[Federal Register: July 9, 2004 (Volume 69, Number 131)]
[Notices]               
[Page 41510-41540]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jy04-100]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0234]

 
Annual Guidance Agenda

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing its 
annual guidance document agenda. FDA committed to publishing, on an 
annual basis, a list of possible topics for future guidance document 
development or revision during the next year, and seeking public 
comment on additional ideas for new guidance documents or revisions of 
existing ones. This commitment was made in FDA's September 2000 good 
guidance practices (GGPs) final rule, which sets forth the agency's 
policies and procedures for the development, issuance, and use of 
guidance documents. This list is intended to seek public comment on 
possible topics for guidance documents and possible revisions to 
existing guidances.

DATES: Submit written or electronic 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
.


FOR FURTHER INFORMATION CONTACT:
    For general information regarding this list contact: Diane 
Sullivan, Office of Policy (HF-26), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-3480.
    For information regarding specific topics or guidances: Please see 
contact persons listed in the table in the SUPPLEMENTARY INFORMATION 
section.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 19, 2000 (65 FR 56468), FDA 
published a final rule announcing its GGPs, which set forth the 
agency's policies and procedures for the development, issuance, and use 
of guidance documents. The agency adopted the GGPs to ensure public 
involvement in the development of guidance documents and to enhance 
public understanding of the availability, nature, and legal effect of 
such guidance.
    As part of FDA's effort to ensure meaningful interaction with the 
public regarding guidance documents, the agency committed to publishing 
an annual guidance document agenda of possible guidance topics or 
documents for development or revision during the coming year. The 
agency also committed to soliciting public input regarding these and 
additional ideas for new topics or revisions to existing guidance 
documents (65 FR 56468 at 56477, 21 CFR 10.115(f)(5)).
    The agency is neither bound by this list of possible topics nor 
required to issue every guidance document on this list or precluded 
from issuing guidance documents not on the list set forth in this 
document.
    The following list of guidance topics or documents represents 
possible new topics or revisions to existing guidance documents that 
the agency is considering. The agency solicits comments on the topics 
listed in this document and also seeks additional ideas from the 
public.
    The guidance documents are organized by the issuing center or 
office within FDA, and are further grouped by topic categories. The 
agency's contact persons are listed for each specific area in the 
table.

----------------------------------------------------------------------------------------------------------------
                       Title/Topic of Guidance                                          Contact
----------------------------------------------------------------------------------------------------------------
                             II. CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)

CATEGORY--COMPLIANCE AND INSPECTION
================================================================================================================
  Reprocessing, Reworking, and Blending of Biological Drug            Stephen M. Ripley, Center for Biologics
   Substances and Drug Products                                        Evaluation and Research (HFM-17), Food
                                                                       and Drug Administration, 1401 Rockville
                                                                       Pike, Rockville, MD 20852-1448, 301-827-
                                                                       6210.
----------------------------------------------------------------------------------------------------------------

[[Page 41511]]


