CBER
------------------------------------------------------------------------
                                                   How to Obtain a Copy
                                       Intended       of the Document
     Name of Document        Date of    User or  -----------------------
                            Issuance  Regulatory    Mailing    Internet
                                        Activity    Address     Address
------------------------------------------------------------------------
Guidelines for              June      FDA         Office of   http://
 Immunization of Source      1980      regulated   Communica   www.fda.g
 Plasma (Human) Donors                 industry    tion,       ov/cber/
 With Blood Substances                             Training,   guideline
                                                   and         s.htm
                                                   Manufactu
                                                   rers
                                                   Assistanc
                                                   e (HFM-
                                                   40),
                                                   Center
                                                   for
                                                   Biologics
                                                   Evaluatio
                                                   n and
                                                   Research,
                                                   Food and
                                                   Drug
                                                   Administr
                                                   ation,
                                                   1401
                                                   Rockville
                                                   Pike,
                                                   Rockville
                                                   , MD
                                                   20852-144
                                                   8, 1-800-
                                                   835-4709
                                                   or 301-
                                                   827-1800
------------------------------------------------------------------------
Collection of Human         January   Ditto (Do)  Do.         http://
 Leukocytes for Further      28,                               www.fda.g
 Manufacturing (Source       1981                              ov/cber/
 Leukocytes)                                                   memo.htm
------------------------------------------------------------------------
Interferon Test             July 28,  Do.         Do.         http://
 Procedures: Draft Points    1983                              www.fda.g
 to Consider (PTC) in the                                      ov/cber/
 Production and Testing of                                     guideline
 Interferon Intended for                                       s.htm
 Investigational Use in
 Humans
------------------------------------------------------------------------
Deferral of Blood Donors    February  Do.         Do.         http://
 Who Have Received the       28,                               www.fda.g
 Drug Accutane               1984                              ov/cber/
 (isotretinoin/Roche; 13-                                      memo.htm
 cis-retinoic acid)
------------------------------------------------------------------------
Equivalent Methods for      December  Do.         Do.         Do.
 Compatibility Testing       14,
                             1984
------------------------------------------------------------------------
Plasma Derived From         December  Do.         Do.         Do.
 Therapeutic Plasma          14,
 Exchange                    1984
------------------------------------------------------------------------
Draft PTC in the            April     Do.         Do.         http://
 Production and Testing of   10,                               www.fda.g
 New Drugs and Biologicals   1985                              ov/cber/
 Produced by Recombinant                                       guideline
 DNA Technology                                                s.htm
------------------------------------------------------------------------
Reduction of the Maximum    June 2,   Do.         Do.         http://
 Platelet Storage Period     1986                              www.fda.g
 to 5 Days in an Approved                                      ov/cber/
 Container                                                     memo.htm
------------------------------------------------------------------------
To In Vitro Diagnostic      December  Do.         Do.         Do.
 Reagent Manufacturers:      6, 1986
 Guidance on the Labeling
 of Human Blood Derived In
 Vitro Diagnostic Devices
 in Regard to Labeling for
 HTLV-III/LAV Antibody
 Testing
------------------------------------------------------------------------
Guideline on General        May 1987  Do.         Do.         http://
 Principles of Process                                         www.fda.g
 Validation                                                    ov/cber/
                                                               guideline
                                                               s/htm
------------------------------------------------------------------------
Deferral of Donors Who      November  Do.         Do.         http://
 Have Received Human         25,                               www.fda.g
 Pituitary-Derived Growth    1987                              ov/cber/
 Hormone                                                       memo.htm
------------------------------------------------------------------------
Guideline on Validation of  December  Do.         Do.         http://
 the Limulus Amebocyte       1987                              www.fda.g
 Lysate Test as an End-                                        ov/cber/
 Product Endotoxin Test                                        guideline
 for Human and Animal                                          s.htm
 Parenteral Drugs,
 Biological Products, and
 Medical Devices
------------------------------------------------------------------------
Recommendations for the     December  Do.         Do.         http://
 Management of Donors and    2, 1987                           www.fda.g
 Units That Are Initially                                      ov/cber/
 Reactive for Hepatitis B                                      memo.htm
 Surface Antigen (HbsAg)
------------------------------------------------------------------------
Extension of Dating Period  December  Do.         Do.         Do.
 for Storage of Red Blood    4, 1987
 Cells, Frozen
------------------------------------------------------------------------
To Licensed In Vitro        December  Do.         Do.         Do.
 Diagnostic Manufacturers:   23,
 Handling of Human Blood     1987
 Source Materials
------------------------------------------------------------------------
Recommendations for         April 6,  Do.         Do.         Do.
 Implementation of           1988
 Computerization in Blood
 Establishments
------------------------------------------------------------------------
Control of Unsuitable       April 6,  Do.         Do.         Do.
 Blood and Blood             1988
 Components
------------------------------------------------------------------------

[[Page 826]]

 
Discontinuance of           July 7,   Do.         Do.         Do.
 Prelicensing Inspection     1988
 for Immunization Using
 Licensed Tetanus Toxoid
 and Hepatitis B and
 Rabies Vaccines
------------------------------------------------------------------------
Physician Substitutes       August    Do.         Do.         Do.
                             15,
                             1988
------------------------------------------------------------------------
To Licensed Manufacturers   August    Do.         Do.         Do.
 of Blood Grouping           26,
 Reagents: Criteria for      1988
 Exemption of Lot Release
------------------------------------------------------------------------
Revised Guideline for the   October   Do.         Do.         Do.
 Collection of Platelets,    7, 1988
 Pheresis
------------------------------------------------------------------------
To Manufacturers of HTLV-I  October   Do.         Do.         Do.
 Antibody Test Kits:         18,
 Antibody to Human T-Cell    1988
 Lymphotropic Virus, Type
 I (HTLV-I) Release Panel
 I
------------------------------------------------------------------------
HTLV-1 Antibody Testing     November  Do.         Do.         Do.
                             29,
                             1988
------------------------------------------------------------------------
Use of Recombigen HIV-1 LA  February  Do.         Do.         Do.
 Test                        1, 1989
------------------------------------------------------------------------
Guidance for Autologous     March     Do.         Do.         Do.
 Blood and Blood             15,
 Components                  1989
------------------------------------------------------------------------
Use of Recombigen HIV-1     August    Do.         Do.         Do.
 Latex Agglutination (LA)    1, 1989
 Test
------------------------------------------------------------------------
Draft PTC in the            August    Do.         Do.         http://
 Manufacture and Clinical    8, 1989                           www.fda.g
 Evaluation of In Vitro                                        ov/cber/
 Tests to Detect                                               guideline
 Antibodies to the Human                                       s.htm
 Immunodeficiency Virus,
 Type 1
------------------------------------------------------------------------
PTC in the Collection,      August    Do.         Do.         Do.
 Processing, and Testing     22,
 of Ex Vivo Activated        1989
 Mononuclear Leukocytes
 for Administration to
 Humans
------------------------------------------------------------------------
Requirements for            Septembe  Do.         Do.         http://
 Computerization of Blood    r 8,                              www.fda.g
 Establishments              1989                              ov/cber/
                                                               memo.htm
------------------------------------------------------------------------
Abbott Laboratories' HIVAG- October   Do.         Do.         Do.
 1 Test for HIV-1            4, 1989
 Antigen(s) Not
 Recommended for Use as a
 Donor Screen
------------------------------------------------------------------------
Guideline for Collection    October   Do.         Do.         Do.
 of Blood or Blood           26,
 Products From Donors With   1989
 Positive Tests for
 Infectious Disease
 Markers (``High Risk''
 Donors)
------------------------------------------------------------------------
Guideline for the           January   Do.         Do.         http://
 Determination of Residual   1990                              www.fda.g
 Moisture in Dried                                             ov/cber/
 Biological Products                                           guideline
                                                               s.htm
------------------------------------------------------------------------
Autologous Blood            February  Do.         Do.         http://
 Collection and Processing   12,                               www.fda.g
 Procedures                  1990                              ov/cber/
                                                               memo.htm
------------------------------------------------------------------------
Use of Genetic Systems HIV- June 21,  Do.         Do.         Do.
 2 EIA                       1990
------------------------------------------------------------------------
FDA Request for             March     Do.         Do.         Do.
 Information on Blood        15,
 Storage Patterns and Red    1991
 Cell Contamination by
 Yersinia Enterocolitica
------------------------------------------------------------------------
Revision to October 26,     April     Do.         Do.         Do.
 1989, Guideline for         17,
 Collection of Blood or      1991
 Blood Products From
 Donors With Positive
 Tests for Infectious
 Disease Markers (``High
 Risk'' Donors)
------------------------------------------------------------------------
Deficiencies Relating to    March     Do.         Do.         Do.
 the Manufacture of Blood    20,
 and Blood Components        1991
------------------------------------------------------------------------
Responsibilities of Blood   March     Do.         Do.         Do.
 Establishments Related to   20,
 Errors and Accidents in     1991
 the Manufacture of Blood
 and Blood Components
------------------------------------------------------------------------
FDA Recommendations         Septembe  Do.         Do.         Do.
 Concerning Testing for      r 10,
 Antibody to Hepatitis B     1991
 Core Antigen (Anti-HBc)
------------------------------------------------------------------------

[[Page 827]]

 
Disposition of Blood        Septembe  Do.         Do.         Do.
 Products Intended for       r 11,
 Autologous Use That Test    1991
 Repeatedly Reactive for
 Anti-HCV
------------------------------------------------------------------------
Clarification of FDA        December  Do.         Do.         Do.
 Recommendations for Donor   12,
 Deferral and Product        1991
 Distribution Based on the
 Results of Syphilis
 Testing
------------------------------------------------------------------------
Supplement to the PTC in    April 6,  Do.         Do.         http://
 the Production and          1992                              www.fda.g
 Testing of New Drugs and                                      ov/cber/
 Biologics Produced by                                         guideline
 Recombinant DNA                                               s.htm
 Technology: Nucleic Acid
 Characterization and
 Genetic Stability
------------------------------------------------------------------------
Revised Recommendations     April     Do.         Do.         http://
 for the Prevention of       23,                               www.fda.g
 Human Immunodeficiency      1992                              ov/cber/
 Virus (HIV) Transmission                                      memo.htm
 by Blood and Blood
 Products
------------------------------------------------------------------------
Use of Fluorognost HIV-1    April     Do.         Do.         Do.
 Immunofluorescent Assay     23,
 (IFA)                       1992
------------------------------------------------------------------------
Revised Recommendations     April     Do.         Do.         Do.
 for Testing Whole Blood,    23,
 Blood Components, Source    1992
 Plasma, and Source
 Leukocytes for Antibody
 to Hepatitis C Virus
 Encoded Antigen (Anti-
 HCV)
------------------------------------------------------------------------
Exemptions to Permit        April     Do.         Do.         Do.
 Persons With a History of   23,
 Viral Hepatitis Before      1992
 the Age of Eleven Years
 to Serve as Donors of
 Whole Blood and Plasma:
 Alternative Procedures,
 21 CFR 640.120
------------------------------------------------------------------------
Changes in Equipment for    July 21,  Do.         Do.         Do.
 Processing Blood Donor      1992
 Samples
------------------------------------------------------------------------
Nomenclature for            Septembe  Do.         Do.         Do.
 Monoclonal Blood Grouping   r 28,
 Reagents                    1992
------------------------------------------------------------------------
Volume Limits for           November  Do.         Do.         Do.
 Automated Collection of     4, 1992
 Source Plasma
------------------------------------------------------------------------
FDA's Policy Statement      November  Do.         Do.         http://
 Concerning Cooperative      25,                               www.fda.g
 Manufacturing               1992                              ov/cber/
 Arrangements for Licensed                                     guideline
 Biologics                                                     s.htm
------------------------------------------------------------------------
Revision of October 7,      December  Do.         Do.         http://
 1988, Memo Concerning Red   16,                               www.fda.g
 Blood Cell Immunization     1992                              ov/cber/
 Programs                                                      memo.htm
------------------------------------------------------------------------
Draft PTC in the            July 12,  Do.         Do.         http://
 Characterization of Cell    1993                              www.fda.g
 Lines Used to Produce                                         ov/cber/
 Biologicals                                                   guideline
                                                               s.htm
------------------------------------------------------------------------
Guidance on Alternatives    July 20,  Do.         Do.         Do.
 to Lot Release for          1993
 Licensed Biological
 Products
------------------------------------------------------------------------
Recommendations Regarding   July 22,  Do.         Do.         http://
 License Amendments and      1993                              www.fda.g
 Procedures for Gamma                                          ov/cber/
 Irradiation of Blood                                          memo.htm
 Products
------------------------------------------------------------------------
Deferral of Blood and       July 28,  Do.         Do.         Do.
 Plasma Donors Based on      1993
 Medications
------------------------------------------------------------------------
Revised Recommendations     August    Do.         Do.         Do.
 for Testing Whole Blood,    5, 1993
 Blood Components, Source
 Plasma, and Source
 Leukocytes for Antibody
 to Hepatitis C Virus
 Encoded Antigen (Anti-
 HCV)
------------------------------------------------------------------------
Clarification of the Use    August    Do.         Do.         Do.
 of Unlicensed Anti-HCV      19,
 Supplemental Test Results   1993
 in Regard to Donor
 Notification
------------------------------------------------------------------------
Draft Guideline for the     Septembe  Do.         Do.         http://
 Validation of Blood         r 28,                             www.fda.g
 Establishment Computer      1993                              ov/cber/
 Systems                                                       guideline
                                                               s.htm
------------------------------------------------------------------------
Guidance Regarding Post     December  Do.         Do.         http://
 Donation Information        10,                               www.fda.g
 Reports                     1993                              ov/cber/
                                                               memo.htm
------------------------------------------------------------------------

[[Page 828]]

 
Donor Suitability Related   December  Do.         Do.         Do.
 to Laboratory Testing for   22,
 Viral Hepatitis and a       1993
 History of Viral
 Hepatitis
------------------------------------------------------------------------
Recommendations for the     January   Do.         Do.         Do.
 Invalidation of Test        3, 1994
 Results When Using
 Licensed Viral Marker
 Assays to Screen Donors
------------------------------------------------------------------------
Recommendations for         July 26,  Do.         Do.         Do.
 Deferral of Donors for      1994
 Malaria Risk
------------------------------------------------------------------------
Office of Establishment     August    Do.         Do.         http://
 Licensing and Product       1994                              www.fda.g
 Surveillance (OELPS),                                         ov/cber/
 Advertising and                                               guideline
 Promotional Labeling                                          s.htm
 Staff, Procedural
 Guidance Document (Draft)
------------------------------------------------------------------------
Guidance for Industry for   November  Do.         Do.         Do.
 the Submission of           1994
 Chemistry, Manufacturing,
 and Controls Information
 for Synthetic Peptide
 Substances
------------------------------------------------------------------------
Recommendations to Users    December  Do.         Do.         http://
 of Medical Devices That     20,                               www.fda.g
 Test for Infectious         1994                              ov/cber/
 Disease Markers by Enzyme                                     memo.htm
 Immunoassay (EIA) Test
 Systems
------------------------------------------------------------------------
Timeframe for Licensing     February  Do.         Do.         Do.
 Irradiated Blood Products   3, 1995
------------------------------------------------------------------------
Revision of August 27,      March     Do.         Do.         Do.
 1982, FDA Memo:             10,
 Requirements for            1995
 Infrequent Plasmapheresis
 Donors
------------------------------------------------------------------------
To All Licensed             March     Do.         Do.         Do.
 Establishments Performing   14,
 Red Blood Cell              1995
 Immunizations: Revised
 Recommendations for Red
 Blood Cell Immunization
 Programs for Source
 Plasma Donors
------------------------------------------------------------------------
Recommendations for the     June 8,   Do.         Do.         Do.
 Deferral of Current and     1995
 Recent Inmates of
 Correctional Institutions
 as Donors of Whole Blood,
 Blood Components, Source
 Leukocytes, and Source
 Plasma
------------------------------------------------------------------------
Guideline for Quality       July 11,  Do.         Do.         http://
 Assurance in Blood          1995                              www.fda.g
 Establishments                                                ov/cber/
                                                               guideline
                                                               s.htm
------------------------------------------------------------------------
FDA Guidance Document       July 11,  Do.         Do.         Do.
 Concerning Use of Pilot     1995
 Manufacturing Facilities
 for the Development and
 Manufacture of Biological
 Products
------------------------------------------------------------------------
Recommendations for         August    Do.         Do.         http://
 Labeling and Use of Units   8, 1995                           www.fda.g
 of Whole Blood, Blood                                         ov/cber/
 Components, Source                                            memo.htm
 Plasma, Recovered Plasma,
 or Source Leukocytes
 Obtained From Donors With
 Elevated Levels of
 Alanine Aminotransferase
 (ALT)
------------------------------------------------------------------------
Recommendations for Donor   August    Do.         Do.         Do.
 Screening With a Licensed   8, 1995
 Test for HIV-1 Antigen
------------------------------------------------------------------------
PTC in the Manufacture and  1995      Do.         Do.         http://
 Testing of Therapeutic                                        www.fda.g
 Products for Human Use                                        ov/cber/
 Derived From Transgenic                                       guideline
 Animals                                                       s.htm
------------------------------------------------------------------------
Draft Reviewers' Guide:     October   FDA         Do.         Do.
 Informed Consent for        1, 1995   personnel
 Plasmapheresis/
 Immunization
------------------------------------------------------------------------
Draft Reviewers' Guide:     October   Do.         Do.         Do.
 Disease Associated          1, 1995
 Antibody Collection
 Program
------------------------------------------------------------------------
Draft Document Concerning   December  Do.         Do.         http://
 the Regulation of           1995                              www.fda.g
 Placental/Umbilical Cord                                      ov/cber/
 Blood Stem Cell Products                                      memo.htm
 Intended for
 Transplantation or
 Further Manufacturing
 Into Injectable Products
------------------------------------------------------------------------

[[Page 829]]

 
Donor Deferral Due to Red   December  FDA         Do.         Do.
 Blood Cell Loss During      4, 1995   regulated
 Collection of Source                  industry
 Plasma by Automated
 Plasmapheresis
------------------------------------------------------------------------
Draft Document Concerning   February  Do.         Do.         Do.
 the Regulation of           1996
 Peripheral Blood
 Hematopoietic Stem Cell
 Products Intended for
 Transplantation or
 Further Manufacturing
 Into Injectable Products
------------------------------------------------------------------------
International Conference    February  Do.         Do.         http://
 on Harmonisation (ICH)      23,                               www.fda.g
 Final Guideline on          1996                              ov/cber/
 Quality of                                                    guideline
 Biotechnological                                              s.htm
 Products: Analysis of the
 Expression Construct in
 Cells Used for Production
 of r-DNA Derived Protein
 Products
------------------------------------------------------------------------
ICH Final Guideline on the  March 1,  Do.         Do.         Do.
 Need for Long-Term Rodent   1996
 Carcinogenicity Studies
 of Pharmaceuticals
------------------------------------------------------------------------
Additional Recommendations  March     Do.         Do.         http://
 for Donor Screening With    14,                               www.fda.g
 a Licensed Test for HIV-1   1996                              ov/cber/
 Antigen                                                       memo.htm
------------------------------------------------------------------------
FDA Guidance Concerning     April     Do.         Do.         http://
 Demonstration of            1996                              www.fda.g
 Comparability of Human                                        ov/cber/
 Biological Products,                                          guideline
 Including Therapeutic                                         s.htm
 Biotechnology-Derived
 Products
------------------------------------------------------------------------
Additional Recommendations  May 16,   Do.         Do.         http://
 for Testing Whole Blood,    1996                              www.fda.g
 Blood Components, Source                                      ov/cber/
 Plasma, and Source                                            memo.htm
 Leukocytes for Antibody
 to Hepatitis C Virus
 Encoded Antigen (Anti-
 HCV)
------------------------------------------------------------------------
Guidance for Industry--The  May 1996  Do.         Do.         http://
 Content and Format for                                        www.fda.g
 Pediatric Use Supplements                                     ov/cber/
                                                               guideline
                                                               s.htm
------------------------------------------------------------------------
Guidance on Applications    May 1996  Do.         Do.         Do.
 for Products Comprised of
 Living Autologous Cells
 Manipulated Ex Vivo and
 Intended for Structural
 Repair or Reconstruction
------------------------------------------------------------------------
Recommendations and         May 29,   Do.         Do.         http://
 Licensure Requirements      1996                              www.fda.g
 for Leukocyte-Reduced                                         ov/cber/
 Blood Products                                                memo.htm
------------------------------------------------------------------------
ICH Final Guidelines on     July 10,  Do.         Do.         http://
 Stablity Testing of         1996                              www.fda.g
 Biotechnological/                                             ov/cber/
 Biological Products                                           guideline
                                                               s.htm
------------------------------------------------------------------------
Recommendations for the     July 19,  Do.         Do.         http://
 Quarantine and              1996                              www.fda.g
 Disposition of Units From                                     ov/cber/
 Prior Collections From                                        memo.htm
 Donors With Repeatedly
 Reactive Screening Tests
 for Hepatitis B Virus
 (HBV), Hepatitis C Virus
 (HCV), and Human T-
 Lymphotropic Virus Type I
 (HTLV-I)
------------------------------------------------------------------------
Guidance for Industry for   August    Do.         Do.         http://
 the Submission of           1996                              www.fda.g
 Chemistry, Manufacturing,                                     ov/cber/
 and Controls Information                                      guideline
 for a Therapeutic                                             s.htm
 Recombinant DNA-Derived
 Product or a Monoclonal
 Antibody Product for In
 Vivo Use
------------------------------------------------------------------------
Interim Recommendations     December  Do.         Do.         http://
 for Deferral of Donors at   11,                               www.fda.g
 Increased Risk for HIV-1    1996                              ov/cber/
 Group O Infection                                             memo.htm
------------------------------------------------------------------------
PTC on Plasmid DNA          December  Do.         Do.         http://
 Vaccines for Preventive     1996                              www.fda.g
 Infectious Disease                                            ov/cber/
 Indications                                                   guideline
                                                               s.htm
------------------------------------------------------------------------
Guidance for the            January   Do.         Do.         Do.
 Submission of Chemistry,    1997
 Manufacturing, and
 Controls Information and
 Establishment Description
 for Autologous Somatic
 Cell Therapy Products
------------------------------------------------------------------------
Reviewer Guidance for a     January   FDA         Do.         Do.
 Premarket Notification      13,       personnel
 Submission for Blood        1997
 Establishment Computer
 Software
------------------------------------------------------------------------

[[Page 830]]

 
PTC in the Manufacture and  February  FDA         Do.         Do.
 Testing of Monoclonal       28,       regulated
 Antibody Products for       1997      industry
 Human Use
------------------------------------------------------------------------
Proposed Approach to        February  Do.         Do.         Do.
 Regulation of Cellular      28,
 and Tissue-Based Products   1997
------------------------------------------------------------------------
Guidance for Industry for   April     Do.         Do.         Do.
 the Evaluation of           1997
 Combination Vaccines for
 Preventable Diseases:
 Production, Testing, and
 Clinical Studies
------------------------------------------------------------------------
ICH Guidelines for the      May 16,   Do.         Do.         Do.
 Photostability Testing of   1997
 New Drug Substances and
 Products
------------------------------------------------------------------------
Guidance for Industry:      July      Do.         Do.         Do.
 Changes to an Approved      1997
 Application: Biological
 Products
------------------------------------------------------------------------
Guidance for Industry:      July      Do.         Do.         Do.
 Changes to an Approved      1997
 Application for Specified
 Biotechnology and
 Specified Synthetic
 Biological Products
------------------------------------------------------------------------
Guidance for Industry:      July      Do.         Do.         Do.
 Screening and Testing of    1997
 Donors of Human Tissue
 Intended for
 Transplantation
------------------------------------------------------------------------
Guidance for Industry:      August    Do.         Do.         Do.
 Donor Screening for         1997
 Antibodies to HTLV-II
------------------------------------------------------------------------
Guidance for Industry:      August    Do.         Do.         Do.
 Postmarketing Adverse       1997
 Experience Reporting for
 Human Drug and Licensed
 Biological Products:
 Clarification of What to
 Report
------------------------------------------------------------------------
Guidance for Industry: The  Septembe  Do.         Do.         Do.
 Sourcing and Processing     r 1997
 of Gelatin to Reduce the
 Potential Risk Posed by
 Bovine Spongiform
 Encephalopathy (BSE) in
 FDA-Regulated Products
 for Human Use
------------------------------------------------------------------------
Guidance for FDA and        November  FDA         Do.         Do.
 Industry: Direct Final      21,       personnel
 Rule Procedures             1997      and
                                       regulated
                                       industry
------------------------------------------------------------------------
Draft Guidance for          December  FDA         Do.         Do.
 Industry: Promoting         1997      regulated
 Medical Products in a                 industry
 Changing Healthcare
 Environment; I. Medical
 Product Promotion by
 Healthcare Organizations
 or Pharmacy Benefits
 Management Companies
 (PBMs)
------------------------------------------------------------------------
Guidance for Industry:      November  Do.         Do.         Do.
 Industry-Supported          1997
 Scientific and
 Educational Activities
------------------------------------------------------------------------
Guidance for Industry:      January   Do.         Do.         Do.
 Year 2000 Date Change for   1998
 Computer Systems and
 Software Applications
 Used in the Manufacture
 of Blood Products
------------------------------------------------------------------------
Draft Guidance for          January   Do.         Do.         Do.
 Industry: Container and     28,
 Closure Integrity Testing   1998
 In Lieu of Sterility
 Testing as a Component of
 the Stability Protocol
 for Sterile Products
------------------------------------------------------------------------
Draft Guidance for          March     Do.         Do.         Do.
 Industry: Manufacturing,    1998
 Processing, or Holding
 Active Pharmaceutical
 Ingredients
------------------------------------------------------------------------
Guidance for Industry:      March     Do.         Do.         Do.
 Guidance for Human          1998
 Somatic Cell Therapy and
 Gene Therapy
------------------------------------------------------------------------
Draft Guidance for          May 1998  Do.         Do.         Do.
 Industry: Instructions
 for Submitting Electronic
 Lot Release Protocols to
 CBER
------------------------------------------------------------------------

[[Page 831]]

 
Guidance for Industry:      May 14,   Do.         Do.         Do.
 Classifying Resubmissions   1998
 in Response to Action
 Letters
------------------------------------------------------------------------
Guidance for Industry:      May 1998  Do.         Do.         Do.
 Pharmacokinetics in
 Patients With Impaired
 Renal Function--Study
 Design, Data Analysis,
 and Impact on Dosing and
 Labeling
------------------------------------------------------------------------
Guidance for Industry:      May 15,   Do.         Do.         Do.
 Standards for the Prompt    1998
 Review of Efficacy
 Supplements, Including
 Priority Efficacy
 Supplements
------------------------------------------------------------------------
Guidance for Industry:      May 1998  Do.         Do.         Do.
 Providing Clinical
 Evidence of Effectiveness
 for Human Drugs and
 Biological Products
------------------------------------------------------------------------
Draft Guidance for          June      Do.         Do.         Do.
 Industry: Stability         1998
 Testing of Drug
 Substances and Drug
 Products
------------------------------------------------------------------------
Guidance for Industry:      June      Do.         Do.         Do.
 Errors and Accidents        1998
 Regarding Saline Dilution
 of Samples Used for Viral
 Marker Testing
------------------------------------------------------------------------
ICH Guidance on Ethnic      June 10,  Do.         Do.         Do.
 Factors in the              1998
 Acceptability of Foreign
 Clinical Data
------------------------------------------------------------------------
Draft Guidance for          June 12,  Do.         Do.         Do.
 Industry: Exports and       1998
 Imports Under the FDA
 Export Reform and
 Enhancement Act of 1996
------------------------------------------------------------------------
Guidance for Industry:      July      Do.         Do.         Do.
 Implementation of Section   1998
 126 of the Food and Drug
 Administration
 Modernization Act of
 1997--Elimination of
 Certain Labeling
 Requirements
------------------------------------------------------------------------
Guidance for Industry:      July      Do.         Do.         Do.
 Environmental Assessment    1998
 of Human Drug and
 Biologics Applications
------------------------------------------------------------------------
Draft Guidance for          Septembe  Do.         Do.         Do.
 Industry: Submitting        r 1998
 Debarment Certification
 Statements
------------------------------------------------------------------------
Guidance for Industry: How  Septembe  Do.         Do.         Do.
 to Complete the Vaccine     r 1998
 Adverse Event Reporting
 System Form (VAERS-1)
------------------------------------------------------------------------
Guidance for Industry:      July      Do.         Do.         Do.
 Fast Track Drug             2004
 Development Programs--
 Designation, Development,
 and Application Review
------------------------------------------------------------------------
ICH Guidance on             Septembe  Do.         Do.         Do.
 Statistical Principles      r 16,
 for Clinical Trials         1998
------------------------------------------------------------------------
ICH Guidance on Quality of  Septembe  Do.         Do.         Do.
 Biotechnological/           r 21,
 Biological Products:        1998
 Derivation and
 Characterization of Cell
 Substrates Used for
 Production of
 Biotechnological/
 Biological Products
------------------------------------------------------------------------
ICH Guidance on Viral       Septembe  Do.         Do.         Do.
 Safety Evaluation of        r 24,
 Biotechnology Products      1998
 Derived From Cell Lines
 of Human or Animal Origin
------------------------------------------------------------------------
Draft Guidance for          November  Do.         Do.         Do.
 Industry: General           1998
 Considerations for
 Pediatric Pharmacokinetic
 Studies for Drugs and
 Biological Products
------------------------------------------------------------------------
Guidance for Industry: FDA  December  Do.         Do.         Do.
 Approval of New Cancer      1998
 Treatment Uses for
 Marketed Drug and
 Biological Products
------------------------------------------------------------------------
Draft Guidance for          January   Do.         Do.         Do.
 Industry: Product Name      1999
 Placement, Size, and
 Prominence in Advertising
 and Promotional Labeling
------------------------------------------------------------------------

[[Page 832]]

 
Guidance for Industry:      January   Do.         Do.         Do.
 Content and Format of       1999
 Chemistry, Manufacturing,
 and Controls Information
 and Establishment
 Description Information
 for a Vaccine or Related
 Product
------------------------------------------------------------------------
Guidance on Amended         January   Do.         Do.         Do.
 Procedures for Advisory     26,
 Panel Meetings              1999
------------------------------------------------------------------------
Draft Guidance for          October   Do.         Do.         http://
 Industry; Providing         2003                              www.fda.g
 Regulatory Submissions in                                     ov/cber/
 Electronic Format--                                           esub/
 General Considerations                                        esubguid.
                                                               htm
------------------------------------------------------------------------
Guidance for Industry:      February  Do.         Do.         http://
 Population                  1999                              www.fda.g
 Pharmacokinetics                                              ov/cber/
                                                               guideline
                                                               s.htm
------------------------------------------------------------------------
Guidance for Industry:      February  Do.         Do.         Do.
 Clinical Development        1999
 Programs for Drugs,
 Devices, and Biological
 Products for the
 Treatment of Rheumatoid
 Arthritis (RA)
------------------------------------------------------------------------
Guidance for Industry: For  February  Do.         Do.         Do.
 the Submission of           1999
 Chemistry, Manufacturing,
 and Controls and
 Establishment Description
 Information for Human
 Plasma-Derived Biological
 Products, Animal Plasma,
 or Serum-Derived Products
------------------------------------------------------------------------
Draft Guidance for          March     Do.         Do.         Do.
 Industry: Accelerated       1999
 Approval Products--
 Submission of Promotional
 Materials
------------------------------------------------------------------------
Guidance for Industry:      March     Do.         Do.         Do.
 Content and Format of       1999
 Chemistry, Manufacturing,
 and Controls Information
 and Establishment
 Description Information
 for a Biological In Vitro
 Diagnostic Product
------------------------------------------------------------------------
Guidance for Industry:      April     Do.         Do.         Do.
 Public Health Issues        1999
 Posed by the Use of
 Nonhuman Primate
 Xenografts in Humans
------------------------------------------------------------------------
Guidance for Industry on    April     Do.         Do.         Do.
 the Content and Format of   1999
 Chemistry, Manufacturing,
 and Controls Information
 and Establishment
 Description Information
 for an Allergenic Extract
 or Allergen Patch Test
------------------------------------------------------------------------
Guidance for Industry for   May 1999  Do.         Do.         Do.
 the 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
 Form FDA 356h
 ``Application to Market a
 New Drug, Biologic, or an
 Antibiotic Drug for Human
 Use''
------------------------------------------------------------------------
Draft Guidance for          May 1999  Do.         Do.         Do.
 Industry for Platelet
 Testing and Evaluation of
 Platelet Substitute
 Products
------------------------------------------------------------------------
Guidance for Industry:      May 1999  Do.         Do.         Do.
 Efficacy Studies to
 Support Marketing of
 Fibrin Sealant Products
 Manufactured for
 Commercial Use
------------------------------------------------------------------------
Draft Reviewer Guidance:    June      FDA         Do.         Do.
 Evaluation of Human         1999      personnel
 Pregnancy Outcome Data
------------------------------------------------------------------------
Draft Guidance for          June      FDA         Do.         Do.
 Industry: Current Good      1999      regulated
 Manufacturing Practice                industry
 for Blood and Blood
 Components: (1)
 Quarantine and
 Disposition of Prior
 Collections From Donors
 With Repeatedly Reactive
 Screening Tests for
 Hepatitis C Virus (HCV);
 (2) Supplemental Testing,
 and the Notification of
 Consignees and
 Transfusion Recipients of
 Donor Test Results for
 Antibody to HCV (Anti-
 HCV)
------------------------------------------------------------------------

[[Page 833]]

 
ICH Guidance on the         June 25,  Do.         Do.         Do.
 Duration of Chronic         1999
 Toxicity Testing in
 Animals (Rodent and
 Nonrodent Toxicity
 Testing)
------------------------------------------------------------------------
Draft Guidance for          July      Do.         Do.         Do.
 Industry: Clinical          1999
 Development Programs for
 Drugs, Devices, and
 Biological Products
 Intended for the
 Treatment of
 Osteoarthritis (OA)
------------------------------------------------------------------------
Draft Guidance for          July      Do.         Do.         Do.
 Industry: Interpreting      1999
 Sameness of Monoclonal
 Antibody Products Under
 the Orphan Drug
 Regulations
------------------------------------------------------------------------
Draft Guidance for          August    Do.         Do.         Do.
 Industry: Cooperative       1999
 Manufacturing
 Arrangements for Licensed
 Biologics
------------------------------------------------------------------------
Guidance for Industry:      August    Do.         Do.         Do.
 Consumer-Directed           1999
 Broadcast Advertisements
------------------------------------------------------------------------
Guidance for Industry:      August    Do.         Do.         Do.
 Possible Dioxin/PCB         1999
 Contamination of Drug and
 Biological Products
------------------------------------------------------------------------
Guidance for Industry:      August    Do.         Do.         Do.
 Submission of Abbreviated   1999
 Reports and Synopses in
 Support of Marketing
 Applications
------------------------------------------------------------------------
ICH Guidance on             August    Do.         Do.         Do.
 Specifications: Test        18,
 Procedures and Acceptance   1999
 Criteria for
 Biotechnological/
 Biological Products
------------------------------------------------------------------------
Guidance for Industry:      Septembe  Do.         Do.         Do.
 Qualifying for Pediatric    r 1999
 Exclusivity Under Section
 505A of the Federal Food,
 Drug, and Cosmetic Act
------------------------------------------------------------------------
Guidance for Industry:      November  Do.         Do.         Do.
 Providing Regulatory        1999
 Submissions to CBER in
 Electronic Format--
 Biologics Marketing
 Applications (Biologics
 License Application
 (BLA), Product License
 Application (PLA)/
 Establishment License
 Application (ELA), and
 New Drug Application
 (NDA)); revised
------------------------------------------------------------------------
Guidance for Industry: In   November  Do.         Do.         Do.
 Vivo Drug Metabolism/Drug   1999
 Interaction Studies--
 Study Design, Data
 Analysis, and
 Recommendations for
 Dosing and Labeling
------------------------------------------------------------------------
ICH of Technical            November  Do.         Do.         Do.
 Requirements for            8, 1999
 Registration of
 Pharmaceuticals for Human
 Use; M4: Common Technical
 Document
------------------------------------------------------------------------
Guidance for Industry: In   December  Do.         Do.         Do.
 the Manufacture and         1999
 Clinical Evaluation of In
 Vitro Tests to Detect
 Nucleic Acid Sequences of
 Human Immunodeficiency
 Viruses Types 1 and 2
------------------------------------------------------------------------
Guidance for Reviewers:     November  FDA         Do.         Do.
 Potency Limits for          2000      personnel
 Standardized Dust Mite
 and Grass Allergen
 Vaccines: A Revised
 Protocol
------------------------------------------------------------------------
Guidance for Industry:      February  FDA         Do.         Do.
 Formal Meetings With        2000      regulated
 Sponsors and Applicants               industry
 for PDUFA Products
------------------------------------------------------------------------
Guidance for Industry:      February  Do.         Do.         Do.
 Formal Dispute              2000
 Resolution: Appeals Above
 the Division Level
------------------------------------------------------------------------
Guidance for Industry:      February  Do.         Do.         Do.
 Gamma Irradiation of        2000
 Blood and Blood
 Components: A Pilot
 Program for Licensing
------------------------------------------------------------------------

[[Page 834]]

 
Draft Guidance for          May 2000  Do.         Do.         Do.
 Industry: Content and
 Format of the Adverse
 Reactions Section of
 Labeling for Human
 Prescription Drugs and
 Biologics
------------------------------------------------------------------------
Guidance for Industry:      June      Do.         Do.         Do.
 Recognition and Use of a    2000
 Standard for the Uniform
 Labeling of Blood and
 Blood Components
------------------------------------------------------------------------
Draft Guidance for          June      Do.         Do.         Do.
 Industry: Recommendations   2000
 for Donor Questioning
 Regarding Possible
 Exposure to Malaria
------------------------------------------------------------------------
Draft Guidance for          June      Do.         Do.         Do.
 Industry: Pediatric         2000
 Oncology Studies in
 Response to a Written
 Request
------------------------------------------------------------------------
Guidance for Industry:      June      Do.         Do.         Do.
 Availability of Licensed    2000
 Donor Screening Tests
 Labeled for Use With
 Cadaveric Blood Specimens
------------------------------------------------------------------------
Draft Guidance for          June      Do.         Do.         Do.
 Industry: Chronic           2000
 Cutaneous Ulcer and Burn
 Wounds--Developing
 Products for Treatment
------------------------------------------------------------------------
Draft Guidance for          August    Do.         Do.         Do.
 Industry: Analytical        2000
 Procedures and Methods
 Validation--Chemistry,
 Manufacturing, and
 Controls Documentation
------------------------------------------------------------------------
Draft Guidance for          August    Do.         Do.         Do.
 Industry: Considerations    2000
 for Reproductive Toxicity
 Studies for Preventive
 Vaccines for Infectious
 Disease Indications
------------------------------------------------------------------------
Guidance for Industry: Q &  October   Do.         Do.         Do.
 A Content and Format of     2000
 INDs for Phase 1 Studies
 of Drugs, Including Well-
 Characterized,
 Therapeutic,
 Biotechnology-Derived
 Products
------------------------------------------------------------------------
Guidance for Industry:      October   Do.         Do.         Do.
 Supplemental Guidance on    2000
 Testing for Replication
 Competent Retrovirus in
 Retroviral Vector Based
 Gene Therapy Products and
 During Followup of
 Patients in Clinical
 Trials Using Retroviral
 Vectors
------------------------------------------------------------------------
Guidance for Industry:      October   Do.         Do.         Do.
 Submitting and Reviewing    2000
 Complete Responses to
 Clinical Holds
------------------------------------------------------------------------
Guidance for Industry:      November  Do.         Do.         Do.
 Testing Limits in           2000
 Stability Protocols for
 Standardized Grass Pollen
 Extracts
------------------------------------------------------------------------
Guidance for Industry: Use  November  Do.         Do.         Do.
 of Sterile Connecting       2000
 Devices in Blood Bank
 Practices
------------------------------------------------------------------------
Draft Guidance for          November  Do.         Do.         Do.
 Industry: Recommendations   2000
 for Complying With the
 Pediatric Rule (21 CFR
 314.55(a) and 601.27(a))
------------------------------------------------------------------------
ICH Guidance for Industry:  December  Do.         Do.         Do.
 E11 Clinical                2000
 Investigation of
 Medicinal Products in the
 Pediatric Population
------------------------------------------------------------------------
Guidance for Industry:      December  Do.         Do.         Do.
 Submitting Separate         2000
 Marketing Applications
 and Clinical Data for
 Purposes of Assessing
 User Fees
------------------------------------------------------------------------
ICH Guidance on Q6A         December  Do.         Do.         Do.
 Specifications: Test        29,
 Procedures and Acceptance   2000
 Criteria for New Drug
 Substances and New Drug
 Products: Chemical
 Substances
------------------------------------------------------------------------
PHS Guideline on            January   Do.         Do.         Do.
 Infectious Disease Issues   19,
 in Xenotransplantation      2001
------------------------------------------------------------------------

[[Page 835]]