  Design, Installation and Operation of Heating, Ventilation and Air  Same as above (Do)
   Conditioning Systems Used in the Manufacture of Products
   Regulated by the Center for Biologics Evaluation and Research and
   the Center for Drug Evaluation and Research
----------------------------------------------------------------------------------------------------------------
  Compliance Program 7341.002--Inspection of Tissue Establishments    Do
----------------------------------------------------------------------------------------------------------------
  Compliance Program 7342.001--Inspection of Licensed and Unlicensed  Do
   Blood Banks, Brokers, Reference Laboratories, and Contractors
----------------------------------------------------------------------------------------------------------------
  Compliance Program 7342.002--Inspection of Source Plasma            Do
   Establishments
----------------------------------------------------------------------------------------------------------------
  Compliance Program 7342.008--Inspections of Licensed Viral Marker   Do
   Test Kits
----------------------------------------------------------------------------------------------------------------
  Compliance Program 7345.001--Inspection of Center for Biologics     Do
   Evaluation and Research-Regulated Biological Drug Products
================================================================================================================
CATEGORY--CELLULAR, TISSUE, AND GENE THERAPY
================================================================================================================
  Submission of Information for the National Xenotransplantation      Do
   Database
----------------------------------------------------------------------------------------------------------------
  Guidance for Reviewers: Instructions and Template for Chemistry,    Do
   Manufacturing, and Controls Reviewers of Human Gene Therapy
   Investigational New Drug Applications
----------------------------------------------------------------------------------------------------------------
  Submission of Information for Adverse Event and Annual Reports for  Do
   Gene Therapy Investigational New Drug Applications
----------------------------------------------------------------------------------------------------------------
  Eligibility Determination for Donors of Human Cells, Tissue and     Do
   Cellular and Tissue-Based Products
================================================================================================================
CATEGORY--BLOOD AND BLOOD COMPONENTS
================================================================================================================
  Blood Establishment Software                                        Do
----------------------------------------------------------------------------------------------------------------
  Collection of Platelets, Pheresis Prepared by Automated Methods     Do
----------------------------------------------------------------------------------------------------------------
  Validation of the Computer Crossmatch                               Do
----------------------------------------------------------------------------------------------------------------
  Blood Contact Materials                                             Do
----------------------------------------------------------------------------------------------------------------
  Nucleic Acid Testing for Human Immunodeficiency Virus and           Do
   Hepatitis C Virus; Testing, Product Disposition, Donor Deferral
   and Re-entry
----------------------------------------------------------------------------------------------------------------
  Efficacy, Pharmokinetic, and Safety Studies to Support Marketing    Do
   of Immune Globulin Intravenous (Human) as a Replacement Therapy
   for Primary Humoral Immunodeficiency
----------------------------------------------------------------------------------------------------------------
  Guidance on the Content of Premarket Submissions for Center for     Do
   Biologics Evaluation and Research-Regulated Automated Instruments
   and Associated Software Systems for Donor Blood Collection and
   Screening
================================================================================================================
CATEGORY--VACCINES
================================================================================================================
  Characterization and Qualification of Cell Substances and Viral     Do
   Seeds Used to Produce Viral Vaccines
----------------------------------------------------------------------------------------------------------------
  Preclinical Toxicity Studies for Prophylactic Vaccines              Do
----------------------------------------------------------------------------------------------------------------
  Immunization Human Plasma Donors to Obtain Source Plasma for        Do
   Preparation of Specific Immune Globulins
----------------------------------------------------------------------------------------------------------------
  Content and Format of Chemistry, Manufacturing, and Controls        Do
   Information and Establishment Description Information for a
   Vaccine or Related Product
----------------------------------------------------------------------------------------------------------------
  Content and Format of Chemistry, Manufacturing, and Controls        Do
   Information and Establishment Description Information for an
   Allergenic Extract or Allergen Patch Test
================================================================================================================
CATEGORY--OTHER
================================================================================================================
  Providing Regulatory Submission in Electronic Format--Stability     Do
----------------------------------------------------------------------------------------------------------------
  Environmental Assessment/National Environmental Policy Act          Do
----------------------------------------------------------------------------------------------------------------
  Filing and Application When the Applicant Protests a Refusal to     Do
   File Action
----------------------------------------------------------------------------------------------------------------

[[Page 41512]]


  Multi-Product Manufacturing With Spore-Forming Microorganisms       Do
----------------------------------------------------------------------------------------------------------------
  Good Review Practices--Track IV                                     Do
----------------------------------------------------------------------------------------------------------------
  Submission of Chemistry, Manufacturing, and Controls and            Do
   Establishment Description Information for Human Plasma-Derived
   Biological Products, Animal Plasma or Serum-Derived Products
----------------------------------------------------------------------------------------------------------------
  Submission of Chemistry, Manufacturing, and Control Information     Do
   for a Therapeutic Recombinant Deoxyribonucleic Acid-Derived
   Product or a Monoclonal Antibody for In-Vivo Use

                                 III. CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

  Implementation of the Inspection by Accredited Persons Program      John F. Stigi, Center for Devices and
   Under the Medical Device User Fee and Modernization Act of 2002;    Radiological Health (HFZ-220), Food and
   Accreditation Criteria: Guidance for Industry, FDA Staff and        Drug Administration, 9200 Corporate
   Third Parties                                                       Blvd., Rockville, MD 20850, 301-443-0806
----------------------------------------------------------------------------------------------------------------
  Implementation of Third Party Programs Under the FDA Modernization  Do
   Act of 1997; Final Guidance for Staff, Industry, and Third
   Parties
----------------------------------------------------------------------------------------------------------------
  Mutual Recognition Agreement Between the European Union and the     Christine Nelson, Center for Devices and
   United States of America: Confidence Building Programme: Overview   Radiological Health (HFZ-220), Food and
   and Procedure; Medical Device Annex, Version 7, June 29, 2000;      Drug Administration, 9200 Corporate
   Draft                                                               Blvd., Rockville, MD 20850, 301-443-0806
----------------------------------------------------------------------------------------------------------------
  Regulation of Medical Devices; Background Information for           Ron Parr, Center for Devices and
   International Officials (Entire Document Available on Disk)         Radiological Health (HFZ-220), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-443-0806
----------------------------------------------------------------------------------------------------------------
  Guidance for Staff, Industry, and Third Parties: Third Party        John F. Stigi, Center for Devices and
   Programs Under the Sectoral Annex on Medical Devices to the         Radiological Health (HFZ-220), Food and
   Agreement on Mutual Recognition Between the United States of        Drug Administration, 9200 Corporate
   America and the European Community                                  Blvd., Rockville, MD 20850, 301-443-0806
----------------------------------------------------------------------------------------------------------------
  Medical Device Appeals and Complaints: A Guidance on Dispute        Do
   Resolution
----------------------------------------------------------------------------------------------------------------
  Overview of Food and Drug Administration Modernization Act of 1997  Do
   Medical Device Provisions (Food and Drug Administration
   Modernization Act)
----------------------------------------------------------------------------------------------------------------
  Medical Device Reporting for Manufacturers                          Do
----------------------------------------------------------------------------------------------------------------
  In Vitro Diagnostic Devices: Guidance for the Preparation of        Do
   Premarket Notification Submissions (FDA 97-4224)
----------------------------------------------------------------------------------------------------------------
  Medical Device Quality Systems Manual: A Small Entity Compliance    Do
   Guide
----------------------------------------------------------------------------------------------------------------
  Comparison Chart: 1996 Quality System Reg vs. 1978 Good             Do
   Manufacturing Practices Reg vs. ANSI/ISO/ASQC Q9001 and ISO/DI
   13485:1996 (Include 126)
----------------------------------------------------------------------------------------------------------------
  Premarket Notification: 510(k)--Regulatory Requirements for         Do
   Medical Devices (FDA 95-4158)
----------------------------------------------------------------------------------------------------------------
  Labeling--Regulatory Requirements for Medical Devices (FDA 89-      Paula G. Silberberg, Center for Devices
   4203)                                                               and Radiological Health (HFZ-230), Food
                                                                       and Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-1217
----------------------------------------------------------------------------------------------------------------
  Impact Resistant Lenses: Questions and Answers (FDA 87-4002)        Do
----------------------------------------------------------------------------------------------------------------
  Use of Symbols on Labels and in Labeling of In Vitro Diagnostic     Lily Ng, Center for Devices and
   Devices Intended for Professional Use (Draft)                       Radiological Health (HFZ-510), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-827-0885
----------------------------------------------------------------------------------------------------------------
  Frequently Asked Questions About the Reprocessing and Reuse of      Do
   Single-Use Devices by Third-Party and Hospital Reprocessors;
   Three Additional Questions
----------------------------------------------------------------------------------------------------------------
  Frequently Asked Questions About the Reprocessing and Reuse of      Paula G. Silberberg, Center for Devices
   Single-Use Devices by Third-Party and Hospital Reprocessors;        and Radiological Health (HFZ-230), Food
   Final Guidance for Industry and FDA Staff                           and Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-1217
----------------------------------------------------------------------------------------------------------------

[[Page 41513]]