 
Draft Guidance for          January   Do.         Do.         Do.
 Industry: Pre-Storage       2001
 Leukocyte Reduction of
 Whole Blood and Blood
 Components Intended for
 Transfusion
------------------------------------------------------------------------
Guidance for Industry:      January   Do.         Do.         Do.
 Recommendations for         2001
 Collecting Red Blood
 Cells by Automated
 Apheresis Methods
------------------------------------------------------------------------
Draft Guidance for          January   Do.         Do.         Do.
 Industry: Providing         2001
 Regulatory Submissions in
 Electronic Format--
 Prescription Drug
 Advertising and
 Promotional Labeling
------------------------------------------------------------------------
Guidance for Industry:      February  Do.         Do.         Do.
 Recommendations for         2001
 Collecting Red Blood
 Cells by Automated
 Apheresis Methods--
 Technical Correction
------------------------------------------------------------------------
Draft Guidance for          February  Do.         Do.         Do.
 Industry: Disclosing        2001
 Information Provided to
 Advisory Committees in
 Connection With Open
 Advisory Committee
 Meetings Related to the
 Testing or Approval of
 Biologic Products and
 Convened by the Center
 for Biologics Evaluation
 and Research
------------------------------------------------------------------------
Draft Guidance for          March     Do.         Do.         Do.
 Industry: Postmarketing     2001
 Safety Reporting for
 Human Drug and Biological
 Products Including
 Vaccines
------------------------------------------------------------------------
Guidance for Industry:      March     Do.         Do.         Do.
 Acceptance of Foreign       2001
 Clinical Studies
------------------------------------------------------------------------
Guidance for Industry:      March     Do.         Do.         Do.
 Financial Disclosure by     2001
 Clinical Investigators
------------------------------------------------------------------------
Guidance for Industry:      March     Do.         Do.         Do.
 Monoclonal Antibodies       2001
 Used as Reagents in Drug
 Manufacturing
------------------------------------------------------------------------
Draft Guidance for          April     Do.         Do.         Do.
 Industry: Reports on the    2001
 Status of Postmarketing
 Studies--Implementation
 of Section 130 of the
 Food and Drug
 Administration
 Modernization Act of 1997
------------------------------------------------------------------------
Draft Guidance for          May 2001  Do.         Do.         Do.
 Industry: Providing
 Regulatory Submissions in
 Electronic Format--
 Postmarketing Expedited
 Safety Reports
------------------------------------------------------------------------
Guidance for Industry: E10  May 2001  Do.         Do.         Do.
 Choice of Control Group
 and Related Issues in
 Clinical Trials
------------------------------------------------------------------------
Draft Guidance for          May 2001  Do.         Do.         Do.
 Industry: IND Meetings
 for Human Drugs and
 Biologics; Chemistry,
 Manufacturing, and
 Controls Information
------------------------------------------------------------------------
Draft Guidance for          July      Do.         Do.         Do.
 Industry: Clinical          2001
 Studies Section of
 Labeling for Prescription
 Drugs and Biologics--
 Content and Format
------------------------------------------------------------------------
Guidance for Industry:      July      Do.         Do.         Do.
 CBER Pilot Licensing        2001
 Program for Immunization
 of Source Plasma Donors
 Using Immunogen Red Blood
 Cells Obtained From an
 Outside Supplier
------------------------------------------------------------------------
Guidance for Industry:      July      Do.         Do.         Do.
 Revised Recommendations     2001
 Regarding Invalidation of
 Test Results of Licensed
 and 510(k) Cleared
 Bloodborne Pathogen
 Assays Used to Test
 Donors
------------------------------------------------------------------------
ICH Guidance for Industry:  July      Do.         Do.         Do.
 S7A Safety Pharmacology     2001
 Studies for Human
 Pharmaceuticals
------------------------------------------------------------------------

[[Page 836]]

 
Guidance for FDA            July      Do.         Do.         Do.
 Reviewers: Premarket        2001
 Notification Submissions
 for Empty Containers for
 the Collection and
 Processing of Blood and
 Blood Components
------------------------------------------------------------------------
Guidance for FDA            July      Do.         Do.         Do.
 Reviewers: Premarket        2001
 Notification Submissions
 for Transfer Sets
 (Excluding Sterile
 Connecting Devices)
------------------------------------------------------------------------
Guidance for FDA            July      Do.         Do.         Do.
 Reviewers: Premarket        2001
 Notification Submissions
 for Blood and Plasma
 Warmers
------------------------------------------------------------------------
Guidance for Industry:      July      Do.         Do.         Do.
 Changes to an Approved      2001
 Application: Biological
 Products: Human Blood and
 Blood Components Intended
 for Transfusion or for
 Further Manufacture
------------------------------------------------------------------------
Draft Guidance for FDA      August    Do.         Do.         Do.
 Reviewers: Premarket        2001
 Notification Submissions
 for Automated Testing
 Instruments Used in Blood
 Establishments
------------------------------------------------------------------------
Draft Guidance for          August    Do.         Do.         Do.
 Industry: Biological        2001
 Product Deviation
 Reporting for Licensed
 Manufacturers of
 Biological Products Other
 Than Blood and Blood
 Components
------------------------------------------------------------------------
Draft Guidance for          August    Do.         Do.         Do.
 Industry: Biological        2001
 Product Deviation
 Reporting for Blood and
 Plasma Establishments
------------------------------------------------------------------------
Guidance for Industry:      August    Do.         Do.         Do.
 Variances for Blood         2001
 Collection From
 Individuals With
 Hereditary
 Hemochromatosis
------------------------------------------------------------------------
Draft Guidance for          August    Do.         Do.         Do.
 Industry: Submitting Type   2001
 V Drug Master Files to
 the CBER
------------------------------------------------------------------------
Draft Guidance for          August    Do.         Do.         Do.
 Industry: Premarket         2001
 Notifications (510(k)s)
 for In Vitro HIV Drug
 Resistance Genotype
 Assays: Special Controls
------------------------------------------------------------------------
Draft Guidance for          August    Do.         Do.         Do.
 Industry: Submitting        2001
 Marketing Applications
 According to the ICH-CTD
 Format--General
 Considerations
------------------------------------------------------------------------
ICH Guidance: Q7A Good      August    Do.         Do.         Do.
 Manufacturing Practice      2001
 Guide for Active
 Pharmaceutical
 Ingredients
------------------------------------------------------------------------
ICH Guidance on M4 Common   August    Do.         Do.         Do.
 Technical Document          2001
------------------------------------------------------------------------
Guidance for Industry:      October   Do.         Do.         Do.
 Cancer Drug and             2001
 Biological Products--
 Clinical Data in
 Marketing Applications
------------------------------------------------------------------------
Guidance for Industry:      October   Do.         Do.         Do.
 Content and Format of       2001
 Geriatric Labeling
------------------------------------------------------------------------
Guidance for Industry:      October   Do.         Do.         Do.
 Recommendations for         2001
 Assessment of Donor
 Suitability and Blood and
 Blood Product Safety in
 Cases of Possible
 Exposure to Anthrax
------------------------------------------------------------------------
Draft Guidance for          November  Do.         Do.         Do.
 Clinical Trial Sponsors     2001
 on the Establishment and
 Operation of Clinical
 Trial Data Monitoring
 Committees
------------------------------------------------------------------------
Guidance for Industry:      November  Do.         Do.         Do.
 Information Request and     2001
 Discipline Review Letters
 Under the Prescription
 Drug User Fee Act
------------------------------------------------------------------------

[[Page 837]]

 
Guidance for Industry:      January   Do.         Do.         Do.
 Revised Preventive          2002
 Measures to Reduce the
 Possible Risk of
 Transmission of
 Creutzfeldt-Jakob Disease
 (CJD) and Variant
 Creutzfeldt-Jakob Disease
 (vCJD) by Blood and Blood
 Products
------------------------------------------------------------------------
Guidance for Industry:      January   Do.         Do.         Do.
 General Principles of       2002
 Software Validation;
 Final Guidance for
 Industry and FDA Staff
------------------------------------------------------------------------
Draft Guidance for          February  Do.         Do.         Do.
 Industry: Precautionary     2002
 Measures to Reduce the
 Possible Risk of
 Transmission of Zoonoses
 by Blood and Blood
 Products From
 Xenotransplantation
 Product Recipients and
 Their Intimate Contacts
------------------------------------------------------------------------
Guidance for Industry:      March     Do.         Do.         Do.
 Validation of Procedures    2002
 for Processing of Human
 Tissues Intended for
 Transplantation
------------------------------------------------------------------------
Guidance for Industry;      March     Do.         Do.         http://
 Information Program on      2002                              www.fda.g
 Clinical Trials for                                           ov/cber/
 Serious or Life-                                              gdlns/
 Threatening Diseases and                                      clintrial
 Conditions                                                    031802.pd
                                                               f
------------------------------------------------------------------------
Guidance for Industry:      March     Do.         Do.         http://
 Providing Regulatory        2002                              www.fda.g
 Submissions to CBER in                                        ov/cber/
 Electronic Format--                                           guideline
 Investigational New Drug                                      s.htm
 Applications (INDs)
------------------------------------------------------------------------
Guidance for Industry:      April     Do.         Do.         Do.
 E2BM Data Elements for      2002
 Transmission of
 Individual Case Safety
 Reports
------------------------------------------------------------------------
Draft Guidance for          April     Do.         Do.         Do.
 Industry: A Modified Lot-   2002
 Release Specification for
 Hepatitis B Surface
 Antigen (HBsAg) Assays
 Used to Test Blood, Blood
 Components, and Source
 Plasma Donations
------------------------------------------------------------------------
Guidance for Industry:      May 1999  Do.         Do.         Do.
 Container Closure Systems
 for Packaging Human Drugs
 and Biologics; Chemistry,
 Manufacturing, and
 Controls Documentation
------------------------------------------------------------------------
Guidance for Industry:      May 2002  Do.         Do.         Do.
 Container Closure Systems
 for Packaging Human Drugs
 and Biologics; Questions
 and Answers
------------------------------------------------------------------------
Draft Guidelines for        May 2002  Do.         Do.         Do.
 Ensuring the Quality of
 Information Disseminated
 to the Public (HHS
 Guideline)
------------------------------------------------------------------------
Guidance for Industry:      May 2002  Do.         Do.         Do.
 Special Protocol
 Assessment
------------------------------------------------------------------------
Draft Guidance for          June      Do.         Do.         Do.
 Industry: Preventive        2002
 Measures to Reduce the
 Possible Risk of
 Transmission of
 Creutzfeldt-Jakob Disease
 (CJD) and Variant
 Creutzfeldt-Jakob Disease
 (vCJD) by Human Cells,
 Tissues, and Cellular and
 Tissue-Based Products
 (HCT/Ps)
------------------------------------------------------------------------
Draft Guidance for          August    Do.         Do.         Do.
 Industry: 21 CFR Part 11;   2002
 Electronic Records;
 Electronic Signatures,
 Electronic Copies of
 Electronic Records
------------------------------------------------------------------------
Guidance for Industry:      August    Do.         Do.         Do.
 Establishing Pregnancy      2002
 Exposure Registries
------------------------------------------------------------------------
Draft Guidance for          Septembe  Do.         Do.         Do.
 Industry: Drugs,            r 2002
 Biologics, and Medical
 Devices Derived From
 Bioengineered Plants for
 Use in Humans and Animals
------------------------------------------------------------------------
Draft Guidance for          Septembe  Do.         Do.         Do.
 Industry: Nonclinical       r 2002
 Studies for Development
 of Pharmaceutical
 Excipients
------------------------------------------------------------------------

[[Page 838]]

 
The Least Burdensome        October   Do.         Do.         Do.
 Provisions of the FDA       2002
 Modernization Act of
 1997: Concept and
 Principles; Final
 Guidance for FDA and
 Industry
------------------------------------------------------------------------
Guidance for Industry and   December  Do.         Do.         http://
 FDA Staff; Class II         18,                               www.fda.g
 Special Controls Guidance   2003                              ov/cber/
 Document: Human Dura                                          gdlns/
 Mater                                                         humdurama
                                                               t.pdf
------------------------------------------------------------------------
Guidance for Industry:      December  Do.         Do.         http://
 Recommendations for         2002                              www.fda.g
 Deferral of Donors and                                        ov/cber/
 Quarantine and Retrieval                                      guideline
 of Blood and Blood                                            s.htm
 Products in Recent
 Recipients of Smallpox
 Vaccine (Vaccinia Virus)
 and Certain Contacts of
 Smallpox Vaccine
 Recipients
------------------------------------------------------------------------
Draft Guidance for          December  Do.         Do.         Do.
 Industry and Reviewers on   2002
 Estimating the Safe
 Starting Dose in Clinical
 Trials for Therapeutics
 in Adult Healthy
 Volunteers
------------------------------------------------------------------------
ICH Guidance for Industry;  January   Do.         Do.         Do.
 Q1D Bracketing and          2003
 Matrixing Designs for
 Stability Testing of New
 Drug Substances and
 Products
------------------------------------------------------------------------
Draft Guidance for          January   Do.         Do.         Do.
 Industry: Collection of     2003
 Race and Ethnicity Data
 in Clinical Trials
------------------------------------------------------------------------
Draft Guidance for          January   Do.         Do.         Do.
 Industry: Drug Product:     2003
 Chemistry, Manufacturing,
 and Controls Information
------------------------------------------------------------------------
ICH Guidance for Industry:  February  Do.         Do.         Do.
 M4 CTD--Safety: Questions   2003
 and Answers
------------------------------------------------------------------------
Guidance for Industry and   February  Do.         Do.         Do.
 FDA Staff: Quality System   2003
 Information for Certain
 Premarket Application
 Reviews
------------------------------------------------------------------------
ICH Guidance for Industry:  February  Do.         Do.         Do.
 Q3A Impurities in New       2003
 Drug Substances
------------------------------------------------------------------------
Draft Guidance for          February  Do.         Do.         Do.
 Industry; Comparability     2003
 Protocols--Chemistry,
 Manufacturing, and
 Controls Information
------------------------------------------------------------------------
Assessing User Fees: PMA    February  Do.         Do.         http://
 Supplement Definitions,     25,                               www.fda.g
 Modular PMA Fees, BLA and   2003                              ov/cber/
 Efficacy Supplement                                           dap/
 Definitions, Bundling                                         devpubs.h
 Multiple Devices in a                                         tm
 Single Application, and
 Fees for Combination
 Products; Guidance for
 Industry and FDA
------------------------------------------------------------------------
Guidance for Industry and   March     Do.         Do.         http://
 FDA: FY 2003 MDUFMA Small   2003                              www.fda.g
 Business Qualification                                        ov/cber/
 Worksheet and                                                 guideline
 Certification                                                 s.htm
------------------------------------------------------------------------
ICH Guidance for Industry:  April     Do.         Do.         Do.
 M2 eCTD: Electronic         2003
 Common Technical Document
 Specification
------------------------------------------------------------------------
Guidance for Industry:      April     Do.         Do.         Do.
 Source Animal, Product,     2003
 Preclinical, and Clinical
 Issues Concerning the Use
 of Xenotransplantation
 Products in Humans
------------------------------------------------------------------------
Guidance for Industry:      April     Do.         Do.         Do.
 Recommendations for the     2003
 Assessment of Donor
 Suitability and Blood
 Product Safety in Cases
 of Suspected Severe Acute
 Respiratory Syndrome
 (SARS) or Exposure to
 SARS
------------------------------------------------------------------------
Guidance for Industry, FDA  October   Do.         Do.         http://
 Staff, and Third Parties;   4, 2004                           www.fda.g
 Implementation of the                                         ov/cber/
 Inspection by Accredited                                      dap/
 Persons Program Under the                                     devpubs.h
 Medical Device User Fee                                       tm
 and Modernization Act of
 2002; Accreditation
 Criteria
------------------------------------------------------------------------

[[Page 839]]

 
Guidance for Industry:      April     Do.         Do.         http://
 Exposure-Response           2003                              www.fda.g
 Relationships--Study                                          ov/cber/
 Design, Data Analysis,                                        guideline
 and Regulatory                                                s.htm
 Applications
------------------------------------------------------------------------
Guidance for Industry:      May 2003  Do.         Do.         Do.
 Revised Recommendations
 for the Assessment of
 Donor Suitability and
 Blood and Blood Product
 Safety in Cases of Known
 or Suspected West Nile
 Virus Infection
------------------------------------------------------------------------
Guidance for Industry:      May 2003  Do.         Do.         Do.
 Pharmacokinetics in
 Patients With Impaired
 Hepatic Function: Study
 Design, Data Analysis,
 and Impact on Dosing and
 Labeling
------------------------------------------------------------------------
Draft Guidance for          June      Do.         Do.         Do.
 Industry and FDA Staff:     2003
 Compliance with Section
 301 of the Medical Device
 User Fee and
 Modernization Act of
 2002--Identification of
 Manufacturer of Medical
 Devices
------------------------------------------------------------------------
Guidance for FDA Staff:     June      Do.         Do.         Do.
 The Leveraging Handbook,    2003
 An Agency Resource for
 Effective Collaborations
------------------------------------------------------------------------
Draft Guidance for          June      Do.         Do.         Do.
 Industry: Providing         2003
 Regulatory Submissions in
 Electronic Format--
 Postmarketing Periodic
 Adverse Drug Experience
 Reports
------------------------------------------------------------------------
Draft Guidance for          June      Do.         Do.         Do.
 Industry: Revised           2003
 Recommendations for Donor
 and Product Management
 Based on Screening Tests
 for Syphilis
------------------------------------------------------------------------
Guidance for Industry and   July      Do.         Do.         Do.
 FDA Staff: Medical Device   2003
 User Fee and
 Modernization Act of
 2002, Validation Data in
 Premarket Notification
 Submissions (510(k)s) for
 Reprocessed Single-Use
 Medical Devices
------------------------------------------------------------------------
Guidance for Industry:      July      Do.         Do.         Do.
 Streamlining the Donor      2003
 Interview Process:
 Recommendations for Self-
 Administered
 Questionnaires
------------------------------------------------------------------------
Draft Guidance for          July      Do.         Do.         Do.
 Industry and FDA Staff:     2003
 Premarket Assessment of
 Pediatric Medical Devices
------------------------------------------------------------------------
Draft Guidance for Review   July      Do.         Do.         Do.
 Staff and Industry: Good    2003
 Review Management
 Principles for PDUFA
 Products
------------------------------------------------------------------------
Compliance Program          Dates     Do.         Do.         http://
 Guidance Manual (drugs      vary--I                           www.fda.g
 and biologics)              ndividu                           ov/cber/
                             al                                cpg/
                             issue                             cpg.htm
                             dates
------------------------------------------------------------------------
ICH Guidance for Industry:  November  Do.         Do.         http://
 Q3C--Tables and List        2003                              www.fda.g
                                                               ov/cber/
                                                               guideline
                                                               s.htm
------------------------------------------------------------------------
ICH Guidance for Industry:  November  Do.         Do.         Do.
 Q3B(R) Impurities in New    2003
 Drug Products
------------------------------------------------------------------------
ICH Guidance for Industry:  November  Do.         Do.         Do.
 Q1A(R2) Stability Testing   2003
 of New Drug Substances
 and Products
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
WITHDRAWN GUIDANCES
------------------------------------------------------------------------
Draft Guidance for          November  Do.                   N/A
 Industry: Application of    1999
 Current Statutory
 Authority to Nucleic Acid
 Testing of Pooled Plasma
------------------------------------------------------------------------
Draft Document Concerning   December  Do.                   Do.
 the Regulation of           1995
 Placental/Umbilical Cord
 Blood Hematopoietic Stem
 Cell Products Intended
 for Transplantation or
 Further Manufacturing
 Into Injectable Products
------------------------------------------------------------------------

[[Page 840]]

 
Draft Document Concerning   February  Do.                   Do.
 the Regulation of           1996
 Peripheral Blood
 Hematopoietic Stem Cell
 Products Intended for
 Transplantation or
 Further Manufacturing
 into Injectable Products
------------------------------------------------------------------------
Draft Advertising and       August    Do.                   Do.
 Promotional Labeling        1994
 Staff Procedural Guidance
------------------------------------------------------------------------
Draft Guidance for          August    Do.                   Do.
 Industry: 21 CFR Part 11;   2001
 Electronic Records;
 Electronic Signatures;
 Validation
------------------------------------------------------------------------
Draft Guidance for          August    Do.                   Do.
 Industry: 21 CFR Part 11;   2001
 Electronic Records;
 Electronic Signatures;
 Glossary of Terms
------------------------------------------------------------------------
Draft Guidance for          February  Do.                   Do.
 Industry: 21 CFR Part 11;   2002
 Electronic Records;
 Electronic Signatures;
 Time Stamps
------------------------------------------------------------------------
Draft Guidance for          July      Do.                   Do.
 Industry: 21 CFR Part 11;   2002
 Electronic Records;
 Electronic Signatures,
 Maintenance of Electronic
 Records
------------------------------------------------------------------------


                    Guidance Documents Issued by CDER
------------------------------------------------------------------------
                                                   How to Obtain a Copy
                                       Intended       of the Document
     Name of Document        Date of    User or  -----------------------
                            Issuance  Regulatory    Mailing    Internet
                                       Activity     Address     Address
------------------------------------------------------------------------
Aerosol Steroid Product     January   Advertisin  Division    http://
 Safety Information in       12,       g           of Drug     www.fda.g
 Prescription Drug           1998                  Informati   ov/cder/
 Advertising and                                   on (HFD-    guidance/
 Promotional Labeling                              200),       index.htm
                                                   Office of
                                                   Training
                                                   and
                                                   Communica
                                                   tions,
                                                   Center
                                                   for Drug
                                                   Evaluatio
                                                   n and
                                                   Research,
                                                   Food and
                                                   Drug
                                                   Administr
                                                   ation,
                                                   5600
                                                   Fishers
                                                   Lane,
                                                   Rockville
                                                   , MD
                                                   20857,
                                                   301-827-4
                                                   573
------------------------------------------------------------------------
Consumer-Directed           August    Do.         Do.         Do.
 Broadcast Advertisements    9, 1999
------------------------------------------------------------------------
Industry-Supported          December  Do.         Do.         Do.
 Scientific and              3, 1997
 Educational Activities
------------------------------------------------------------------------
Accelerated Approval        March     Advertisin  Do.         Do.
 Products--Submission of     26,       g draft
 Promotional Materials       1999
------------------------------------------------------------------------
Brief Summary: Disclosing   February  Do.         Do.         Do.
 Risk Information in         10,
 Consumer-Directed Print     2004
 Advertisements
------------------------------------------------------------------------
``Help-Seeking'' and Other  February  Do.         Do.         Do.
 Disease Awareness           10,
 Communications by or on     2004
 Behalf of Drug and Device
 Firms
------------------------------------------------------------------------
Product Name Placement,     March     Do.         Do.         Do.
 Size, and Prominence in     12,
 Advertising and             1999
 Promotional Labeling
------------------------------------------------------------------------
Promoting Medical Products  January   Do.         Do.         Do.
 in a Changing Healthcare    5, 1998
 Environment; I. Medical
 Product Promotion by
 Healthcare Organizations
 or Pharmacy Benefits
 Management Companies
 (PBMs)
------------------------------------------------------------------------
Bioanalytical Method        May 23,   Biopharmac  Do.         Do.
 Validation                  2001      eutics
------------------------------------------------------------------------

[[Page 841]]

 
Bioavailability and         March     Do.         Do.         Do.
 Bioequivalence Studies      19,
 for Orally Administered     2003
 Drug Products--General
 Considerations
------------------------------------------------------------------------
Cholestyramine Powder In    July 15,  Do.         Do.         Do.
 Vitro Bioequivalence        1993
------------------------------------------------------------------------
Clozapine Tablets In Vivo   November  Do.         Do.         Do.
 Bioequivalence and In       15,
 Vitro Dissolution Testing   1996
------------------------------------------------------------------------
Corticosteroids,            June 2,   Do.         Do.         Do.
 Dermatologic (topical) In   1995
 Vivo
------------------------------------------------------------------------
Dissolution Testing of      August    Do.         Do.         Do.
 Immediate Release Solid     25,
 Oral Dosage Forms           1997
------------------------------------------------------------------------
Extended Release Oral       Septembe  Do.         Do.         Do.
 Dosage Forms:               r 26,
 Development, Evaluation,    1997
 and Application of In
 Vitro/In Vivo
 Correlations
------------------------------------------------------------------------
Food-Effect                 December  Do.         Do.         Do.
 Bioavailability and Fed     2002
 Bioequivalence Studies
------------------------------------------------------------------------
Metaproterenol Sulfate and  June 27,  Do.         Do.         Do.
 Albuterol Metered Dose      1989
 Inhalers In Vitro
------------------------------------------------------------------------
Phenytoin/Phenytion Sodium  March 4,  Do.         Do.         Do.
 (capsules, tablets,         1994
 suspension) In Vivo
 Bioequivalence and In
 Vitro Dissolution Testing
------------------------------------------------------------------------
Statistical Approaches to   February  Do.         Do.         Do.
 Establishing                2, 2001
 Bioequivalence
------------------------------------------------------------------------
Waiver of In Vivo           August    Do.         Do.         Do.
 Bioavailability and         31,
 Bioequivalence Studies      2000
 for Immediate-Release
 Solid Oral Dosage Forms
 Based on a
 Biopharmaceutics
 Classification System
------------------------------------------------------------------------
Antifungal (topical)        February  Biopharmac  Do.         N/A
                             24,       eutics
                             1990      draft
------------------------------------------------------------------------
Antifungal (vaginal)        February  Do.         Do.         Do.
                             24,
                             1990
------------------------------------------------------------------------
Bioavailability and         April     Do.         Do.         http://
 Bioequivalence Studies      2003                              www.fda.g
 for Nasal Aerosols and                                        ov/cder/
 Nasal Sprays for Local                                        guidance/
 Action                                                        index.htm
------------------------------------------------------------------------
Clozapine Tablets: In Vivo  December  Do.         Do.         Do.
 Bioequivalence and In       2003
 Vitro Dissolution Testing
------------------------------------------------------------------------
Conjugated Estrogens, USP-  March     Do.         Do.         Do.
 LC-MS Method for Both       2000
 Qualitative Chemical
 Characterization and
 Documentation of
 Qualitative
 Pharmaceutical
 Equivalence
------------------------------------------------------------------------
BACPAC I: Intermediates in  February  Chemistry   Do.         http://
 Drug Substance Synthesis:   16,                               www.fda.g
 Bulk Actives Postapproval   2001                              ov/cder/
 Changes: Chemistry,                                           guidance/
 Manufacturing, and                                            index.htm
 Controls Documentation
------------------------------------------------------------------------
Changes to an Approved      July 24,  Do.         Do.         Do.
 Application for Specified   1997
 Biotechnology and
 Specified Synthetic
 Biological Products
------------------------------------------------------------------------
Changes to an Approved NDA  April     Do.         Do.         Do.
 or ANDA                     2004
------------------------------------------------------------------------
Changes to an Approved NDA  January   Do.         Do.         Do.
 or ANDA: Questions and      22,
 Answers                     2001
------------------------------------------------------------------------
Container Closure Systems   May 1999  Do.         Do.         Do.
 for Packaging Human Drugs
 and Biologics
------------------------------------------------------------------------

[[Page 842]]

 
Demonstration of            April     Do.         Do.         Do.
 Comparability of Human      1996
 Biological Products,
 Including Therapeutic
 Biotechnology-Derived
 Products
------------------------------------------------------------------------
Development of New          May 1,    Do.         Do.         Do.
 Stereoisomeric Drugs        1992
------------------------------------------------------------------------
Drug Master Files           Septembe  Do.         Do.         Do.
                             r 1,
                             1989
------------------------------------------------------------------------
Drug Master Files for Bulk  November  Do.         Do.         Do.
 Antibiotic Drug             29,
 Substances                  1999
------------------------------------------------------------------------
Environmental Assessment    July 27,  Do.         Do.         Do.
 of Human Drug and           1998
 Biologics Applications
------------------------------------------------------------------------
Format and Content for the  Septembe  Do.         Do.         Do.
 CMC Section of an Annual    r 1,
 Report                      1994
------------------------------------------------------------------------
Format and Content of the   February  Do.         Do.         Do.
 Chemistry, Manufacturing,   1, 1987
 and Controls Section of
 an Application
------------------------------------------------------------------------
Format and Content of the   February  Do.         Do.         Do.
 Microbiology Section of     1, 1987
 an Application
------------------------------------------------------------------------
IND Meetings for Human      May 25,   Do.         Do.         Do.
 Drugs and Biologics;        2001
 Chemistry, Manufacturing,
 and Controls Information
------------------------------------------------------------------------
INDs for Phase 2 and 3      May 20,   Do.         Do.         Do.
 Studies; Chemistry,         2003
 Manufacturing, and
 Controls Information
------------------------------------------------------------------------
Monoclonal Antibodies Used  March     Do.         Do.         Do.
 as Reagents in Drug         29,
 Manufacturing               2001
------------------------------------------------------------------------
Nasal Spray and Inhalation  July 5,   Do.         Do.         Do.
 Solution, Suspension, and   2002
 Spray Drug Products--
 Chemistry, Manufacturing,
 and Controls
 Documentation
------------------------------------------------------------------------
NDAs: Impurities in Drug    February  Do.         Do.         Do.
 Substances                  25,
                             2000
------------------------------------------------------------------------
PAC-ALTS: Postapproval      April     Do.         Do.         Do.
 Changes--Analytical         28,
 Testing Laboratory Sites    1998
------------------------------------------------------------------------
Reviewer Guidance:          November  Do.         Do.         Do.
 Validation of               1994
 Chromatographic Methods
------------------------------------------------------------------------
Submission Documentation    November  Do.         Do.         Do.
 for Sterilization Process   1, 1994
 Validation in
 Applications for Human
 and Veterinary Drug
 Products
------------------------------------------------------------------------
Submission of Chemistry,    November  Do.         Do.         Do.
 Manufacturing, and          1994
 Controls Information for
 Synthetic Peptide
 Substances
------------------------------------------------------------------------
Submitting Documentation    February  Do.         Do.         Do.
 for the Manufacturing of,   1, 1987
 and Controls for, Drug
 Products
------------------------------------------------------------------------
Submitting Documentation    February  Do.         Do.         Do.
 for the Stability of        1, 1987
 Human Drugs and Biologics
------------------------------------------------------------------------
Submitting Samples and      February  Do.         Do.         Do.
 Analytical Data for         1987
 Methods Validation
------------------------------------------------------------------------
Submitting Supporting       February  Do.         Do.         N/A
 Documentation in Drug       1, 1987
 Applications for the
 Manufacture of Drug
 Products
------------------------------------------------------------------------
Submitting Supporting       February  Do.         Do.         http://
 Documentation in Drug       1987                              www.fda.g
 Applications for the                                          ov/cder/
 Manufacture of Drug                                           guidance/
 Substances                                                    index.htm
------------------------------------------------------------------------

[[Page 843]]

 
SUPAC IR--Immediate-        November  Do.         Do.         Do.
 Release Solid Oral Dosage   1995
 Forms: Scale-Up and
 Postapproval Changes:
 Chemistry, Manufacturing
 and Controls, In Vitro
 Dissolution Testing, and
 In Vivo Bioequivalence
 Documentation
------------------------------------------------------------------------
SUPAC IR/MR: Immediate      January   Do.         Do.         Do.
 Release and Modified        1999
 Release Solid Oral Dosage
 Forms Manufacturing
 Equipment Addendum
------------------------------------------------------------------------
SUPAC-IR Questions and      February  Do.         Do.         Do.
 Answers About SUPAC-IR      18,
 Guidance                    1997
------------------------------------------------------------------------
SUPAC-MR: Modified Release  October   Do.         Do.         Do.
 Solid Oral Dosage Forms     6, 1997
 Scale-Up and Postapproval
 Changes: Chemistry,
 Manufacturing, and
 Controls; In Vitro
 Dissolution Testing and
 In Vivo Bioequivalence
 Documentation
------------------------------------------------------------------------
SUPAC-SS--Nonsterile        May 1997  Do.         Do.         Do.
 Semisolid Dosage Forms
 Scale-Up and Postapproval
 Changes: Chemistry,
 Manufacturing, and
 Controls; In Vitro
 Release Testing and In
 Vivo Bioequivalence
 Documentation
------------------------------------------------------------------------
The Sourcing and            December  Do.         Do.         Do.
 Processing of Gelatin to    20,
 Reduce the Potential Risk   2000
 Posed by Bovine
 Spongiform Encephalopathy
 (BSE)
------------------------------------------------------------------------
Analytical Procedures and   August    Chemistry   Do.         Do.
 Methods Validation:         30,       draft
 Chemistry, Manufacturing,   2000
 and Controls
 Documentation
------------------------------------------------------------------------
Botanical Drug Products     June 9,   Do.         Do.         Do.
                             2004
------------------------------------------------------------------------
Comparability Protocols--   February  Do.         Do.         Do.
 Chemistry, Manufacturing,   25,
 and Controls Information    2003
------------------------------------------------------------------------
Drug Product: Chemistry,    January   Do.         Do.         Do.
 Manufacturing, and          28,
 Controls Information        2003
------------------------------------------------------------------------
Drug Substance: Chemistry,  January   Do.         Do.         Do.
 Manufacturing, and          7, 2004
 Controls Information
------------------------------------------------------------------------
Drugs, Biologics, and       Septembe  Do.         Do.         Do.
 Medical Devices Derived     r 2002
 From Bioengineered Plants
 for Use in Humans and
 Animals
------------------------------------------------------------------------
Interpreting Sameness of    July      Do.         ..........  Do.
 Monoclonal Antibody         1999
 Products Under the Orphan
 Drug Regulations
------------------------------------------------------------------------
Liposome Drug Products:     August    Do.         Do.         Do.
 Chemistry, Manufacturing,   2002
 and Controls; Human
 Pharmacokinetics and
 Bioavailability; and
 Labeling Documentation
------------------------------------------------------------------------
Metered Dose Inhaler (MDI)  November  Do.         Do.         Do.
 and Dry Powder Inhaler      19,
 (DPI) Drug Products;        1998
 Chemistry, Manufacturing,
 and Controls
 Documentation
------------------------------------------------------------------------
Stability Testing of Drug   June 8,   Do.         Do.         Do.
 Substances and Drug         1998
 Products
------------------------------------------------------------------------
Submitting Supporting       November  Do.         Do.         N/A
 Chemistry Documentation     1, 1991
 in Radiopharmaceutical
 Drug Applications
------------------------------------------------------------------------
SUPAC-SS: Nonsterile        January   Do.         Do.         http://
 Semisolid Dosage Forms      5, 1999                           www.fda.g
 Manufacturing Equipment                                       ov/cder/
 Addendum                                                      guidance/
                                                               index.htm
------------------------------------------------------------------------

[[Page 844]]

 
Antiretroviral Drugs Using  October   Clinical    Do.         Do.
 Plasma HIV RNA              2002      antimicro
 Measurements--Clinical                bial
 Considerations for
 Accelerated and
 Traditional Approval
------------------------------------------------------------------------
Clinical Development and    October   Do.         Do.         Do.
 Labeling of Anti-           26,
 Infective Drug Products     1992
------------------------------------------------------------------------
Clinical Evaluation of      Septembe  Do.         Do.         Do.
 Anti-Infective Drugs        r 1,
 (Systemic)                  1977
------------------------------------------------------------------------
Preclinical Development of  November  Do.         Do.         Do.
 Antiviral Drugs             1990
------------------------------------------------------------------------
Acute Bacterial             July 22,  Clinical    Do.         Do.
 Exacerbation of Chronic     1998      antimicro
 Bronchitis; Developing                bial
 Antimicrobial Drugs for               draft
 Treatment
------------------------------------------------------------------------
Acute Bacterial             July 22,  Do.         Do.         Do.
 Meningitis; Developing      1998
 Antimicrobial Drugs for
 Treatment
------------------------------------------------------------------------
Acute Bacterial Sinusitis;  July 22,  Do.         Do.         Do.
 Developing Antimicrobial    1998
 Drugs for Treatment
------------------------------------------------------------------------
Acute or Chronic Bacterial  July 22,  Do.         Do.         Do.
 Prostatitis; Developing     1998
 Antimicrobial Drugs for
 Treatment
------------------------------------------------------------------------
Acute Otitis Media;         July 22,  Do.         Do.         Do.
 Developing Antimicrobial    1998
 Drugs for Treatment
------------------------------------------------------------------------
Bacterial Vaginosis;        July 22,  Do.         Do.         Do.
 Developing Antimicrobial    1998
 Drugs for Treatment
------------------------------------------------------------------------
Catheter-Related            October   Do.         Do.         Do.
 Bloodstream Infections--    18,
 Developing Antimicrobial    1999
 Drugs for Treatment
------------------------------------------------------------------------
Community Acquired          July 22,  Do.         Do.         Do.
 Pneumonia; Developing       1998
 Antimicrobial Drugs for
 Treatment
------------------------------------------------------------------------
Complicated Urinary Tract   July 22,  Do.         Do.         Do.
 Infections and              1998
 Pylonephritis--Developing
 Antimicrobial Drugs for
 Treatment
------------------------------------------------------------------------
Developing Antimicrobial    July 22,  Do.         Do.         Do.
 Drugs--General              1998
 Considerations for
 Clinical Trials
------------------------------------------------------------------------
Developing Drugs to Treat   March     Do.         Do.         Do.
 Inhalational Anthrax        18,
 (Post-Exposure)             2002
------------------------------------------------------------------------
Empiric Therapy of Febrile  July 22,  Do.         Do.         Do.
 Neutropenia--Developing     1998
 Antimicrobial Drugs for
 Treatment
------------------------------------------------------------------------
Evaluating Clinical         February  Do.         Do.         Do.
 Studies of Antimicrobials   1997
 in the Division of Anti-
 Infective Drug Products
------------------------------------------------------------------------
Lyme Disease--Developing    July 22,  Do.         Do.         Do.
 Antimicrobial Drugs for     1998
 Treatment
------------------------------------------------------------------------
Nosocomial Pneumonia--      July 22,  Do.         Do.         Do.
 Developing Antimicrobial    1998
 Drugs for Treatment
------------------------------------------------------------------------
Secondary Bacterial         July 22,  Do.         Do.         Do.
 Infections of Acute         1998
 Bronchitis--Developing
 Antimicrobial Drugs for
 Treatment
------------------------------------------------------------------------
Streptococcal Pharyngitis   July 22,  Do.         Do.         Do.
 and Tonsillitis--           1998
 Developing Antimicrobial
 Drugs for Treatment
------------------------------------------------------------------------
Uncomplicated and           July 22,  Do.         Do.         Do.
 Complicated Skin and Skin   1998
 Structure Infections--
 Developing Antimicrobial
 Drugs for Treatment
------------------------------------------------------------------------

[[Page 845]]

 
Uncomplicated Gonorrhea--   July 22,  Do.         Do.         Do.
 Developing Antimicrobial    1998
 Drugs for Treatment
------------------------------------------------------------------------
Uncomplicated Urinary       July 22,  Do.         Do.         Do.
 Tract Infections--          1998
 Developing Antimicrobial
 Drugs for Treatment
------------------------------------------------------------------------
Vaccinia Virus--Developing  March     Do.         Do.         Do.
 Drugs to Mitigate           2004
 Complications From
 Smallpox Vaccination
------------------------------------------------------------------------
Vuvlovaginal Candidiasis--  July 22,  Do.         Do.         Do.
 Developing Antimicrobial    1998
 Drugs for Treatment
------------------------------------------------------------------------
Acceptance of Foreign       March     Clinical    Do.         Do.
 Clinical Studies            2001      medical
------------------------------------------------------------------------
Calcium DTPA and Zinc DTPA  August    Do.         Do.         Do.
 Drug Products--Submitting   2004
 a New Drug Application
------------------------------------------------------------------------
Cancer Drug and Biological  October   Do.         Do.         Do.
 Products--Clinical Data     2001
 in Marketing Applications
------------------------------------------------------------------------
Clinical Development        February  Do.         Do.         Do.
 Programs for Drugs,         1999
 Devices, and Biological
 Products for the
 Treatment of Rheumatoid
 Arthritis (RA)
------------------------------------------------------------------------
Clinical Development        Septembe  Do.         Do.         Do.
 Programs for MDI and DPI    r 19,
 Drug Products               1994
------------------------------------------------------------------------
Clinical Evaluation of      April     Do.         Do.         Do.
 Anti-Inflammatory and       1988
 Antirheumatic Drugs
 (adults and children)
------------------------------------------------------------------------
Clinical Evaluation of      Septembe  Do.         Do.         Do.
 Antianxiety Drugs           r 1,
                             1977
------------------------------------------------------------------------
Clinical Evaluation of      Septembe  Do.         Do.         Do.
 Antidepressant Drugs        r 1,
                             1977
------------------------------------------------------------------------
Clinical Evaluation of      January   Do.         Do.         Do.
 Antiepileptic Drugs         1, 1981
 (adults and children)
------------------------------------------------------------------------
Clinical Evaluation of      May 1,    Do.         Do.         Do.
 General Anesthetics         1982
------------------------------------------------------------------------
Clinical Evaluation of      Septembe  Do.         Do.         Do.
 Hypnotic Drugs              r 1,
                             1977
------------------------------------------------------------------------
Clinical Evaluation of      May 1982  Do.         Do.         Do.
 Local Anesthetics
------------------------------------------------------------------------
Clinical Evaluation of      July      Do.         Do.         Do.
 Psychoactive Drugs in       1979
 Infants and Children
------------------------------------------------------------------------
Content and Format for      May 1996  Do.         Do.         Do.
 Pediatric Use Supplements
------------------------------------------------------------------------
Content and Format of       November  Do.         Do.         Do.
 Investigational New Drug    1995
 Applications (INDs) for
 Phase 1 Studies of Drugs,
 Including Well-
 Characterized,
 Therapeutic,
 Biotechnology-Derived
 Products
------------------------------------------------------------------------
Establishing Pregnancy      August    Do.         Do.         Do.
 Exposure Registries         2002
------------------------------------------------------------------------
FDA Approval of New Cancer  February  Do.         Do.         Do.
 Treatment Uses for          2, 1999
 Marketed Drug and
 Biological Products
------------------------------------------------------------------------
FDA Requirements for        January   Do.         Do.         Do.
 Approval of Drugs to        1991
 Treat Non-Small Cell Lung
 Cancer
------------------------------------------------------------------------
Format and Content of the   July 1,   Do.         Do.         Do.
 Clinical and Statistical    1988
 Sections of an
 Application
------------------------------------------------------------------------
Format and Content of the   February  Do.         Do.         Do.
 Summary for New Drug and    1, 1987
 Antibiotic Applications
------------------------------------------------------------------------
Formatting, Assembling and  February  Do.         Do.         Do.
 Submitting New Drug and     1, 1987
 Antiobiotic Applications
------------------------------------------------------------------------