  Guidance on Medical Device Patient Labeling; Final Guidance for     Do
   Industry and FDA Reviewers
----------------------------------------------------------------------------------------------------------------
  Center for Devices and Radiological Health Manual for the Good      Ron D. Kaye, Center for Devices and
   Guidance Practices Regulations; Final Guidance for FDA Staff        Radiological Health (HFZ-205), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-3265
----------------------------------------------------------------------------------------------------------------
  Medical Device Use--Safety: Incorporating Human Factors             Center for Devices and Radiological Health
   Engineering Into Risk Management; Guidance for Industry and FDA     (HFZ-230), Food and Drug Administration,
   Premarket and Design Control Reviewers                              9200 Corporate Blvd., Rockville, MD
                                                                       20850, 301-594-1217
----------------------------------------------------------------------------------------------------------------
  Human Factors Points to Consider for Investigational Device         Alvin W. Thomas, Center for Devices and
   Exemption Devices                                                   Radiological Health (HFZ-230), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-443-2436
----------------------------------------------------------------------------------------------------------------
  Do It By Design--An Introduction to Human Factors in Medical        Walter l. Scott, Center for Devices and
   Devices                                                             Radiological Health (HFZ-240), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-3266
----------------------------------------------------------------------------------------------------------------
  Medical Device Reporting for User Facilities                        Margaret T. Tolbert, Center for Devices
                                                                       and Radiological Health (HFZ-230), Food
                                                                       and Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-443-2436
----------------------------------------------------------------------------------------------------------------
  Human Factors Principles for Medical Device Labeling                Center for Devices and Radiological Health
                                                                       (HFZ-230), Food and Drug Administration,
                                                                       9200 Corporate Blvd., Rockville, MD
                                                                       20850, 301-594-1217
----------------------------------------------------------------------------------------------------------------
  Write It Right                                                      Charles A. Finder, Center for Devices and
                                                                       Radiological Health (HFZ-240), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-3332
----------------------------------------------------------------------------------------------------------------
  The Mammography Quality Standards Act Final Regulations             Do
   Modifications and Additions to Policy Guidance Help System < greek-
   i>8 (Incorporated into Policy Guidance Help Systems)
----------------------------------------------------------------------------------------------------------------
  The Mammography Quality Standards Act Final Regulations             Do
   Modifications and Additions to Policy Guidance Help System < greek-
   i>6; Guidance for Industry and FDA (Incorporated into Policy
   Guidance Help System)
----------------------------------------------------------------------------------------------------------------
  The Mammography Quality Standards Act Final Regulations             Do
   Modifications and Additions to Policy Guidance Help System < greek-
   i>7; Guidance for Industry and FDA (Incorporated into Policy
   Guidance Help System)
----------------------------------------------------------------------------------------------------------------
  The Mammography Quality Standards Act Final Regulations             Do
   Modifications and Additions to Policy Guidance Help System < greek-
   i>5; Guidance for Industry and FDA (Incorporated into Policy
   Guidance Help System)
----------------------------------------------------------------------------------------------------------------
  The Mammography Quality Standards Act Final Regulations             Do
   Modifications and Additions to Policy Guidance Help System < greek-
   i>4; Guidance for Industry and FDA (Incorporated into Policy
   Guidance Help System)
----------------------------------------------------------------------------------------------------------------
  Compliance Guidance--The Mammography Quality Standards Act Final    Do
   Regulations--Preparing for Mammography Quality Standards Act
   Inspections (Incorporated into Policy Guidance Help System)
----------------------------------------------------------------------------------------------------------------
  The Mammography Quality Standards Act Final Regulations             Do
   Modifications and Additions to Policy Guidance Help System < greek-
   i>3; Guidance for Industry and FDA (Incorporated into Policy
   Guidance Help System)
----------------------------------------------------------------------------------------------------------------
  The Mammography Quality Standards Act Final Regulations             Do
   Modifications to the Policy Guidance Help System Due to the
   September 11, 2001, Terrorist Attacks; Final Guidance for
   Industry and FDA (Incorporated into Policy Guidance Help System)
----------------------------------------------------------------------------------------------------------------
  The Mammography Quality Standards Act Final Regulations             Do
   Modifications and Additions to Policy Guidance Help System < greek-
   i>4; Guidance for Industry and FDA (Incorporated into Policy
   Guidance Help System)
----------------------------------------------------------------------------------------------------------------

[[Page 41514]]


  The Mammography Quality Standards Act Final Regulations;            Do
   Modifications and Additions to Policy Guidance Help System < greek-
   i>2; Final Guidance for Industry and FDA (Incorporated into
   Policy Guidance Help System)
----------------------------------------------------------------------------------------------------------------
  Compliance Guidance--Mammography Facility Survey, Equipment         Do
   Evaluation and Medical Physicist Qualification Requirements Under
   MQSA; Final (Incorporated into Policy Guidance Help System)
----------------------------------------------------------------------------------------------------------------
  Compliance Guidance: The Mammography Quality Standards Act Final    Do
   Regulations Document 3 (Incorporated into Policy
   Guidance Help System)
----------------------------------------------------------------------------------------------------------------
  The Mammography Quality Standards Act Final Regulations             Do
   Modifications to the Policy Guidance Help System 1;
   Guidance for Industry and FDA (Incorporated into Policy Guidance
   Help System)
----------------------------------------------------------------------------------------------------------------
  Compliance Guidance: The Mammography Quality Standards Act Final    Do
   Regulations Document 2 (Incorporated into Policy
   Guidance Help System)
----------------------------------------------------------------------------------------------------------------
  Compliance Guidance: The Mammography Quality Standards Act Final    Do
   Regulations Quality Assurance Documentation (Incorporated into
   Policy Guidance Help System)
----------------------------------------------------------------------------------------------------------------
  Guidance for Request and Issuance of Interim Notice Letters for     Do
   Mammography Facilities Under the Mammography Quality Standards
   Act (42 U.S.C. 263(b)) (Incorporated into Policy Guidance Help
   System)
----------------------------------------------------------------------------------------------------------------
  Compliance Guidance: The Mammography Quality Standards Act Final    Do
   Regulations Motion of Tube-Image Receptor Assembly (Incorporated
   into Policy Guidance Help System)
----------------------------------------------------------------------------------------------------------------
  Guidance: The Mammography Quality Standards Act Final Regulations   Do
   Document 1 (Incorporated into Policy Guidance Help
   System)
----------------------------------------------------------------------------------------------------------------
  Guidance for Industry--Requalification for Interpreting             Do
   Physician's Continuing Experience Requirement (Incorporated into
   Policy Guidance Help System)
----------------------------------------------------------------------------------------------------------------
  Policy and Standard Operating Procedures When Mammography           Do
   Facilities in States That Have Accreditation Bodies Intend to
   Change Accreditation Bodies (Incorporated into Policy Guidance
   Help System)
----------------------------------------------------------------------------------------------------------------
  Guidance for Review of Requests for Reconsideration of Adverse      Paula G. Silberberg, Center for Devices
   Decisions on Accreditation of Mammography Facilities Under the      and Radiological Health (HFZ-230), Food
   Mammography Quality Standards Act (42 U.S.C. 263(b)) (April 8,      and Drug Administration, 9200 Corporate
   1998) (Incorporated into Policy Guidance Help System)               Blvd., Rockville, MD 20850, 301-594-1217
----------------------------------------------------------------------------------------------------------------
  Guidance for Submission of Request for Reconsideration of Adverse   Do
   Decisions on Accreditation of Mammography Facilities Under the
   Mammography Quality Standards Acts (42 U.S.C. 263(b)) (April 8,
   1998) (Incorporated into Policy Guidance Help System)
----------------------------------------------------------------------------------------------------------------
  Continuing Education Credit for Reading/Writing Articles/Papers     Do
   and Presenting Courses/Lectures (Incorporated into the Policy
   Guidance Help System)
----------------------------------------------------------------------------------------------------------------
  Accidental Radioactive Contamination of Human Food and Animal       Thomas E. Cardamone, Center for Devices
   Feeds: Recommendations to State and Local Agencies                  and Radiological Health (HFZ-220), Food
                                                                       and Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-443-0806,
                                                                       ext. 117
================================================================================================================
Office of Device Evaluation
================================================================================================================
  Fiscal Year 2004 MDUFMA Small Business Qualification Worksheet and  Joanne R. Less, Center for Devices and
   Certification--Guidance for Industry and FDA                        Radiological Health (HFZ-403), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-1190
----------------------------------------------------------------------------------------------------------------
  Premarket Assessment of Pediatric Medical Devices--Draft Guidance   Heather S. Rosecrans, Center for Devices
   for Industry and FDA Staff                                          and Radiological Health (HFZ-230), Food
                                                                       and Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-1190
----------------------------------------------------------------------------------------------------------------
  Pediatric Expertise for Advisory Panels--Guidance for Industry and  Joanne R. Less, Center for Devices and
   FDA Staff                                                           Radiological Health (HFZ-403), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-1190
----------------------------------------------------------------------------------------------------------------

[[Page 41515]]