[[Page 846]]

 
General Considerations for  December  Do.         Do.         Do.
 the Clinical Evaluation     1, 1978
 of Drugs
------------------------------------------------------------------------
General Considerations for  Septembe  Do.         Do.         Do.
 the Clinical Evaluation     r 1,
 of Drugs in Infants and     1977
 Children
------------------------------------------------------------------------
Guidance for the            April     Do.         Do.         Do.
 Development of Vaginal      1995
 Contraceptive Drugs (NDA)
------------------------------------------------------------------------
IND Exemptions for Studies  January   Do.         Do.         Do.
 of Lawfully Marketed Drug   15,
 or Biological Products      2004
 for the Treatment of
 Cancer
------------------------------------------------------------------------
Integration of Dose-        March     Do.         Do.         Do.
 Counting Mechanisms Into    2003
 MDI Drug Products
------------------------------------------------------------------------
Levothyroxine Sodium        March 8,  Do.         Do.         Do.
 Tablets--In Vivo            2001
 Pharmacokinetic and
 Bioavailability Studies
 and In Vitro Dissolution
 Testing
------------------------------------------------------------------------
Oncologic Drugs Advisory    April     Do.         Do.         Do.
 Committee Discussion on     19,
 FDA Requirements for        1988
 Approval of New Drugs for
 Treatment of Colon and
 Rectal Cancer
------------------------------------------------------------------------
Oncologic Drugs Advisory    April     Do.         Do.         Do.
 Committee Discussion on     1988
 FDA Requirements for
 Approval of New Drugs for
 Treatment of Ovarian
 Cancer
------------------------------------------------------------------------
Postmarketing Adverse       August    Do.         Do.         Do.
 Experience Reporting for    27,
 Human Drug and Licensed     1997
 Biological Products:
 Clarification of What to
 Report
------------------------------------------------------------------------
Postmarketing Reporting of  March 1,  Do.         Do.         Do.
 Adverse Drug Experiences    1992
------------------------------------------------------------------------
Preclinical Development of  Septembe  Do.         Do.         Do.
 Immunomodulatory Drugs      r 1992
 for Treatment of HIV
 Infection and Associated
 Disorders
------------------------------------------------------------------------
Preparation of              November  Do.         Do.         Do.
 Investigational New Drug    1, 1992
 Products (Human and
 Animal)
------------------------------------------------------------------------
Providing Clinical          May 1998  Do.         Do.         Do.
 Evidence of Effectiveness
 for Human Drug and
 Biological Products
------------------------------------------------------------------------
Prussian Blue Drug          February  Do.         Do.         Do.
 Products--Submitting a      4, 2003
 New Drug Application
------------------------------------------------------------------------
Study and Evaluation of     July 22,  Do.         Do.         Do.
 Gender Differences in the   1993
 Clinical Evaluation of
 Drugs
------------------------------------------------------------------------
Study of Drugs Likely to    November  Do.         Do.         Do.
 be Used in the Elderly      1, 1989
------------------------------------------------------------------------
Submission of Abbreviated   Septembe  Do.         Do.         Do.
 Reports and Synopses in     r 13,
 Support of Marketing        1999
 Applications
------------------------------------------------------------------------
Abuse Liability Assessment  July 1,   Clinical    Do.         N/A
                             1990      medical
                                       draft
------------------------------------------------------------------------
Allergic Rhinitis:          June 21,  Do.         Do.         http://
 Clinical Development        2000                              www.fda.g
 Programs for Drug                                             ov/cder/
 Products                                                      guidance/
                                                               index.htm
--------------------------------------
------------------------------------------------------------------------
Chronic Cutaneous Ulcer     June 28,  Do.         Do.         Do.
 and Burn Wounds--           2000
 Developing Products for
 Treatment
------------------------------------------------------------------------

[[Page 847]]

 
Clinical Development        July      Do.         Do.         Do.
 Programs for Drugs,         1999
 Devices, and Biological
 Products Intended for the
 Treatment of
 Osteoarthritis (OA)
------------------------------------------------------------------------
Clinical Evaluation of      January   Do.         Do.         N/A
 Anti-Anginal Drugs          1, 1989
------------------------------------------------------------------------
Clinical Evaluation of      July 1,   Do.         Do.         Do.
 Anti-Arrhythmic Drugs       1985
------------------------------------------------------------------------
Clinical Evaluation of      May 1,    Do.         Do.         Do.
 Antihypertensive Drugs      1988
------------------------------------------------------------------------
Clinical Evaluation of      December  Do.         Do.         Do.
 Drugs for the Treatment     1, 1987
 of Congestive Heart
 Failure
------------------------------------------------------------------------
Clinical Evaluation of      Septembe  Do.         Do.         http://
 Lipid-Altering Agents in    r 1990                            www.fda.g
 Adults and Children                                           ov/cder/
                                                               guidance/
                                                               index.htm
------------------------------------------------------------------------
Clinical Evaluation of      Septembe  Do.         Do.         Do.
 Weight-Control Drugs        r 24,
                             1996
------------------------------------------------------------------------
Clinical Trial Sponsors on  November  Do.         Do.         Do.
 the Establishment and       2001
 Operation of Clinical
 Trial Data Monitoring
 Committees
------------------------------------------------------------------------
Collection of Race and      January   Do.         Do.         Do.
 Ethnicity Data in           30,
 Clinical Trials for FDA-    2003
 Regulated Products
------------------------------------------------------------------------
Developing Medical Imaging  May 19,   Do.         Do.         Do.
 Drug and Biological         2003
 Products--2nd draft
------------------------------------------------------------------------
Development and Evaluation  February  Do.         Do.         N/A
 of Drugs for the            12,
 Treatment of Psychoactive   1992
 Substance Use Disorders
------------------------------------------------------------------------
Development of Parathyroid  May 2000  Do.         Do.         http://
 Hormone for the                                               www.fda.g
 Prevention and Treatment                                      ov/cder/
 of Osteoporosis                                               guidance/
                                                               index.htm
------------------------------------------------------------------------
Drugs, Biologics, and       Septembe  Do.         Do.         Do.
 Medical Devices Derived     r 2002
 From Bioengineered Plants
 for Use in Humans and
 Animals
------------------------------------------------------------------------
Estrogen and Estrogen/      January   Do.         Do.         Do.
 Progestin Drug Products     2003
 to Treat Vasomotor
 Symptoms and Vulvar and
 Vaginal Atrophy Symptoms--
 Recommendations for
 Clinical Evaluation
------------------------------------------------------------------------
Evaluation of Human         June      Do.         Do.         Do.
 Pregnancy Outcome Data      1999
------------------------------------------------------------------------
Evaluation of the Effects   November  Do.         Do.         Do.
 of Orally Inhaled and       6, 2001
 Intranasal
 Corticosteroids on Growth
 in Children
------------------------------------------------------------------------
Exercise-Induced            February  Do.         Do.         Do.
 Bronchospasm (EIB)--        20,
 Development of Drugs to     2002
 Prevent EIB
------------------------------------------------------------------------
Female Sexual Dysfunction:  May 19,   Do.         Do.         Do.
 Clinical Development of     2000
 Drug Products for
 Treatment
------------------------------------------------------------------------
Guidance for Institutional  March     Do.         Do.         Do.
 Review Boards, Clinical     2000
 Investigators, and
 Sponsors: Exception from
 Informed Consent
 Requirements for
 Emergency Research
------------------------------------------------------------------------
Inhalation Drug Products    July 26,  Do.         Do.         Do.
 Packaged in Semipermeable   2002
 Container Closure Systems
------------------------------------------------------------------------
OTC Treatment of Herpes     March 8,  Do.         Do.         Do.
 Labialis with Antiviral     2000
 Agents
------------------------------------------------------------------------
Pediatric Oncology Studies  June 21,  Do.         Do.         Do.
 in Response to a Written    2000
 Request
------------------------------------------------------------------------

[[Page 848]]

 
Preclinical and Clinical    April 1,  Do.         Do.         Do.
 Evaluation of Agents Used   1994
 in the Prevention or
 Treatment of
 Postmenopausal
 Osteoporosis
------------------------------------------------------------------------
Preparation of IND          Septembe  Do.         Do.         N/A
 Applications for New        r 1,
 Drugs Intended for the      1991
 Treatment of HIV-Infected
 Individuals
------------------------------------------------------------------------
Recommendations for         November  Do.         Do.         http://
 Complying With the          2000                              www.fda.g
 Pediatric Rule                                                ov/cder/
                                                               guidance/
                                                               index.htm
------------------------------------------------------------------------
Drug Metabolism/Drug        April 7,  Clinical    Do.         Do.
 Interaction Studies in      1997      pharmacol
 the Drug Development                  ogy
 Process: Studies In Vitro
------------------------------------------------------------------------
Exposure-Response           April     Do.         Do.         Do.
 Relationships--Study        2003
 Design, Data Analysis,
 and Regulatory
 Applications
------------------------------------------------------------------------
Format and Content of the   February  Do.         Do.         Do.
 Human Pharmacokinetics      1, 1987
 and Bioavailability
 Section of an Application
------------------------------------------------------------------------
In Vivo Metabolism/Drug     November  Do.         Do.         Do.
 Interaction Studies--       24,
 Study Design, Data          1999
 Analysis, and
 Recommendations for
 Dosing and Labeling
------------------------------------------------------------------------
Pharmacokinetics in         May 30,   Do.         Do.         Do.
 Patients With Impaired      2003
 Hepatic Function; Study
 Design, Data Analysis,
 and Impact on Dosing and
 Labeling
------------------------------------------------------------------------
Pharmacokinetics in         May 1998  Do.         Do.         Do.
 Patients with Impaired
 Renal Function--Study
 Design, Data Analysis,
 and Impact on Dosing and
 Labeling
------------------------------------------------------------------------
Population                  February  Do.         Do.         Do.
 Pharmacokinetics            10,
                             1999
------------------------------------------------------------------------
General Considerations for  November  Clinical    Do.         Do.
 Pediatric Pharmacokinetic   30,       pharmacol
 Studies for Drugs and       1998      ogy draft
 Biological Products
------------------------------------------------------------------------
A Review of FDA's           May 1990  Compliance  Do.         Do.
 Implementation of the
 Drug Export Amendments of
 1986
------------------------------------------------------------------------
Compressed Medical Gases    February  Do.         Do.         Do.
                             1989
------------------------------------------------------------------------
Computerized Systems Used   April     Do.         Do.         Do.
 in Clinical Trials          1999
------------------------------------------------------------------------
Expiration Dating and       June 27,  Do.         Do.         Do.
 Stability Testing of        1997
 Solid Oral Dosage Form
 Drugs Containing Iron
------------------------------------------------------------------------
General Principles of       May 1987  Do.         Do.         Do.
 Process Validation
------------------------------------------------------------------------
Good Laboratory Practice    June      Do.         Do.         Do.
 Regulations Questions and   1981
 Answers
------------------------------------------------------------------------
Guidance for Hospitals,     March     Do.         Do.         Do.
 Nursing Homes, and Other    2001
 Health Care Facilities--
 FDA Public Health
 Advisory
------------------------------------------------------------------------
Guideline for Validation    December  Do.         Do.         Do.
 of Limulus Amebocyte        1987
 Lysate Test as an End-
 Product Endotoxin Test
 for Human and Animal
 Parenteral Drugs,
 Biological Products, and
 Medical Devices
------------------------------------------------------------------------
Monitoring of Clinical      January   Do.         Do.         Do.
 Investigations              1988
------------------------------------------------------------------------
Nuclear Pharmacy Guideline  May 1984  Do.         Do.         Do.
 Criteria for Determining
 When to Register as a
 Drug Establishment
------------------------------------------------------------------------
Pharmacy Compounding:       May 2002  Do.         Do.         Do.
 Compliance Policy Guide
------------------------------------------------------------------------

[[Page 849]]

 
Possible Dioxin/PCB         August    Do.         Do.         Do.
 Contamination of Drug and   23,
 Biological Products         1999
------------------------------------------------------------------------
Sterile Drug Products       June      Do.         Do.         Do.
 Produced by Aseptic         1987
 Processing
------------------------------------------------------------------------
Street Drug Alternatives    March     Do.         Do.         Do.
                             2000
------------------------------------------------------------------------
Current Good Manufacturing  May 6,    Compliance  Do.         Do.
 Practices for Medical       2003      draft
 Gases
------------------------------------------------------------------------
Good Manufacturing          April 1,  Do.         Do.         Do.
 Practice for Positron       2002
 Emission Tomography Drug
 Products
------------------------------------------------------------------------
Guidance for IRBs,          May 12,   Do.         Do.         Do.
 Clinical Investigators,     2000
 and Sponsors: Exception
 from Informed Consent
 Requirements for
 Emergency Research
------------------------------------------------------------------------
Investigating Out of        Septembe  Do.         Do.         Do.
 Specification (OOS) Test    r 30,
 Results for                 1998
 Pharmaceutical Production
------------------------------------------------------------------------
Manufacture, Processing,    April     Do.         Do.         Do.
 or Holding of Active        17,
 Pharmaceutical              1998
 Ingredients
------------------------------------------------------------------------
Marketed Unapproved Drugs-- October   Do.         ..........  Do.
 Compliance Policy Guide     2003
------------------------------------------------------------------------
Prescription Drug           June 27,  Do.         Do.         Do.
 Marketing Act Regulations   2002
 for Donation of
 Prescription Drug Samples
 to Free Clinics
------------------------------------------------------------------------
Repackaging of Solid Oral   February  Do.         Do.         N/A
 Dosage Form Drug Products   1, 1992
------------------------------------------------------------------------
Part 11, Electronic         August    Current     Do.         http://
 Records; Electronic         2003      good                    www.fda.g
 Signatures--Scope and                 manufactu               ov/cder/
 Application                           ring                    guidance/
                                       practices               index.htm
                                       (CGMPs)
------------------------------------------------------------------------
Comparability Protocols--   Septembe  CGMPs       Do.         Do.
 Protein Drug Products and   r 2003    draft
 Biological Products--
 Chemistry, Manufacturing,
 and Controls Information
------------------------------------------------------------------------
Formal Dispute Resolution:  August    Do.         Do.         Do.
 Scientific and Technical    2003
 Issues Related to
 Pharmaceutical Current
 Good Manufacturing
 Practices
------------------------------------------------------------------------
Powder Blends and Finished  November  Do.         Do.         Do.
 Dosage Units--Stratified    7, 2003
 In-Process Dosage Unit
 Sampling and Assessment
------------------------------------------------------------------------
Process Analytical          October   Do.         Do.         Do.
 Technology--A Framework     4, 2004
 for Innovative
 Pharmaceutical
 Manufacturing and Quality
 Assurance
------------------------------------------------------------------------
Sterile Drug Products       October   Do.         Do.         Do.
 Produced by Aseptic         4, 2004
 Processing
------------------------------------------------------------------------
Providing Electronic        June 27,  Electronic  Do.         Do.
 Submissions in Electronic   2002      submissio
 Format--ANDAs                         ns
------------------------------------------------------------------------
Regulatory Submissions in   January   Do.         Do.         Do.
 Electronic Format;          28,
 General Considerations      1999
------------------------------------------------------------------------
Regulatory Submissions in   January   Do.         Do.         Do.
 Electronic Format; New      28,
 Drug Applications           1999
------------------------------------------------------------------------
Providing Regulatory        August    Electronic  Do.         Do.
 Submissions in Electronic   2003      submissio
 Format--Annual Reports                ns draft
 for NDAs and ANDAs
------------------------------------------------------------------------

[[Page 850]]

 
Providing Regulatory        February  Do.         Do.         Do.
 Submissions in Electronic   2004
 Format--Content of
 Labeling
------------------------------------------------------------------------
Providing Regulatory        October   Do.         Do.         Do.
 Submissions in Electronic   22,
 Format--General             2003
 Considerations
------------------------------------------------------------------------
Providing Regulatory        August    Do.         Do.         Do.
 Submissions in Electronic   29,
 Format--Human               2003
 Pharmaceutical Product
 Applications and Related
 Submissions
------------------------------------------------------------------------
Providing Regulatory        May 4,    Do.         Do.         Do.
 Submissions in Electronic   2001
 Format--Postmarketing
 Expedited Safety Reports
------------------------------------------------------------------------
Providing Regulatory        June      Do.         Do.         Do.
 Submissions in Electronic   2003
 Format--Postmarketing
 Periodic Adverse Drug
 Experience Reports
------------------------------------------------------------------------
Providing Regulatory        January   Do.         Do.         Do.
 Submissions in Electronic   31,
 Format, Prescription Drug   2001
 Advertising and
 Promotional Labeling
------------------------------------------------------------------------
180-Day Exclusivity When    July      Generics    Do.
 Multiple Abbreviated New    2003
 Drug Applications Are
 Submitted on the Same Day
------------------------------------------------------------------------
Alternate Source of Active  December  Do.         Do.         Do.
 Pharmaceutical              12,
 Ingredients in Pending      2000
 ANDAs
------------------------------------------------------------------------
ANDAs: Impurities in Drug   November  Do.         Do.         Do.
 Substances                  1999
------------------------------------------------------------------------
Court Decisions, ANDA       March     Do.         Do.         Do.
 Approvals, and 180-Day      2000
 Exclusivity Under the
 Hatch-Waxman Amendments
 to the Federal Food,
 Drug, and Cosmetic Act
------------------------------------------------------------------------
Letter announcing that the  August    Do.         Do.         Do.
 OGD will now accept the     1995
 ICH long-term storage
 conditions as well as the
 stability studies
 conducted in the past
------------------------------------------------------------------------
Letter describing efforts   October   Do.         Do.         Do.
 by the CDER & the ORA to    1994
 clarify the
 responsibilities of CDER
 chemistry review
 scientists and ORA field
 investigators in the new
 & abbreviated drug
 approval process in order
 to reduce duplication or
 redundancy in the process
------------------------------------------------------------------------
Letter on incomplete        April     Do.         Do.         Do.
 Abbreviated Applications,   1994
 Convictions Under GDEA,
 Multiple Supplements,
 Annual Reports for Bulk
 Antibiotics, Batch Size
 for Transdermal Drugs,
 Bioequivalence Protocols,
 Research, Deviations from
 OGD Policy
------------------------------------------------------------------------
Letter on the provision of  July      Do.         Do.         Do.
 new information             1992
 pertaining to new
 bioequivalence guidelines
 and refuse-to-file
 letters
------------------------------------------------------------------------
Letter on the provision of  March     Do.         Do.         Do.
 new procedures and          1989
 policies affecting the
 generic drug review
 process
------------------------------------------------------------------------
Letter on the request for   November  Do.         Do.         Do.
 cooperation of regulated    1991
 industry to improve the
 efficiency and
 effectiveness of the
 generic drug review
 process, by assuring the
 completeness and accuracy
 of required information
 and data submissions
------------------------------------------------------------------------
Letter on the response to   March     Do.         Do.         Do.
 12/20/84 letter from the    1985
 Pharmaceutical
 Manufacturers Association
 about the Drug Price
 Competition and Patent
 Term Restoration Act
------------------------------------------------------------------------

[[Page 851]]

 
Letter to all ANDA and      January   Do.         Do.         Do.
 AADA applicants about the   1993
 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         August    Do.         Do.         Do.
 industry notifying          1993
 interested parties about
 important detailed
 information regarding
 labeling, scale-up,
 packaging, minor/major
 amendment criteria, and
 bioequivalence
 requirements
------------------------------------------------------------------------
Major, Minor, and           December  Do.         Do.         Do.
 Telephone Amendments to     2001
 Abbreviated New Drug
 Applications
------------------------------------------------------------------------
Organization of an ANDA     March 2,  Do.         Do.         Do.
                             1999
------------------------------------------------------------------------
Revising ANDA Labeling      May 2000  Do.         Do.         Do.
 Following Revision of the
 RLD Labeling
------------------------------------------------------------------------
Skin Irritation and         February  Do.         Do.         Do.
 Sensitization Testing of    3, 2000
 Generic Transdermal Drug
 Products
------------------------------------------------------------------------
Variations in Drug          December  Do.         Do.         Do.
 Products that May Be        1998
 Included in a Single ANDA
------------------------------------------------------------------------
ANDAs: Impurities in Drug   January   Generics    Do.         Do.
 Products                    5, 1999   draft
------------------------------------------------------------------------
Handling and Retention of   May 26,   Do.         Do.         Do.
 Bioavailability and         2004
 Bioequivalence Testing
 Samples
------------------------------------------------------------------------
Potassium Chloride          August    Do.         Do.         Do.
 Modified-Release Tablets    7, 2002
 and Capsules: In Vivo
 Bioequivalence and In
 Vitro Dissolution Testing
 (revised)
------------------------------------------------------------------------
Pharmacology/Toxicology     May 2001  Good        Do.         Do.
 Review Format                         review
                                       practices
                                       (GRP)
------------------------------------------------------------------------
Conducting a Clinical       November  GRP draft   Do.         Do.
 Safety Review of a New      22,
 Product Application and     1996
 Preparing a Report on the
 Review
------------------------------------------------------------------------
Good Review Management      July 28,  Do.         Do.         Do.
 Principles for              2003
 Prescription Drug User
 Fee Act Products
------------------------------------------------------------------------
E10--Choice of Control      May 14,   ICH,        Do.         Do.
 Group and Related Issues    2001      efficacy
 in Clinical Trials
------------------------------------------------------------------------
E11--Clinical               December  Do.         Do.         Do.
 Investigation of            15,
 Medicinal Products in the   2000
 Pediatric Population
------------------------------------------------------------------------
E1A--The Extent of          March     Do.         Do.         Do.
 Population Exposure to      1995
 Assess Clinical Safety:
 for Drugs Intended for
 Long-Term Treatment of
 Non-Life-Threatening
 Conditions
------------------------------------------------------------------------
E2A--Clinical Safety Data   March     Do.         Do.         Do.
 Management: Definitions     1995
 and Standards for
 Expedited Reporting
------------------------------------------------------------------------
E2B--Data Elements for      January   Do.         Do.         Do.
 Transmission of             15,
 Individual Case Safety      1998
 Reports
------------------------------------------------------------------------
E2BM--Data Elements for     April 3,  Do.         Do.         Do.
 Transmission of             2002
 Individual Case Safety
 Reports (revised)
------------------------------------------------------------------------
E2BM--Data Elements for     May 2004  Do.         Do.         Do.
 Transmission of
 Individual Case Safety
 Reports--Questions and
 Answers
------------------------------------------------------------------------
E2C--Clinical Safety Data   May 19,   Do.         Do.         Do.
 Management: Periodic        1997
 Safety Update Reports for
 Marketed Drugs
------------------------------------------------------------------------

[[Page 852]]

 
E2C Addendum--Clinical      February  Do.         Do.         Do.
 Safety Data Management:     5, 2004
 Periodic Safety Update
 Reports for Marketed
 Drugs
------------------------------------------------------------------------
E3--Structure and Content   July      Do.         Do.         Do.
 of Clinical Study Reports   1996
------------------------------------------------------------------------
E4--Dose-Response           November  Do.         Do.         Do.
 Information to Support      1994
 Drug Registration
------------------------------------------------------------------------
E5--Ethnic Factors in the   June      Do.         Do.         Do.
 Acceptability of Foreign    1998
 Clinical Data
------------------------------------------------------------------------
E6--Good Clinical           May 9,    Do.         Do.         Do.
 Practice: Consolidated      1997
 Guideline
------------------------------------------------------------------------
E7--Studies in Support of   August    Do.         Do.         Do.
 Special Populations:        1994
 Geriatrics
------------------------------------------------------------------------
E8--General Considerations  December  Do.         Do.         Do.
 for Clinical Trials         24,
                             1997
------------------------------------------------------------------------
E9--Statistical Principles  Septembe  Do.         Do.         Do.
 for Clinical Trials         r 1998
------------------------------------------------------------------------
M2 eCTD: Electronic Common  April 2,  ICH, joint  Do.         Do.
 Technical Document          2003      safety/
 Specification                         efficacy
                                       (multidis
                                       ciplinary
                                       )
------------------------------------------------------------------------
M3--Nonclinical Safety      November  Do.         Do.         Do.
 Studies for the Conduct     25,
 of Human Clinical Trials    1997
 for Pharmaceuticals
------------------------------------------------------------------------
M4--Organization of the     August    Do.         Do.         Do.
 CTD                         2004
------------------------------------------------------------------------
M4--The CTD--Efficacy       May 2004  Do.         Do.         Do.
 Questions and Answers
------------------------------------------------------------------------
M4--The CTD--General        May 2004  Do.         Do.         Do.
 Questions and Answers
------------------------------------------------------------------------
M4--The CTD--Safety         February  Do.         Do.         Do.
 Questions and Answers       4, 2003
------------------------------------------------------------------------
Q1A(R2)--Stability Testing  November  ICH,        Do.         Do.
 of New Drug Substances      21,       quality
 and Products                2003
------------------------------------------------------------------------
Q1B--Photostability         November  Do.         Do.         Do.
 Testing of New Drug         1996
 Substances and Products
------------------------------------------------------------------------
Q1C--Stability Testing for  May 9,    Do.         Do.         Do.
 New Dosage Forms            1997
------------------------------------------------------------------------
Q1D--Bracketing and         January   Do.         Do.         Do.
 Matrixing Designs for       16,
 Stability Testing of New    2003
 Drug Substances and
 Products
------------------------------------------------------------------------
Q1F--Stability Data         June      Do.         Do.         Do.
 Package for the             2004
 Registration in Climatic
 Zones III and IV
------------------------------------------------------------------------
Q2A--Text on Validation of  March     Do.         Do.         Do.
 Analytical Procedures       1995
------------------------------------------------------------------------
Q2B--Validation of          May 19,   Do.         Do.         Do.
 Analytical Procedures:      1997
 Methodology
------------------------------------------------------------------------
Q3A--Impurities in New      February  Do.         Do.         Do.
 Drug Substances             2003
------------------------------------------------------------------------
Q3B(R)--Impurities in Drug  November  Do.         Do.         Do.
 Products                    14,
                             2003
------------------------------------------------------------------------
Q3C--Impurities: Residual   December  Do.         Do.         Do.
 Solvents                    24,
                             1997
------------------------------------------------------------------------
Q3C--Tables and List        November  Do.         Do.         Do.
 (revised recommendations    2003
 for N-Methylpyrrolidone
 and Tetrahydrofuran)
------------------------------------------------------------------------
Q5A--Viral Safety           Septembe  Do.         Do.         Do.
 Evaluation of               r 24,
 Biotechnology Products      1998
 Derived From Cell Lines
 of Human or Animal Origin
------------------------------------------------------------------------

[[Page 853]]

 
Q5B--Quality of             February  Do.         Do.         Do.
 Biotechnology Products:     1996
 Analysis of the
 Expression Construct in
 Cells Used for Production
 of r-DNA Derived Protein
 Products
------------------------------------------------------------------------
Q5C--Quality of             July      Do.         Do.         Do.
 Biotechnological            1996
 Products: Stability
 Testing of Biotechnology/
 Biological Products
------------------------------------------------------------------------
Q5D--Quality of             Septembe  Do.         Do.         Do.
 Biotechnological/           r 21,
 Biological Products:        1998
 Derivation and
 Characterization of Cell
 Substrates Used for
 Production of
 Biotechnological/
 Biological Products
------------------------------------------------------------------------
Q6A--Specifications: Test   December  Do.         Do.         Do.
 Procedures and Acceptance   29,
 Criteria for New Drug       2000
 Substances and New Drug
 Products: Chemical
 Substances
------------------------------------------------------------------------
Q6B--Test Procedures and    August    Do.         Do.         Do.
 Acceptance Criteria for     18,
 Biotechnological/           1999
 Biological Products
------------------------------------------------------------------------
Q7A--Good Manufacturing     August    Do.         Do.         Do.
 Practice for Active         2001
 Pharmaceutical
 Ingredients
------------------------------------------------------------------------
S1A--The Need for Long-     March     ICH,        Do.         Do.
 Term Rodent                 1996      safety
 Carcinogenicity Studies
 of Pharmaceuticals
------------------------------------------------------------------------
S1B--Testing for            July      Do.         Do.         Do.
 Carcinogenicity of          1997
 Pharmaceuticals
------------------------------------------------------------------------
S1C--Dose Selection for     March     Do.         Do.         Do.
 Carcinogenicity Studies     1995
 of Pharmaceuticals
------------------------------------------------------------------------
S1C(R)--Dose Selection for  December  Do.         Do.         Do.
 Carcinogenicity Studies     4, 1997
 of Pharmaceuticals:
 Addendum on a Limit Dose
 and Related Notes
------------------------------------------------------------------------
S2A--Specific Aspects of    April     Do.         Do.         Do.
 Regulatory Genotoxicity     1996
 Tests for Pharmaceuticals
------------------------------------------------------------------------
S2B--Genotoxicity: A        November  Do.         Do.         Do.
 Standard Battery for        21,
 Genotoxicity Testing of     1997
 Pharmaceuticals
------------------------------------------------------------------------
S3A--Toxicokinetics: The    March     Do.         Do.         Do.
 Assessment of Systemic      1995
 Exposure in Toxicity
 Studies
------------------------------------------------------------------------
S3B--Pharmacokinetics:      March     Do.         Do.         Do.
 Repeated Dose Tissue        1995
 Distribution Studies
------------------------------------------------------------------------
S4A--Duration of Chronic    June 25,  Do.         Do.         Do.
 Toxicity Testing in         1999
 Animals (Rodent and
 Nonrodent Toxicity
 Testing)
------------------------------------------------------------------------
S5A--Detection of Toxicity  Septembe  Do.         Do.         Do.
 to Reproduction for         r 22,
 Medicinal Products          1994
------------------------------------------------------------------------
S5B--Detection of Toxicity  April     Do.         Do.         Do.
 to Reproduction for         1996
 Medicinal Products:
 Addendum on Toxicity to
 Male Fertility
------------------------------------------------------------------------
S6--Preclinical Safety      November  Do.         Do.         Do.
 Evaluation of               18,
 Biotechnology-Derived       1997
 Pharmaceuticals
------------------------------------------------------------------------
S7A--Safety Pharmacology    July 13,  Do.         Do.         Do.
 Studies for Human           2001
 Pharmaceuticals
------------------------------------------------------------------------
E2D--Postapproval Safety    July      ICH draft,  Do.         Do.
 Data Management:            2003      efficacy
 Definitions and Standards
 for Expedited Reporting
------------------------------------------------------------------------
E12A--Principles for        August    Do.         Do.         Do.
 Clinical Evaluation of      9, 2000
 New Antihypertensive
 Drugs
------------------------------------------------------------------------

[[Page 854]]

 
M4--Common Technical        December  ICH draft,  Do.         Do.
 Document--Quality:          30,       joint
 Questions and Answers/      2002      safety/
 Location Issues                       efficacy
                                       (multidis
                                       ciplinary
                                       )
------------------------------------------------------------------------
Submitting Marketing        Septembe  Do.         Do.         Do.
 Appilcations According to   r 5,
 the ICH-CTD Format--        2001
 General Considerations
------------------------------------------------------------------------
Q1E--Evaluation of          June 14,  ICH draft,  Do.         Do.
 Stability Data              2002      quality
------------------------------------------------------------------------
S7B--The Nonclinical        June      ICH draft,  Do.         Do.
 Evaluation of the           2004      safety
 Potential for Delayed
 Ventricular
 Repolarization (QT
 Interval Prolongation) by
 Human Pharmaceuticals
------------------------------------------------------------------------
Content and Format of INDs  November  IND         Do.         Do.
 for Phase 1 Studies of      1995
 Drugs; Including Well-
 Characterized,
 Therapeutic,
 Biotechnology-Derived
 Products
------------------------------------------------------------------------
A Revision in Sample        July 15,  Industry    Do.         N/A
 Collection Under the        1996      letters
 Compliance Program
 Pertaining to Preapproval
 Inspections
------------------------------------------------------------------------
Continuation of a series    March 2,  Do.         Do.         http://
 of letters communicating    1998                              www.fda.g
 interim and informal                                          ov/cder/
 generic drug policy and                                       guidance/
 guidance. Availability of                                     index.htm
 Policy and Procedure
 Guides, and further
 operational changes to
 the generic drug review
 program
------------------------------------------------------------------------
Fifth of a series of        April     Do.         Do.         Do.
 letters providing           1987
 informal notice about the
 Act, discussing the
 statutory mechanism by
 which ANDA applicants may
 make modifications in
 approved drugs where
 clinical data is required
------------------------------------------------------------------------
Fourth of a series of       October   Do.         Do.         Do.
 letters providing           1986
 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  October   Do.         Do.         Do.
 Price Competition and       1984
 Patent Term Restoration
 Act. Preliminary Guidance
------------------------------------------------------------------------
Implementation Plan USP     October   Do.         Do.         Do.
 injection nomenclature      1995
------------------------------------------------------------------------
Instructions for Filing     April     Do.         Do.         N/A
 Supplements Under the       11,
 Provisions of SUPAC-IR      1996
------------------------------------------------------------------------
Seventh of a series of      July      Do.         Do.         http://
 letters about the Act       1988                              www.fda.g
 providing guidance on the                                     ov/cder/
 ``180-day exclusivity''                                       guidance/
 provision of section                                          index.htm
 505(j)(4)(B)(iv) of the
 FD&C Act
------------------------------------------------------------------------
Sixth of a series of        April     Do.         Do.         Do.
 informal notice letters     1988
 about the Act discussing
 3- and 5-year exclusivity
 provisions of sections
 505(c)(3)(D) and
 505(j)(4)(D) of the FD&C
 Act
------------------------------------------------------------------------
Streamlining Initiatives    December  Do.         Do.         N/A
                             24,
                             1996
------------------------------------------------------------------------
Supplement to 10/11/84      November  Do.         Do.         http://
 letter about policies,      1984                              www.fda.g
 procedures and                                                ov/cder/
 implementation of the Act                                     guidance/
 (Q & A format)                                                index.htm
------------------------------------------------------------------------
Third of a series of        May 1985  Do.         Do.         Do.
 letters regarding the
 implementation of the Act
------------------------------------------------------------------------
Year 2000 Letter from Dr.   October   Do.         Do.         Do.
 Janet Woodcock              19,
                             1998
------------------------------------------------------------------------
Barbiturate, Single Entity- March 1,  Labeling    Do.         N/A
 Class Labeling              1981
------------------------------------------------------------------------

[[Page 855]]

 
Content and Format for      October   Do.         Do.         http://
 Geriatric Labeling          5, 2001                           www.fda.g
                                                               ov/cder/
                                                               guidance/
                                                               index.htm
------------------------------------------------------------------------
Hypoglycemic Oral Agents    April 1,  Do.         Do.         N/A
                             1984
------------------------------------------------------------------------
Labeling Over-the-Counter   October   Do.         Do.         http://
 Human Drug Products;        18,                               www.fda.g
 Updating Labeling in        2002                              ov/cder/
 Reference Listed Drugs                                        guidance/
 and Abbreviated New Drug                                      index.htm
 Applications
------------------------------------------------------------------------
Local Anesthetics--Class    Septembe  Do.         Do.         N/A
 Labeling                    r 1,
                             1982
------------------------------------------------------------------------
Clinical Studies Section    July 9,   Labeling    Do.         http://
 of Labeling for             2001      draft                   www.fda.g
 Prescription Drugs and                                        ov/cder/
 Biologics--Content and                                        guidance/
 Format                                                        index.htm
------------------------------------------------------------------------
Content and Format of the   March 5,  Do.         Do.         Do.
 Adverse Reactions Section   2004
 of Labeling for Human
 Prescription Drugs and
 Biologics
------------------------------------------------------------------------
Labeling for Combined Oral  March     Do.         Do.         Do.
 Contraceptives              2004
------------------------------------------------------------------------
Labeling for                February  Do.         Do.         Do.
 Noncontraceptive Estrogen   2004
 Drug Products for the
 Treatment of Vasomotor
 Symptoms and Vulvar and
 Vaginal Atrophy Symptoms--
 Prescribing Information
 for Health Care Providers
 and Patient Labeling
------------------------------------------------------------------------
OTC Topical Drug Products   June      Do.         Do.         Do.
 for the Treatment of        1998
 Vaginal Yeast Infections
 (Vulvovaginal
 Candidiasis)
------------------------------------------------------------------------
Referencing Discontinued    October   Do.         Do.         Do.
 Labeling for Listed Drugs   26,
 in Abbreviated New Drug     2000
 Applications
------------------------------------------------------------------------
Enforcement Policy on       May 1984  OTC         Do.         Do.
 Marketing OTC Combination
 Products (CPG 7132b.16)
------------------------------------------------------------------------
General Guidelines for OTC  Septembe  Do.         Do.         Do.
 Combination Products        r 1978
------------------------------------------------------------------------
Labeling OTC Human Drug     December  Do.         Do.         Do.
 Products Using a Column     19,
 Format                      2000
------------------------------------------------------------------------
Upgrading Category III      October   Do.         Do.         Do.
 Antiperspirants to          1978
 Category I (43 FR 46728-
 46731)
------------------------------------------------------------------------
Labeling OTC Human Drug     December  OTC draft   Do.         Do.
 Products--Submitting        19,
 Requests for Exemptions     2000
 and Deferrals
------------------------------------------------------------------------
Labeling OTC Human Drug     February  Do.         Do.         Do.
 Products Updating           2001
 Labeling in ANDAs
------------------------------------------------------------------------
OTC Actual Use Studies      July 22,  Do.         Do.         N/A
                             1994
------------------------------------------------------------------------
OTC Nicotine Substitutes    March 1,  Do.         Do.         Do.
                             1994
------------------------------------------------------------------------
Time and Extent             February  Do.         Do.         http://
 Applications                10,                               www.fda.g
                             2004                              ov/cder/
                                                               guidance/
                                                               index.htm
------------------------------------------------------------------------
Carcinogenicity Study       May 2002  Pharmacolo  Do.         Do.
 Protocol Submissions                  gy/
                                       Toxicolog
                                       y
------------------------------------------------------------------------
Format and Content of the   February  Do.         Do.         Do.
 Nonclinical Pharmacology/   1987
 Toxicology Section of an
 Application
------------------------------------------------------------------------
Immunotoxicology            October   Do.         Do.         Do.
 Evaluation of               2002
 Investigational New Drugs
------------------------------------------------------------------------

[[Page 856]]

 
Nonclinical Pharmacology/   October   Do.         Do.         Do.
 Toxicology Development of   1996
 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
------------------------------------------------------------------------
Photosafety Testing         May 7,    Do.         Do.         Do.
                             2003
------------------------------------------------------------------------
Reference Guide for the     February  Do.         Do.         Do.
 Nonclinical Toxicity        1989
 Studies of Antiviral
 Drugs Indicated for the
 Treatment of N/A Non-Life
 Threatening Disease:
 Evaluation of Drug
 Toxicity Prior to Phase I
 Clinical Studies
------------------------------------------------------------------------
Single Dose Acute Toxicity  August    Do.         Do.         Do.
 Testing for                 1996
 Pharmaceuticals
------------------------------------------------------------------------
Estimating the Safe         January   Pharmacolo  Do.         Do.
 Starting Dose in Clinical   16,       gy/
 Trials for Therapeutics     2003      Toxicolog
 in Adult Healthy                      y draft
 Volunteers
------------------------------------------------------------------------
Integration of Study        November  Do.         Do.         Do.
 Results to Access           13,
 Concerns About Human        2001
 Reproductive and
 Developmental Toxicities
------------------------------------------------------------------------
Nonclinical Safety          February  Do.         Do.         Do.
 Evaluation of Pediatric     2003
 Drug Products
------------------------------------------------------------------------
Nonclinical Studies for     October   Do.         Do.         Do.
 Development of              2, 2002
 Pharmaceutical Excipients
------------------------------------------------------------------------
Statistical Aspects of the  May 8,    Do.         Do.         Do.
 Design, Analysis, and       2001
 Interpretation of Chronic
 Rodent Carcinogenicity
 Studies of
 Pharmaceuticals
------------------------------------------------------------------------
180-Day Generic Drug        June      Procedural  Do.         Do.
 Exclusivity Under the       1998
 Hatch-Waxman Amendments
 to the Federal Food,
 Drug, and Cosmetic Act
------------------------------------------------------------------------
Continuous Marketing        October   Do.         Do.         Do.
 Applications: Pilot 1--     2003
 Reviewable Units for Fast
 Track Products Under the
 PDUFA
------------------------------------------------------------------------
Continuous Marketing        October   Do.         Do.         Do.
 Applications: Pilot 2--     2003
 Scientific Feedback and
 Interactions During Drug
 Development of Fast Track
 Products Under the PDUFA
------------------------------------------------------------------------
Court Decisions, ANDA       March     Do.         Do.         Do.
 Approvals, and 180-Day      27,
 Exclusivity Under the       2000
 Hatch-Waxman Amendments
 to the Federal Food,
 Drug, and Cosmetic Act
------------------------------------------------------------------------
Disclosure of Materials     November  Do.         Do.         Do.
 Provided to Advisory        30,
 Committees in Connection    1999
 with Open Advisory
 Committee Meetings
 Convened by the Center
 for Drug Evaluation and
 Research Beginning on
 January 1, 2000
------------------------------------------------------------------------
Drug Products Containing    June 3,   Do.         Do.         Do.
 Ensulizole, Hypromellose,   2003
 Meradimate, Octinoxate,
 and Octisalate--Labeling
 Enforcement Policy
------------------------------------------------------------------------
Enforcement Policy During   November  Do.         Do.         Do.
 Implementation of Section   23,
 503A of the Federal Food,   1998
 Drug, and Cosmetic Act
------------------------------------------------------------------------
Fast Track Drug             July      Do.         Do.         Do.
 Development Programs--      2004
 Designation, Development,
 and Application Review
------------------------------------------------------------------------
Financial Disclosure by     March     Do.         Do.         Do.
 Clinical Investigators      2001
------------------------------------------------------------------------
Formal Dispute Resolution:  February  Do.         Do.         Do.
 Appeals Above the           2000
 Division Level
------------------------------------------------------------------------