  Premarket Approval Application Filing Review--Guidance for          Center for Devices and Radiological Health
   Industry and FDA Staff                                              (HFZ-403), Food and Drug Administration,
                                                                       9200 Corporate Blvd., Rockville, MD
                                                                       20850, 301-594-1190
----------------------------------------------------------------------------------------------------------------
  Guidance for Industry and FDA: Fiscal Year 2003 MDUFMA Small        Do
   Business Qualification Worksheet and Certification
----------------------------------------------------------------------------------------------------------------
  Assessing User Fees: Premarket Approval Application Supplement      Do
   Definitions, Modular Premarket Approval Application Fees,
   Biologics License Application and Efficacy Supplement
   Definitions, Bundling Multiple Devices in a Single Application,
   and Fees for Combination Products
----------------------------------------------------------------------------------------------------------------
  Determination of Intended Use for 510(k) Devices; Guidance for      Do
   Center for Devices and Radiological Health Staff
----------------------------------------------------------------------------------------------------------------
  The Least Burdensome Provisions of the FDA Modernization Act of     Thninh Nguyen, Center for Devices and
   1997: Concept and Principles: Final Guidance for FDA and Industry   Radiological Health (HFZ-402), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-2186
----------------------------------------------------------------------------------------------------------------
  Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for  Robert R. Gatling, Center for Devices and
   Industry and FDA                                                    Radiological Health (HFZ-402), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-1190
----------------------------------------------------------------------------------------------------------------
  Availability of Information Given to Advisory Committee Members in  Nancy J. Pluhowski, Center for Devices and
   Connection With Center for Devices and Radiological Health Open     Radiological Health (HFZ-400), Food and
   Public Panel Meetings; Draft Guidance for Industry and FDA Staff    Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-2022
----------------------------------------------------------------------------------------------------------------
  Humanitarian Device Exemptions Regulation: Questions and Answers;   Heather S. Rosecrans, Center for Devices
   Final Guidance for Industry                                         and Radiological Health (HFZ-230), Food
                                                                       and Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-1190
----------------------------------------------------------------------------------------------------------------
  Changes or Modifications During the Conduct of a Clinical           Donna-Bea Tillman, Center for Devices and
   Investigation; Final Guidance for Industry and Center for Devices   Radiological Health (HFZ-400), Food and
   and Radiological Health Staff                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-2022
----------------------------------------------------------------------------------------------------------------
  Early Collaboration Meetings Under the FDA Modernization Act;       Do
   Final Guidance for Industry and for Center for Devices and
   Radiological Health Staff
----------------------------------------------------------------------------------------------------------------
  Deciding When to Submit a 510(k) for a Change to an Existing        Karen F. Warbuton, Center for Devices and
   Wireless Telemetry Medical Device; Final Guidance for FDA           Radiological Health (HFZ-460), Food and
   Reviewers and Industry                                              Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-1744
----------------------------------------------------------------------------------------------------------------
  Guidance on Section 216 of the Food and Drug Administration         Nicole Wolanski, Center for Devices and
   Modernization Act of 1997                                           Radiological Health (HFZ-402), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-2186
----------------------------------------------------------------------------------------------------------------
  Guidance on Amended Procedures for Advisory Panel Meetings; Final   Daniel G. Schultz, Center for Devices and
                                                                       Radiological Health (HFZ-400), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-2022
----------------------------------------------------------------------------------------------------------------
  Guidance on the Use of Standards in Substantial Equivalence         Heather S. Rosecrans, Center for Devices
   Determinations; Final                                               and Radiological Health (HFZ-230), Food
                                                                       and Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-1190
----------------------------------------------------------------------------------------------------------------
  Guidance for Off-the-Shelf Software Use in Medical Devices; Final   Joanna H. Weitershausen, Center for
                                                                       Devices and Radiological Health (HFZ-
                                                                       480), Food and Drug Administration, 9200
                                                                       Corporate Blvd., Rockville, MD 20850, 301-
                                                                       443-8611
----------------------------------------------------------------------------------------------------------------
  Medical Devices Containing Materials Derived From Animal Sources    Nicole Wolanski, Center for Devices and
   (Except In Vitro Diagnostic Devices), Guidance for FDA Reviewers    Radiological Health (HFZ-402), Food and
   and Industry; Final                                                 Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-2186
----------------------------------------------------------------------------------------------------------------

[[Page 41516]]


  Premarket Approval Application Modular Review                       Philip J. Phillips, Center for Devices and
                                                                       Radiological Health (HFZ-400), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-2022
----------------------------------------------------------------------------------------------------------------
  Guidance for Industry; General/Specific Intended Use; Final         Thninh Nguyen, Center for Devices and
                                                                       Radiological Health (HFZ-402), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-2186
----------------------------------------------------------------------------------------------------------------
  Frequently Asked Questions on the New 510(k) Paradigm; Final        Do
----------------------------------------------------------------------------------------------------------------
  Guidance for the Content of Premarket Submissions for Software      Do
   Contained in Medical Devices; Final
----------------------------------------------------------------------------------------------------------------
  Guidance to Industry Supplements to Approved Applications for       Do
   Class III Medical Devices: Use of Published Literature, Use of
   Previously Submitted Materials, and Priority Review; Final
----------------------------------------------------------------------------------------------------------------
  A New 510(k) Paradigm--Alternate Approaches to Demonstrating        Do
   Substantial Equivalence in Premarket Notifications
----------------------------------------------------------------------------------------------------------------
  Guidance for Industry and FDA Staff: Expedited Review of Premarket  Joanne R. Less, Center for Devices and
   Submissions for Devices                                             Radiological Health (HFZ-403), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-1190
----------------------------------------------------------------------------------------------------------------
  PMA/510(k) Expedited Review G94-4 (blue book memo)                  Thninh Nguyen, Center for Devices and
                                                                       Radiological Health (HFZ-402), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-2186
----------------------------------------------------------------------------------------------------------------
  30-Day Notices and 135-Day Premarket Approval Application           Heather S. Rosecrans, Center for Devices
   Supplements for Manufacturing Method or Process Changes, Guidance   and Radiological Health (HFZ-230), Food
   for Industry and Center for Devices and Radiological Health         and Drug Administration, 9200 Corporate
   (Docket 98D-0080); Final                                            Blvd., Rockville, MD 20850, 301-594-1190
----------------------------------------------------------------------------------------------------------------
  Guidance on Premarket Approval Application Interactive Procedures   Thninh Nguyen, Center for Devices and
   for Day-100 Meetings and Subsequent Deficiencies--for Use by        Radiological Health (HFZ-402), Food and
   Center for Devices and Radiological Health and Industry; Final      Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-2186
----------------------------------------------------------------------------------------------------------------
  New Section 513(f)(2)--Evaluation of Automatic Class III            Do
   Designation: Guidance for Industry and Center for Devices and
   Radiological Health Staff; Final
----------------------------------------------------------------------------------------------------------------
  Procedures for Class II Device Exemptions From Premarket            Do
   Notification Guidance for Industry and Center for Devices and
   Radiological Health Staff; Final
----------------------------------------------------------------------------------------------------------------
  Guidance on Investigational Device Exemption Policies and           Heather S. Rosecrans, Center for Devices
   Procedures; Final                                                   and Radiological Health (HFZ-230), Food
                                                                       and Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-1190
----------------------------------------------------------------------------------------------------------------
  Distribution and Public Availability of Premarket Approval          Do
   Application Summary of Safety and Effectiveness Data Packages
----------------------------------------------------------------------------------------------------------------
  Kit Certification for Premarket Notifications                       Do
----------------------------------------------------------------------------------------------------------------
  Convenience Kits Interim Regulatory Guidance                        Do
----------------------------------------------------------------------------------------------------------------
  Real-Time Review Program for Premarket Approval Application         Do
   Supplements
----------------------------------------------------------------------------------------------------------------
  Deciding When to Submit a Premarket Notification for a Change to    Do
   an Existing Device (K97-1)
----------------------------------------------------------------------------------------------------------------
  Questions and Answers for the FDA Reviewer Guidance: Labeling       Do
   Reusable Medical Devices for Reprocessing in Health Care
   Facilities
----------------------------------------------------------------------------------------------------------------
  Memorandum of Understanding Regarding Patient Labeling Review       Do
   (blue book memo G96-3)
----------------------------------------------------------------------------------------------------------------
  Continued Access to Investigational Devices During Premarket        Do
   Approval Application Preparation and Review (blue book memo) (D96-
   1)
----------------------------------------------------------------------------------------------------------------

[[Page 41517]]