[[Page 857]]

 
Formal Meetings With        February  Do.         Do.         Do.
 Sponsors and Applicants     2003
 For PDUFA Products
------------------------------------------------------------------------
Implementation of Section   November  Do.         Do.         Do.
 120 of the Food and Drug    2, 1998
 Administration
 Modernization Act of
 1997--Advisory Committees
------------------------------------------------------------------------
Implementation of Section   July 21,  Do.         Do.         Do.
 126 of the Food and Drug    1998
 Administration
 Modernization Act of
 1997--Elimination of
 Certain Labeling
 Requirements
------------------------------------------------------------------------
Information Program on      January   Do.         Do.         Do.
 Clinical Trials for         27,
 Serious or Life-            2004
 Threatening Diseases and
 Conditions
------------------------------------------------------------------------
Potassium Iodide in         December  Do.         Do.         Do.
 Radiation Emergencies--     23,
 Questions and Answers       2002
------------------------------------------------------------------------
Potassium Iodide Tablets    March 8,  Do.         Do.         Do.
 for Shelf Life Extension    2004
 for Federal Agencies and
 State and Local
 Governments
------------------------------------------------------------------------
Levothyroxine Sodium        July 13,  Do.         Do.         Do.
 Products Enforcement of     2001
 August 14, 2001,
 Compliance Date and
 Submission of New
 Applications
------------------------------------------------------------------------
National Uniformity for     April 9,  Do.         Do.         Do.
 Nonprescription Drugs--     1998
 Ingredient Listing for
 OTC Drugs
------------------------------------------------------------------------
Potassium Iodide as a       December  Do.         Do.         Do.
 Thyroid Blocking Agent in   11,
 Radiation Emergencies       2001
------------------------------------------------------------------------
Qualifying for Pediatric    Septembe  Do.         Do.         Do.
 Exclusivity Under Section   r 1999
 505A of the Federal Food,
 Drug, and Cosmetic Act
 (revised)
------------------------------------------------------------------------
Refusal to File             July 12,  Do.         Do.         Do.
                             1993
------------------------------------------------------------------------
Repeal of Section 507 of    May 1998  Do.         Do.         Do.
 the Federal Food, Drug,
 and Cosmetic Act
------------------------------------------------------------------------
Special Protocol            May 17,   Do.         Do.         Do.
 Assessment                  2002
------------------------------------------------------------------------
Standards for the Prompt    May 15,   Do.         Do.         Do.
 Review of Efficacy          1998
 Supplements, Including
 Priority Efficacy
 Supplements
------------------------------------------------------------------------
Guidance for FDA Staff:     June 19,  Do.         Do.         Do.
 The Leveraging Handbook;    2003
 an Agency Resource for
 Effective Collaborations
------------------------------------------------------------------------
Women and Minorities        July 20,  Do.         Do.         Do.
 Guidance Requirements       1998
------------------------------------------------------------------------
Applications Covered by     October   Procedural  Do.         Do.
 Section 505(b)(2)           1999      draft
------------------------------------------------------------------------
Clinical Trial Sponsors On  November  Do.         Do.         Do.
 the Establishment and       2001
 Operation of Clinical
 Trial Data Monitoring
 Committees
------------------------------------------------------------------------
PET Drug Applications--     March     Do.         Do.         Do.
 Content and Format for      2000
 NDAs and ANDAs
------------------------------------------------------------------------
Disclosing Information      December  Do.         Do.         Do.
 Provided to Advisory        22,
 Committees in Connection    1999
 with Open Advisory
 Committee Meetings
 Related to the Testing or
 Approval of New Drugs and
 Convened by CDER,
 Beginning January 1, 2000
------------------------------------------------------------------------
Disclosure of Conflicts of  February  Do.         Do.         Do.
 Interest for Special        14,
 Government Employees        2002
 Participating in FDA
 Product Specific Advisory
 Committees
------------------------------------------------------------------------

[[Page 858]]

 
Forms for Registration of   April     Do.         Do.         Do.
 Producers of Drugs and      2001
 Listing of Drugs in
 Commercial Distribution
------------------------------------------------------------------------
Good Review Management      July 28,  Do.         Do.         Do.
 Principles for PDUFA        2003
 Products
------------------------------------------------------------------------
Independent Consultants     May 7,    Do.         Do.         Do.
 for Biotechnology           2003
 Clinical Trial Protocols
------------------------------------------------------------------------
Information Program on      January   Do.         Do.         Do.
 Clinical Trials for         27,
 Serious or Life-            2004
 Threatening Diseases and
 Conditions
------------------------------------------------------------------------
Pharmacogenomic Data        January   Do.         Do.         Do.
 Submissions                 27,
                             2004
------------------------------------------------------------------------
Postmarketing Safety        March     Do.         Do.         Do.
 Reporting for Human Drug    12,
 and Biological Products     2001
 Including Vaccines
------------------------------------------------------------------------
Reports on the Status of    April 4,  Do.         Do.         Do.
 Postmarketing Studies--     2001
 Implementation of Section
 130 of the Food and Drug
 Administration
 Modernization Act of 1997
------------------------------------------------------------------------
Submitting Debarment        October   Do.         Do.         Do.
 Certification Statements    2, 1998
------------------------------------------------------------------------
Submitting Marketing        Septembe  Do.         Do.         Do.
 Applications According to   r 5,
 the ICH/CTD Format--        2001
 General Considerations
------------------------------------------------------------------------
The Use of Clinical Holds   April     Do.         Do.         Do.
 Following Clinical          2002
 Investigator Misconduct
------------------------------------------------------------------------
Sterility Requirements for  November  Small       Do.         Do.
 Aqueous-Based Drug          7, 2001   entity
 Products for Oral                     complianc
 Inhalation--Small Entity              e guides
 Compliance Guide
------------------------------------------------------------------------
Applicability of User Fees  July 12,  User fee    Do.         Do.
 to (1) Applications         1993
 Withdrawn Before Filing,
 or (2) Applications the
 Agency Has Refused to
 File and That Are
 Resubmitted or Filed Over
 Protest (Attachment F)
------------------------------------------------------------------------
Application, Product, and   December  Do.         Do.         Do.
 Establishment Fees:         16,
 Common Issues and Their     1994
 Resolution (revised)
 (attachment D) (I)
------------------------------------------------------------------------
Classifying Resubmissions   May 14,   Do.         Do.         Do.
 in Response to Action       1998
 Letters
------------------------------------------------------------------------
Fees-Exceed-the-Costs       June      Do.         Do.         Do.
 Waivers Under the           1999
 Prescription Drug User
 Fee Act
------------------------------------------------------------------------
Information Request and     November  Do.         Do.         Do.
 Discipline Review Letters   21,
 Under the Prescription      2001
 Drug User Fee Act
------------------------------------------------------------------------
Submitting and Reviewing    October   Do.         Do.         Do.
 Complete Responses to       26,
 Clinical Holds (revised)    2000
------------------------------------------------------------------------
Document for Waivers of     July 16,  User fees   Do.         Do.
 and Reductions in User      1993      draft
 Fees (attachment G)
------------------------------------------------------------------------
Submitting Separate         December  Do.         Do.         Do.
 Marketing Applications      2000
 and Clinical Data for
 Purposes of Assessing
 User Fees
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
WITHDRAWALS
------------------------------------------------------------------------
In Vivo Bioequivalence      December  Do.                   Do.
 Studies on Population and   30,
 Individual Bioequivalence   1987
 Studies
------------------------------------------------------------------------
Clinical Evaluation of      April 1,  N/A                   N/A
 Antacid Drugs               1978
------------------------------------------------------------------------
Clinical Evaluation of      Septembe  Do.                   Do.
 Antidiarrheal Drugs         r 1,
                             1977
------------------------------------------------------------------------

[[Page 859]]

 
Clinical Evaluation of      Septembe  Do.                   Do.
 Gastric Secretory           r 1,
 Depressant (GSD) Drugs      1977
------------------------------------------------------------------------
Clinical Evaluation of      April 1,  Do.                   Do.
 Laxative Drugs              1978
------------------------------------------------------------------------
Clinical Evaluation of      October   Do.                   Do.
 Radiopharmaceutical Drugs   1, 1981
------------------------------------------------------------------------
FDA Requirements for        June 20,  Do.                   Do.
 Approval of Drugs to        1989
 Treat Superficial Bladder
 Cancer
------------------------------------------------------------------------
ANDAs: Blend Uniformity     August    Do.                   Do.
 Analysis                    27,
                             1999
------------------------------------------------------------------------
Topical Dermatological      June 18,  Do.                   Do.
 Drug Products NDAs and      1998
 ANDAs--In Vivo
 Bioavailability,
 Bioequivalence, In Vitro
 Release, and Associated
 Studies
------------------------------------------------------------------------
Clinical Evaluation of      March 1,  Do.                   Do.
 Combination Estrogen/       1995
 Progestin-Containing Drug
 Products Used for Hormone
 Replacement Therapy of
 Postmenopausal Women
------------------------------------------------------------------------
Noncontraceptive Estrogen   Septembe  Do.                   Do.
 Drug Products--             r 27,
 Prescribing Information     1999
 for Healthcare Providers
 and Patient Labeling
------------------------------------------------------------------------
Chlordiazepoxide            January   Do.                   Do.
 Hydrochloride Capsules      1, 1988
------------------------------------------------------------------------
Clorazepate Dipotassium     March 1,  Do.                   Do.
 Capsules/Tablets            1993
------------------------------------------------------------------------
Cyproheptadine              December  Do.                   Do.
 Hydrochloride Tablets/      1, 1986
 Syrup
------------------------------------------------------------------------
Dipivefrin Hydrochloride    November  Do.                   Do.
 Ophthalmic Solution, 0.1%   2, 1998
------------------------------------------------------------------------
Ergoloid Mesylate Tablets   January   Do.                   Do.
                             1, 1988
------------------------------------------------------------------------
Hydroxyzine Hydrochloride   December  Do.                   Do.
 Injection                   1, 1989
------------------------------------------------------------------------
Isoetharine Inhalation      March 1,  Do.                   Do.
 Solution                    1989
------------------------------------------------------------------------
Meclofenamate Sodium        July 1,   Do.                   Do.
 Capsules                    1992
------------------------------------------------------------------------
Naphazoline Hydrochloride   March 1,  Do.                   Do.
 Ophthalmic Solution         1989
------------------------------------------------------------------------
Niacin Tablets              July 1,   Do.                   Do.
                             1992
------------------------------------------------------------------------
Phendimetrazine Tartrate    February  Do.                   Do.
 Capsules/Tablets and        1, 1991
 Extended-Release Capsules
------------------------------------------------------------------------
Phentermine Hydrochloride   August    Do.                   Do.
 Capsules/Tablets            1, 1988
------------------------------------------------------------------------
Promethazine Hydrochloride  March 1,  Do.                   Do.
 Tablets                     1990
------------------------------------------------------------------------
Propantheline Bromide       August    Do.                   Do.
 Tablets                     1, 1988
------------------------------------------------------------------------
Pyridoxine Hydrochloride    June 1,   Do.                   Do.
 Injection                   1984
------------------------------------------------------------------------
Quinidine Sulfate Capsules  October   Do.                   Do.
 USP                         1, 1995
------------------------------------------------------------------------
Sulfamethoxazole and        February  Do.                   Do.
 Phenazopyridine             1, 1992
 Hydrochloride Tablets
------------------------------------------------------------------------
Theophylline Immediate      February  Do.                   Do.
 Release Oral Dosage Forms   1, 1995
------------------------------------------------------------------------
Thiamine Hydrochloride      February  Do.                   Do.
 Injection                   1, 1988
------------------------------------------------------------------------
Vitamin A Capsules          February  Do.                   Do.
                             1, 1992
------------------------------------------------------------------------
Part 11; Electronic         November  Do.                   Do.
 Records; Electronic         12,
 Signatures, Electronic      2002
 Copies of Electronic
 Records
------------------------------------------------------------------------

[[Page 860]]

 
Clinical Evaluation of      December  Do.                   Do.
 Analgesic Drugs             1, 1992
------------------------------------------------------------------------
Using FDA-Approved Patient  April     Do.                   Do.
 Labeling in Consumer-       23,
 Directed Print              2001
 Advertisements
------------------------------------------------------------------------


                                        Guidance Documents Issued by CDRH
----------------------------------------------------------------------------------------------------------------
                                            Date of        Intended User or Regulatory     How to Obtain a Copy
           Name of Document                 Issuance                 Activity                 of the Document
----------------------------------------------------------------------------------------------------------------
Guidance for Industry, FDA Staff, and   October 4, 2004  FDA, regulated industry, and     Division of Small
 Third Parties; Implementation of the                     third parties                    Manufacturers,
 Inspection by Accredited Persons                                                          International and
 Program Under the Medical Device User                                                     Consumer Assistance,
 Fee and Modernization Act of 2002;                                                        1-800-638-2041 or 301-
 Accreditation Criteria                                                                    443-6597; or Facts-on-
                                                                                           Demand,\1\ 301-827-
                                                                                           0111; or Internet at
                                                                                           http://www.fda.gov/cdrh/guidance.html
----------------------------------------------------------------------------------------------------------------
Implementation of Third Party Programs  February 2,      Do.                              Do.
 Under the FDA Modernization Act of      2001
 1997; Final Guidance for Staff,
 Industry, and Third Parties
----------------------------------------------------------------------------------------------------------------
Mutual Recognition Agreement Between    June 29, 2000    FDA and regulated industry       Do.
 the European Union and the United
 States of America: Confidence
 Building Programme: Overview and
 Procedure; Medical Device Annex,
 Version 7, June 29, 2000; Draft
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry and FDA;    July 30, 1999    Do.                              Do.
 Medical Glove Guidance Manual
----------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA;          April 14, 1999   Do.                              Do.
 Regulation of Medical Devices;
 Background Information for
 International Officials (entire
 document available on disk)
----------------------------------------------------------------------------------------------------------------
Guidance for Staff, Industry, and       January 6, 1999  Do.                              Do.
 Third 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)
----------------------------------------------------------------------------------------------------------------
Medical Device Appeals and Complaints:  February 1998    Do.                              Do.
 Guidance on Dispute Resolution
----------------------------------------------------------------------------------------------------------------
Overview of FDA Modernization Act of    February 19,     Do.                              Do.
 1997 Medical Device Provisions          1998
----------------------------------------------------------------------------------------------------------------
Medical Device Reporting for            March 1997       Do.                              Do.
 Manufacturers
----------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Devices: Guidance   January 1997     Do.                              Do.
 for the Preparation of 510(k)
 Submissions (FDA 97-4224)
----------------------------------------------------------------------------------------------------------------
Medical Device Quality Systems Manual:  April 14, 1999   Do.                              Do.
 A Small Entity Compliance Guide
----------------------------------------------------------------------------------------------------------------
Comparison Chart: 1996 Quality System   November 29,     Do.                              Do.
 Regulation vs. 1978 Good                1996
 Manufacturing Practices Regulation
 vs. ANSI/ISO/ASQC Q9001-1994 and ISO/
 DIS 13485:1996
----------------------------------------------------------------------------------------------------------------
Premarket Notification: 510(k)--        August 1995      Do.                              Do.
 Regulatory Requirements for Medical
 Devices (FDA 95-4158)
----------------------------------------------------------------------------------------------------------------

[[Page 861]]

 
Labeling--Regulatory Requirements for   September 1,     Do.                              Do.
 Medical Devices                         1989
----------------------------------------------------------------------------------------------------------------
Impact Resistant Lenses: Questions and  September 1987   Do.                              Do.
 Answers (FDA 87-4002)
----------------------------------------------------------------------------------------------------------------
CDRH Manual for the GGP Regulations;    February 9,      FDA                              Do.
 Final Guidance for FDA Staff            2001
----------------------------------------------------------------------------------------------------------------
Human Factors Principles for Medical    September 1,     FDA, regulated industry          Do.
 Device Labeling                         1993
----------------------------------------------------------------------------------------------------------------
Human Factors PTC for IDE Devices       January 17,      Do.                              Do.
                                         1997
----------------------------------------------------------------------------------------------------------------
Write It Right                          August 1993      Do.                              Do.
----------------------------------------------------------------------------------------------------------------
Do It By Design--An Introduction to     December 1996    Do.                              Do.
 Human Factors in Medical Devices
----------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA           July 18, 2000    Do.                              Do.
 Premarket and Design Control
 Reviewers; Medical Device Use--
 Safety: Incorporating Human Factors
 Engineering into Risk Management
----------------------------------------------------------------------------------------------------------------
Guidance on Medical Device Patient      April 19, 2001   Do.                              Do.
 Labeling; Final Guidance for Industry
 and FDA Reviewers
----------------------------------------------------------------------------------------------------------------
Medical Device Reporting for User       April 1996       FDA and user facilities          Do.
 Facilities
----------------------------------------------------------------------------------------------------------------
Frequently-Asked Questions About the    July 6, 2001     FDA, regulated industry, third   Do.
 Reprocessing and Reuse of Single-Use                     party, and hospital
 Devices by Third-Party and Hospital                      reprocessors
 Reprocessors; Final Guidance for
 Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
Frequently-Asked Questions About the    July 16, 2003    Do.                              Do.
 Reprocessing and Reuse of Single-Use
 Devices by Third-Party and Hospital
 Reprocessors; Three Additional
 Questions
----------------------------------------------------------------------------------------------------------------
Continuing Education Credit for         March 17, 1998   FDA, accreditation bodies, and   Do.
 Reading/Writing Articles/Papers and                      mammography facilities
 Presenting Courses/Lectures
 (incorporated into the Policy
 Guidance Help System (PGHS))
----------------------------------------------------------------------------------------------------------------
Guidance for Submission of Request for  March 26, 1998   Do.                              Do.
 Reconsideration of Adverse Decisions
 on Accreditation of Mammography
 Facilities Under the Mammography
 Quality Standards Acts, 42 U.S.C.
 263(b)/4/8, 1998 (incorporated into
 PGHS)
----------------------------------------------------------------------------------------------------------------
Guidance for Review of Requests for     March 26, 1998   Do.                              Do.
 Reconsideration of Adverse Decisions
 on Accreditation of Mammography
 Facilities Under the Mammography
 Quality Standards Act, 42 U.S.C.
 263(b)/4/8, 1998 (incorporated into
 PGHS)
----------------------------------------------------------------------------------------------------------------
Policy and Standard Operating           April 15, 1998   Do.                              Do.
 Procedures When Mammography
 Facilities in States That Have
 Accreditation Bodies Intend to Change
 Accreditation Bodies (incorporated
 into PGHS)
----------------------------------------------------------------------------------------------------------------
Guidance for Industry; Requalification  May 28, 1998     Do.                              Do.
 for Interpreting Physician's
 Continuing Experience Requirement
 (incorporated into PGHS)
----------------------------------------------------------------------------------------------------------------
Guidance; The Mammography Quality       March 19, 1999   Do.                              Do.
 Standards Act Final Regulations;
 Document 1 (incorporated
 into PGHS)
----------------------------------------------------------------------------------------------------------------

[[Page 862]]

 
Compliance Guidance; The Mammography    March 23, 1999   Do.                              Do.
 Quality Standards Act Final
 Regulations Motion of Tube-Image
 Receptor Assembly (incorporated into
 PGHS)
----------------------------------------------------------------------------------------------------------------
Guidance for Request and Issuance of    May 4, 1999      Do.                              Do.
 Interim Notice Letters for
 Mammography Facilities Under the
 Mammography Quality Standards Act, 42
 U.S.C. Section 263(b) (incorporated
 into PGHS)
----------------------------------------------------------------------------------------------------------------
Compliance Guidance; The Mammography    December 7,      Do.                              Do.
 Quality Standards Act Final             1999
 Regulations Quality Assurance
 Documentation (incorporated into
 PGHS)
----------------------------------------------------------------------------------------------------------------
Compliance Guidance; The Mammography    February 25,     Do.                              Do.
 Quality Standards Act Final             2000
 Regulations; Document 2
 (incorporated into PGHS)
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act   July 5, 2000     Do.                              Do.
 Final Regulations Modifications to
 the Policy Guidance Help System
 1; Guidance for Industry and
 FDA (incorporated into PGHS)
----------------------------------------------------------------------------------------------------------------
Compliance Guidance; The Mammography    July 18, 2000    Do.                              Do.
 Quality Standards Act Final
 Regulations; Document 3
 (incorporated into PGHS)
----------------------------------------------------------------------------------------------------------------
Compliance Guidance; Mammography        November 6,      Do.                              Do.
 Facility Survey, Equipment              2000
 Evaluation, and Medical Physicist
 Qualification Requirements Under
 MQSA; Final (incorporated into PGHS)
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act   January 24,      Do.                              Do.
 Final Regulations; Modifications and    2001
 Additions to Policy Guidance Help
 System 2; Final Guidance for
 Industry and FDA (incorporated into
 PGHS)
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act   May 23, 2001     Do.                              Do.
 Final Regulations Modifications and
 Additions to Policy Guidance Help
 System 4; Guidance for
 Industry and FDA (incorporated into
 PGHS)
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act   October 5, 2001  Do.                              Do.
 Final Regulations Modifications to
 the Policy Guidance Help System Due
 to the September 11, 2002, Terrorist
 Attacks; Final Guidance for Industry
 and FDA (incorporated into PGHS)
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act   November 5,      Do.                              Do.
 Final Regulations Modifications and     2001
 Additions to Policy Guidance Help
 System 3; Guidance for
 Industry and FDA (incorporated into
 PGHS)
----------------------------------------------------------------------------------------------------------------
Compliance Guidance; The Mammography    November 5,      Do.                              Do.
 Quality Standards Act Final             2001
 Regulations--Preparing for MQSA
 Inspections (incorporated into PGHS)
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act   March 25, 2002   Do.                              Do.
 Final Regulations Modifications and
 Additions to Policy Guidance Help
 System 4; Guidance for
 Industry and FDA (incorporated into
 PGHS)
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act   July 8, 2002     Do.                              Do.
 Final Regulations Modifications and
 Additions to Policy Guidance Help
 System 5; Guidance for
 Industry and FDA (incorporated into
 PGHS)
----------------------------------------------------------------------------------------------------------------

[[Page 863]]

 
The Mammography Quality Standards Act   January 28,      Do.                              Do.
 Final Regulations Modifications and     2003
 Additions to Policy Guidance Help
 System 7; Guidance for
 Industry and FDA (incorporated into
 PGHS)
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act   August 19, 2003  Do.                              Do.
 Final Regulations Modifications and
 Additions to Policy Guidance Help
 System 6 (incorporated into
 PGHS)
----------------------------------------------------------------------------------------------------------------
Accidental Radioactive Contamination    August 13, 1998  FDA, State and local agencies    Do.
 of Human Food and Animal Feeds:
 Recommendations to State and Local
 Agencies
----------------------------------------------------------------------------------------------------------------
Office of Device Evaluation
----------------------------------------------------------------------------------------------------------------
FY 2004 MDUFMA Small Business           August 1, 2003   Office of Device Evaluation      Do.
 Qualification Worksheet and
 Certification; Guidance for Industry
 and FDA
----------------------------------------------------------------------------------------------------------------
Premarket Assessment of Pediatric       July 24, 2003    Do.                              Do.
 Medical Devices; Draft Guidance for
 Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
Pediatric Expertise for Advisory        June 3, 2003     Do.                              Do.
 Panels; Guidance for Industry and FDA
 Staff
----------------------------------------------------------------------------------------------------------------
Premarket Approval Application Filing   May 1, 2003      Do.                              Do.
 Review; Guidance for Industry and FDA
 Staff
----------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA; FY 2003  March 27, 2003   Do.                              Do.
 MDUFMA Small Business Qualification
 Worksheet and Certification
----------------------------------------------------------------------------------------------------------------
Assessing User Fees: PMA Supplement     February 21,     Do.                              Do.
 Definitions, Modular PMA Fees, BLA      2003
 and Efficacy Supplement Definitions,
 Bundling Multiple Devices in a Single
 Application, and Fees for Combination
 Products
----------------------------------------------------------------------------------------------------------------
Determination of Intended Use for       December 3,      Do.                              Do.
 510(k) Devices; Guidance for CDRH       2002
 Staff
----------------------------------------------------------------------------------------------------------------
The Least Burdensome Provisions of the  October 4, 2002  Do.                              Do.
 FDA Modernization Act of 1997:
 Concept and Principles; Final
 Guidance for FDA and Industry
----------------------------------------------------------------------------------------------------------------
Medical Devices Made With               September 6,     Do.                              Do.
 Polyvinylchloride (PVC) Using the       2002
 Plasticizer di-(2-
 Ethylhexyl)phthalate (DEHP); Draft
 Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Updated 510(k) Sterility Review         August 30, 2002  Do.                              Do.
 Guidance K90-1; Final Guidance for
 Industry and FDA
----------------------------------------------------------------------------------------------------------------
Availability of Information Given to    July 18, 2001    Do.                              Do.
 Advisory Committee Members in
 Connection With CDRH Open Public
 Panel Meetings; Draft Guidance for
 Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
Humanitarian Device Exemptions (HDE)    July 12, 2001    Do.                              Do.
 Regulation: Questions and Answers;
 Final Guidance for Industry
----------------------------------------------------------------------------------------------------------------
Changes or Modifications During the     May 29, 2001     Do.                              Do.
 Conduct of a Clinical Investigation;
 Final Guidance for Industry and CDRH
 Staff
----------------------------------------------------------------------------------------------------------------
Early Collaboration Meetings Under the  February 28,     Do.                              Do.
 FDA Modernization Act (FDAMA); Final    2001
 Guidance for Industry and for CDRH
 Staff
----------------------------------------------------------------------------------------------------------------

[[Page 864]]

 
Deciding When To Submit a 510(k) for a  November 30,     Do.                              Do.
 Change to an Existing Wireless          2000
 Telemetry Medical Device; Final
 Guidance for FDA Reviewers and
 Industry
----------------------------------------------------------------------------------------------------------------
Guidance on Section 216 of the Food     August 9, 2000   Do.                              Do.
 and Drug Administration Modernization
 Act of 1997
----------------------------------------------------------------------------------------------------------------
Guidance on Amended Procedures for      July 22, 2000    Do.                              Do.
 Advisory Panel Meetings; Final
----------------------------------------------------------------------------------------------------------------
Guidance on the Use of Standards in     March 12, 2000   Do.                              Do.
 Substantial Equivalence
 Determinations; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Off-the-Shelf Software     September 9,     Do.                              Do.
 Use in Medical Devices; Final           1999
----------------------------------------------------------------------------------------------------------------
Draft Guidance on Evidence Models for   September 1,     Do.                              Do.
 the Least Burdensome Means to Market    1999
----------------------------------------------------------------------------------------------------------------
Medical Devices Containing Materials    November 16,     Do.                              Do.
 Derived from Animal Sources (Except     1998
 In Vitro Diagnostic Devices); Final
 Guidance for FDA Reviewers and
 Industry
----------------------------------------------------------------------------------------------------------------
Guidance for the Medical Device         November 6,      Do.                              Do.
 Industry on PMA Shell Development and   1998
 Modular Review; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry; General/         November 4,      Do.                              Do.
 Specific Intended Use; Final            1998
----------------------------------------------------------------------------------------------------------------
Frequently Asked Questions on the New   October 22,      Do.                              Do.
 510(k) Paradigm; Final                  1998
----------------------------------------------------------------------------------------------------------------
Modifications to Devices Subject to     August 6, 1998   Do.                              Do.
 Premarket Approval--The PMA
 Supplement Decision Making Process;
 Draft
----------------------------------------------------------------------------------------------------------------
Guidance for Industry; Contents of a    July 27, 1998    Do.                              Do.
 Product Development Protocol; Draft
----------------------------------------------------------------------------------------------------------------
New Model Medical Device Development    July 21, 1998    Do.                              Do.
 Process; Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket   May 29, 1998     Do.                              Do.
 Submissions for Software Contained in
 Medical Devices; Final
----------------------------------------------------------------------------------------------------------------
Guidance to Industry Supplements to     May 20, 1998     Do.                              Do.
 Approved Applications for Class III
 Medical Devices: Use of Published
 Literature, Use of Previously
 Submitted Materials, and Priority
 Review; Final
----------------------------------------------------------------------------------------------------------------
A New 510(k) Paradigm--Alternate        March 20, 1998   Do.                              Do.
 Approaches to Demonstrating
 Substantial Equivalence in Premarket
 Notifications
----------------------------------------------------------------------------------------------------------------
PMA/510(k) Expedited Review; Guidance   March 20, 1998   Do.                              Do.
 for Industry and CDRH Staff; Final
----------------------------------------------------------------------------------------------------------------
PMA/510(k) Expedited Review G94-4       March 20, 1998   Do.                              Do.
 (blue book memo)
----------------------------------------------------------------------------------------------------------------
30-Day Notices and 135-Day PMA          February 19,     Do.                              Do.
 Supplements for Manufacturing Method    1998
 or Process Changes; Guidance for
 Industry and CDRH (Docket No. 98D-
 0080); Final
----------------------------------------------------------------------------------------------------------------
Guidance on PMA Interactive Procedures  February 19,     Do.                              Do.
 for Day-100 Meetings and Subsequent     1998
 Deficiencies--for Use by CDRH and
 Industry; Final
----------------------------------------------------------------------------------------------------------------

[[Page 865]]

 
New section 513(f)(2)--Evaluation of    February 19,     Do.                              Do.
 Automatic Class III Designation;        1998
 Guidance for Industry and CDRH Staff;
 Final
----------------------------------------------------------------------------------------------------------------
Procedures for Class II Device          February 19,     Do.                              Do.
 Exemptions from Premarket               1998
 Notification Guidance for Industry
 and CDRH Staff; Final
----------------------------------------------------------------------------------------------------------------
Guidance on IDE Policies and            January 20,      Do.                              Do.
 Procedures; Final                       1998
----------------------------------------------------------------------------------------------------------------
Distribution and Public Availability    October 10,      Do.                              Do.
 of PMA Summary of Safety and            1997
 Effectiveness Data Packages
----------------------------------------------------------------------------------------------------------------
Kit Certification for 510(k)s           July 1, 1997     Do.                              Do.
----------------------------------------------------------------------------------------------------------------
Convenience Kits Interim Regulatory     May 20, 1997     Do.                              Do.
 Guidance
----------------------------------------------------------------------------------------------------------------
Real-Time Review Program for Premarket  April 22, 1997   Do.                              Do.
 Aproval Application (PMA) Supplements
----------------------------------------------------------------------------------------------------------------
Deciding When to Submit a 510(k) for a  January 10,      Do.                              Do.
 Change to an Existing Device (K97-1)    1997
----------------------------------------------------------------------------------------------------------------
Questions and Answers for the FDA       September 3,     Do.                              Do.
 Reviewer Guidance: Labeling Reusable    1996
 Medical Devices for Reprocessing in
 Health Care Facilities
----------------------------------------------------------------------------------------------------------------
Memorandum of Understanding Regarding   August 9, 1996   Do.                              Do.
 Patient Labeling Review (blue book
 memo G96-3)
----------------------------------------------------------------------------------------------------------------
Continued Access to Investigational     July 15, 1996    Do.                              Do.
 Devices During PMA Preparation and
 Review (blue book memo D96-
 1)
----------------------------------------------------------------------------------------------------------------
Document Review by the Office of the    June 6, 1996     Do.                              Do.
 Chief Counsel (blue book memo G96-1)
----------------------------------------------------------------------------------------------------------------
Format for IDE Progress Reports         June 1, 1996     Do.                              Do.
----------------------------------------------------------------------------------------------------------------
Labeling Reusable Medical Devices for   April 1, 1996    Do.                              Do.
 Reprocessing in Health Care
 Facilities: FDA Reviewer Guidance
----------------------------------------------------------------------------------------------------------------
510(k) Quality Review Program (blue     March 29, 1996   Do.                              Do.
 book memo)
----------------------------------------------------------------------------------------------------------------
Suggested Content for Original IDE      February 27,     Do.                              Do.
 Application Cover Letter                1996
----------------------------------------------------------------------------------------------------------------
Indications for Use Statement           January 2, 1996  Do.                              Do.
----------------------------------------------------------------------------------------------------------------
Letter--Vascular Graft Industry         November 22,     Do.                              Do.
 (Philip Phillips)                       1995
----------------------------------------------------------------------------------------------------------------
Cover Letter: 510(k) Requirements       November 21,     Do.                              Do.
 During Firm-Initiated Recalls;          1995
 Attachment A: Guidance on Recall and
 Premarket Notification Review
 Procedures During Firm-Initiated
 Recalls of Legally Marketed Devices
 (blue book memo K95-1)
----------------------------------------------------------------------------------------------------------------
Color Additives for Medical Devices     November 15,     Do.                              Do.
 (Snesko)                                1995
----------------------------------------------------------------------------------------------------------------
D95-2, Attachment A            September 15,    Do.                              Do.
 (Interagency Agreement between FDA      1995
 and HCFA)
----------------------------------------------------------------------------------------------------------------
D95-2, Attachment B (Criteria  September 15,    Do.                              Do.
 for Categorization of Investigational   1995
 Devices (HCFA))
----------------------------------------------------------------------------------------------------------------

[[Page 866]]

 
HCFA Reimbursement Categorization       September 15,    Do.                              Do.
 Determinations for FDA-Approved IDEs    1995
----------------------------------------------------------------------------------------------------------------
Implementation of the FDA/HCFA          September 15,    Do.                              Do.
 Interagency Agreement Regarding         1995
 Reimbursement Categorization of
 Investigational Devices, Attachment A
 Interagency Agreement, Attachment B
 Criteria for Catergorization of
 Investigational Devices, and
 Attachment C--List (blue book memo
 D95-2)
----------------------------------------------------------------------------------------------------------------
Goals and Initiatives for the IDE       July 12, 1995    Do.                              Do.
 Program (blue book memo D95-
 1)
----------------------------------------------------------------------------------------------------------------
Memorandum: Electromagnetic             June 13, 1995    Do.                              Do.
 Compatibility for Medical Devices:
 Issues and Solutions
----------------------------------------------------------------------------------------------------------------
Use of International Standard ISO-      May 1, 1995      Do.                              Do.
 10993, ``Biological Evaluation of
 Medical Devices Part 1: Evaluation
 and Testing'' (replaces G87-
 1 8294) (blue book memo)
----------------------------------------------------------------------------------------------------------------
Premarket Approval Application (PMA)    July 8, 1994     Do.                              Do.
 Closure (blue book memo P94-
 2)
----------------------------------------------------------------------------------------------------------------
510(k) Sign-Off Procedures (blue book   June 3, 1994     Do.                              Do.
 memo K94-2)
----------------------------------------------------------------------------------------------------------------
Letter to Industry, Powered Wheelchair/ May 26, 1994     Do.                              Do.
 Scooter or Accessory/Component
 Manufacturer from Susan Alpert,
 Ph.D., M.D.
----------------------------------------------------------------------------------------------------------------
510(k) Refuse to Accept Procedures      May 20, 1994     Do.                              Do.
 (blue book memo K94-1)
----------------------------------------------------------------------------------------------------------------
IDE Refuse to Accept Procedures (blue   May 20, 1994     Do.                              Do.
 book memo D94-1)
----------------------------------------------------------------------------------------------------------------
PMA/510(k) Triage Review Procedures     May 20, 1994     Do.                              Do.
 (blue book memo G94-1)
----------------------------------------------------------------------------------------------------------------
Preamendments Class III Strategy        April 19, 1994   Do.                              Do.
----------------------------------------------------------------------------------------------------------------
Premarket Notification (510(k)) Status  March 7, 1994    Do.                              Do.
 Request Form
----------------------------------------------------------------------------------------------------------------
Documentation and Resolution of         December 23,     Do.                              Do.
 Differences of Opinion on Product       1993
 Evaluations (blue book memo G93-1)
----------------------------------------------------------------------------------------------------------------
510(k) Additional Information           July 23, 1993    Do.                              Do.
 Procedures (blue book memo K93-1)
----------------------------------------------------------------------------------------------------------------
CDRH's Investigational Device           June 30, 1993    Do.                              Do.
 Exemption (IDE) Refuse to Accept
 Policy
----------------------------------------------------------------------------------------------------------------
CDRH's Premarket Notification (510(k))  June 30, 1993    Do.                              Do.
 Refuse to Accept Policy (updated
 checklist March 14, 1995)
----------------------------------------------------------------------------------------------------------------
Proposal for Establishing Mechanisms    June 30, 1993    Do.                              Do.
 for Setting Review Priorities Using
 Risk Assesment and Allocating Review
 Resources
----------------------------------------------------------------------------------------------------------------
Classified Convenience Kits             April 30, 1993   Do.                              Do.
----------------------------------------------------------------------------------------------------------------
Telephone Communications Between ODE    January 29,      Do.                              Do.
 Staff and Manufacturers (blue book      1993
 memo I93-1)
----------------------------------------------------------------------------------------------------------------
Preamendment Class III Devices          March 11, 1992   Do.                              Do.
----------------------------------------------------------------------------------------------------------------
Nondisclosure of Financially Sensitive  March 5, 1992    Do.                              Do.
 Information (blue book memo I92-1)
----------------------------------------------------------------------------------------------------------------

[[Page 867]]

 
Document Review Processing (blue book   February 12,     Do.                              Do.
 memo I91-1)                    1992
----------------------------------------------------------------------------------------------------------------
4-of-a-Kind PMAs                        October 1, 1991  Do.                              Do.
----------------------------------------------------------------------------------------------------------------
Review of 510(k)s for Computer          August 29, 1991  Do.                              Do.
 Controlled Medical Devices (blue book
 memo K91-1)
----------------------------------------------------------------------------------------------------------------
Review of Final Draft Medical Device    August 29, 1991  Do.                              Do.
 Labeling (blue book memo P91-
 4)
----------------------------------------------------------------------------------------------------------------
Integrity of Data and Information       May 29, 1991     Do.                              Do.
 Submitted to ODE (blue book memo
 I91-2)
----------------------------------------------------------------------------------------------------------------
Clinical Utility and Premarket          May 3, 1991      Do.                              Do.
 Approval (blue book memo P91-
 1)
----------------------------------------------------------------------------------------------------------------
Panel Review of Premarket Approval      May 3, 1991      Do.                              Do.
 Applications (blue book memo P91-2)
----------------------------------------------------------------------------------------------------------------
PMA Compliance Program (blue book memo  May 3, 1991      Do.                              Do.
 P91-3)
----------------------------------------------------------------------------------------------------------------
Shelf Life of Medical Devices           April 1, 1991    Do.                              Do.
----------------------------------------------------------------------------------------------------------------
Device Labeling Guidance (blue book     March 8, 1991    Do.                              Do.
 memo G91-1)
----------------------------------------------------------------------------------------------------------------
Review and Approval of PMAs of          October 22,      Do.                              Do.
 Licensees (blue book memo P86-4)
----------------------------------------------------------------------------------------------------------------
Consolidated Review of Submissions for  October 19,      Do.                              Do.
 Diagnostic Ultrasound Equipment,        1990
 Accessories and Related Measurement
 Devices (blue book memo G90-
 2)
----------------------------------------------------------------------------------------------------------------
Consolidated Review of Submissions for  October 19,      Do.                              Do.
 Lasers and Accessories (blue book       1990
 memo G90-1)
----------------------------------------------------------------------------------------------------------------
Assignment of Review Documents (blue    August 24, 1990  Do.                              Do.
 book memo I90-2)
----------------------------------------------------------------------------------------------------------------
PMA Supplements: ODEs Letter to         April 24, 1990   Do.                              Do.
 Manufacturers; Identifies Situations
 Which May Require the Submission of a
 PMA Supplement (When PMA Supplements
 Are Required) (blue book memo P90-1)
----------------------------------------------------------------------------------------------------------------
Policy Development and Review           February 15,     Do.                              Do.
 Procedures (blue book memo I90-1)
----------------------------------------------------------------------------------------------------------------
Substantial Equivalence (SE) Decision   January 1, 1990  Do.                              Do.
 Making Documentation Attached: ``SE''
 Decision Making Process (detailed);
 i.e., The Decision Making Tree
----------------------------------------------------------------------------------------------------------------
Threshold Assessment of the Impact of   January 1, 1990  Do.                              Do.
 Requirements for Submission of PMAs
 for 31 Medical Devices Marketed Prior
 to May 28, 1976
----------------------------------------------------------------------------------------------------------------
Meetings with the Regulated Industry    November 20,     Do.                              Do.
 (blue book memo I89-3)         1989
----------------------------------------------------------------------------------------------------------------
FDA Policy for The Regulation of        November 13,     Do.                              Do.
 Computer Products; Draft                1989
----------------------------------------------------------------------------------------------------------------
Toxicology Risk Assessment Committee    August 9, 1989   Do.                              Do.
 (blue book memo G89-1)
----------------------------------------------------------------------------------------------------------------
Review of IDEs for Feasibility Studies  May 17, 1989     Do.                              Do.
 (blue book memo D89-1)
----------------------------------------------------------------------------------------------------------------

[[Page 868]]

 
Premarket Notification--Consistency of  February 28,     Do.                              Do.
 Reviews (blue book memo K89-   1989
 1)
----------------------------------------------------------------------------------------------------------------
Review of Laser Submissions (blue book  April 15, 1988   Do.                              Do.
 memo G88-1)
----------------------------------------------------------------------------------------------------------------
PMA Review Schedules (P87-1); replaced  March 31, 1988   Do.                              Do.
 by P94-2
----------------------------------------------------------------------------------------------------------------
Guideline on Validation of the Limulus  December 1,      Do.                              Do.
 Amebocyte Lysate (LAL) Test as an End-  1987
 Product Endotoxin Test
----------------------------------------------------------------------------------------------------------------
Necessary Information for Diagnostic    November 24,     Do.                              Do.
 Ultrasound 510(k); Draft                1987
----------------------------------------------------------------------------------------------------------------
Limulus Amebocute Lysate; Reduction of  October 23,      Do.                              Do.
 Samples for Testing                     1987
----------------------------------------------------------------------------------------------------------------
ODE Executive Secretary Guidance        August 7, 1987   Do.                              Do.
 Manual G87-3
----------------------------------------------------------------------------------------------------------------
Guideline on Sterile Drug Products      June 1, 1987     Do.                              Do.
 Produced by Aseptic Processing
----------------------------------------------------------------------------------------------------------------
Master Files Part III; Guidance on      June 1, 1987     Do.                              Do.
 Scientific and Technical Information
----------------------------------------------------------------------------------------------------------------
ODE Regulatory Information for the      May 15, 1987     Do.                              Do.
 Office of Compliance--Information
 Sharing Procedures (blue book memo
 G87-2)
----------------------------------------------------------------------------------------------------------------
Guideline on General Principles of      May 1, 1987      Do.                              Do.
 Process Validation
----------------------------------------------------------------------------------------------------------------
Industry Representatives on Scientific  March 27, 1987   Do.                              Do.
 Panel
----------------------------------------------------------------------------------------------------------------
Panel Review of ``Me-Too'' Devices      July 1, 1986     Do.                              Do.
 (blue book memo P86-6)
----------------------------------------------------------------------------------------------------------------
Guidance on CDRH's Premarket            June 30, 1986    Do.                              Do.
 Notification Review Program (blue
 book memo K86-3)
----------------------------------------------------------------------------------------------------------------
Panel Report and Recommendations on     April 18, 1986   Do.                              Do.
 PMA Approvals (blue book memo P86-5)
----------------------------------------------------------------------------------------------------------------
Criteria for Panel Review of PMA        January 30,      Do.                              Do.
 Supplements (blue book memo P86-3)
----------------------------------------------------------------------------------------------------------------
PMAs--Early Review and Preparation of   January 27,      Do.                              Do.
 Summaries of Safety and Effectiveness   1986
 (blue book memo P86-1)
----------------------------------------------------------------------------------------------------------------
PTC in the Characterization of Cell     June 1, 1984     Do.                              Do.
 Lines Used to Produce Biological
 Products
----------------------------------------------------------------------------------------------------------------
Application of the Device Good          December 1,      Do.                              Do.
 Manufacturing Practice (GMP)            1983
 Regulation to the Manufacture of
 Sterile Devices
----------------------------------------------------------------------------------------------------------------
Methods for Conducting Recall           June 16, 1978    Do.                              Do.
 Effectiveness Checks
----------------------------------------------------------------------------------------------------------------
Guidance for Submitting                 1997             Do.                              Do.
 Reclassification Petition
----------------------------------------------------------------------------------------------------------------
Reprocessing and Reuse of Single-Use    February 8,      Do.                              Do.
 Devices: Review Prioritization          2000
 Scheme; Draft
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance      July 17, 2002    Do.                              Do.
 Document: Apnea Monitors; Guidance
 for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance      December 13,     Do.                              Do.
 Document: Cutaneous Carbon Dioxide      2002
 (PcCo2) and Oxygen (PcO2) Monitors;
 Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------

[[Page 869]]

 
Class II Special Controls Guidance      October 5, 2001  Do.                              Do.
 Document: Indwelling Blood Gas
 Analyzers; Final Guidance for
 Industry and FDA
----------------------------------------------------------------------------------------------------------------
Heated Humidifier Review Guidance       August 30, 1991  Do.                              Do.
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance      April 22, 2003   Do.                              Do.
 Document: Optical Impression Systems
 for Computer Assisted Design and
 Manufacturing (CAD/CAM) of Dental
 Restorations; Guidance for Industry
 and FDA
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance      November 12,     Do.                              Do.
 Document: Intraoral Devices for         2002
 Snoring and/or Obstructive Sleep
 Apnea; Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance      August 14, 2002  Do.                              Do.
 Document: Dental Sonography and Jaw
 Tracking Devices; Draft Guidance for
 Industry and FDA Reviewers
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance      May 14, 2002     Do.                              Do.
 Document: Root-Form Endosseous Dental
 Implants and Abutments; Draft
 Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Special Control Guidance Document on    February 20,     Do.                              Do.
 Encapsulated Amalgam, Amalgam Alloy,    2002
 and Dental Mercury Labeling; Draft
 Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Overview of Information Necessary for   April 21, 1999   Do.                              Do.
 Premarket Notification Submissions
 for Endosseous Implants; Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of         November 27,     Do.                              Do.
 Premarket Notifications for Dental      1998
 Composites
----------------------------------------------------------------------------------------------------------------
Dental Cements--Premarket               August 18, 1998  Do.                              Do.
 Notification; Final
----------------------------------------------------------------------------------------------------------------
Dental Impression Materials--Premarket  August 17, 1998  Do.                              Do.
 Notification; Final
----------------------------------------------------------------------------------------------------------------
OTC Denture Cushions, Pads, Reliners,   August 17, 1998  Do.                              Do.
 Repair Kits, and Partially Fabricated
 Denture Kits; Final
----------------------------------------------------------------------------------------------------------------
Draft Guidance Document for the         March 3, 1997    Do.                              Do.
 Preparation of Premarket Notification
 510(k)s for Dental Alloys
----------------------------------------------------------------------------------------------------------------
Information Necessary for Premarket     December 9,      Do.                              Do.
 Notification Submissions for Screw-     1996
 Type Endosseous Implants
----------------------------------------------------------------------------------------------------------------
Guidance Document on Dental Handpieces  July 1, 1995     Do.                              Do.
----------------------------------------------------------------------------------------------------------------
Guidance for the Arrangement and        May 16, 1989     Do.                              Do.
 Content of a Premarket Approval (PMA)
 Application for an Endosseous Implant
 for Prosthetic Attachment
----------------------------------------------------------------------------------------------------------------
Supplementary Guidance on Premarket     December 31,     Do.                              Do.
 Notifications for Medical Devices       2002
 With Sharps Injury Prevention
 Features; Guidance for Industry and
 FDA
----------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notifications     October 12,      Do.                              Do.
 for Intravascular Administration Sets   2000
----------------------------------------------------------------------------------------------------------------
Neonatal and Neonatal Transport         September 18,    Do.                              Do.
 Incubators--Premarket Notifications;    1998
 Final
----------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket    December 1,      Do.                              Do.
 Notification (510(k)) Submissions for   1995
 Protective Restraints
----------------------------------------------------------------------------------------------------------------

[[Page 870]]

 
Guidance on Premarket Notification      March 16, 1995   Do.                              Do.
 (510(k)) Submissions for Short-Term
 and Long-Term Intravascular Catheters
----------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket    April 1, 1993    Do.                              Do.
 Notification (510(k)) Submissions for
 Hypodermic Single Lumen Needles
----------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket    April 1, 1993    Do.                              Do.
 Notification (510(k)) Submissions for
 Piston Syringes
----------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket    March 1, 1993    Do.                              Do.
 Notification (510(k)) Submissions for
 Clinical Electronic Thermometers
----------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket    March 1, 1993    Do.                              Do.
 Notification (510(k)) Submissions for
 External Infusion Pumps
----------------------------------------------------------------------------------------------------------------
Guidance on 510(k) Submissions for      October 1, 1990  Do.                              Do.
 Implanted Infusion Ports
----------------------------------------------------------------------------------------------------------------
Surgical Masks--Premarket Notification  May 15, 2003     Do.                              Do.
 (510(k)) Submissions; Draft Guidance
----------------------------------------------------------------------------------------------------------------
Regulatory Status of Disinfectants      August 30, 2002  Do.                              Do.
 Used to Process Dialysate Delivery
 Systems and Water Purification
 Systems for Hemodialysis; Guidance
 for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Premarket Notification (510(k))         March 7, 2002    Do.                              Do.
 Submissions for Medical Sterilization
 Packaging Systems in Health Care
 Facilities; Draft Guidance for
 Industry and FDA
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance      February 7,      Do.                              Do.
 Document: Medical Washers and Medical   2002
 Washer-Disinfectors; Guidance for the
 Medical Device Industry and FDA
 Review Staff
----------------------------------------------------------------------------------------------------------------
Premarket Guidance: Reprocessing and    June 1, 2001     Do.                              Do.
 Reuse of Single-Use Devices; Draft
 Guidance for Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
Premarket Notifications (510(k)) for    May 21, 2001     Do.                              Do.
 Biological Indicators Intended to
 Monitor Sterilizers Used in Health
 Care Facilities; Draft Guidance for
 Industry and FDA Reviewers
----------------------------------------------------------------------------------------------------------------
Premarket Approval Applications (PMA)   March 2, 2001    Do.                              Do.
 for Sharps Needle Destruction
 Devices; Final Guidance for Industry
 and FDA
----------------------------------------------------------------------------------------------------------------
Guidance on the Content and Format of   January 3, 2000  Do.                              Do.
 Premarket Notification (510(k))
 Submissions for Liquid Chemical
 Sterilants and High Level
 Disinfectants; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Conducting Stability       November 16,     Do.                              Do.
 Testing to Support an Expiration Date   1999
 Labeling Claim for Medical Gloves;
 Draft
----------------------------------------------------------------------------------------------------------------
Premarket Notification (510(k))         January 13,      Do.                              Do.
 Submissions for Testing for Skin        1999
 Sensitization to Chemicals in Natural
 Rubber Products; Final
----------------------------------------------------------------------------------------------------------------
CDRH Regulatory Guidance for Washers    June 2, 1998     Do.                              Do.
 and Washer-Disinfectors Intended for
 Use in Processing Reusable Medical
 Devices
----------------------------------------------------------------------------------------------------------------
Testing for Sensitizing Chemicals in    July 28, 1997    Do.                              Do.
 Natural Rubber Latex Medical Devices
 (addendum to 944)
----------------------------------------------------------------------------------------------------------------

[[Page 871]]

 
Addendum to Guidance on Premarket       September 19,    Do.                              Do.
 Notification (510(k)) Submissions for   1995
 Sterilizers Intended for Use in
 Health Care Facilities
----------------------------------------------------------------------------------------------------------------
Guidance on the Content and Format of   October 1, 1993  Do.                              Do.
 Premarket Notification (510(k))
 Submissions for Sharps Containers
----------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notification      August 1, 1993   Do.                              Do.
 (510(k)) Submissions for Automated
 Endoscope Washers, Washer/
 Disinfectors, and Disinfectors
 Intended for Use in Health Care
 Facilities
----------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notification      August 1, 1993   Do.                              Do.
 (510(k)) Submissions for Surgical
 Gowns and Surgical Drapes
----------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notification      March 1, 1993    Do.                              Do.
 510(k) for Sterilizers Intended for
 Use in Health Care Facilities
----------------------------------------------------------------------------------------------------------------
Battery Guidance                        January 1, 1994  Do.                              Do.
----------------------------------------------------------------------------------------------------------------
Policy for Expiration Dating (DCRND     October 30,      Do.                              Do.
 RB92-G)                                 1992
----------------------------------------------------------------------------------------------------------------
Balloon Valvuloplasty Guidance for the  January 1, 1989  Do.                              Do.
 Submission of an IDE Application and
 a PMA Application
----------------------------------------------------------------------------------------------------------------
Cardiac Ablation Catheters Generic      July 1, 2002     Do.                              Do.
 Arrhythmia Indications for Use;
 Guidance for Industry
----------------------------------------------------------------------------------------------------------------
Investigational Device Exemption (IDE)  November 8,      Do.                              Do.
 Study Enrollment for Cardiac Ablation   2000
 of Typical Atrial Flutter; Final
 Guidance for Industry and FDA
 Reviewers
----------------------------------------------------------------------------------------------------------------
Recommended Clinical Study Design for   May 7, 1999      Do.                              Do.
 Ventricular Tachycardia Ablation
----------------------------------------------------------------------------------------------------------------
Non-Automated Sphygmomanometer (Blood   November 19,     Do.                              Do.
 Pressure Cuff) Guidance Version 1;      1998
 Final
----------------------------------------------------------------------------------------------------------------
Non-Invasive Blood Pressure (NIBP)      March 10, 1997   Do.                              Do.
 Monitor Guidance
----------------------------------------------------------------------------------------------------------------
Electrocardiograph (ECG) Electrode      February 11,     Do.                              Do.
                                         1997
----------------------------------------------------------------------------------------------------------------
Electrocardiograph (ECG) Lead           February 11,     Do.                              Do.
 Switching Adapter                       1997
----------------------------------------------------------------------------------------------------------------
Electrocardiograph (ECG) Surface        February 11,     Do.                              Do.
 Electrode Tester                        1997
----------------------------------------------------------------------------------------------------------------
Draft Version Cardiac Ablation          March 1, 1995    Do.                              Do.
 Preliminary Guidance (Data To Be
 Submitted to the FDA in Support
 Investigation Device Exemption
 Application)
----------------------------------------------------------------------------------------------------------------
Draft Version Electrode Recording       March 1, 1995    Do.                              Do.
 Catheter Preliminary Guidance (Data
 To Be Submitted to the FDA in Support
 of Premarket Notifications)
----------------------------------------------------------------------------------------------------------------
Guidance for Annuloplasty Rings 510(k)  January 31,      Do.                              Do.
 Submissions; Final Guidance for         2001
 Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
Guidance for Cardiopulmonary Bypass     November 29,     Do.                              Do.
 Arterial Line Blood Filter 510(k)       2000
 Submissions; Final Guidance for
 Industry and FDA
----------------------------------------------------------------------------------------------------------------
Guidance for Extracorporeal Blood       November 29,     Do.                              Do.
 Circuit Defoamer 510(k) Submissions;    2000
 Final Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------

[[Page 872]]

 
Guidance for Cardiopulmonary Bypass     November 13,     Do.                              Do.
 Oxygenators 510(k) Submissions; Final   2000
 Guidance for Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
Draft Replacement Heart Valve Guidance  October 14,      Do.                              Do.
                                         1994
----------------------------------------------------------------------------------------------------------------
Draft Guidance; Human Heart Valve       June 21, 1991    Do.                              Do.
 Allografts
----------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of the     April 1, 1990    Do.                              Do.
 Annual Report to the PMA Approved
 Heart Valve Prostheses
----------------------------------------------------------------------------------------------------------------
Draft Intravascular Brachytherapy--     May 24, 1996     Do.                              Do.
 Guidance for Data To Be Submitted to
 FDA in Support of Investigational
 Device Exemption (IDE) Applications
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Submission of    May 1, 1995      Do.                              Do.
 Research and Marketing Applications
 for Interventional Cardiology
 Devices: PTCA Catheters, Atherectomy
 Catheters, Lasers, Intravascular
 Stents
----------------------------------------------------------------------------------------------------------------
Draft Percutaneous Transluminal         February 7,      Do.                              Do.
 Coronary Angioplasty Package Insert     1995
 Template
----------------------------------------------------------------------------------------------------------------
Coronary and Cerebrovascular Guidewire  January 1, 1995  Do.                              Do.
 Guidance
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of          November 1,      Do.                              Do.
 Research and Marketing Applications     2000
 for Permanent Pacemaker Leads and for
 Pacemaker Lead Adaptor 510(k)
 Submissions
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Implantable          June 19, 1996    Do.                              Do.
 Cardioverter-Defibrillators
----------------------------------------------------------------------------------------------------------------
Implantable Pacemaker Testing Guidance  January 12,      Do.                              Do.
                                         1990
----------------------------------------------------------------------------------------------------------------
Guidance Document for Vascular          November 1,      Do.                              Do.
 Prostheses 510(k) Submissions           2000
----------------------------------------------------------------------------------------------------------------
Guidance for Cardiovascular             November 26,     Do.                              Do.
 Intravascular Filter 510(k)             1999
 Submissions; Final
----------------------------------------------------------------------------------------------------------------
Carotid Stent--Suggestions for Content  October 26,      Do.                              Do.
 of Submissions to FDA in Support of     1996
 Investigational Devices Exemption
 (IDE) Applications
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Preparation of   August 1, 1993   Do.                              Do.
 Research and Marketing Applications
 for Vascular Graft Prostheses
----------------------------------------------------------------------------------------------------------------
Guidance Document for Powered Suction   September 30,    Do.                              Do.
 Pump 510(k)s                            1998
----------------------------------------------------------------------------------------------------------------
Guidance Document for Surgical Lamp     July 13, 1998    Do.                              Do.
 510(k)s; Final
----------------------------------------------------------------------------------------------------------------
Electroencephalograph Devices Draft     November 3,      Do.                              Do.
 Guidance for 510(k) Content             1997
----------------------------------------------------------------------------------------------------------------
Guidelines for Reviewing Premarket      February 1,      Do.                              Do.
 Notifications That Claim Substantial    1997
 Equivalence to Evoked Response
 Stimulators
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation   July 26, 1995    Do.                              Do.
 of Premarket Notification (510(k))
 Applications for Electromyograph
 Needle Electrodes
----------------------------------------------------------------------------------------------------------------
Guidance on the Content and             June 1, 1995     Do.                              Do.
 Organization of a Premarket
 Notification for a Medical Laser
----------------------------------------------------------------------------------------------------------------

[[Page 873]]

 
Draft 510(k) Guideline for General      May 10, 1995     Do.                              Do.
 Surgical Electrosurgical Devices
----------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of a       August 30, 1994  Do.                              Do.
 Premarket Notification for Extended
 Laparoscopy Devices
----------------------------------------------------------------------------------------------------------------
Galvanic Skin Response Measurement      August 23, 1994  Do.                              Do.
 Devices; Draft Guidance for 510(k)
 Content
----------------------------------------------------------------------------------------------------------------
Draft Version 1; Biofeedback Devices;   August 1, 1994   Do.                              Do.
 Draft Guidance for 510(k) Content
----------------------------------------------------------------------------------------------------------------
Draft Version Cranial Perforator        July 13, 1994    Do.                              Do.
 Guidance
----------------------------------------------------------------------------------------------------------------
Draft Version Neuro Endoscope Guidance  July 7, 1994     Do.                              Do.
----------------------------------------------------------------------------------------------------------------
Draft Premarket Notification Review     June 1, 1994     Do.                              Do.
 Guidance for Evoked Response
 Somatosensory Stimulators
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Arthroscope and      May 1, 1994      Do.                              Do.
 Accessory 510(k)s
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance      January 16,      Do.                              Do.
 Document; Knee Joint                    2003
 Patellofemorotibial and Femorotibial
 Metal/Polymer Porous-Coated
 Uncemented Prostheses; Guidance for
 Industry and FDA
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance      July 17, 2002    Do.                              Do.
 Document; Polymethylmethacrylate
 (PMMA) Bone Cement; Guidance for
 Industry and FDA
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance      April 30, 2002   Do.                              Do.
 Document: Hip Joint Metal/Polymer
 Constrained Cemented or Uncemented
 Prosthesis
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance:     October 31,      Do.                              Do.
 Shoulder Joint Metal/Polymer/Metal      2000
 Nonconstrained or Semiconstrained
 Porous-Coated Uncemented Prosthesis
----------------------------------------------------------------------------------------------------------------
Guidance for Spinal System 510(k)s      September 27,    Do.                              Do.
                                         2000
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation   January 13,      Do.                              Do.
 of IDEs for Spinal Systems              2000
----------------------------------------------------------------------------------------------------------------
Guidance Document for Industry and      March 18, 1998   Do.                              Do.
 CDRH Staff for the Preparation of
 Investigational Device Exemptions and
 Premarket Approval Applications for
 Bone Growth Stimulator Devices; Draft
----------------------------------------------------------------------------------------------------------------
Draft Guidance Document for the         July 16, 1997    Do.                              Do.
 Preparation of Premarket Notification
 (510(k)) Applications for Orthopedic
 Devices--The Basic Elements
----------------------------------------------------------------------------------------------------------------
ORDB 510(k) Sterility Review Guidance   July 3, 1997     Do.                              Do.
----------------------------------------------------------------------------------------------------------------
Calcium Phosphate (Ca-P) Coating Draft  February 21,     Do.                              Do.
 Guidance for Preparation of FDA         1997
 Submissions for Orthopedic and Dental
 Endosseous Implants
----------------------------------------------------------------------------------------------------------------
Reviewers Guidance Checklist for        February 21,     Do.                              Do.
 Intramedullary Rods                     1997
----------------------------------------------------------------------------------------------------------------
Reviewers Guidance Checklist for        February 21,     Do.                              Do.
 Orthopedic External Fixation Devices    1997
----------------------------------------------------------------------------------------------------------------
510(k) Information Needed for           February 20,     Do.                              Do.
 Hydroxyapatite Coated Orthopedic        1997
 Implants
----------------------------------------------------------------------------------------------------------------

[[Page 874]]

 
Guidance Document for Testing           April 20, 1996   Do.                              Do.
 Biodegradable Polymer Implant Devices
----------------------------------------------------------------------------------------------------------------
Guidance Document for Testing Bone      April 20, 1996   Do.                              Do.
 Anchor Devices
----------------------------------------------------------------------------------------------------------------
Draft Guidance Document for Femoral     August 1, 1995   Do.                              Do.
 Stem Prostheses
----------------------------------------------------------------------------------------------------------------
Draft Guidance Document for Testing     May 1, 1995      Do.                              Do.
 Acetabular Cup Prostheses
----------------------------------------------------------------------------------------------------------------
Guidance Document for Testing Non-      May 1, 1995      Do.                              Do.
 Articulating, ``Mechanically
 Locked,'' Modular Implant Components
----------------------------------------------------------------------------------------------------------------
Draft Data Requirements for Ultrahigh   March 28, 1995   Do.                              Do.
 Molecular Weight Polyethylene
 (Uhmupe) Used in Orthopedic Devices
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation   January 10,      Do.                              Do.
 of Premarket Notification for Ceramic   1995
 Ball Hip Systems
----------------------------------------------------------------------------------------------------------------
Guidance Document for Testing           April 28, 1994   Do.                              Do.
 Orthopedic Implants With Modified
 Metallic Surfaces Apposing Bone or
 Bone Cement
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Preparation of   April 1, 1993    Do.                              Do.
 Premarket Notifications (510(k)s) for
 Cemented, Semiconstrained Total Knee
 Prostheses
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation   February 18,     Do.                              Do.
 of IDE and PMA Applications for Intra-  1993
 Articular Prothetic Knee Ligament
 Devices
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance      June 3, 2003     Do.                              Do.
 Document; Surgical Sutures; Guidance
 for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Guidance for Saline, Silicone Gel, and  February 11,     Do.                              Do.
 Alternative Breast Implants; Guidance   2003
 for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance      October 22,      Do.                              Do.
 Document; Human Dura Mater; Draft       2002
 Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Guidance for Resorbable Adhesion        June 18, 2002    Do.                              Do.
 Barrier Devices for Use in Abdominal
 and/or Pelvic Surgery; Guidance for
 Industry
----------------------------------------------------------------------------------------------------------------
Guidance Document for Dura Substitute   November 9,      Do.                              Do.
 Devices; Final Guidance for Industry    2000
----------------------------------------------------------------------------------------------------------------
Guidance for Neurological Embolization  November 1,      Do.                              Do.
 Devices                                 2000
----------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of a       October 14,      Do.                              Do.
 Premarket Notification Application      1999
 for Processed Human Dura Mater; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Dermabrasion Devices;      March 2, 1999    Do.                              Do.
 Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of a       March 2, 1999    Do.                              Do.
 Premarket Notification Application
 for a Surgical Mesh; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Content of Premarket       April 28, 1998   Do.                              Do.
 Notifications for Esophageal and
 Tracheal Prostheses; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Testing MR Interaction     May 22, 1996     Do.                              Do.
 With Aneurysm Clips
----------------------------------------------------------------------------------------------------------------

[[Page 875]]

 
Draft Guidance for the Preparation of   April 4, 1995    Do.                              Do.
 IDE Submission for Interactive Wound
 and Burn Dressing
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Preparation of   March 31, 1995   Do.                              Do.
 a Premarket Notification for a Non-
 Interactive Wound and Burn Dressing
----------------------------------------------------------------------------------------------------------------
Draft Version; Guidance on              September 12,    Do.                              Do.
 Biocompatibility Requirements for       1994
 Long Term Neurological Implants: Part
 3--Implant Model
----------------------------------------------------------------------------------------------------------------
Protocol for Dermal Toxicity Testing    January 1, 1985  Do.                              Do.
 for Devices in Contact With Skin;
 Draft
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance      June 2, 2003     Do.                              Do.
 Document; Resorbable Calcium Salt
 Bone Void Filler Device; Guidance for
 Industry and FDA
----------------------------------------------------------------------------------------------------------------
Guidance Document for Powered Muscle    June 9, 1999     Do.                              Do.
 Stimulator 510(k)s; Final
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation   July 26, 1995    Do.                              Do.
 of Notification (510(k)) Applications
 for Therapeutic Massagers and
 Vibrators
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation   July 26, 1995    Do.                              Do.
 of Premarket Notification (510(k))
 Applications for Beds
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation   July 26, 1995    Do.                              Do.
 of Premarket Notification (510(k))
 Applications for Communications
 Systems (Powered and Nonpowered) and
 Powered Environmental Control Systems
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation   July 26, 1995    Do.                              Do.
 of Premarket Notification (510(k))
 Applications for Exercise Equipment
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation   July 26, 1995    Do.                              Do.
 of Premarket Notification (510(k))
 Applications for Heating and Cooling
 Devices
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation   July 26, 1995    Do.                              Do.
 of Premarket Notification (510(k))
 Applications for Immersion Hydrobaths
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation   July 26, 1995    Do.                              Do.
 of Premarket Notification (510(k))
 Applications for Powered Tables and
 Multifunctional Physical Therapy
 Tables
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation   July 26, 1995    Do.                              Do.
 of Premarket Notification (510(k))
 Applications for Submerged
 (Underwater) Exercise Equipment
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation   July 26, 1995    Do.                              Do.
 of Premarket Notification (510(k))
 Applications for Mechanical and
 Powered Wheelchairs, and Motorized
 Three-Wheeled Vehicles
----------------------------------------------------------------------------------------------------------------
Guide for TENS 510(k) Content; Draft    August 1, 1994   Do.                              Do.
----------------------------------------------------------------------------------------------------------------
Draft Version Guidance for Clinical     August 20, 1992  Do.                              Do.
 Data To Be Submitted for Premarket
 Approval Application for Cranial
 Electrotherapy Stimulators
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Cortical Electrode   August 10, 1992  Do.                              Do.
 510(k) Content
----------------------------------------------------------------------------------------------------------------
Guidance for Studies for Pain Therapy   May 12, 1988     Do.                              Do.
 Devices--General Consideration in the
 Design of Clinical Studies for Pain-
 Alleviating Devices
----------------------------------------------------------------------------------------------------------------

[[Page 876]]

 
Accountability Analysis for Clinical    August 4, 1999   Do.                              Do.
 Studies for Ophthalmic Devices; Draft
----------------------------------------------------------------------------------------------------------------
Guidance Document for Nonprescription   October 9, 1998  Do.                              Do.
 Sunglasses; Final
----------------------------------------------------------------------------------------------------------------
Ophthalmoscope Guidance                 July 8, 1998     Do.                              Do.
----------------------------------------------------------------------------------------------------------------
Retinoscope Guidance; Final             July 8, 1998     Do.                              Do.
----------------------------------------------------------------------------------------------------------------
Slit Lamp Guidance; Final               July 8, 1998     Do.                              Do.
----------------------------------------------------------------------------------------------------------------
Discussion Points for Expansion of the  September 5,     Do.                              Do.
 ``Checklist of Information Usually      1997
 Submitted in an Investigational
 Device Exemption (IDE) Application
 for Refractive Surgery Lasers;''
 Draft Document
----------------------------------------------------------------------------------------------------------------
Third Party Review Guidance for         January 31,      Do.                              Do.
 Phacofragmentation System Device        1997
 Premarket Notification (510(k))
----------------------------------------------------------------------------------------------------------------
Third Party Review Guidance for         January 31,      Do.                              Do.
 Vitreous Aspiration and Cutting         1997
 Device Premarket Notification
 (510(k))
----------------------------------------------------------------------------------------------------------------
Checklist of Information Usually        October 10,      Do.                              Do.
 Submitted in an Investigational         1996
 Device Exemptions (IDE) Application
 for Refractive Surgery Lasers
 (excimer)
----------------------------------------------------------------------------------------------------------------
Guidance for Manufacturers Seeking      March 12, 2000   Do.                              Do.
 Marketing Clearance of Ear, Nose, and
 Throat Endoscope Sheaths Used as
 Protective Barriers; Final
----------------------------------------------------------------------------------------------------------------
Tympanostomy Tubes, Submission          January 14,      Do.                              Do.
 Guidance for a 510(k) Premarket         1998
 Notification; Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Arrangement and        May 1, 1990      Do.                              Do.
 Content of a Premarket Approval (PMA)
 Application for a Cochlear Implant in
 Children Ages 2 through 17 Years
----------------------------------------------------------------------------------------------------------------
Guideline for the Arrangement and       May 1, 1990      Do.                              Do.
 Content of a Premarket Approval (PMA)
 Application for a Cochlear Implant in
 Adults at Least 18 Years of Age
----------------------------------------------------------------------------------------------------------------
Refractive Implants: Guidance for       August 1, 2000   Do.                              Do.
 Investigational Device Exemptions
 (IDE) and Premarket Approval (PMA)
 Applications; Draft
----------------------------------------------------------------------------------------------------------------
Intraocular Lens Guidance Document;     October 14,      Do.                              Do.
 Draft                                   1999
----------------------------------------------------------------------------------------------------------------
Guidance on 510(k) Submissions for      March 3, 1999    Do.                              Do.
 Keratoprostheses; Final
----------------------------------------------------------------------------------------------------------------
Aqueous Shunts--510(k) Submissions;     November 16,     Do.                              Do.
 Final                                   1998
----------------------------------------------------------------------------------------------------------------
FDA Guidelines for Multifocal           May 29, 1997     Do.                              Do.
 Intraocular Lens IDE Studies and PMAs
----------------------------------------------------------------------------------------------------------------
Important Information About Rophae      August 20, 1992  Do.                              Do.
 Intraocular Lenses
----------------------------------------------------------------------------------------------------------------
Guidance for Premarket Submissions of   April 10, 2000   Do.                              Do.
 Orthokeratology Rigid Gas Permeable
 Contact Lenses; Final
----------------------------------------------------------------------------------------------------------------
Revised Procedures for Adding Lens      August 11, 1998  Do.                              Do.
 Finishing Laboratories to Approved
 Premarket Approval Applications for
 Class III Rigid Gas Permeable Contact
 Lenses for Extended Wear; Final
----------------------------------------------------------------------------------------------------------------

[[Page 877]]

 
Premarket Notification 510(k) Guidance  May 1, 1997      Do.                              Do.
 for Contact Lens Care Products
----------------------------------------------------------------------------------------------------------------
Premarket Notification (510(k))         June 28, 1994    Do.                              Do.
 Guidance Document for Class II Daily
 Wear Contact Lenses
----------------------------------------------------------------------------------------------------------------
New FDA Recommendations and Results of  May 30, 1989     Do.                              Do.
 Contact Lens Study (7-day letter)
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance      November 28,     Do.                              Do.
 Document; Ingestible Telemetric         2001
 Gastrointestinal Capsule Imaging
 System; Final Guidance for Industry
 and FDA
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance      May 16, 2001     Do.                              Do.
 Document; Tissue Culture Media for
 Human Ex Vivo Tissue and Cell Culture
 Processing Applications; Final
 Guidance for Industry and FDA
 Reviewers
----------------------------------------------------------------------------------------------------------------
Guidance for Investigational Device     January 16,      Do.                              Do.
 Exemptions for Solutions for            2001
 Hypothermic Flushing, Transport, and
 Storage of Organs for
 Transplantation; Final Guidance for
 Industry and FDA Reviewers
----------------------------------------------------------------------------------------------------------------
Guidance for Industry and CDRH          August 7, 1998   Do.                              Do.
 Reviewers on the Content of Premarket
 Notifications for Hemodialysis
 Delivery Systems; Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket   August 7, 1998   Do.                              Do.
 Notification for Conventional and
 High Permeability Hemodialyzers;
 Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket   February 5,      Do.                              Do.
 Notifications for Metal Expandable      1998
 Biliary Stents; Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket   May 30, 1997     Do.                              Do.
 Notifications for Water Purification
 Components and Systems for
 Hemodialysis
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Hemodialyzer Reuse   October 6, 1995  Do.                              Do.
 Labeling
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance      July 28, 2003    Do.                              Do.
 Document; Breast Lesion Documentation
 System; Guidance for Industry and FDA
 Staff
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance for  March 9, 2001    Do.                              Do.
 Home Uterine Activity Monitors; Final
 Guidance for Industry and FDA
 Reviewers
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance      July 3, 2000     Do.                              Do.
 Document for Clitoral Engorgement
 Devices
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry; Electro-   August 25, 1999  Do.                              Do.
 optical Sensors for the In Vivo
 Detection of Cervical Cancer and Its
 Precursors: Submission Guidance for
 an IDE/PMA
----------------------------------------------------------------------------------------------------------------
Devices Used for In Vitro               September 10,    Do.                              Do.
 Fertilization and Related Assisted      1998
 Reproduction Procedures; Draft
----------------------------------------------------------------------------------------------------------------
Latex Condoms for Men--Information for  July 23, 1998    Do.                              Do.
 510(k) Premarket Notifications: Use
 of Consensus Standards for
 Abbreviated Submissions
----------------------------------------------------------------------------------------------------------------
Uniform Contraceptive Labeling; Final   July 23, 1998    Do.                              Do.
----------------------------------------------------------------------------------------------------------------
Intrapartum Continuous Monitors for     June 14, 1997    Do.                              Do.
 Fetal Oxygen Saturation and Fetal pH;
 Submission Guidance for a PMA; Draft
 Document
----------------------------------------------------------------------------------------------------------------

[[Page 878]]

 
Letter to Manufacturers of              September 6,     Do.                              Do.
 Prescription Home Monitors for          1996
 Nonstress Tests
----------------------------------------------------------------------------------------------------------------
Letter to Manufacturers of              September 5,     Do.                              Do.
 Falloposcopes                           1996
----------------------------------------------------------------------------------------------------------------
Thermal Endometrial Ablation Devices    March 14, 1996   Do.                              Do.
 (Submission Guidance for an IDE)
----------------------------------------------------------------------------------------------------------------
Hysteroscopes and Gynecology            March 7, 1996    Do.                              Do.
 Laparoscopes (Submission Guidance for
 a 510(k))
----------------------------------------------------------------------------------------------------------------
Hysteroscopes and Laparoscopic          August 1, 1995   Do.                              Do.
 Insufflators (Submission Guidance for
 a 510(k))
----------------------------------------------------------------------------------------------------------------
Testing Guidance for Male Condoms Made  June 29, 1995    Do.                              Do.
 From New Material (Nonlatex)
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Content of       May 25, 1995     Do.                              Do.
 Premarket Notifications for Menstrual
 Tampons
----------------------------------------------------------------------------------------------------------------
Information for a Latex Condom 510(k)   April 13, 1994   Do.                              Do.
 Submission for Obstetrics-Gynecology
 Devices Branch; Draft
----------------------------------------------------------------------------------------------------------------
Premarket Testing Guidelines for        November 20,     Do.                              Do.
 Falloposcopes                           1992
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Content of       July 29, 1991    Do.                              Do.
 Premarket Notifications for Loop and
 Rollerball Electrodes for GYN
 Electrosurgical Excisions
----------------------------------------------------------------------------------------------------------------
Premarket Testing Guidelines for        April 4, 1990    Do.                              Do.
 Female Barrier Contraceptive Devices
 Also Intended to Prevent Sexually
 Transmitted Diseases
----------------------------------------------------------------------------------------------------------------
Guidance (``Guidelines'') for           May 10, 1978     Do.                              Do.
 Evaluation of Hysteroscopic
 Sterilization Devices
----------------------------------------------------------------------------------------------------------------
Guidance (``Guidelines'') for           May 1, 1978      Do.                              Do.
 Evaluation of Laparoscopic Bipolar
 and Thermal Coagulators (and
 Accessories)
----------------------------------------------------------------------------------------------------------------
Guidance (``Guidelines'') for           November 22,     Do.                              Do.
 Evaluation of Tubal Occlusion Devices   1977
----------------------------------------------------------------------------------------------------------------
Guidance (``Guidelines'') for           March 8, 1977    Do.                              Do.
 Evaluation of Fetal Clip Electrode
----------------------------------------------------------------------------------------------------------------
Guidelines for Evaluation of Nondrug    September 28,    Do.                              Do.
 IUDs                                    1976
----------------------------------------------------------------------------------------------------------------
Criteria for Significant Risk           July 14, 2003    Do.                              Do.
 Investigations of Magnetic Resonance
 Diagnostic Devices; Guidance for
 Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
Bone Sonometer PMA Applications; Final  June 21, 2001    Do.                              Do.
 Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Premarket Applications for Digital      February 16,     Do.                              Do.
 Mammography Systems; Final Guidance     2001
 for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of          August 2, 2000   Do.                              Do.
 Premarket Notifications for Photon-
 Emitting Brachytherapy Sources
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of          July 27, 2000    Do.                              Do.
 Premarket Notifications for Medical
 Image Management Devices
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of 510(k)s  August 6, 1999   Do.                              Do.
 for Solid State X-ray Imaging
 Devices; Final
----------------------------------------------------------------------------------------------------------------

[[Page 879]]

 
Guidance for the Submission of          December 3,      Do.                              Do.
 Premarket Notifications for Emission    1998
 Computed Tomography Devices and
 Accessories (SPECT and PET) and
 Nuclear Tomography Systems; Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of          November 20,     Do.                              Do.
 Premarket Notifications for             1998
 Radionuclide Dose Calibrators; Final
----------------------------------------------------------------------------------------------------------------
Harmonic Imaging With/Without           November 16,     Do.                              Do.
 Contrast--Premarket Notification;       1998
 Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of          November 14,     Do.                              Do.
 Premarket Notifications for Magnetic    1998
 Resonance Diagnostic Devices; Final
----------------------------------------------------------------------------------------------------------------
Information for Manufacturers Seeking   September 30,    Do.                              Do.
 Marketing Clearance of Diagnostic       1997
 Ultrasound Systems and Transducers
----------------------------------------------------------------------------------------------------------------
Letter: Notice to Manufacturers of      September 25,    Do.                              Do.
 Bone Mineral Densitometers              1997
----------------------------------------------------------------------------------------------------------------
Simplified 510(k) Procedures for        December 21,     Do.                              Do.
 Certain Radiology Devices: 12/21/93     1993
 letter from L. Yin, ODE/DRAERD, to
 NEMA
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Review of Bone       November 9,      Do.                              Do.
 Densitometer 510(k) Submissions         1992
----------------------------------------------------------------------------------------------------------------
Reviewer Guidance for Automatic X-Ray   February 1,      Do.                              Do.
 Film Processor 510(k)                   1990
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket   August 9, 2000   Do.                              Do.
 Notifications (510(k)s) for
 Extracorporeal Shock Wave
 Lithotripters Indicated for the
 Fragmentation of Kidney and Ureteral
 Calculi
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket   January 16,      Do.                              Do.
 Notifications for Penile Rigidity       2000
 Implants; Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket   November 30,     Do.                              Do.
 Notifications for Intracorporeal        1998
 Lithotripters; Final
----------------------------------------------------------------------------------------------------------------
CDRH Interim Regulatory Policy for      September 10,    Do.                              Do.
 External Penile Rigidity Devices        1997
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Preclinical and      November 29,     Do.                              Do.
 Clinical Investigations of Urethral     1995
 Bulking Agents Used in the Treatment
 of Urinary Incontinence
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Clinical         November 2,      Do.                              Do.
 Investigation of Urethral Stents        1995
----------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Endoscopic   August 16, 1995  Do.                              Do.
 Electrosurgical Unit (ESU) and
 Accessories Used in Gastroenterology
 and Urology
----------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Urological   August 1, 1995   Do.                              Do.
 Irrigation System and Tubing Set
----------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Endoscopic   June 22, 1995    Do.                              Do.
 Light Sources Used in
 Gastroenterology and Urology
----------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Non-         June 6, 1995     Do.                              Do.
 Implanted Electrical Stimulators Used
 for the Treatment of Urinary
 Incontinence
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Preparation of PMA   May 1, 1995      Do.                              Do.
 Applications for the Implanted
 Mechanical/Hydraulic Urinary
 Continence Device (Artificial Urinary
 Sphincter)
----------------------------------------------------------------------------------------------------------------

[[Page 880]]

 
Draft Guidance for the Content of       March 17, 1995   Do.                              Do.
 Premarket Notifications for
 Endoscopes Used in Gastroenterology
 and Urology
----------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Condom       February 23,     Do.                              Do.
 Catheters                               1995
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Clinical             November 11,     Do.                              Do.
 Investigations of Devices Used for      1994
 the Treatment of Benign Prostatic
 Hyperplasia (BPH)
----------------------------------------------------------------------------------------------------------------
Checklist for Mechanical Lithotripters  November 1,      Do.                              Do.
 and Stone Dislodgers Used in            1994
 Gastroenterology and Urology
----------------------------------------------------------------------------------------------------------------
510(k) Checklist for Sterile            September 19,    Do.                              Do.
 Lubricating Jelly Used With             1994
 Transurethral Surgical Instruments
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket   September 12,    Do.                              Do.
 Notifications for Conventional and      1994
 Antimicrobial Foley Catheters
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket   July 29, 1994    Do.                              Do.
 Notifications for Urodynamic/
 Uroflowmetry Systems
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket   June 7, 1994     Do.                              Do.
 Notifications for Urine Drainage Bags
----------------------------------------------------------------------------------------------------------------
Draft Guidance Outline--PTC for         November 30,     Do.                              Do.
 Clinical Studies for Vasovasostomy      1993
 Devices
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Preparation of PMA   March 16, 1993   Do.                              Do.
 Applications for Penile Inflatable
 Implants
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Preparation of PMA   March 16, 1993   Do.                              Do.
 Applications for Testicular
 Prostheses
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket   February 10,     Do.                              Do.
 Notifications for Biopsy Devices Used   1993
 in Gastroenterology and Urology
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket   February 10,     Do.                              Do.
 Notifications for Ureteral Stents       1993
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Content of       January 24,      Do.                              Do.
 Premarket Notifications for             1992
 Urological Balloon Dilatation
 Cathethers
----------------------------------------------------------------------------------------------------------------
Draft of Suggested Information for      January 18,      Do.                              Do.
 Reporting Extracorporeal Shock Wave     1991
 Lithotripsy Device Shock Wave
 Measurements
----------------------------------------------------------------------------------------------------------------
Draft Guidance to Firms on Biliary      August 2, 1990   Do.                              Do.
 Lithotripsy Studies
----------------------------------------------------------------------------------------------------------------
Office of In Vitro Diagnostic Device Evaluation and Safety
----------------------------------------------------------------------------------------------------------------
Analyte Specific Reagents; Small        February 26,     Do.                              Do.
 Entity Compliance Guidance; Guidance    2003
 for Industry
----------------------------------------------------------------------------------------------------------------
Assessing the Safety/Effectiveness of   October 1, 1988  Do.                              Do.
 Home-Use In Vitro Diagnostic Devices
 (IVDs): Draft PTC Regarding Labeling
 and Premarket Submissions
----------------------------------------------------------------------------------------------------------------
Data for Commercialization of Original  June 10, 1996    Do.                              Do.
 Equipment Manufacturer, Secondary and
 Generic Reagents for Automated
 Analyzers
----------------------------------------------------------------------------------------------------------------
Determination of Intended Use for       December 3,      Do.                              Do.
 510(k) Devices; Guidance for CDRH       2002
 Staff
----------------------------------------------------------------------------------------------------------------
Guidance for Administrative Procedures  August 14, 2000  Do.                              Do.
 for CLIA Categorization
----------------------------------------------------------------------------------------------------------------

[[Page 881]]

 
Guidance for Clinical Laboratory        March 1, 2001    Do.                              Do.
 Improvement Amendments of 1988 (CLIA)
 Criteria for Waiver; Draft Guidance
 for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Guidance for Industry; Abbreviated      February 22,     Do.                              Do.
 510(k) Submissions for In Vitro         1999
 Diagnostic Calibrators; Final
----------------------------------------------------------------------------------------------------------------
Guidance on Labeling for Laboratory     June 24, 1999    Do.                              Do.
 Tests; Draft
----------------------------------------------------------------------------------------------------------------
Letter to IVD Manufacturers on          December 22,     Do.                              Do.
 Streamlined PMA; Final                  1997
----------------------------------------------------------------------------------------------------------------
PTC for Collection of Data in Support   September 26,    Do.                              Do.
 of In Vitro Device Submissions for      1994
 510(k) Clearance
----------------------------------------------------------------------------------------------------------------
PTC for Review of Calibration and       February 1,      Do.                              Do.
 Quality Control Labeling for In Vitro   1996
 Diagnostic Devices (cover letter
 dated March 14, 1996)
----------------------------------------------------------------------------------------------------------------
PTC Guidance Document on Assayed and    February 3,      Do.                              Do.
 Unassayed Quality Control Material;     1999
 Draft
----------------------------------------------------------------------------------------------------------------
Premarket Approval Application Filing   May 1, 2003      Do.                              Do.
 Review; Guidance for Industry and FDA
 Staff
----------------------------------------------------------------------------------------------------------------
Breath Nitric Oxide Test System; Class  July 7, 2003     Do.                              Do.
 II Special Controls Guidance Document
----------------------------------------------------------------------------------------------------------------
Class II Special Control Guidance       November 30,     Do.                              Do.
 Document for B-Type Natriuretic         2000
 Peptide Premarket Notifications;
 Final Guidance for Industry and FDA
 Reviewers
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance      September 16,    Do.                              Do.
 Document; Cyclosporine and Tacrolimus   2002
 Assays; Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Prescription Use of  November 14,     Do.                              Do.
 Drugs of Abuse Assays Premarket         2000
 Notifications
----------------------------------------------------------------------------------------------------------------
Draft Guidance on the Labeling for      December 21,     Do.                              Do.
 Over-the-Counter Sample Collection      1999
 Systems for Drugs of Abuse Testing
----------------------------------------------------------------------------------------------------------------
Guidance for 510(k)s on Cholesterol     July 14, 1995    Do.                              Do.
 Tests for Clinical Laboratory,
 Physicians' Office Laboratory, and
 Home Use
----------------------------------------------------------------------------------------------------------------
Guidance for Industry In Vitro          July 6, 1998     Do.                              Do.
 Diagnostic Bicarbonate/Carbon Dioxide
 Test System; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry In Vitro          July 6, 1998     Do.                              Do.
 Diagnostic Chloride Test System;
 Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry In Vitro          July 2, 1998     Do.                              Do.
 Diagnostic Creatinine Test System;
 Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry In Vitro          July 6, 1998     Do.                              Do.
 Diagnostic Glucose Test System; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry In Vitro          July 6, 1998     Do.                              Do.
 Diagnostic Potassium Test System;
 Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry In Vitro          July 6, 1998     Do.                              Do.
 Diagnostic Sodium Test System; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry In Vitro          July 6, 1998     Do.                              Do.
 Diagnostic Urea Nitrogen Test System;
 Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry; In Vitro         July 20, 1998    Do.                              Do.
 Diagnostic C-Reactive Protein
 Immunological Test System
----------------------------------------------------------------------------------------------------------------

[[Page 882]]

 
Guidance for Over-the-Counter (OTC)     July 22, 2000    Do.                              Do.
 Human Chorionic Gonadotropin (hCG)
 510(k)s
----------------------------------------------------------------------------------------------------------------
Guidance for Over-the-Counter (OTC)     July 22, 2000    Do.                              Do.
 Ovulation Predictor 510(k)s
----------------------------------------------------------------------------------------------------------------
Over-the-Counter (OTC) Screening Tests  November 14,     Do.                              Do.
 for Drugs of Abuse; Guidance for        2000
 Premarket Notifications
----------------------------------------------------------------------------------------------------------------
PTC for Portable Blood Glucose          February 20,     Do.                              Do.
 Monitoring Devices Intended for         1996
 Bedside Use in the Neonate Nursery
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of In    August 31, 1995  Do.                              Do.
 Vitro Diagnostic Devices for Drugs of
 Abuse Assays Using Various
 Methodologies
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of       February 14,     Do.                              Do.
 Portable Blood Glucose In Vitro         1996
 Diagnostic Devices Using Glucose
 Oxidase, Dehydrogenase, or Hexokinase
 Methodology
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of       November 6,      Do.                              Do.
 Professional Use Human Chorionic        1996
 Gonadotropin (hCG) In Vitro
 Diagnostic Devices (IVDs)
----------------------------------------------------------------------------------------------------------------
510(k) Submissions for Coagulation      June 19, 2003    Do.                              Do.
 Instruments; Guidance for Industry
 and FDA Staff
----------------------------------------------------------------------------------------------------------------
Class II Special Control Guidance       August 23, 2000  Do.                              Do.
 Document for Anti-Saccharomyces
 cerevisia (S. cerevisiae) Antibody
 (ASCA) Premarket Notifications
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance      December 4,      Do.                              Do.
 Document: Premarket Notifications for   2001
 Automated Differential Cell Counters
 for Immature or Abnormal Blood Cells;
 Final Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Document for Special Controls for       April 28, 1999   Do.                              Do.
 Erythropoietin Assay Premarket
 Notifications (510(k)s); Final
----------------------------------------------------------------------------------------------------------------
Draft Guidance Document for 510(k)      July 29, 1992    Do.                              Do.
 Submission of Fecal Occult Blood
 Tests
----------------------------------------------------------------------------------------------------------------
Draft Guidance Document for 510(k)      September 30,    Do.                              Do.
 Submission of Glycohemoglobin           1991
 (Glycated or Glycosylated) Hemoglobin
 for IVDs
----------------------------------------------------------------------------------------------------------------
Draft Guidance Document for 510(k)      September 1,     Do.                              Do.
 Submission of Immunoglobulins A, G,     1992
 M, D and E Immunoglobulin System In
 Vitro Devices
----------------------------------------------------------------------------------------------------------------
Draft Guidance for 510(k) Submission    September 26,    Do.                              Do.
 of Lymphocyte Immunophenotyping IVDs    1991
 Using Monoclonal Antibodies
----------------------------------------------------------------------------------------------------------------
Draft; Premarketing Approval Review     September 10,    Do.                              Do.
 Criteria for Premarket Approval of      1992
 Estrogen (ER) or Progesterone (PGR)
 Receptors In Vitro Diagnostic Devices
 Using Steroid Hormone Binding (SBA)
 with Dextran-Coated Charcoal (DCC)
 Separation, Histochemical Receptor
 Bind
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Submission    September 19,    Do.                              Do.
 of Tumor Associated Antigen Premarket   1996
 Notification (510(k)) to FDA
----------------------------------------------------------------------------------------------------------------
Guidance for Submission of              June 3, 1998     Do.                              Do.
 Immunohistochemistry Applications to
 the FDA; Final
----------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Fibrin Monomer      April 27, 1999   Do.                              Do.
 Paracoagulation Test; Final
----------------------------------------------------------------------------------------------------------------

[[Page 883]]

 
Multiplex Tests for Heritable DNA       February 27,     Do.                              Do.
 Markers, Mutations, and Expression      2003
 Patterns; Draft Guidance for Industry
 and FDA Reviewers
----------------------------------------------------------------------------------------------------------------
PTC for Cervical Cytology Devices       July 25, 1994    Do.                              Do.
----------------------------------------------------------------------------------------------------------------
PTC for Hematology Quality Control      September 30,    Do.                              Do.
 Materials                               1997
----------------------------------------------------------------------------------------------------------------
Radioallergosorbent Test (RAST)         August 22, 2001  Do.                              Do.
 Methods for Allergen-Specific
 Immunoglobulin E (IgE) 510(k)s; Final
 Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of       July 15, 1994    Do.                              Do.
 Alpha-Fetoprotein (AFP) In Vitro
 Diagnostic Devices for Fetal Open
 Neural Tube Defects Using
 Immunological Test Methodologies
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of       July 15, 1991    Do.                              Do.
 Cytogenetic Analysis Using Automated
 and Semi-Automated Chromosome
 Analyzers
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of       February 21,     Do.                              Do.
 Rheumatoid Factor (RF) In Vitro         1997
 Diagnostic Devices Using Enzyme-
 Linked Immunoassay (EIA), Enzyme
 Linked Immunosorbent Assay (ELISA),
 Particle Agglutination Tests, and
 Laser and Rate Nephelometry
----------------------------------------------------------------------------------------------------------------
Review Criteria for Blood Culture       August 12, 1991  Do.                              Do.
 Systems
----------------------------------------------------------------------------------------------------------------
Review Criteria for In Vitro            August 1, 1992   Do.                              Do.
 Diagnostic Devices for Detection of
 IGM Do Antibodies to Viral Agents
----------------------------------------------------------------------------------------------------------------
Review Criteria for In Vitro            February 1,      Do.                              Do.
 Diagnostic Devices for the Assessment   1994
 of Thyroid Autoantibodies Using
 Indirect Immunofluorescence Assay
 (IFA), Indirect Hemagglutination
 Assay (IHA), Radioimmunoasay (RIA),
 and Enzyme Linked Immunosorbent Assay
 (ELISA)
----------------------------------------------------------------------------------------------------------------
Review Criteria for In Vitro            February 15,     Do.                              Do.
 Diagnostic Devices That Utilize         1996
 Cytogenetic In Situ Hybridization
 Technology for the Detection of Human
 Genetic Mutations (Germ Line and
 Somatic)
----------------------------------------------------------------------------------------------------------------
Review Criteria for the Assessment of   September 1,     Do.                              Do.
 Anti-Nuclear Antibodies (ANA) In        1992
 Vitro Diagnostic Devices Using
 Indirect Immunofluorescence Assay
 (IFA), Immunodiffusion (IMD), and
 Enzyme Linked Immunosorbant Assay
 (ELISA)
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance      February 5,      Do.                              Do.
 Document; Antimicrobial                 2003
 Susceptibility Test (AST) Systems;
 Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Draft Review Criteria for Nucleic Acid  June 14, 1993    Do.                              Do.
 Amplification Based In Vitro
 Diagnostic Devices for Direct
 Detection of Infectious
 Microorganisms
----------------------------------------------------------------------------------------------------------------
Premarket Approval Applications for In  April 27, 2001   Do.                              Do.
 Vitro Diagnostic Devices Pertaining
 to Hepatitis C Viruses (HCV): Assays
 Intended for Diagnosis, Prognosis, or
 Monitoring of HCV Infection,
 Hepatitis C, or Other HCV-Associated
 Disease; Draft Guidance for Industry
 and FDA
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of       October 30,      Do.                              Do.
 Antimicrobial Susceptibility Test       1996
 Discs
----------------------------------------------------------------------------------------------------------------

[[Page 884]]

 
Review Criteria for Assessment of In    January 1, 1992  Do.                              Do.
 Vitro Diagnostic Devices for Direct
 Detection of Chlamydiae in Clinical
 Specimens
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of In    July 6, 1993     Do.                              Do.
 Vitro Diagnostic Devices for Direct
 Detection of Mycobacterium Spp.
 (Tuberculosis (TB))
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of       September 17,    Do.                              Do.
 Laboratory Tests for the Detection of   1992
 Antibodies to Helicobacter pylori
----------------------------------------------------------------------------------------------------------------
Review Criteria for Devices Assisting   May 31, 1990     Do.                              Do.
 in the Diagnosis of C. Difficile
 Associated Diseases
----------------------------------------------------------------------------------------------------------------
Review Criteria for Devices Intended    December 30,     Do.                              Do.
 for the Detection of Hepatitis B `e'    1991
 Antigen and Antibody to HBe
----------------------------------------------------------------------------------------------------------------
Review Criteria for Premarket Approval  May 15, 1992     Do.                              Do.
 of In Vitro Diagnostic Devices for
 Detection of Antibodies to Parvovirus
 B19
----------------------------------------------------------------------------------------------------------------
Office of Surveillance and Biometrics
----------------------------------------------------------------------------------------------------------------
PMA Review Statistical Checklist        (no date         Do.                              Do.
                                         available)
----------------------------------------------------------------------------------------------------------------
Statistical Aspects of Submissions to   June 1, 1984     Do.                              Do.
 FDA: A Medical Device Perspective
 (also includes as appendix the
 article ``Observed Uses and Abuses of
 Statistical Procedures in Medical
 Device Submissions'')
----------------------------------------------------------------------------------------------------------------
Statistical Guidance for Clinical       January 1, 1996  Do.                              Do.
 Trials of Nondiagnostic Medical
 Devices
----------------------------------------------------------------------------------------------------------------
MDR Guidance Document: Remedial Action  September 26,    Industry and FDA                 Do.
 Exemption; Final                        2001
----------------------------------------------------------------------------------------------------------------
Guidance on Adverse Event Reporting     April 24, 2001   Industry                         Do.
 for Hospitals That Reprocess Devices
 Intended by the Original Equipment
 Manufacturer for Single Use
----------------------------------------------------------------------------------------------------------------
MDR Guidance Document No. 1--IOL--      August 7, 1996   Do.                              Do.
 E1996004; Final
----------------------------------------------------------------------------------------------------------------
Common Problems: Baseline Reports and   January 1, 1997  Do.                              Do.
 Medwatch Form 3500A
----------------------------------------------------------------------------------------------------------------
Medical Device Reporting: An Overview;  April 1, 1996    Do.                              Do.
 Final
----------------------------------------------------------------------------------------------------------------
Instructions for Completing FDA Form    December 15,     Do.                              Do.
 3500A With Coding Manual for Form       1995
 3500A (MEDWATCH) (MDR); Final
----------------------------------------------------------------------------------------------------------------
MEDWATCH FDA Form 3500A for Use by      June 1, 1993     Industry and user facilities     Do.
 User Facilities, Distributors and
 Manufacturers for Mandatory Reporting
 (MDR); Final
----------------------------------------------------------------------------------------------------------------
Variance from Manufacturer Report       July 16, 1996    Industry                         Do.
 Number Format (MDR letter); Final
----------------------------------------------------------------------------------------------------------------
Instructions for Completing Form 3417:  March 31, 1997   Do.                              Do.
 Medical Device Reporting Baseline
 Report (MDR); Final
----------------------------------------------------------------------------------------------------------------
Medical Device Reporting--Alternative   October 19,      Do.                              Do.
 Summary Reporting (ASR) Program;        2000
 Guidance for Industry
----------------------------------------------------------------------------------------------------------------
Addendum to the Instructions for        June 9, 1999     Do.                              Do.
 Completing FDA Form 3500A With Coding
 Manual (MEDWATCH) (MDR); Final
----------------------------------------------------------------------------------------------------------------

[[Page 885]]

 
Needlesticks--Medical Device Reporting  November 12,     Industry and user facilities     Do.
 Guidance                                2002
----------------------------------------------------------------------------------------------------------------
Guidance to Sponsors on the             June 9, 1993     Industry and FDA reviewers       Do.
 Development of a Discretionary
 Postmarket Surveillance Study for
 Permanent Implantable Cardiac
 Pacemaker Electrodes (Leads)
----------------------------------------------------------------------------------------------------------------
Guidance on Criteria and Approaches     November 2,      Do.                              Do.
 for Postmarket Surveillance             1998
----------------------------------------------------------------------------------------------------------------
Guidance on Procedures to Determine     February 19,     FDA reviewers                    Do.
 Application of Postmarket               1998
 Surveillance Strategies (FDAMA);
 Final
----------------------------------------------------------------------------------------------------------------
Guidance on Procedures for Review of    February 19,     Do.                              Do.
 Postmarket Surveillance Submissions     1998
 (FDAMA); Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA Staff;    November 2,      Industry and FDA reviewers       Do.
 SMDA to FDAMA: Guidance on FDA's        1998
 Transition Plan for Existing
 Postmarket Surveillance Protocols
 (FDAMA); Final
----------------------------------------------------------------------------------------------------------------
Amendment to Guidance on Discretionary  March 30, 1994   Do.                              Do.
 Postmarket Surveillance on Pacemaker
 Leads; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry on the Testing    February 2,      Do.                              Do.
 of Metallic Plasma Sprayed Coatings     2000
 on Orthopedic Implants to Support
 Reconsideration of Postmarket
----------------------------------------------------------------------------------------------------------------
Office of Compliance
----------------------------------------------------------------------------------------------------------------
Commercial Distribution/Exhibit Letter  March 11, 1992   Do.                              Do.
----------------------------------------------------------------------------------------------------------------
FDA Guide for Validation of Biological  January 1, 1986  Do.                              Do.
 Indicator Incubation Time
----------------------------------------------------------------------------------------------------------------
Guide for Establishing and Maintaining  March 1, 1988    Do.                              Do.
 a Calibration Constancy
 Intercomparison System for Microwave
 Oven Compliance Survey Instruments
 (FDA 88-8264)
----------------------------------------------------------------------------------------------------------------
General Principles of Software          January 11,      Do.                              Do.
 Validation; Draft Guidance              2002
----------------------------------------------------------------------------------------------------------------
Guidance on Medical Device Tracking     May 23, 2003     Do.                              Do.
 (FDAMA); Guidance for Industry and
 FDA Staff
----------------------------------------------------------------------------------------------------------------
Compliance Program Guidance Manual:     February 7,      Do.                              Do.
 Inspection of Medical Devices; Draft    2001
----------------------------------------------------------------------------------------------------------------
Procedures for Laboratory Compliance    May 1, 1986      Do.                              Do.
 Testing of Television Revivers--Part
 of TV Packet
----------------------------------------------------------------------------------------------------------------
Guidance on Quality System Regulation   February 3,      Do.                              Do.
 Information for Various Premarket       2003
 Submissions; Draft
----------------------------------------------------------------------------------------------------------------
Surveillance and Detention Without      July 26, 2000    Do.                              Do.
 Physical Examination of Surgeons' and/
 or Patient Examination Gloves;
 Guidance for Industry
----------------------------------------------------------------------------------------------------------------
Manufacturers/Assemblers of Diagnostic  October 13,      Do.                              Do.
 X-Ray Systems: Enforcement Policy for   1993
 Positive-Beam Limitation (PBL)
 Requirements in 21 CFR 1020.31(g)
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Initial  January 1, 1982  Do.                              Do.
 Reports on Diagnostic X-Ray Systems
 and Their Major Components
----------------------------------------------------------------------------------------------------------------

[[Page 886]]

 
Exemption From Reporting and            September 16,    Do.                              Do.
 Recordkeeping Requirements for          1981
 Certain Sunlamp Product Manufacturers
----------------------------------------------------------------------------------------------------------------
Letter to Medical Device Industry on    May 17, 1993     Do.                              Do.
 Endoscopy and Laparoscopy Accessories
 (Galdi)
----------------------------------------------------------------------------------------------------------------
Clarification of Radiation Control      March 1, 1989    Do.                              Do.
 Regulations for Diagnostic X-Ray
 Equipment (FDA 89-8221)
----------------------------------------------------------------------------------------------------------------
CPG 7133.19: Retention of Microwave     March 1, 1995    Do.                              Do.
 Oven Test Record/Cover Letter: August
 24, 1981; Retention of Records
 Required by 21 CFR 1002
----------------------------------------------------------------------------------------------------------------
A Guidance for the Submission of        March 1, 1996    Do.                              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 an        March 1, 1996    Do.                              Do.
 Abbreviated Radiation Safety Report
 on X-Ray Tables, Cradles, Film
 Changers or Cassette Holders Intended
 for Diagnostic Use
----------------------------------------------------------------------------------------------------------------
A Guide for the Submission of           March 1, 1996    Do.                              Do.
 Abbreviated Radiation Safety Reports
 on Image Receptor Support Devices for
 Mammography X-Ray Systems
----------------------------------------------------------------------------------------------------------------
Compliance Program Guidance Manual;     March 15, 2000   Do.                              Do.
 Field Compliance Testing of
 Diagnostic (Medical) X-Ray Equipment;
 Guidance for FDA Staff
----------------------------------------------------------------------------------------------------------------
Information Disclosure by               April 2, 2001    Do.                              Do.
 Manufacturers to Assemblers for
 Diagnostic X-Ray Systems; Final
 Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Guide for Submission of Information on  April 1, 1971    Do.                              Do.
 Accelerators Intended to Emit X-
 Radiation Required Pursuant to 21 CFR
 1002.10
----------------------------------------------------------------------------------------------------------------
Abbreviated Report on Radiation Safety  August 1, 1995   Do.                              Do.
 for Microwave Products (Other Than
 Microwave Ovens)--e.g., Microwave
 Heating, Microwave Diathermy, RF
 Sealers, Induction, Dielectric
 Heaters, Security Systems
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Reports on          March 1, 1985    Do.                              Do.
 Radiation Safety of Microwave Ovens
----------------------------------------------------------------------------------------------------------------
Reporting Guide for Laser Light Shows   September 1,     Do.                              Do.
 and Displays (21 CFR 1002) (FDA 88-     1995
 8140)
----------------------------------------------------------------------------------------------------------------
Guide for Filing Annual Reports for X-  July 1, 1980     Do.                              Do.
 Ray Components and Systems
----------------------------------------------------------------------------------------------------------------
Reporting and Compliance Guide for      October 1, 1995  Do.                              Do.
 Television Products Including Product
 Report, Supplemental Report,
 Radiation Safety Abbreviated Report,
 Annual Report, Information, and
 Guidance
----------------------------------------------------------------------------------------------------------------
Revised Guide for Preparing Annual      September 1,     Do.                              Do.
 Reports on Radiation Safety Testing     1995
 of Laser and Laser Light Show
 Products (replaces FDA 82-8127)
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Abbreviated         September 1,     Do.                              Do.
 Reports of Microwave and RF Emitting    1996
 Electronic Products Intended for
 Medical Use
----------------------------------------------------------------------------------------------------------------

[[Page 887]]

 
Letter to Manufacturers and Importers   October 31,      Do.                              Do.
 of Microwave Ovens: Information         1988
 Requirements for Cookbooks and User
 and Service Manuals
----------------------------------------------------------------------------------------------------------------
Abbreviated Report on Radiation Safety  August 1, 1995   Do.                              Do.
 of Nonmedical Ultrasonic Products
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports     September 1,     Do.                              Do.
 for Medical Ultrasound Products         1996
----------------------------------------------------------------------------------------------------------------
Letter to Manufacturers, Distributors,  February 23,     Do.                              Do.
 and Importers of Condom Products        1994
----------------------------------------------------------------------------------------------------------------
Letter to Manufacturers, Importers,     February 13,     Do.                              Do.
 and Repackagers of Condoms for          1989
 Contraception or Sexually-Transmitted
 Disease Prevention (Holt)
----------------------------------------------------------------------------------------------------------------
Letter to Condom Manufacturers and      April 5, 1994    Do.                              Do.
 Distributors
----------------------------------------------------------------------------------------------------------------
Letter to Manufacturers/Repackers       April 22, 1994   Do.                              Do.
 Using Cotton
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports     September 1,     Do.                              Do.
 for Lasers and Products Containing      1995
 Lasers
----------------------------------------------------------------------------------------------------------------
Compliance Guide for Laser Products     September 1,     Do.                              Do.
 (FDA 86-8260)                           1985
----------------------------------------------------------------------------------------------------------------
Condoms: Inspection and Sampling at     April 8, 1987    Do.                              Do.
 Domestic Manufacturers and of All
 Repackers; Sampling From All
 Importers (Damaska memo to field on
 April 8, 1987)
----------------------------------------------------------------------------------------------------------------
Dental Hand Piece Sterilization (dear   September 28,    Do.                              Do.
 doctor letter)                          1992
----------------------------------------------------------------------------------------------------------------
Latex Labeling Letter (Johnson)         March 18, 1993   Do.                              Do.
----------------------------------------------------------------------------------------------------------------
Pesticide Regulation Notice 94-4:       June 30, 1994    Do.                              Do.
 Interim Measures for the Registration
 of Antimicrobial Products/Liquid
 Chemical Germicides With Medical
 Device Use Claims Under the
 Memorandum of Understanding Between
 EPA and FDA
----------------------------------------------------------------------------------------------------------------
Letter to Industry, Powered Wheelchair  May 10, 1993     Do.                              Do.
 Manufacturers, from RM Johnson
----------------------------------------------------------------------------------------------------------------
Hazards of Volume Ventilators and       September 15,    Do.                              Do.
 Heated Humidifiers                      1993
----------------------------------------------------------------------------------------------------------------
Manufacturers and Initial Distributors  February 3,      Do.                              Do.
 of Sharps Containers and Destroyers     1994
 Used by Health Care Professionals
----------------------------------------------------------------------------------------------------------------
Ethylene Oxide; Ethylene Chlorohydrin;  June 23, 1978    Do.                              Do.
 and Ethylene Glycol: Proposed Maximum
 Residue Limits and Maximum Levels of
 Exposure
----------------------------------------------------------------------------------------------------------------
Letter to Manufacturers and Users of    October 10,      Do.                              Do.
 Lasers for Refractive Surgery           1996
 (excimer)
----------------------------------------------------------------------------------------------------------------
Shielded Trocars and Needles Used for   August 23, 1996  Do.                              Do.
 Abdominal Access During Laparoscopy
----------------------------------------------------------------------------------------------------------------
Surveillance and Detention Without      August 14, 2000  Do.                              Do.
 Physical Examination of Condoms;
 Draft Guidance for Industry
----------------------------------------------------------------------------------------------------------------
All U.S. Condom Manufacturers,          April 7, 1987    Do.                              Do.
 Importers, and Repackagers
----------------------------------------------------------------------------------------------------------------
Manufacturers and Initial Distributors  May 23, 1996     Do.                              Do.
 of Hemodialyzers
----------------------------------------------------------------------------------------------------------------

[[Page 888]]

 
Laser Light Show Safety--Who's          May 1, 1986      Do.                              Do.
 Responsible? (FDA 86-8262)
----------------------------------------------------------------------------------------------------------------
Suggested State Regulations for         January 1, 1982  Do.                              Do.
 Control of Radiation; Volume II;
 Nonionizing Radiation--Lasers (FDA
 Pub. No. 83-8220)
----------------------------------------------------------------------------------------------------------------
Letter to All Foreign Manufacturers     May 28, 1981     Do.                              Do.
 and Importers of Electronic Products
 For Which Applicable FDA Performance
 Standards Exist
----------------------------------------------------------------------------------------------------------------
Guide for Submission of Information on  March 1, 1973    Do.                              Do.
 Industrial X-Ray Equipment Required
 Pursuant to 21 CFR 1002.10
----------------------------------------------------------------------------------------------------------------
Guide for Submission of Information on  April 30, 1974   Do.                              Do.
 Analytical X-Ray Equipment Required
 Pursuant to 21 CFR 1002.10
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Cabinet  February 1,      Do.                              Do.
 X-Ray System Reports Pursuant to 21     1975
 CFR 1020.40
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Annual Reports in   October 1, 1987  Do.                              Do.
 Radiation Safety Testing of
 Electronic Products (General)
----------------------------------------------------------------------------------------------------------------
Computerized Devices/Processes          May 1, 1992      Do.                              Do.
 Guidance--Application of the Medical
 Device GMP to Computerized Devices
 and Manufacturing Processes
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports     August 1, 1996   Do.                              Do.
 for Ultrasonic Therapy Products
 (Physical Therapy Only)
----------------------------------------------------------------------------------------------------------------
Guide for Submission of Information on  November 1,      Do.                              Do.
 Industrial Radiofrequency Dielectric    1980
 Heater and Sealer Equipment Pursuant
 to 21 CFR 1002.10 and 1002.12 (FDA 81-
 8137)
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Annual Reports for  September 1,     Do.                              Do.
 Ultrasonic Therapy Products             1996
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Annual Reports on   September 1,     Do.                              Do.
 Radiation Safety Testing of Sunlamps    1995
 and Sunlamp Products (replaces FDA 82-
 8127)
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Annual Reports on   September 1,     Do.                              Do.
 Radiation Safety Testing of Mercury     1995
 Vapor (replaces FDA 82-8127)
----------------------------------------------------------------------------------------------------------------
Quality Control Guide for Sunlamp       September 1,     Do.                              Do.
 Products (FDA 88-8234)                  1984
----------------------------------------------------------------------------------------------------------------
Guide for the Submission of Initial     December 1,      Do.                              Do.
 Reports on Computed Tomography X-Ray    1985
 Systems
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports on  September 1,     Do.                              Do.
 Sunlamps and Sunlamp Products (21 CFR   1995
 1002)
----------------------------------------------------------------------------------------------------------------
Letter: Policy on Maximum Timer         June 25, 1985    Do.                              Do.
 Interval and Exposure Schedule for
 Sunlamp Products
----------------------------------------------------------------------------------------------------------------
Reporting Guide for Product Reports on  September 1,     Do.                              Do.
 High Intensity Mercury Vapor            1995
 Discharge Lamps (21 CFR 1002)
----------------------------------------------------------------------------------------------------------------
Quality Control Practices for           May 1, 1980      Do.                              Do.
 Compliance With the Federal Mercury
 Vapor Lamp Performance Standard
----------------------------------------------------------------------------------------------------------------
Keeping Up With the Microwave           March 1, 1990    Do.                              Do.
 Revolution (FDA Publication No. 91-
 4160)
----------------------------------------------------------------------------------------------------------------

[[Page 889]]

 
Quality Assurance Guidelines for        February 1,      Do.                              Do.
 Hemodialysis Devices                    1991
----------------------------------------------------------------------------------------------------------------
Letter to Manufacturers and Importers   March 28, 1980   Do.                              Do.
 of Microwave Ovens--Open Door
 Operation of Microwave Ovens as a
 Result of Oven Miswiring
----------------------------------------------------------------------------------------------------------------
Reporting of New Model Numbers to       June 14, 1983    Do.                              Do.
 Existing Model Families
----------------------------------------------------------------------------------------------------------------
Import: Radiation-Producing Electronic  November 1,      Do.                              Do.
 Products (FDA 89-8008)                  1988
----------------------------------------------------------------------------------------------------------------
Unsafe Patient Lead Wires and Cables    September 3,     Do.                              Do.
                                         1993
----------------------------------------------------------------------------------------------------------------
Application of a Variance From 21 CFR   July 1, 1998     Do.                              Do.
 1040.11(c) for a Laser Light Show,
 Display, or Device (form FDA 3147)
----------------------------------------------------------------------------------------------------------------
Letter to Trade Association: Reuse of   December 27,     Do.                              Do.
 Single-Use or Disposable Medical        1995
 Devices
----------------------------------------------------------------------------------------------------------------
Design Control Guidance for Medical     March 11, 1997   Do.                              Do.
 Device Manufacturers
----------------------------------------------------------------------------------------------------------------
Keeping Medical Devices Safe from       July 1, 1995     Do.                              Do.
 Electromagnetic Interference
----------------------------------------------------------------------------------------------------------------
Safety of Electrically Powered          September 18,    Do.                              Do.
 Products: Letter to Medical Devices     1996
 and Electronic Products Manufacturers
 from Lilliam Gill and BHB Correction
 Memo
----------------------------------------------------------------------------------------------------------------
Enforcement Priorities for Single-Use   August 14, 2000  Do.                              Do.
 Devices Reprocessed by Third Parties
 and Hospitals; Guidance for Industry
 and for FDA Staff
----------------------------------------------------------------------------------------------------------------
Labeling for Electronic Anti-theft      August 15, 2000  Do.                              Do.
 Systems; Final Guidance for Industry
----------------------------------------------------------------------------------------------------------------
Wireless Medical Telemetry Risks and    September 27,    Do.                              Do.
 Recommendations; Final Guidance for     2000
 Industry
----------------------------------------------------------------------------------------------------------------
Policy on Warning Label Required on     June 25, 1985    Do.                              Do.
 Sunlamp Products
----------------------------------------------------------------------------------------------------------------
Policy on Lamp Compatibility            September 2,     Do.                              Do.
 (Sunlamps)                              1986
----------------------------------------------------------------------------------------------------------------
Office of Science and Technology
----------------------------------------------------------------------------------------------------------------
Guidance on Frequently Asked Questions  December 21,     Do.                              Do.
 on Recognition of Consensus Standards   1998
 (FDAMA)
----------------------------------------------------------------------------------------------------------------
Guidance on the Recognition and Use of  February 19,     Do.                              Do.
 Consensus Standards; appendix A         1998
 (FDAMA)
----------------------------------------------------------------------------------------------------------------
CDRH Standard Operating Procedures for  August 6, 1999   Do.                              Do.
 the Identification and Evaluation of
 Candidate Consensus Standard for
 Recognition
----------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA           May 6, 1999      Do.                              Do.
 Reviewers: Guidance on Immunotoxicity
 Testing
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
WITHDRAWN GUIDANCES
----------------------------------------------------------------------------------------------------------------
Medical Devices Made With               September 6,     N/A                              N/A
 Polyvinylchloride (PVC) Using the       2002
 Plasticizer di-(2-
 Ethylhexyl)phthalate (DEHP); Draft
 Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------

[[Page 890]]

 
Draft Guidance on Evidence Models for   September 1,     Do.                              Do.
 the Least Burdensome Means to Market    1999
----------------------------------------------------------------------------------------------------------------
Modifications to Devices Subject to     August 6, 1998   Do.                              Do.
 Premarket Approval--The PMA
 Supplement Decision Making Process;
 Draft
----------------------------------------------------------------------------------------------------------------
Guidance for Industry; Contents of a    July 27, 1998    Do.                              Do.
 Product Development Protocol; Draft
----------------------------------------------------------------------------------------------------------------
New Model Medical Device Development    July 21, 1998    Do.                              Do.
 Process; Final
----------------------------------------------------------------------------------------------------------------
Document Review by the Office of the    June 6, 1999     Do.                              Do.
 Chief Counsel (blue book memo G96-1)
----------------------------------------------------------------------------------------------------------------
Letter: Vascular Graft Industry         November 22,     Do.                              Do.
 (Philip Phillips)                       1995
----------------------------------------------------------------------------------------------------------------
Color Additives for Medical Devices     November 15,     Do.                              Do.
 (Snesko)                                1995
----------------------------------------------------------------------------------------------------------------
PMA/510(k) Triage Review Procedures     May 20, 1994     Do.                              Do.
 (blue book memo G94-1)
----------------------------------------------------------------------------------------------------------------
Proposal for Establishing Mechanisms    June 30, 1993    Do.                              Do.
 for Setting Review Priorities Using
 Risk Assessment and Allocating Review
 Resources
----------------------------------------------------------------------------------------------------------------
4-of-a-Kind PMAs                        October 1, 1999  Do.                              Do.
----------------------------------------------------------------------------------------------------------------
Review of 510(k)s for Computer          August 29, 1991  Do.                              Do.
 Controlled Medical Devices (blue book
 memo K91-1)
----------------------------------------------------------------------------------------------------------------
Review of Final Draft Medical Device    August 29, 1991  Do.                              Do.
 Labeling (blue book memo P91-
 4)
----------------------------------------------------------------------------------------------------------------
Clinical Utility and Premarket          May 3, 1991      Do.                              Do.
 Approval (blue book memo P91-
 1)
----------------------------------------------------------------------------------------------------------------
Review and Approval of PMAs of          October 22,      Do.                              Do.
 Licensees (blue book memo P86-4)
----------------------------------------------------------------------------------------------------------------
PMA Supplements: ODEs Letter to         April 24, 1990   Do.                              Do.
 Manufacturers; Identifies Situation
 Which May Require the Submission of a
 PMA Supplement (blue book memo P90-1)
----------------------------------------------------------------------------------------------------------------
FDA Policy for the Regulation of        November 13,     Do.                              Do.
 Computer Products; Draft                1989
----------------------------------------------------------------------------------------------------------------
PMA Review Schedules (P87-1) (replaced  March 31, 1988   Do.                              Do.
 by P94-2)
----------------------------------------------------------------------------------------------------------------
Necessary Information for Diagnostic    November 24,     Do.                              Do.
 Ultrasound 510(k); Draft                1987
----------------------------------------------------------------------------------------------------------------
Guideline on Sterile Drug Products      June 1, 1987     Do.                              Do.
 Produced by Aseptic Processing
----------------------------------------------------------------------------------------------------------------
ODE Regulatory Information for the      May 15, 1987     Do.                              Do.
 Office of Compliance; Information
 Sharing Procedures (blue book memo
 G87-2)
----------------------------------------------------------------------------------------------------------------
Panel Review of ``Me-Too'' Devices      July 1, 1986     Do.                              Do.
 (blue book memo P86-6)
----------------------------------------------------------------------------------------------------------------
Criteria for Panel Review of PMA        January 30,      Do.                              Do.
 Supplements (blue book memo P86-3)
----------------------------------------------------------------------------------------------------------------

[[Page 891]]

 
PMAs-Early Review and Preparation of    January 27,      Do.                              Do.
 Summaries of Safety and Effectiveness   1986
 (blue book memo P86-1)
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Preparation of   March 3, 1997    Do.                              Do.
 Premarket Notification 510(k)s for
 Dental Alloys
----------------------------------------------------------------------------------------------------------------
Premarket Guidance; Reprocessing and    June 1, 2001     Do.                              Do.
 Reuse of Single-Use Devices; Draft
----------------------------------------------------------------------------------------------------------------
Guidance for Conducting Stability       November 16,     Do.                              Do.
 Testing to Support an Expiration Date   1999
 Labeling Claim for Medical Gloves;
 Draft
----------------------------------------------------------------------------------------------------------------
Draft Version Cardiac Ablation          March 1, 1995    Do.                              Do.
 Preliminary Guidance (Data To Be
 Submitted to the FDA in Support
 Investigation Device Exemption
 Application)
----------------------------------------------------------------------------------------------------------------
Draft Version Electrode Recording       March 1, 1995    Do.                              Do.
 Catheter Preliminary Guidance (Data
 To Be Submitted to the FDA in Support
 of Premarket Notifications)
----------------------------------------------------------------------------------------------------------------
Draft Replacement Heart Valve Guidance  October 14,      Do.                              Do.
                                         1994
----------------------------------------------------------------------------------------------------------------
Draft Guidance on Human Heart Valve     June 21, 1991    Do.                              Do.
 Allografts
----------------------------------------------------------------------------------------------------------------
Draft Intravascular Brachytherapy--     May 24, 1996     Do.                              Do.
 Guidance for Data To Be Submitted to
 FDA in Support of Investigational
 Device Exemption (IDE) Applications
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Submission of    May 1, 1995      Do.                              Do.
 Research and Marketing Applications
 for Interventional Cardiology
 Devices: PTCA Catheters, Atherectomy
 Catheters, Lasers, Intravascular
 Stents
----------------------------------------------------------------------------------------------------------------
Draft Percutaneous Transluminal         February 7,      Do.                              Do.
 Coronary Angioplasty Package Insert     1995
 Template
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Implantable          June 19, 1996    Do.                              Do.
 Cardioverter-Defibrillators
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Preparation of   August 1, 1993   Do.                              Do.
 Research and Marketing Applications
 for Vascular Graft Prostheses
----------------------------------------------------------------------------------------------------------------
Electroencephalograph Devices Draft     November 3,      Do.                              Do.
 Guidance for 510(k) Content             1997
----------------------------------------------------------------------------------------------------------------
Draft 510(k) Guideline for General      May 10, 1995     Do.                              Do.
 Surgical Electrosurgical Devices
----------------------------------------------------------------------------------------------------------------
Galvanic Skin Response Measurement      August 23, 1994  Do.                              Do.
 Devices; Draft Guidance for 510(k)
 Content
----------------------------------------------------------------------------------------------------------------
Draft Version 1; Biofeedback Devices;   August 1, 1994   Do.                              Do.
 Draft Guidance for 510(k) Content
----------------------------------------------------------------------------------------------------------------
Draft Version Cranial Perforator        July 13, 1994    Do.                              Do.
 Guidance
----------------------------------------------------------------------------------------------------------------
Draft Version Neuro Endoscope Guidance  July 7, 1994     Do.                              Do.
----------------------------------------------------------------------------------------------------------------
Draft Premarket Notification Review     June 1, 1994     Do.                              Do.
 Guidance for Evoked Response
 Somatosensory Stimulators
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Arthroscope and      May 1, 1994      Do.                              Do.
 Accessory 510(k)s
----------------------------------------------------------------------------------------------------------------

[[Page 892]]

 
Guidance Document for Industry and      March 18, 1998   Do.                              Do.
 CDRH Staff for the Preparation of
 Investigational Device Exemptions and
 Premarket Approval Applications for
 Bone Growth Stimulator Devices; Draft
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Preparation of       July 16, 1997    Do.                              Do.
 Premarket Notification (510(k))
 Applications for Orthopedic Devices:
 The Basic Elements
----------------------------------------------------------------------------------------------------------------
Calcium Phosphate (Ca-P) Coating Draft  February 21,     Do.                              Do.
 Guidance for Preparation of FDA         1997
 Submission for Orthopedic and Dental
 Endosseous Implants
----------------------------------------------------------------------------------------------------------------
Draft Guidance Document for Femoral     August 1, 1995   Do.                              Do.
 Stem Prostheses
----------------------------------------------------------------------------------------------------------------
Draft Guidance Document for Testing     May 1, 1995      Do.                              Do.
 Acetabular Cup Prostheses
----------------------------------------------------------------------------------------------------------------
Draft Data Requirements for Ultrahigh   March 23, 1995   Do.                              Do.
 Molecular Weight Polyethylene
 (Uhmupe) Used in Orthopedic Devices
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Preparation of   April 1, 1993    Do.                              Do.
 Premarket Notifications (510(k)s) for
 Cemented, Semiconstrained Total Knee
 Prostheses
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Preparation of   April 4, 1995    Do.                              Do.
 IDE Submission for Interactive Wound
 and Burn Dressing
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Preparation of   March 31, 1995   Do.                              Do.
 a Premarket Notification for a Non-
 Interactive Wound and Burn Dressing
----------------------------------------------------------------------------------------------------------------
Draft Version; Guidance on              September 12,    Do.                              Do.
 Biocompatibility Requirements for       1994
 Long Term Neurological Implants: Part
 3--Implant Model
----------------------------------------------------------------------------------------------------------------
Protocol for Dermal Toxicity Testing    January 1, 1985  Do.                              Do.
 for Devices in Contact with Skin;
 Draft
----------------------------------------------------------------------------------------------------------------
Guide for TENS 510(k) Content; Draft    August 1, 1994   Do.                              Do.
----------------------------------------------------------------------------------------------------------------
Draft Version Guidance for Clinical     August 20, 1992  Do.                              Do.
 Data To Be Submitted for Premarket
 Approval Application for Cranial
 Electrotherapy Stimulators
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Cortical Electrode   August 10, 1999  Do.                              Do.
 510(k) Content
----------------------------------------------------------------------------------------------------------------
Accountability Analysis for Clinical    August 4, 1999   Do.                              Do.
 Studies for Ophthalmic Devices; Draft
----------------------------------------------------------------------------------------------------------------
Refractive Implants: Guidance for       August 1, 2000   Do.                              Do.
 Investigational Device Exemptions
 (IDE) and Premarket Approval (PMA)
 Applications; Draft
----------------------------------------------------------------------------------------------------------------
Intraocular Lens Guidance Document;     October 14,      Do.                              Do.
 Draft                                   1999
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Hemodialyzer Reuse   October 6, 1995  Do.                              Do.
 Labeling
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Electro-   August 25, 1999  Do.                              Do.
 Optical Sensors for the In Vivo
 Detection of Cervical Cancer and its
 Precursors; Submission Guidance for
 an IDE/PMA
----------------------------------------------------------------------------------------------------------------
Devices Used for In Vitro               September 10,    Do.                              Do.
 Fertilization and Related Assisted      1988
 Reproduction Procedures; Draft
----------------------------------------------------------------------------------------------------------------

[[Page 893]]

 
Intrapartum Continuous Monitors for     June 14, 1997    Do.                              Do.
 Fetal Oxygen Saturation and Fetal pH;
 Submission Guidance for a PMA; Draft
 Document
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Content of       May 25, 1995     Do.                              Do.
 Premarket Notifications for Menstrual
 Tampons
----------------------------------------------------------------------------------------------------------------
Information for a Latex Condom 510(k)   April 13, 1994   Do.                              Do.
 Submission for Obstetrics-Gynecology
 Devices Branch; Draft
----------------------------------------------------------------------------------------------------------------
Premarket Testing Guidelines for        November 20,     Do.                              Do.
 Falloscopes                             1992
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Content of       July 29, 1991    Do.                              Do.
 Premarket Notifications for Loop and
 Rollerball Electrodes for GYN
 Electrosurgical Excisions
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Review of Bone       November 9,      Do.                              Do.
 Densitometer 510(k) Submissions         1992
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Preclinical and      November 29,     Do.                              Do.
 Clinical Investigations of Urethral     1995
 Bulking Agents Used in the Treatment
 of Urinary Incontinence
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Clinical             November 2,      Do.                              Do.
 Investigation of Urethral Stents        1995
----------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Endoscopic   August 16, 1995  Do.                              Do.
 Electrosurgical Unit (ESU) and
 Accessories Used in Gastroenterology
 and Urology
----------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Urological   August 1, 1995   Do.                              Do.
 Irrigation System and Tubing Set
----------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Endoscopic   June 22, 1995    Do.                              Do.
 Light Sources Used in
 Gastroenterology and Urology
----------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Non-         June 6, 1995     Do.                              Do.
 Implanted Electrical Stimulators Used
 for the Treatment of Urinary
 Incontinence
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Preparation of PMA   May 1, 1995      Do.                              Do.
 Applications for the Implanted
 Mechanical/Hydraulic Urinary
 Continence Device (Artificial Urinary
 Sphincter)
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Content of       March 17, 1995   Do.                              Do.
 Premarket Notifications for
 Endoscopes Used in Gastroenterology
 and Urology
----------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Condom       February 23,     Do.                              Do.
 Catheters                               1995
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Clinical             November 11,     Do.                              Do.
 Investigations of Devices Used for      1994
 the Treatment of Benign Prostatic
 Hyperplasia (BPH)
----------------------------------------------------------------------------------------------------------------
Draft Guidance Outline; PTC for         November 30,     Do.                              Do.
 Clinical Studies for Vasovasostomy      1993
 Devices
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Preparation of PMA   March 16, 1993   Do.                              Do.
 Applications for Penile Inflatable
 Implants
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Preparation of PMA   March 16, 1993   Do.                              Do.
 Applications for Testicular
 Prostheses
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Content of       January 24,      Do.                              Do.
 Premarket Notifications for             1992
 Urological Balloon Dilatation
 Catheters
----------------------------------------------------------------------------------------------------------------
Draft of Suggested Information for      January 18,      Do.                              Do.
 Reporting Extracorporeal Shock Wave     1991
 Lithotripsy Device Shock Wave
 Measurements
----------------------------------------------------------------------------------------------------------------

[[Page 894]]

 
Draft Guidance to Firms on Biliary      August 2, 1990   Do.                              Do.
 Lithotripsy Studies
----------------------------------------------------------------------------------------------------------------
Statistical Aspects of Submissions to   June 1, 1984     Do.                              Do.
 FDA: A Medical Device Perspective
 (also includes as appendix the
 article ``Observed Uses and Abuses of
 Statistical Procedures in Medical
 Device Submissions'')
----------------------------------------------------------------------------------------------------------------
Guidance to Sponsors on the             June 9, 1993     Do.                              Do.
 Development of a Discretionary
 Postmarket Surveillance Study for
 Permanent Implantable Cardiac
 Pacemaker Electrodes (Leads)
----------------------------------------------------------------------------------------------------------------
Amendment to Guidance on Discretionary  March 30, 1994   Do.                              Do.
 Postmarket Surveillance on Pacemaker
 Leads; Final
----------------------------------------------------------------------------------------------------------------
Premarketing Approval Review Criteria   September 10,    Do.                              Do.
 for Premarket Approval of Estrogen      1992
 (ER) or Progesterone (PGR) Receptors
 In Vitro Diagnostic Devices Using
 Steroid Hormone Binding (SBA) With
 Dextran-Coated Charcoal (DCC)
 Separation, Histochemical Receptor
 Bind; Draft
----------------------------------------------------------------------------------------------------------------
Premarket Approval Applications for In  April 27, 2001   Do.                              Do.
 Vitro diagnostic Devices Pertaining
 to Hepatitis C Viruses (HCV): Assays
 Intended for Diagnosis, Prognosis, or
 Monitoring of HCV Infection,
 Hepatitis C, Other HCV-Associated
 Disease; Draft Guidance for Industry
 and FDA
----------------------------------------------------------------------------------------------------------------
Premarket Approval (PMA) Manual         January 1998     Do.                              Do.
----------------------------------------------------------------------------------------------------------------
SMDA Changes--PMA Manual Insert         April 17, 1992   Do.                              Do.
----------------------------------------------------------------------------------------------------------------
Investigational Device Exemptions       June 1, 1996     Do.                              Do.
 (IDE) Manual (FDA 96-4159)
----------------------------------------------------------------------------------------------------------------
510(k) Manual--Premarket Notification:  August 1, 1995   Do.                              Do.
 510(k)--Regulatory Requirements for
 Medical Devices
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation   July 26, 1995    Do.                              Do.
 of Premarket Notification [510(k)]
 Applications for Beds
----------------------------------------------------------------------------------------------------------------
\1\See Internet address for Facts-on-Demand number.


                   Guidance Documents Issued by CFSAN
------------------------------------------------------------------------
                                           Intended User
                                Date of          or        How to Obtain
      Name of Document          Issuance     Regulatory    a Copy of the
                                              Activity       Document
------------------------------------------------------------------------
Compliance Policy Guides      August       General        http://
 Manual                        2000;        publications   www.cfsan.fda
                               updated in                  .gov/
                               April 2001                 guidance.html
------------------------------------------------------------------------
Compliance Programs Guidance  March 1995   Do.            Do.
 Manual
------------------------------------------------------------------------
FDA Recall Policy             2002         Do.            Do.
------------------------------------------------------------------------
Guidance for FDA Staff; The   2003         Do.            Do.
 Leveraging Handbook; An
 Agency Resource for
 Effective Collaborations
------------------------------------------------------------------------
Guidance for Small            2002         Do.            Do.
 Businesses; Submission of
 Comments for CFSAN
 Rulemaking
------------------------------------------------------------------------
Investigations Operations     May 1996     Do.            Do.
 Manual
------------------------------------------------------------------------
Regulatory Procedures Manual  August 1997  Do.            Do.
------------------------------------------------------------------------

[[Page 895]]

 
Draft Guidance: Channels of   July 2003    Chemical and   Do.
 Trade Policy for                           pesticide
 Commodities With Residues                  contaminants
 of Pesticide Chemicals, For                publications
 Which Tolerances Have Been
 Revoked, Suspended, or
 Modified by the
 Environmental Protection
 Agency
------------------------------------------------------------------------
Channels of Trade Policy for  June 2002    Do.            Do.
 Commodities With
 Vinclozolin Residues
------------------------------------------------------------------------
FDA Recommendations for       January      Do.            Do.
 Sampling and Testing Yellow   2001
 Corn and Dry-Milled Yellow
 Corn Shipments for Cry9C
 Protein Residues
------------------------------------------------------------------------
Channels of Trade Policy for  December     Do.            Do.
 Commodities With Methyl       2000
 Parathion Residues
------------------------------------------------------------------------
Action Levels for Poisonous   2000         Do.            Do.
 or Deleterious Substances
 in Human Food and Animal
 Feed
------------------------------------------------------------------------
Pesticides Analytical Manual  1999         Do.            Do.
------------------------------------------------------------------------
FDA Advisory for              September    Do.            Do.
 Deoxynivanol (DON) in         1993
 Finished Wheat Products
 Intended for Human
 Consumption and in Grain
 and Grain By-Products for
 Animal Feed
------------------------------------------------------------------------
FDA's Cosmetic Labeling       October      Cosmetic       Do.
 Manual                        1991         publications
------------------------------------------------------------------------
Draft Guidance: Labeling for  December 2,  Do.            Do.
 Topically Applied Cosmetic    2002
 Products Containing Alpha
 Hydroxy Acids as
 Ingredients
------------------------------------------------------------------------
Interim Procedures for        July 10,     Dietary        Do.
 Qualified Health Claims in    2003         supplements
 the Labeling of                            publications
 Conventional Human Food and
 Human Dietary Supplements
------------------------------------------------------------------------
Interim Evidence-Based        July 10,     Do.            Do.
 Ranking System for            2003
 Scientific Data
------------------------------------------------------------------------
Structure/Function Claims:    January 9,   Do.            Do.
 Small Entity Compliance       2002
 Guide
------------------------------------------------------------------------
Statement of Identity,        January      Do.            Do.
 Nutrition Labeling, and       1999
 Ingredient Labeling of
 Dietary Supplements Small
 Entity Compliance Guide
------------------------------------------------------------------------
Significant Scientific        December     Do.            Do.
 Agreement in the Review of    1999
 Health Claims for
 Conventional Foods and
 Dietary Supplements
------------------------------------------------------------------------
Notification of a Health      July 1998    Do.            Do.
 Claim or Nutrient Content
 Claim Based on an
 Authoritative Statement of
 a Scientific Body
------------------------------------------------------------------------
Iron-Containing Supplements   October 17,  Do.            Do.
 and Drugs: Label Warning      2003
 Statements: Small Entity
 Compliance Guide
------------------------------------------------------------------------
Providing Regulatory          July 2001    Food and       Do.
 Submissions in Electronic                  color
 Format; General                            additives
 Considerations                             publications
------------------------------------------------------------------------
Providing Food and Color      July 2001    Do.            Do.
 Additive Petitions in
 Electronic Format
------------------------------------------------------------------------
Electronic Submission Forms   July 2001    Do.            Do.
------------------------------------------------------------------------
FDA's Policy for Foods        1995         Do.            Do.
 Developed by Biotechnology
------------------------------------------------------------------------
Partial List of Enzyme        2001         Do.            Do.
 Preparations That Are Used
 in Foods
------------------------------------------------------------------------
Partial List of               2001         Do.            Do.
 Microorganisms and
 Microbial-Derived
 Ingredients That Are Used
 in Food
------------------------------------------------------------------------
Use of Antibiotic Resistance  September    Do.            Do.
 Marker Genes in Transgenic    1998
 Plants
------------------------------------------------------------------------
Enzyme Preparations:          January      Do.            Do.
 Chemistry Recommendations     1993
 for Food Additive and GRAS
 Affirmation Petitions
------------------------------------------------------------------------

[[Page 896]]

 
Guidance for Submitting       1996         Do.            Do.
 Requests Under 21 CFR
 170.39; Threshold of
 Regulation for Substances
 Used in Food Contact
 Articles
------------------------------------------------------------------------
PTC for the Use of Recycled   December     Do.            Do.
 Plastics in Food Packaging:   1992
 Chemistry Considerations
------------------------------------------------------------------------
How to Submit a GRAS Notice   April 17,    Do.            Do.
                               1997
------------------------------------------------------------------------
Recommendations for           May 1993     Do.            Do.
 Submission of Chemical and
 Technological Data for
 Direct Food Additive and
 GRAS Food Ingredient
 Petitions
------------------------------------------------------------------------
Statement of Policy; Foods    May 1992     Do.            Do.
 Derived from New Plant
 Varieties; Notice
------------------------------------------------------------------------
Guidelines for the            1996         Do.            Do.
 Preparation of Petition
 Submissions
------------------------------------------------------------------------
Guidelines for Approval of    1996         Do.            Do.
 Color Additives in Contact
 Lenses Intended as Colors
------------------------------------------------------------------------
FDA Recommendations for       January      Do.            Do.
 Submission of Chemical and    1997
 Technological Data on Color
 Additives for Food, Drug,
 or Cosmetic Use
------------------------------------------------------------------------
Estimating Exposure to        September    Do.            Do.
 Direct Food Additive and      1995
 Chemical Contaminants in
 the Diet
------------------------------------------------------------------------
Toxicological Principles for  1982         Do.            Do.
 the Safety Assessment of
 Direct Food Additives and
 Color Additives Used in
 Food (also known as redbook
 I)
------------------------------------------------------------------------
Toxicological Principles for  April 2004   Do.            Do.
 the Safety of Food
 Ingredients (redbook 2000)
------------------------------------------------------------------------
Draft Guidance; Preparing a   September    Do.            Do.
 Claim of Categorical          17, 2003
 Exclusion or an
 Environmental Assessment
 for Submission to CFSAN
------------------------------------------------------------------------
Environmental Assessment      March 1987   Do.            Do.
 Technical Handbook
------------------------------------------------------------------------
Toxicological Testing of      1983         Do.            Do.
 Food Additives
------------------------------------------------------------------------
Guidance on Consultation      October      Do.            Do.
 Procedures Foods Derived      1997
 From New Plant Varieties
------------------------------------------------------------------------
Bovine Spongiform             1997         Do.            Do.
 Encephalopathy (BSE) in
 Products for Human Use
------------------------------------------------------------------------
Food Additive Petition        January      Do.            Do.
 Expedited Review; Guidance    1999
 for Industry and CFSAN
------------------------------------------------------------------------
Antimicrobial Food Additives  July 1999    Do.            Do.
 Guidance
------------------------------------------------------------------------
Preparation of Premarket      May 2002     Do.            Do.
 Notifications for Food
 Contact Substances (Food
 Contact Notifications
 (FCN)): Administrative
 Recommendations
------------------------------------------------------------------------
Preparation of Food Contact   April 2002   Do.            Do.
 Notifications and Food
 Additive Petitions for Food
 Contact Substances:
 Chemistry Recommendations
------------------------------------------------------------------------
Preparation of Premarket      April 2002   Do.            Do.
 Notifications for Food
 Contact Substances:
 Toxicology Recommendations
------------------------------------------------------------------------
A Food Labeling Guide         May 1997     Food labeling  Do.
                                            publications
------------------------------------------------------------------------
Food Labeling: Trans Fatty    August 20,   Do.            Do.
 Acids in Nutrition            2003
 Labeling, Nutrient Content
 Claims, and Health Claims;
 Small Entity Compliance
 Guide
------------------------------------------------------------------------

[[Page 897]]

 
Qualified Health Claims in    December     Do.            Do.
 the Labeling of               18, 2002
 Conventional Foods and
 Dietary Supplements
------------------------------------------------------------------------
Draft Guidance; Voluntary     January      Do.            Do.
 Labeling Indicating Whether   2001
 Foods Have or Have Not Been
 Developed Using
 Bioengineering
------------------------------------------------------------------------
Small Business Food Labeling  June 1996    Do.            Do.
 Exemption
------------------------------------------------------------------------
Food Labeling: Questions and  August 1994  Do.            Do.
 Answers (volume I)
------------------------------------------------------------------------
Food Labeling: Questions and  February     Do.            Do.
 Answers (volume II)           1996
------------------------------------------------------------------------
Fair Packaging and Labeling   June 1978    Do.            Do.
 Act Manual
------------------------------------------------------------------------
Implementation of Section     2002         Do.            Do.
 10809 of the Farm Security
 and Investment Act of 2002,
 Public Law No. 107-171,
 Sec.   10809 (2002),
 Regarding the Petition
 Process to Request Approval
 of Labeling for Foods That
 Have Been Treated by
 Irradiation
------------------------------------------------------------------------
FDA Nutrition Labeling        March 1998   Do.            Do.
 Manual--A Guide for
 Developing and Using
 Databases
------------------------------------------------------------------------
Guidelines for Determining    October 1,   Do.            Do.
 Metric Equivalents of         1993
 Household Measures
------------------------------------------------------------------------
Food Labeling--Safe Handling  July 2001    Do.            Do.
 Statements, Labeling of
 Shell Eggs; Refrigeration
 of Shell Eggs Held for
 Retail Distribution; Small
 Entity Compliance Guide
------------------------------------------------------------------------
Exemptions From the Warning   October 7,   Do.            Do.
 Label Requirement for         2002
 Juice--Recommendations for
 Effectively Achieving a 5-
 Log Pathogen Reduction
------------------------------------------------------------------------
Food Labeling--Serving Sizes  July 2001    Do.            Do.
 Reference Amount for Baking
 Powder, Baking Soda,
 Pectin; Small Entity
 Compliance Guide
------------------------------------------------------------------------
Bacteriological Analytical    1992         Food           Do.
 Manual (7th ed.)                           processing
                                            publicatons
------------------------------------------------------------------------
Bacteriological Analytical    2001         Do.            Do.
 Manual Online
------------------------------------------------------------------------
Questions and Answers         August 6,    Food and       Do.
 Regarding Registration of     2004         cosmetic
 Food Facilities (4th ed.)                  security
                                            publications
------------------------------------------------------------------------
Cosmetics Processors and      December     Do.            Do.
 Transporters: Cosmetics       17, 2003
 Security Preventive
 Measures Guidance
------------------------------------------------------------------------
Retail Food Stores and Food   December     Do.            Do.
 Service Establishments:       17, 2003
 Food Security Preventive
 Measures Guidance
------------------------------------------------------------------------
What You Need to Know About   November     Do.            Do.
 Registration of Food          25, 2003
 Facilities
------------------------------------------------------------------------
What You Need to Know About   November     Do.            Do.
 Prior Notice of Imported      25, 2003
 Food Shipments
------------------------------------------------------------------------
Necessity of the Use of Food  July 17,     Do.            Do.
 Product Categories in         2003
 Registration of Food
 Facilities
------------------------------------------------------------------------
Dairy Farms, Bulk Milk        July 11,     Do.            Do.
 Transporters, Bulk Milk       2003
 Transfer Stations, and
 Fluid Milk Processors: Food
 Security Preventive
 Measures Guidance
------------------------------------------------------------------------
Food Producers, Processors,   March 21,    Do.            Do.
 and Transporters: Food        2003
 Security Preventive
 Measures Guidance
------------------------------------------------------------------------
Importers and Filers: Food    March 21,    Do.            Do.
 Security Preventive           2003
 Measures Guidance
------------------------------------------------------------------------

[[Page 898]]

 
Compliance Policy Guide;      2003         Do.            Do.
 Guidance for FDA Staff on
 Registration of Food
 Facilities
------------------------------------------------------------------------
Compliance Policy Guide;      2003         Do.            Do.
 Guidance for FDA Staff on
 Prior Notice of Imported
 Foods
------------------------------------------------------------------------
Prior Notice of Imported      May 2004     Imports and    Do.
 Food Questions and Answers                 exports
 (2nd ed.)                                  publications
------------------------------------------------------------------------
Prior Notice of Imported      August 2004  Do.            Do.
 Food: Harmonized Tariff
 Schedule Codes Flagged With
 Prior Notice Indicators
------------------------------------------------------------------------
Guidance for Industry and     May 23,      Do.            Do.
 FDA; Establishing and         2003
 Maintaining a List of U.S.
 Dairy Product Manufacturers/
 Processors With Interest in
 Exporting to Chile
------------------------------------------------------------------------
FDA Food Importer's Guide     1985         Do.            Do.
 for Low-Acid Canned and
 Acidified Foods
------------------------------------------------------------------------
Guidance for Industry; FDA    2002         Do.            Do.
 Export Certificates
------------------------------------------------------------------------
Draft Guidance; Regulatory    November 5,  Do.            Do.
 Procedures Manual, chapter    2002
 9, subchapter: Guidance
 Concerning Recommending
 Customs' Seizure and
 Destruction of Imported
 Human and Animal Food That
 Has Not Been Reconditioned
------------------------------------------------------------------------
Guidelines Concerning         1985         Infant         Do.
 Notification and Testing of                formula
 Infant Formula                             publications
------------------------------------------------------------------------
Guidelines for Evaluation of  1988         Do.            Do.
 the Safety and Suitability
 of New Infant Formulas for
 Feeding Preterm Infants
------------------------------------------------------------------------
Clinical Testing of Infant    1988         Do.            Do.
 Formulas With Respect to
 Nutritional Suitability for
 Term Infants
------------------------------------------------------------------------
Guidelines for Evaluation of  1990         Do.            Do.
 the Safety and Suitability
 of Infant Formulas for
 Feeding Infants With
 Allergic Diseases
------------------------------------------------------------------------
Guidelines for the Clinical   1987         Do.            Do.
 Evaluation of New Products
 Used in the Dietary
 Management of Infants,
 Children, and Pregnant
 Women With Metabolic
 Disorders
------------------------------------------------------------------------
The Juice HACCP Regulation:   September    Juice          Do.
 Questions and Answers         4, 2003      publications
------------------------------------------------------------------------
Standardized Training         June 2003    Do.            Do.
 Curriculum for Application
 of HACCP Principles to
 Juice Processing
------------------------------------------------------------------------
Bulk Transport of Juice       April 24,    Do.            Do.
 Concentrates and Certain      2002
 Shelf Stable Juices
------------------------------------------------------------------------
Juice HACCP Small Entity      April 4,     Do.            Do.
 Compliance Guide              2003
------------------------------------------------------------------------
Draft Guidance; Juice HACCP   March 3,     Do.            Do.
 Hazards and Control           2004
 Guidance (1st ed.)
------------------------------------------------------------------------
Apple Juice, Apple Juice      October      Do.            Do.
 Concentrates, and Apple       2001
 Juice Products--
 Adulteration With Patulin
------------------------------------------------------------------------
The Juice HACCP Regulation:   August 31,   Do.            Do.
 Questions and Answers         2001
------------------------------------------------------------------------
FDA Food Importer's Guide     1985         Low-acid and   Do.
 for Low-Acid Canned and                    acidified
 Acidified Foods                            foods
                                            publications
------------------------------------------------------------------------
Grade ``A'' Pasteurized Milk  May 15,      Milk           Do.
 Ordinance (2001 revision)     2002         sanitation
                                            publications
------------------------------------------------------------------------
Importation of PMO Defined    April 11,    Do.            Do.
 Dairy Products (M-I-00-4)     2000
------------------------------------------------------------------------
Evaluation of Milk            1995         Do.            Do.
 Laboratories
------------------------------------------------------------------------

[[Page 899]]

 
Methods of Making Sanitation  1999         Do.            Do.
 Ratings of Milk Supplies
------------------------------------------------------------------------
Procedures Governing the      1999         Do.            Do.
 Cooperative State-Public
 Health Service/FDA Program
 for Certification of
 Interstate Milk Shippers
------------------------------------------------------------------------
Frozen Dessert Processing     1989         Do.            Do.
 Guidelines
------------------------------------------------------------------------
Dry Milk Ordinance            1995         Do.            Do.
------------------------------------------------------------------------
Pasteurized Milk Ordinance    1999         Do.            Do.
------------------------------------------------------------------------
Fumonisin Levels in Human     November 9,  Natural        Do.
 Foods and Animal Feeds        2001         toxins
                                            publications
------------------------------------------------------------------------
List of Products for Each     October 8,   Nutrition and  Do.
 Product Category              1992         food science
                                            publications
------------------------------------------------------------------------
Label Declaration of          June 10,     Do.            Do.
 Allergenic Substances in      1996
 Foods; Notice to
 Manufacturers
------------------------------------------------------------------------
Guidance on Labeling of       February     Do.            Do.
 Foods That Need               24, 1997
 Refrigeration by Consumers
------------------------------------------------------------------------
Interim Guidance on the       February     Do.            Do.
 Voluntary Labeling of Milk    10, 1994
 and Milk Products That Have
 Not Been Treated With
 Recombinant Bovine
 Somatropin
------------------------------------------------------------------------
Guide to Minimize Microbial   October 26,  Produce        Do.
 Food Safety Hazards for       1998         publications
 Fresh Fruits and Vegetables
------------------------------------------------------------------------
Reducing Microbial Food       October      Do.            Do.
 Safety Hazards for Sprouted   1999
 Seeds
------------------------------------------------------------------------
Sampling and Microbial        October      Do.            Do.
 Testing of Spent Irrigation   1999
 Water During Sprout
 Production
------------------------------------------------------------------------
Retail Food Stores and Food   December     Retail food    Do.
 Service Establishments:       17, 2003     protection
 Food Security Preventive                   publications
 Measures Guidance
------------------------------------------------------------------------
Foods--Adulteration           February     Sanitation     Do.
 Involving Hard or Sharp       1999         publications
 Foreign Objects
------------------------------------------------------------------------
Defect Action Levels (DALs)   May 1998     Do.            Do.
------------------------------------------------------------------------
Action Levels for Poisonous   2000         Do.            Do.
 or Deleterious Substances
 in Human Food and Feed
------------------------------------------------------------------------
Refusal of Inspection or      July 2001    Seafood        Do.
 Access to HACCP Records                    publications
 Pertaining to the Safe and
 Sanitary Processing of Fish
 and Fishery Products
------------------------------------------------------------------------
Seafood HACCP Transition      December     Do.            Do.
 Policy                        1999
------------------------------------------------------------------------
Seafood List                  1993         Do.            Do.
------------------------------------------------------------------------
Fish and Fisheries Products   2001         Do.            Do.
 Hazards and Control Guide
 (3rd ed.)
------------------------------------------------------------------------
HACCP Regulation for Fish     1998         Do.            Do.
 and Fishery Products:
 Questions and Answers
------------------------------------------------------------------------
Implementation of Section     December     Do.            Do.
 403(t) of the Federal Food,   2002
 Drug, and Cosmetic Act (21
 U.S.C. 343(t)) Regarding
 the Use of the Term
 ``Catfish''
------------------------------------------------------------------------
Letter to Various Seafood     February     Do.            Do.
 Trade Associations            28, 2003
 Regarding the Labeling of
 Catfish
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
WITHDRAWN GUIDANCES
------------------------------------------------------------------------

[[Page 900]]

 
Guidance for Industry:        June 2000    N/A            N/A
 Fumonisin Levels in Human
 Foods and Animal Feeds,
 Draft (replaced by Guidance
 for Industry: Fumonisin
 Levels in Human Foods and
 Animal Feeds; Final
 (November 2001)
------------------------------------------------------------------------
Guidance for Industry         December     Do.            Do.
 Qualified Health Claims in    2002
 the Labeling of
 Conventional Foods and
 Dietary Supplements
 (replaced by Interim
 Procedures for Qualified
 Health Claims in the
 Labeling of Conventional
 Human Food and Human
 Dietary Supplements and
 Interim Evidence-Based
 Ranking System for
 Scientific Data (July
 2003))
------------------------------------------------------------------------
Guidance for Industry         June 2000    Do.            Do.
 Preparation of Premarket
 Notifications for Food
 Contact Substances:
 Administrative; Draft
 (replaced by Guidance for
 Industry Preparation of
 Premarket Notifications for
 Food Contact Substances:
 Administrative; Final (May
 2002))
------------------------------------------------------------------------
Guidance for Industry         May 2000     Do.            Do.
 Preparation of Premarket
 Notifications for Food
 Contact Substances:
 Chemistry Recommendations,
 Draft (replaced by Guidance
 for Industry Preparation of
 Food Contact Notifications
 for Food Contact
 Substances: Chemistry
 Recommendations; Final
 (April 2002))
------------------------------------------------------------------------
Recommendations for           June 1995    Do.            Do.
 Chemistry Data for Indirect
 Food Additive Petitions
 (replaced by Guidance for
 Industry Preparation of
 Food Contact Notifications
 for Food Contact
 Substances: Chemistry
 Recommendations; Final
 (April 2002))
------------------------------------------------------------------------
Guidance for Industry         September    Do.            Do.
 Preparation of Premarket      1999
 Notifications for Food
 Contact Substances:
 Toxicology Recommendations
 (replaced by Guidance for
 Industry Preparation of
 Food Contact Notifications
 for Food Contact
 Substances: Toxicology
 Recommendations; Final
 (April 2002))
------------------------------------------------------------------------
Iron-Containing Supplements   November     Do.            Do.
 and Drugs: Label Warning      1997
 and Unit Dose Packaging
 Small Entity Compliance
 Guide (replaced by Guidance
 for Industry; Iron-
 Containing Supplements and
 Drugs: Label Warning
 Statements; Small Entity
 Compliance Guide (October
 2003))
------------------------------------------------------------------------
Guidance for Industry         July 2001    Do.            Do.
 Channels of Trade Policy
 for Commodities With
 Vinclozolin Residues; Draft
 (replaced by Guidance for
 Industry Channels of Trade
 Policy for Commodities With
 Vinclozolin Residues; Final
 (June 2002))
------------------------------------------------------------------------
Guidance for Industry         November     Do.            Do.
 Refusal of Inspection or      2000
 Access to HACCP Records
 Pertaining to the Safe and
 Sanitary Processing of Fish
 and Fishery Products; Draft
 (replaced by Guidance for
 Industry Refusal of
 Inspection or Access to
 HACCP Records Pertaining to
 the Safe and Sanitary
 Processing of Fish and
 Fishery Products; Final
 (July 2001))
------------------------------------------------------------------------
Guidance Document for         1993         Do.            Do.
 Arsenic
------------------------------------------------------------------------
Guidance Document for         1993         Do.            Do.
 Cadmium
------------------------------------------------------------------------
Guidance Document for         1993         Do.            Do.
 Chromium
------------------------------------------------------------------------
Guidance Document for Lead    1993         Do.            Do.
------------------------------------------------------------------------
Guidance Document for Nickel  1993         Do.            Do.
------------------------------------------------------------------------


[[Page 901]]


                    Guidance Documents Issued by CVM
------------------------------------------------------------------------
                                           Intended User
                                Date of          or        How to Obtain
      Name of Document          Issuance     Regulatory    a Copy of the
                                              Activity       Document
------------------------------------------------------------------------
159 Studies to       November     FDA personnel  Internet via
 Evaluate the Safety of        12, 2003     and            http://
 Residues of Veterinary                     regulated      www.fda.gov/
 Drugs in Human Food:                       industry       cvm/guidance/
 General Approach to                                       published.htm
 Establish a Microbiological                               , or
 ADI (VICH GL36)                                           Communication
                                                           s Staff (HFV-
                                                           12), FDA/CVM,
                                                           7519 Standish
                                                           Pl.,
                                                           Rockville,
                                                           MD, 301-827-
                                                           3800, FAX:
                                                           301-827-4065
------------------------------------------------------------------------
158 Use of Material  September    Regulated      Do.
 From Deer and Elk in Animal   15, 2003     industry
 Feed; Final
------------------------------------------------------------------------
156 Comparability    February     Do.            Do.
 Protocols; Chemistry,         2003
 Manufacturing, and Controls
 Information; Draft
------------------------------------------------------------------------
153 Drugs,           September    Do.            Do.
 Biologics, and Medical        2002
 Devices Derived From
 Bioengineered Plants for
 Use in Humans and Animals;
 Draft
------------------------------------------------------------------------
152 Evaluating the   October 23,  Do.            Do.
 Safety of Antimicrobial New   2003
 Animal Drugs With Regard to
 Their Microbiological
 Effects on Bacteria of
 Human Health Concern
------------------------------------------------------------------------
151 FDA Export       July 2004    Do.            Do.
 Certificates
------------------------------------------------------------------------
150 Status of Clove  June 11,     Do.            Do.
 Oil and Eugenol for           2002
 Anesthesia of Fish
------------------------------------------------------------------------
149 Studies to       May 18,      Do.            Do.
 Evaluate the Safety of        2004
 Residues of Veterinary
 Drugs in Human Food:
 General Approach to Testing
 (VICH GL33)
------------------------------------------------------------------------
148 Studies to       March 19,    Do.            Do.
 Evaluate the Safety of        2004
 Residues of Veterinary
 Drugs in Human Food:
 Developmental Toxicity
 Testing (VICH GL32); Final
 Guidance
------------------------------------------------------------------------
147 Studies to       November     Do.            Do.
 Evaluate the Safety of        12, 2003
 Residues of Veterinary
 Drugs in Human Food; Repeat
 Dose (90-day) Toxicity
 Testing (VICH GL31)
------------------------------------------------------------------------
145 Bioanalytical    May 2001     Do.            Do.
 Method Validation
------------------------------------------------------------------------
144 Pre-Approval     April 27,    Do.            Do.
 Information for               2004
 Registration of New
 Veterinary Medicinal
 Products for Food-producing
 Animals with Respect to
 Antimicrobial Resistance
 (VICH GL27); Final Guidance
------------------------------------------------------------------------
143                  February 1,  Do.            Do.
 Pharmacovigilance of          2002
 Veterinary Medicinal
 Products: Controlled List
 of Terms (VICH GL30); Draft
 Guidance
------------------------------------------------------------------------
142                  December     Do.            Do.
 Pharmacovigilance of          12, 2001
 Veterinary Medicinal
 Products: Management of
 Periodic Summary Update
 Reports (PSUs) (VICH GL29);
 Draft Guidance
------------------------------------------------------------------------
141 Studies to       May 24,      Do.            Do.
 Evaluate the Safety of        2004
 Residues of Veterinary
 Drugs in Human Food:
 Carcinogenicity Testing
 (VICH GL28); Final Guidance
------------------------------------------------------------------------
132 The              November 6,  Do.            Do.
 Administrative New Animal     2002
 Drug Application Process;
 Draft
------------------------------------------------------------------------
126 BACPAC I:        February     Do.            Do.
 Intermediates in Drug         2001
 Substance Synthesis; Bulk
 Actives Postapproval
 Changes: Chemistry,
 Manufacturing, and Controls
 Documentation
------------------------------------------------------------------------
124 Voluntary        January      Do.            Do.
 Labeling Indicating Whether   2001
 Foods Have or Have Not Been
 Developed Using
 Bioengineering; Draft
------------------------------------------------------------------------
122 Manufacture and  November 9,  Do.            Do.
 Labeling of Raw Meat Foods    2004
 for Companion and Captive
 Noncompanion Carnivores and
 Omnivores
------------------------------------------------------------------------

[[Page 902]]

 
121 Expedited        March 6,     Do.            Do.
 Review for New Animal Drug    2001
 Applications for Human
 Pathogen Reduction Claims
------------------------------------------------------------------------
 120 Veterinary      March 1,     Do.            Do.
 Feed Directive Regulation     2001
------------------------------------------------------------------------
 119 How CVM         August 29,   Do.            Do.
 Intends to Handle Deficient   2002
 Submissions Filed During
 the Investigation of a New
 Animal Drug; Final Guidance
------------------------------------------------------------------------
118 Mass             May 1, 2003  Do.            Do.
 Spectrometry for
 Confirmation of the
 Identity of Animal Drug
 Residues; Final Guidance
------------------------------------------------------------------------
117                  December     Do.            Do.
 Pharmacovigilance of          12, 2000
 Veterinary Medical
 Products: Management of
 Adverse Event Reports
 (AERs) (VICH GL24); Draft
 Guidance
------------------------------------------------------------------------
116 Studies to       January 3,   Do.            Do.
 Evaluate the Safety of        2002
 Residues of Veterinary
 Drugs in Human Food:
 Genotoxicity Testing (VICH
 GL23); Final Guidance
------------------------------------------------------------------------
115 Safety Studies   January 3,   Do.            Do.
 for Veterinary Drug           2002
 Residues in Human Food;
 Reproduction Toxicity
 Testing (VICH GL22); Final
 Guidance
------------------------------------------------------------------------
114 Effectiveness    June 19,     Do.            Do.
 of Anthelmintics: Specific    2002
 Recommendations for Poultry-
 Gallus Gallus (VICH GL21);
 Final Guidance
------------------------------------------------------------------------
113 Effectiveness    June 19,     Do.            Do.
 of Anthelmintics: Specific    2002
 Recommendations for Feline
 (VICH GL20); Final Guidance
------------------------------------------------------------------------
112 Fumonisin        November 9,  Do.            Do.
 Levels in Human Foods and     2001
 Animal Feeds; Final
 Guidance
------------------------------------------------------------------------
111 Effectiveness    June 27,     Do.            Do.
 of Anthelmintics: Specific    2002
 Recommendations for Canine
 (VICH GL19); Final Guidance
------------------------------------------------------------------------
110 Effectiveness    June 27,     Do.            Do.
 of Anthelmintics: Specific    2002
 Recommendations for Porcine
 (VICH GL16); Final Guidance
------------------------------------------------------------------------
109 Effectiveness    June 27,     Do.            Do.
 of Anthelmintics: Specific    2002
 Recommendations for Equine
 (VICH GL15); Final Guidance
------------------------------------------------------------------------
108 How to Submit    May 21,      Do.            Do.
 Information in Electronic     2004
 Format by E-mail
------------------------------------------------------------------------
107 How to Submit a  May 21,      Do.            Do.
 Protocol in Electronic        2004
 Format by E-mail
------------------------------------------------------------------------
106 The Use of       August 31,   Do.            Do.
 Published Literature in       2000
 Support of New Animal Drug
 Approval
------------------------------------------------------------------------
105 Computerized     September    Do.            Do.
 Systems Used in Clinical      2004
 Trials
------------------------------------------------------------------------
104 Content and      July 10,     Do.            Do.
 Format of Effectiveness and   2001
 Target Animal Safety
 Technical Sections and
 Final Study Reports for
 Submission to the Division
 of Therapeutic Drugs for
 Nonfood Animals
------------------------------------------------------------------------
103 Possible Dioxin/ August 1999  Do.            Do.
 PCB Contamination of Drug
 and Biological Products
------------------------------------------------------------------------
102 Manufacture and  August 27,   Do.            Do.
 Distribution of Unapproved    1999
 Piperazine Products;
 Revised
------------------------------------------------------------------------
100 Impurities:      May 15,      Do.            Do.
 Residual Solvents in New      2001
 Veterinary Medicinal
 Products, Active Substances
 and Excipients (VICH GL18);
 Final Guidance
------------------------------------------------------------------------
99 Stability         March 26,    Do.            Do.
 Testing of New                2001
 Biotechnological/Biological
 Veterinary Medicinal
 Products (VICH GL17); Final
 Guidance
------------------------------------------------------------------------

[[Page 903]]

 
98 Dioxin in         April 14,    Do.            Do.
 Anticaking Agents Used in     2000
 Animal Feed and Feed
 Ingredients; Revised
------------------------------------------------------------------------
97 Effectiveness of  March 26,    Do.            Do.
 Anthelmintics: Specific       2001
 Recommendations for Caprine
 (VICH GL14); Final Guidance
------------------------------------------------------------------------
96 Effectiveness of  March 26,    Do.            Do.
 Anthelmintics: Specific       2001
 Recommendations for Ovine
 (VICH GL13); Final Guidance
------------------------------------------------------------------------
95 Efficacy of       March 26,    Do.            Do.
 Anthelmintics: Specific       2001
 Recommendations for
 Bovines; (VICH GL12); Final
 Guidance
------------------------------------------------------------------------
93 Impurities in     May 1, 2000  Do.            Do.
 New Veterinary Medical
 Products (VICH GL11)
------------------------------------------------------------------------
92 Impurities in     May 1, 2000  Do.            Do.
 New Veterinary Drug
 Substances (VICH GL10)
------------------------------------------------------------------------
91 Stability         March 2000   Do.            Do.
 Testing for Medicated
 Premixes (VICH GL8); Final
 Guidance
------------------------------------------------------------------------
90 Effectiveness of  October 11,  Do.            Do.
 Anthelmintics: General        2001
 Recommendations (VICH GL7);
 Final Guidance (replaces
 March 26, 2001)
------------------------------------------------------------------------
89 Environmental     March 7,     Do.            Do.
 Impact Assessments (EIAs)     2001
 for Veterinary Medicinal
 Products (VMPs)--Phase I
 (VICH GL6); Final Guidance
------------------------------------------------------------------------
88 How to Submit a   May 21,      Do.            Do.
 Request for a Meeting or      2004
 Teleconference in
 Electronic Format by E-mail
------------------------------------------------------------------------
87 How to Submit a   May 21,      Do.            Do.
 Notice of Intent to           2004
 Slaughter for Human Food
 Purposes in Electronic
 Format by E-mail
------------------------------------------------------------------------
86 How to Submit a   May 21,      Do.            Do.
 Notice of Final Disposition   2004
 of Investigational Animals
 Not Intended for Immediate
 Slaughter in Electronic
 Format by E-mail
------------------------------------------------------------------------
85 Good Clinical     May 9, 2001  Do.            Do.
 Practice (VICH GL9); Final
 Guidance
------------------------------------------------------------------------
84 Product Name      January      Do.            Do.
 Placement, Size and           1999
 Prominence in Advertising
 and Promotional Labeling;
 Draft Guidance
------------------------------------------------------------------------
83 Chemistry,        June 1999    Do.            Do.
 Manufacturing, and Controls
 Changes to an Approved NADA
 or ANADA; Draft Guidance
------------------------------------------------------------------------
82 Development of    October 28,  Do.            Do.
 Supplemental Applications     2002
 for Approved New Animal
 Drugs; Final Guidance
------------------------------------------------------------------------
80 Studies to        November     Do.            Do.
 Evaluate the Utility of       21, 2002
 Anti-Salmonella Chemical
 Food Additives in Feeds
------------------------------------------------------------------------
79 Dispute           May 16,      Do.            Do.
 Resolution Procedures for     2003
 Science-Based Decisions on
 Products Regulated by CVM;
 Draft Guidance
------------------------------------------------------------------------
78 Consideration of  December     Do.            Do.
 the Human Health Impact of    13, 1999
 the Microbial Effects of
 Antimicrobial New Animal
 Drugs Intended for Use in
 Food-Producing Animals
------------------------------------------------------------------------
76 Questions and     July 1998    Do.            Do.
 Answers: BSE Feed
 Regulation
------------------------------------------------------------------------
75 Stability         September    Do.            Do.
 Testing: Photostability       1999
 Testing of New Veterinary
 Drug Substances and
 Medicinal Products; Final
 Guidance
------------------------------------------------------------------------
74 Stability         September    Do.            Do.
 Testing of New Veterinary     1999
 Dosage Forms (VICH GL4);
 Final Guidance
------------------------------------------------------------------------
73 Stability         September    Do.            Do.
 Testing of New Veterinary     1999
 Drug Substances and
 Medicinal Products (VICH
 GL3); Final Guidance
------------------------------------------------------------------------

[[Page 904]]

 
72 GMPs for          May 1998     Do.            Do.
 Medicated Feed
 Manufacturers Not Required
 to Register and Be Licensed
 With FDA
------------------------------------------------------------------------
70 Para              February     Do.            Do.
 Alimentadores de Animales     1998
 Rumiantes Sin Operaciones
 de Mezclado de Alimentos en
 la Granja
------------------------------------------------------------------------
70 Small Entities    February     Do.            Do.
 Compliance Guide for          1998
 Feeders of Ruminant Animals
 Without On-Farm Feed Mixing
 Operations
------------------------------------------------------------------------
69 Para              February     Do.            Do.
 Alimentadores de Animales     1998
 Rumiantes Con Operaciones
 de Mezclado de Alimentos en
 la Granja
------------------------------------------------------------------------
69 Small Entities    February     Do.            Do.
 Compliance Guide for          1998
 Feeders of Ruminant Animals
 With On-Farm Feed Mixing
 Operations
------------------------------------------------------------------------
68 Para Mezcladores  February     Do.            Do.
 de Prote[Iacute]nas,          1999
 Fabricantes de Alimentos
 para Animales y
 Distribuidores
------------------------------------------------------------------------
68 Small Entities    February     Do.            Do.
 Compliance Guide for          1998
 Protein Blenders, Feed
 Manufacturers, and
 Distributors
------------------------------------------------------------------------
67 Para Extractores  February     Do.            Do.
 de Grasa por Fusion           1998
------------------------------------------------------------------------
67 Small Entities    February     Do.            Do.
 Compliance Guide for          1998
 Renderers
------------------------------------------------------------------------
65 Industry-         November     Do.            Do.
 Supported Scientific and      1997
 Educational Activities
------------------------------------------------------------------------
64 Validation of     July 1999    Do.            Do.
 Analytical Procedures:
 Methodology; Final Guidance
------------------------------------------------------------------------
63 Validation of     July 1999    Do.            Do.
 Analytical Procedures:
 Definition and Terminology
------------------------------------------------------------------------
62 Consumer-         August 1999  Do.            Do.
 Directed Broadcast
 Advertisements; Final
 Guidance
------------------------------------------------------------------------
61 FDA Approval of   April 1999   Do.            Do.
 New Animal Drugs for Minor
 Uses and for Minor Species
------------------------------------------------------------------------
59 How to Submit a   May 21,      Do.            Do.
 Notice of Claimed             2004
 Investigational Exemption
 in Electronic Format by E-
 mail
------------------------------------------------------------------------
57 Guidance for      1995         Do.            Do.
 Industry for the
 Preparation and Submission
 of Veterinary Master Files
------------------------------------------------------------------------
56 Protocol          July 10,     Do.            Do.
 Development Guideline for     2001
 Clinical Effectiveness and
 Target Animal Safety Trials
------------------------------------------------------------------------
55 Supportive Data   June 1994    Do.            Do.
 for Cat Food Labels Bearing
 ``Reduces Urinary pH''
 Claims: Guideline in
 Protocol Development
------------------------------------------------------------------------
54 Draft Guideline   June 22,     Do.            Do.
 for Utility Studies for       1994
 Anti-Salmonella Chemical
 Food Additives in Animal
 Feeds (see final guidance
 80)
------------------------------------------------------------------------
53 Guideline for     May 1994     Do.            Do.
 the Evaluation of the
 Utility of Food Additives
 in Diets Fed to Aquatic
 Animals
------------------------------------------------------------------------
52 Assessment of     February     Do.            Do.
 the Effects of                18, 2004
 Antimicrobial Drug Residues
 From Food of Animal Origin
 on the Human Intestinal
 Flora
------------------------------------------------------------------------
50 Draft Guideline   February 1,  Do.            Do.
 for Target Animal and Human   1993
 Food Safety, Drug Efficacy,
 Environmental and
 Manufacturing Studies for
 Teat Antiseptic Products
------------------------------------------------------------------------
49 Guidance          April 4,     Do.            Do.
 Document for Target Animal    1996
 Safety and Drug
 Effectiveness Studies for
 Antimicrobial Bovine
 Mastitis Products
 (Lactating and Nonlactating
 Cow Products)
------------------------------------------------------------------------

[[Page 905]]

 
48 Guidance for      November     Do.            Do.
 Industry for the Submission   1994
 Documentation for
 Sterilization Process
 Validation in Applications
 for Human and Veterinary
 Drug Products
------------------------------------------------------------------------
45 Guideline for     August 1993  Do.            Do.
 Uniform Labeling of Drugs
 for Dairy and Beef Cattle
------------------------------------------------------------------------
43 Guidance on       October      Do.            Do.
 Generic Animal Drug           1995
 Products Containing
 Fermentation-Derived Drug
 Substances
------------------------------------------------------------------------
42 Animal Drug       1994         Do.            Do.
 Manufacturing Guidelines
------------------------------------------------------------------------
41 Draft Guideline   June 1992    Do.            Do.
 for Formatting, Assembling,
 and Submitting New Animal
 Drug Applications
------------------------------------------------------------------------
40 Draft Guideline   April 1992   Do.            Do.
 for the Evaluation of the
 Efficacy of Anticoccidial
 Drugs and Anticoccidial
 Drug Combinations in
 Poultry
------------------------------------------------------------------------
38 Guideline for     August 21,   Do.            Do.
 Effectiveness Evaluation of   1984
 Topical/OTIC Animal Drugs
------------------------------------------------------------------------
37 Guidelines for    March 1984   Do.            Do.
 Evaluation of Effectiveness
 of New Animal Drugs for Use
 in Poultry Feeds for
 Pigmentation
------------------------------------------------------------------------
36 Guideline for     July 18,     Do.            Do.
 Efficacy Evaluation of        1985
 Canine/Feline Anthelmintics
------------------------------------------------------------------------
35 Bioequivalence    Revised      Do.            Do.
 Guideline                     October 9,
                               2002
------------------------------------------------------------------------
33 Target Animal     June 1989    Do.            Do.
 Safety Guidelines for New
 Animal Drugs
------------------------------------------------------------------------
31 Guidelines for    July 1981    Do.            Do.
 the Evaluation of Bovine
 Anthelmintics
------------------------------------------------------------------------
29 Guidelines for    September    Do.            Do.
 the Effectiveness             30, 1980
 Evaluation of Swine
 Anthelmintics
------------------------------------------------------------------------
28 Animal Drug       December 3,  Do.            Do.
 Applications Expedited        1997
 Review Guideline (see
 Policy and Procedures Guide
 1240.3135)
------------------------------------------------------------------------
27 New Animal Drug   July 1989    Do.            Do.
 Determination (see Policy
 and Procedures Guide
 1240.3500)
------------------------------------------------------------------------
24 Guideline for     October      Do.            Do.
 Drug Combinations for Use     1983
 in Animals
------------------------------------------------------------------------
23 Medicated Free-   July 1,      Do.            Do.
 Choice Feeds-Manufacturing    1985
 Controls
------------------------------------------------------------------------
22 Labeling of       ...........  Do.            Do.
 Arecoline Base Drugs
 Intended for Animal Use
------------------------------------------------------------------------
21 Nutritional       March 1993   Do.            Do.
 Ingredients in Animal Drugs
 and Feeds (see Policy and
 Procedures Guide 1240.3420)
------------------------------------------------------------------------
16 Freedom of        May 10,      Do.            Do.
 Information Summary           1985
 Guidelines
------------------------------------------------------------------------
13 Guidelines for    January      Do.            Do.
 Evaluation and                1985
 Effectiveness of New Animal
 Drugs for Use in Free-
 Choice Feeds (revision of
 The Cattle Medicated Block
 Guideline)
------------------------------------------------------------------------
10 Amendment of      October      Do.            Do.
 Section II(G)(1)(b)(4) of     1975
 the Preclearance Guidelines
------------------------------------------------------------------------
9 Preclearance       Withdrawn    Do.            Do.
 Guidelines for Production     pending
 Drugs                         revisions
------------------------------------------------------------------------
6 Guideline for      October 20,  Do.            Do.
 Submitting NADAs for          1971;
 Generic Drugs Reviewed by     revised
 NAS/NRC                       March 19,
                               1976
------------------------------------------------------------------------
5 Drug Stability     December 1,  Do.            Do.
 Guidelines                    1990
------------------------------------------------------------------------

[[Page 906]]

 
3 General            July 1994    Do.            Do.
 Principles for Evaluating
 the Safety of Compounds
 Used in Food-Producing
 Animals (revised) (see
 guidance 118 for
 update to Section V.B.1)
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
WITHDRAWN DOCUMENTS
------------------------------------------------------------------------
58 Guidance for      May 1997     N/A            N/A
 Industry; Good Target
 Animal Study Practices:
 Clinical Investigators and
 Monitors
------------------------------------------------------------------------
155 Guidance for     March 1997/  Do.            Do.
 Industry; 21 CFR Part 11;     February
 Electronic Records;           2003
 Electronic Signatures,
 Electronic Copies of
 Electronic Records
------------------------------------------------------------------------
154 Draft Guidance   March 1997/  Do.            Do.
 for Industry on Part 11;      February
 Electronic Records,           2003
 Electronic Signatures--
 Scope and Application
------------------------------------------------------------------------
77 Interpretation    September    Do.            Do.
 of On-Farm Feed               1998/June
 Manufacturing and Mixing      2003
 Operations
------------------------------------------------------------------------
66 Professional      August 1998/ Do.            Do.
 Flexible Labeling of          January
 Antimicrobial Drugs           2002
20 Antibacterial     December     Do.            Do.
 Drugs in Animal Feeds:        2004
 Antibacterial Effectiveness
 Criteria
------------------------------------------------------------------------
19 Antibacterial     December     Do.            Do.
 Drugs in Animal Feeds:        2004
 Animal Health Safety
 Criteria
------------------------------------------------------------------------
18 Antibacterial     December     Do.            Do.
 Drugs in Animal Feeds:        2004
 Human Health Safety
 Criteria
------------------------------------------------------------------------
15 Guideline for     February     Do.            Do.
 Reporting the Details of      1977/
 Clinical Trials Using an      December
 Investigational New Animal    2004
 Drug in Non-Food Producing
 Animals
------------------------------------------------------------------------
14 Guideline for     December     Do.            Do.
 Reporting the Details of      2004
 Clinical Trials Using an
 Investigational New Animal
 Drug in Food-Producing
 Animals
------------------------------------------------------------------------
4 Guideline for      December     Do.            Do.
 Efficacy Studies for          2004
 Systemic Sustained Release
 Sulfonamide Boluses for
 Cattle
------------------------------------------------------------------------
2 Anthelmintics      December     Do.            Do.
                               2004
------------------------------------------------------------------------


   Guidance Documents Issued by the Office of the Commissioner and the
                            Office of Policy
------------------------------------------------------------------------
                                         Intended
                             Date of     User or    How to Obtain a Copy
     Name of Document        Issuance   Regulatory     of the Document
                                         Activity
------------------------------------------------------------------------
FDA Information Sheets for  September  Regulated    Internet via http://
 Institutional Review        1998       industry     www.fda.gov/oc/ohrt/
 Boards and Clinical                                 irbs/default.htm or
 Investigators                                       Good Clinical
                                                     Practice Programs
                                                     (HF-34), Food and
                                                     Drug
                                                     Administration,
                                                     5600 Fishers Lane,
                                                     rm. 9C-24,
                                                     Rockville, MD
                                                     20857, 301-827-
                                                     3340, http://www.fda.gov/oc/gcp/guidance.html
------------------------------------------------------------------------
Guidance for Industry;      April      Do.          Internet via http://
 Computerized Systems Used   1999                    www.fda.gov/ora/
 in Clinical Trials                                  compliance--ref/
                                                     bimo/ffinalcct.pdf
                                                     or Good Clinical
                                                     Practice Programs
                                                     (HF-34), Food and
                                                     Drug
                                                     Administration,
                                                     5600 Fishers Lane,
                                                     rm. 9C-24,
                                                     Rockville, MD
                                                     20857, 301-827-
                                                     3340, http://
                                                     www.fda.gov/oc/gcp/
                                                     guidance.htm
------------------------------------------------------------------------
Draft Guidance for          March 30,  Do.          Internet via http://
 Institutional Review        2000                    www.fda.gov/ora/
 Boards, Clinical                                    compliance--ref/
 Investigators, and                                  bimo/err--guide.htm
 Sponsors: Exceptions From                           or Good Clinical
 Informed Consent                                    Practice Programs
 Requirements for                                    (HF-34), Food and
 Emergency Research                                  Drug
                                                     Administration,
                                                     5600 Fishers Lane,
                                                     rm. 9C-24,
                                                     Rockville, MD
                                                     20857, 301-827-3340
------------------------------------------------------------------------

[[Page 907]]

 
Draft Guidance for          February   Do.          Internet via http://
 Industry on Exports and     1998                    www.fda.gov/opacom/
 Imports Under the FDA                               fedregister/
 Export Reform and                                   frexport.html
 Enhancement Act of 1996
------------------------------------------------------------------------
Guidance for FDA and        November   FDA          Internet via http://
 Industry: Direct Final      21, 1997   personnel    www.fda.gov/opacom/
 Rule Procedures                                     morechoices/
                                                     industry/
                                                     guidance.htm, or
                                                     Office of Policy,
                                                     301-827-3360
------------------------------------------------------------------------
International               October    Regulated    60 FR 53078, October
 Harmonization; Policy on    11, 1995   industry     11, 1995; or Office
 Standards                              and FDA      of International
                                        personnel    Programs, 301-827-
                                                     4480
------------------------------------------------------------------------


                                        Guidance Documents Issued by ORA
----------------------------------------------------------------------------------------------------------------
                                                 Intended User or       How to Obtain a Copy of the Document
      Name of Document        Date of Issuance      Regulatory     ---------------------------------------------
                                                     Activity         Mailing Address        Internet Address
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guides      Updated December  FDA staff           National Technical   http://www.fda.gov/ora/
 Manual (replaces Compliance   12, 2003                              Information          cpgm
 Policy Guide--January 1996)                                         Service, 5285 Port
                                                                     Royal Rd.,
                                                                     Springfield, VA
                                                                     22161
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide,      April 2001        Do.                 Division of          http://www.fda.gov/ora/
 Section 615.115: Extra-                                             Compliance Policy   compliance--ref/
 Label Use of Medicated                                              (HFC-230), Office    revisions.htm
 Feeds for Minor Species                                             of Enforcement,
                                                                     Food and Drug
                                                                     Administration,
                                                                     5600 Fishers Lane,
                                                                     Rockville, MD
                                                                     20857, 301-827-
                                                                     0420
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide,      July 2003         Do.                 Do.                  Do.
 Section 608.400:
 Compounding of Drugs for
 Use in Animals
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide,      November 14,      Do.                 Do.                  Do.
 Section 555.600: Filth From   2002
 Insects, Rodents, and Other
 Pests in Foods
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide,      May 29, 2002      Do.                 Do.                  Do.
 Section 460.200: Pharmacy
 Compounding
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide,      May 16, 2002      Do.                 Do.                  Do.
 Section 575.100: Pesticide
 Residues in Food and Feed--
 Enforcement Criteria (CPG
 7141.01) (revised)
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide,      May 7, 2002       Do.                 Do.                  Do.
 Section 230.150: Blood
 Donor Classification
 Statement, Paid or
 Volunteer Donor
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide,      October 2001      Do.                 Do.                  Do.
 Section 510.150: Apple
 Juice, Apple Juice
 Concentrates, and Apple
 Juice Products--
 Adulteration With Patulin
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide,      April 2001        Do.                 Do.                  Do.
 Section 555.250: Statement
 of Policy for Labeling and
 Preventing Cross-Contact of
 Common Food Allergens
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide,      Reformatted       Do.                 Do.                  http://www.fda.gov/ora/
 Section 220.100: Interstate   March 2001                                                compliance--ref/cpg/
 Shipment of Biological
 Products for Use in Medical
 Emergencies
----------------------------------------------------------------------------------------------------------------

[[Page 908]]

 
Compliance Policy Guide,      Reformatted       Do.                 Do.                  Do.
 Section 270.100: Final        March 2001
 Container Labels--
 Allergenic Extracts
 Containing Glycerin;
 Reporting Changes
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide,      December 2000     Do.                 Do.                  Do.
 Section 230.150: Blood
 Donor Incentives; Draft
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide,      July 1991         FDA staff and       Do.                  http://www.fda.gov/ora/
 Section 7150.09: Fraud,                         regulated                               compliance--ref/cpg/
 Untrue Statements of                            industry                                 cpggenl/cpg120-
 Material Facts, Bribery,                                                                100.html
 and Illegal Gratuities
----------------------------------------------------------------------------------------------------------------
Glossary of Computerized      August 1995       Do.                 National Technical   http://www.fda.gov/ora/
 System and Software                                                 Information          inspect--ref/igs/
 Development Terminology                                             Service, 5285 Port   gloss.html
                                                                     Royal Rd.,
                                                                     Springfield, VA
                                                                     22161 (NTIS Order
                                                                     No. PB96-127352)
----------------------------------------------------------------------------------------------------------------
Guidelines for Entry Review   March 12, 1999    FDA staff           Division of Import   N/A
 of Radiation-Emitting                                               Operations and
 Electronic Devices                                                  Policy (HFC-170),
                                                                     Office of Regional
                                                                     Operations, Food
                                                                     and Drug
                                                                     Administration,
                                                                     5600 Fishers Lane,
                                                                     Rockville, MD
                                                                     20857, 301-594-
                                                                     1218
----------------------------------------------------------------------------------------------------------------
Laboratory Procedures Manual  June 1994         Do.                 Division of Field    http://www.fda.gov/ora/
                                                                     Science (HFC-141),   science--ref/
                                                                     Food and Drug
                                                                     Administration,
                                                                     5600 Fishers Lane,
                                                                     rm. 12-41,
                                                                     Rockville, MD
                                                                     20857
----------------------------------------------------------------------------------------------------------------
Laboratory Procedures         May 1999          Do.                 Do.                  Do.
 Manual; ch. 10: Method
 Validation Samples
----------------------------------------------------------------------------------------------------------------
Memorandum: ORA               May 15, 2000      Do.                 Division of Field    N/A
 Investigational Strategy on                                         Investigations,
 Gamma-Butyrolactone (GBL)                                           Office of Regional
 and Related Products                                                Operations, Food
                                                                     and Drug
                                                                     Administration,
                                                                     5600 Fishers Lane,
                                                                     Rockville, MD
                                                                     20857
----------------------------------------------------------------------------------------------------------------
IOM: Investigations           March 2004        Do.                 National Technical   http://www.fda.gov/ora/
 Operations Manual                                                   Information          inspect--ref/
                                                                     Service, 5285 Port
                                                                     Royal Rd.,
                                                                     Springfield, VA
                                                                     22161 (NTIS Order
                                                                     No. PB2001-913399)
----------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual  March 2004        Do.                 Do (NTIS Order No.   http://www.fda.gov/ora/
                                                                     PB97-196182)        compliance--ref/rpm/
                                                                                          default.htm
----------------------------------------------------------------------------------------------------------------
Regulatory Procedures         March 2004        Do.                 Division of          Do.
 Manual; ch. 5-7-10: Civil                                           Compliance Policy
 Money Penalty Reduction                                             (HFC-230), Office
 Policy for Small Entities                                           of Enforcement,
                                                                     Food and Drug
                                                                     Administration,
                                                                     5600 Fishers Lane,
                                                                     Rockville, MD
                                                                     20857, 301-827-
                                                                     0420
----------------------------------------------------------------------------------------------------------------
Regulatory Procedures         March 2004        Do.                 Do.                  Do.
 Manual; ch. 10-9:
 Application Integrity
 Policy
----------------------------------------------------------------------------------------------------------------

[[Page 909]]

 
Regulatory Procedures         September 2002    Do.                 Do.                  Do.
 Manual; ch. 9: Import
 Operations/Actions
----------------------------------------------------------------------------------------------------------------
Regulatory Procedures         March 2004        Do.                 Do.                  Do.
 Manual; ch. 6-1: Seizure
----------------------------------------------------------------------------------------------------------------
Regulatory Procedures         March 2004        Do.                 Do.                  Do.
 Manual; ch. 6-6: Civil
 Penalties--Electronic
 Product Radiation Control
----------------------------------------------------------------------------------------------------------------
Regulatory Procedures         March 2004        Do.                 Do.                  http://www.fda.gov/ora/
 Manual; ch. 4-1: Warning                                                                compliance--ref/rpm--
 Letters                                                                                  new2/ch4.html
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of Bulk  May 1994          Do.                 National Technical   http://www.fda.gov/ora/
 Pharmaceutical Chemicals                                            Information          inspect--ref/igs/
                                                                     Service, 5285 Port   iglist.html
                                                                     Royal Rd.,
                                                                     Springfield, VA
                                                                     22161 (NTIS Order
                                                                     No. PB96-127154)
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of       July 1993         Do.                 Do (NTIS Order No.   Do.
 Pharmaceutical Quality                                              PB96-127279)
 Control Laboratories
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of       July 1993         Do.                 Do (NTIS Order No.   Do.
 Microbiological                                                     PB96-127287)
 Pharmaceutical Quality
 Control Laboratories
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of       July 1993         Do.                 Do (NTIS Order No.   Do.
 Validation of Cleaning                                              PB96-127246)
 Processes
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of       July 1993         Do.                 Do (NTIS Order No.   Do.
 Lyophilization of                                                   PB96-127253)
 Parenterals
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of High  July 1993         Do.                 Do (NTIS Order No.   Do.
 Purity Water Systems                                                PB96-127261)
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of       October 1993      Do.                 Do (NTIS Order No.   Do.
 Dosage Form Drug                                                    PB96-127212)
 Manufacturers--CGMPs
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of Oral  January 1994      Do.                 Do (NTIS Order No.   Do.
 Solid Dosage Forms Pre/Post                                         PB96-127345)
 Approval Issues for
 Development and Validation
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of       July 1994         Do.                 Do (NTIS Order No.   Do.
 Topical Drug Products                                               PB96-127394)
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of       July 1994         Do.                 Do (NTIS Order No.   Do.
 Sterile Drug Substance                                              PB96-127295)
 Manufacturers
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of Oral  August 1994       Do.                 Do (NTIS Order No.   Do.
 Solutions and Suspensions                                           PB96-127147)
----------------------------------------------------------------------------------------------------------------
Guide to Nutritional          February 1995     Do.                 Do (NTIS Order No.   Do.
 Labeling and Education Act                                          PB96-127378)
 (NLEA) Requirements
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of       April 1995        Do.                 Do (NTIS Order No.   Do.
 Interstate Carriers and                                             PB96-127386)
 Support Facilities
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of       April 1995        Do.                 Do (NTIS Order No.   Do.
 Dairy Product Manufacturers                                         PB96-127329)
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of       May 1995          Do.                 Do (NTIS Order No.   Do.
 Manufacturers of                                                    PB97-127220)
 Miscellaneous Foods--vol. 1
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of       September 1996    Do.                 Do (NTIS Order No.   Do.
 Manufacturers of                                                    PB97-196133)
 Miscellaneous Food
 Products--vol. 2
----------------------------------------------------------------------------------------------------------------

[[Page 910]]

 
Guide to Inspections of       February 1995     Do.                 Do (NTIS Order No.   Do.
 Cosmetic Product                                                    PB96-127238)
 Manufacturers
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of Low   November 1996     Do.                 Do (NTIS Order No.   Do.
 Acid Canned Food                                                    PB97-196141)
 Manufacturers, Part 1--
 Administrative Procedures/
 Scheduled Processes
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of Low   April 1997        Do.                 Do (NTIS Order No.   Do.
 Acid Canned Food                                                    PB97-196158)
 Manufacturers, Part 2--
 Manufacturing Processes/
 Procedures
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of Low   November 1998     FDA staff           Do (NTIS Order No.   N/A
 Acid Canned Food                                                    PB00-133795)
 Manufacturers, Part 3--
 Container/Closures
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of       September 1994    Do.                 Do (NTIS Order No.   http://www.fda.gov/ora/
 Blood Banks                                                         PB96-127303)         inspect--ref/igs/
                                                                                          iglist.html
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of       Revised April     Do.                 N/A                  Do.
 Source Plasma                 2001
 Establishments
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of       October 1996      Do.                 National Technical   Do.
 Infectious Disease Marker                                           Information
 Testing Facilities                                                  Service, 5285 Port
                                                                     Royal Rd.,
                                                                     Springfield, VA
                                                                     22161 (NTIS Order
                                                                     No. PB96-199476)
----------------------------------------------------------------------------------------------------------------
Biotechnology Inspection      November 1991     Do.                 Do (NTIS Order No.   Do.
 Guide Reference Materials                                           PB96-127402)
 and Training Aids
----------------------------------------------------------------------------------------------------------------
Guide to Inspection of        February 1983     Do.                 Do (NTIS Order No.   Do.
 Computerized Systems in                                             PB96-127337)
 Drug Processing
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of       September 1995    Do.                 Do (NTIS Order No.   Do.
 Foreign Medical Device                                              PB96-127311)
 Manufacturers
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of       May 1996          Do.                 Do (NTIS Order No.   Do.
 Foreign Pharmaceutical                                              PB96-199468)
 Manufacturers
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of       December 1997     Do.                 Do (NTIS Order No.   Do.
 Medical Device                                                      PB 98-127145 )
 Manufacturers
----------------------------------------------------------------------------------------------------------------
Mammography Quality           January 1998      Do.                 Do (NTIS Order No.   Do.
 Standards Act (MQSA)                                                PB98-127178)
 Auditor's Guide
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of       December 1997     Do.                 Do (NTIS Order No.   Do.
 Electromagnetic                                                     PB98-127152)
 Compatibility Aspects of
 Medical Device Quality
 Systems
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of       May 1998          Do.                 N/A                  Do.
 Acidified Food
 Manufacturers
----------------------------------------------------------------------------------------------------------------
Guide to Inspection of        February 2001     Do.                 Division of Field    N/A
 Aseptic Processing and                                              Investigations,
 Packaging for the Food                                              Office of Regional
 Industry                                                            Operations, Food
                                                                     and Drug
                                                                     Administration,
                                                                     5600 Fishers Lane,
                                                                     Rockville, MD
                                                                     20857
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of       July 2003         Do.                 Do (NTIS Order No.   Do.
 Grain Product Manufacturers                                         PB98-137128)
----------------------------------------------------------------------------------------------------------------
Guide to Bioresearch          February 1998     Do.                 Do (NTIS Order No.   Do.
 Monitoring Inspections of                                           PB98-137151)
 In Vitro Diagnostic Devices
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of       March 1998        Do.                 Do (NTIS Order No.   Do.
 Viral Clearance Processes                                           PB-98137144)
 for Plasma Derivatives
----------------------------------------------------------------------------------------------------------------

[[Page 911]]

 
Guide to Traceback of Fresh   April 2001        Do.                 N/A                  Do.
 Fruits and Vegetables
 Implicated in
 Epidemiological
 Investigations
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of       August 1998       Do.                 National Technical   Do.
 Computerized Systems in the                                         Information
 Food Processing Industry                                            Service, 5285 Port
                                                                     Royal Rd.,
                                                                     Springfield, VA
                                                                     22161 (NTIS Order
                                                                     No. PB98-137136)
----------------------------------------------------------------------------------------------------------------
Guide to International        November 2002     Do.                 N/A                  http://www.fda.gov/ora/
 Inspections and Travel                                                                   inspect--ref/giit/
 (revision) (formerly FDA/                                                               default.htm
 ORA International
 Inspection Manual and
 Travel Guide)
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of       August 1999       Do.                 N/A                  http://www.fda.gov/ora/
 Quality Systems                                                                          inspect--ref/igs/qsit/
                                                                                          QSITGUIDE.PDF
----------------------------------------------------------------------------------------------------------------
Guide to Inspection of Firms  August 2001       Do.                 N/A                  http://www.fda.gov/ora/
 Producing Food Products                                                                  inspect--ref/igs/
 Susceptible to                                                                           iglist.html
 Contamination With
 Allergenic Ingredients
----------------------------------------------------------------------------------------------------------------
Computerized Systems Used in  April 1999        Do.                 N/A                  http://www.fda.gov/ora/
 Clinical Trials                                                                         compliance--ref/bimo/
----------------------------------------------------------------------------------------------------------------
Compliance Program 7348.001:  October 1, 1999   Do.                 Division of          Do.
 Bioresearch Monitoring,                                             Compliance Policy
 Human Drugs, In Vivo                                                (HFC-230), Office
 Bioequivalence                                                      of Enforcement,
                                                                     Food and Drug
                                                                     Administration,
                                                                     5600 Fishers Lane,
                                                                     Rockville, MD
                                                                     20857, 301-827-
                                                                     0420
----------------------------------------------------------------------------------------------------------------
Guide for Detecting Fraud in  April 2003        Do.                 Division of Freedom  N/A
 Bioresearch Monitoring                                              of Information
 Inspections                                                         (HFI-35), Food and
                                                                     Drug
                                                                     Administration,
                                                                     5600 Fishers Lane,
                                                                     Rockville, MD
                                                                     20857
----------------------------------------------------------------------------------------------------------------
Good Laboratory Practice      October 1, 2000   Do.                 Division of          http://www.fda.gov/ora/
 Program 7348.808A                                                   Compliance Policy   compliance--ref/bimo/
 (Nonclinical Laboratories);                                         (HFC-230), Office
 EPA Data Audit Inspections                                          of Enforcement,
                                                                     Food and Drug
                                                                     Administration,
                                                                     5600 Fishers Lane,
                                                                     Rockville, MD
                                                                     20857, 301-827-
                                                                     0420
----------------------------------------------------------------------------------------------------------------
Guideline for the Monitoring  January 1988      FDA regulated       Do.                  Do.
 of Clinical Investigations                      industry
----------------------------------------------------------------------------------------------------------------
Small Business Guide to FDA   Revised March     Do.                 Federal-State        http://www.fda.gov/ora/
                               31, 2004                              Relations (HFC-      fed--state/small--
                                                                     150), Office of      business/sb--guide/
                                                                     Regulatory           default.htm
                                                                     Affairs, Food and
                                                                     Drug
                                                                     Administration,
                                                                     5600 Fishers Lane,
                                                                     Rockville, MD
                                                                     20857, 301-827-
                                                                     2905
----------------------------------------------------------------------------------------------------------------
Compliance Program 7348.808;  Revised February  FDA staff           Division of          http://www.fda.gov/ora/
 Bioresearch Monitoring,       21, 2001                              Compliance Policy   compliance--ref/bimo/
 Good Laboratory Practice                                            (HFC-230), Office
 (Nonclinical Laboratories)                                          of Enforcement,
                                                                     Food and Drug
                                                                     Administration,
                                                                     5600 Fishers Lane,
                                                                     Rockville, MD
                                                                     20857, 301-827-
                                                                     0420
----------------------------------------------------------------------------------------------------------------

[[Page 912]]

 
Compliance Program 7348.809;  October 1, 1994   Do.                 Do.                  Do.
 Bioresearch Monitoring;
 Institutional Review Board
----------------------------------------------------------------------------------------------------------------
Compliance Program 7348.811;  October 1, 1997   Do.                 Do.                  Do.
 Bioresearch Monitoring,
 Clinical Investigators
----------------------------------------------------------------------------------------------------------------
Good Laboratory Practice      August 1979       Do.                 Do.                  Do.
 Regulations; Management
 Briefings; Post Conference
 Report
----------------------------------------------------------------------------------------------------------------
Good Laboratory Practices;    June 1981         Do.                 Do.                  Do.
 Questions and Answers
----------------------------------------------------------------------------------------------------------------
 Guidance for FDA Staff on    April 4, 2003     FDA staff           N/A                  http://www.fda.gov/
 Sampling or Detention                                                                    ohrms/dockets/98fr/03-
 Without Physical                                                                         8315.pdf
 Examination of Decorative
 Contact Lenses (Import
 Alert 86-10)
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide;      March 29, 2002    FDA staff and       Division of          http://www.fda.gov/ora/
 Section 345.100: Male                           industry            Compliance Policy   compliance--ref/cpg/
 Condom Defects (CPG                                                 (HFC-230), Office
 7124.21); Draft                                                     of Enforcement,
                                                                     Food and Drug
                                                                     Administration,
                                                                     5600 Fishers Lane,
                                                                     Rockville, MD
                                                                     20857, 301-827-
                                                                     0420
----------------------------------------------------------------------------------------------------------------
PTC for Internal Reviews and  June 1991         Do.                 N/A                  http://www.fda.gov/ora/
 Corrective Action Operating                                                             compliance--ref/aip--
 Plans                                                                                    points.html
----------------------------------------------------------------------------------------------------------------
WITHDRAWALS
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide--     June 15, 1976     FDA staff and                            N/A
 Section 305.100:                                industry
 Acupuncture Devices and
 Accessories (CPG 7124.11)
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide--     October 1, 1980   Do.                                      Do.
 Section 396.100:
 Applicability of the
 Sunlamp Performance
 Standard to UVA Tanning
 Products (CPG 7133.16)
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide--     October 1, 1980   Do.                                      Do.
 Section 391.100:
 Advertisement Literature
 for High-Intensity Mercury
 Vapor Discharge Lamps (CPG
 7133.13)
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide--     April 26, 1976    Do.                                      Do.
 Section 315.200: Status of
 Dental Supplies Such As
 Denture Cleaners,
 Adhesives, Cushions, and
 Repair Materials as a
 Device or Cosmetic (CPG
 7124.05)
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide--     October 1, 1980   Do.                                      Do.
 Section 398.475: Minimum X-
 Ray Field Size for Spot-
 Film Operation of
 Fluoroscopic Systems With
 Fixed SID and Without
 Stepless Adjustment of the
 Field Size (CPG 7133.17)
----------------------------------------------------------------------------------------------------------------
Medical Device Warning        March 8, 1999     Do.                                      Do.
 Letter Pilot Termination
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide--     May 13, 1999      Do.                                      Do.
 Section 160.850:
 Enforcement Policy: 21 CFR
 Part 11; Electronic
 Records; Electronic
 Signatures (CPG 7153.17)
----------------------------------------------------------------------------------------------------------------
Draft Guidance--21 CFR Part   August 2002       Do.                                      Do.
 11; Electronic Records;
 Electronic Signatures,
 Electronic Copies of
 Electronic Records
----------------------------------------------------------------------------------------------------------------

[[Page 913]]

 
Draft Guidance--21 CFR Part   August 2001       Do.                                      Do.
 11; Electronic Records;
 Electronic Signatures
 Validation
----------------------------------------------------------------------------------------------------------------
Draft Guidance--21 CFR Part   August 2001       Do.                                      Do.
 11; Electronic Records;
 Electronic Signatures,
 Glossary of Terms
----------------------------------------------------------------------------------------------------------------
Draft Guidance--21 CFR Part   February 2002     Do.                                      Do.
 11; Electronic Records;
 Electronic Signatures, Time
 Stamps
----------------------------------------------------------------------------------------------------------------
Draft Guidance--21 CFR Part   July 2002         Do.                                      Do.
 11; Electronic Records;
 Electronic Signatures,
 Maintenance of Electronic
 Records
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide--     February 26,      Do.                                      Do.
 Section 300.700: Direct       1991
 Reference Authority for
 Class III Medical Devices
 Without a Premarket
 Notification (510(k)) or an
 Approved Premarket Approval
 Application (PMA) (CPG
 7124.30)
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide--     October 1, 1980   Do.                                      Do.
 Section 405.100:
 Prescriptions Prepared From
 Certified Antibiotics (CPG
 7122.01)
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide--     October 1, 1980   Do.                                      Do.
 Section 405.200: Export of
 Uncertified Antibiotics
 (CPG 7122.02)
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide--     July 1, 1981      Do.                                      Do.
 Section 405.210: Returned
 Antibiotics Exported Under
 801(d) of the Act (CPG
 7122.03)
----------------------------------------------------------------------------------------------------------------
Draft Compliance Policy       August 28, 1997   Do.                                      Do.
 Guide--Distributor Medical
 Device Reporting
----------------------------------------------------------------------------------------------------------------


    Dated: December 22, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-155 Filed 1-4-05; 8:45 am]
BILLING CODE 4160-01-S