  Format for Investigational Device Exemption Progress Reports        Do
----------------------------------------------------------------------------------------------------------------
  Labeling Reusable Medical Devices for Reprocessing in Health Care   Do
   Facilities: FDA Reviewer Guidance
----------------------------------------------------------------------------------------------------------------
  Premarket Notification Quality Review Program (blue book memo)      Do
----------------------------------------------------------------------------------------------------------------
  Suggested Content for Original Investigational Device Exemption     Do
   Application Cover Letter
----------------------------------------------------------------------------------------------------------------
  Indications for Use Statement                                       Do
----------------------------------------------------------------------------------------------------------------
  Cover Letter: Premarket Notification Requirements During Firm-      Do
   Initiated Recalls; Attachment A: Guidance on Recall and Premarket
   Notification Review Procedures During Firm-Initiated Recalls of
   Legally Marketed Devices (blue book memo K95-1)
----------------------------------------------------------------------------------------------------------------
  D95-2, Attachment A (Interagency Agreement Between FDA &   Do
   Health Care Financing Administration
----------------------------------------------------------------------------------------------------------------
  D95-2, Attachment B (Criteria for Categorization of        Do
   Investigational Devices Health Care Financing Administration
----------------------------------------------------------------------------------------------------------------
  Health Care Financing Administration Reimbursement Categorization   Do
   Determinations for FDA-Approved Investigational Device Exemptions
----------------------------------------------------------------------------------------------------------------
  Implementation of the FDA/Health Care Financing Administration      Do
   Interagency Agreement Regarding Reimbursement Categorization of
   Investigational Devices, Attachment A Interagency Agreement,
   Attachment B Criteria for Categorization of Investigational
   Devices, and Attachment C -List D95-2 (blue book memo)
----------------------------------------------------------------------------------------------------------------
  Goals and Initiatives for the Investigational Device Exemption      Joanne R. Less, Center for Devices and
   Program D95-1 (blue book memo)                             Radiological Health (HFZ-403), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-1190
----------------------------------------------------------------------------------------------------------------
  Memorandum: Electromagnetic Compatibility for Medical Devices:      Heather S. Rosecrans, Center for Devices
   Issues and Solutions                                                and Radiological Health (HFZ-230), Food
                                                                       and Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-1190
----------------------------------------------------------------------------------------------------------------
  Use of International Standard ISO-10993, `Biological Evaluation of  Do
   Medical Devices Part 1: Evaluation and Testing7rsquo; (Replaces
   G87-1 8294) (blue book memo)
----------------------------------------------------------------------------------------------------------------
  Premarket Approval Application Closure P94-2 (blue book    Do
   memo)
----------------------------------------------------------------------------------------------------------------
  Premarket Notification Sign-Off Procedures K94-2 (blue     Do
   book memo)
----------------------------------------------------------------------------------------------------------------
  Letter to Industry, Powered Wheelchair/Scooter or Accessory/        Do
   Component Manufacturer From Susan Alpert
----------------------------------------------------------------------------------------------------------------
  Premarket Notification Refuse to Accept Procedures K94-1   Do
   (blue book memo)
----------------------------------------------------------------------------------------------------------------
  Investigational Device Exemption Refuse to Accept Procedures        Do
   D94-1 (blue book memo)
----------------------------------------------------------------------------------------------------------------
  Preamendments Class III Strategy Premarket Notification Status      Do
   Request Form
----------------------------------------------------------------------------------------------------------------
  Documentation and Resolution of Differences of Opinion on Product   Do
   Evaluations G93-1 (blue book memo)
----------------------------------------------------------------------------------------------------------------
  Premarket Notification Additional Information Procedures < greek-    Do
   i>K93-1 (blue book memo)
----------------------------------------------------------------------------------------------------------------
  Center for Devices and Radiological Health's Investigational        Do
   Device Exemption Refuse to Accept Policy
----------------------------------------------------------------------------------------------------------------
  Center for Devices and Radiological Health's Premarket              Do
   Notification Refuse to Accept Policy--(Updated Checklist for
   March 14, 1995)
----------------------------------------------------------------------------------------------------------------
  Classified Convenience Kits                                         Do
----------------------------------------------------------------------------------------------------------------
  Telephone Communications Between Office of Device Evaluation Staff  Do
   and Manufacturers I93-1 (blue book memo)
----------------------------------------------------------------------------------------------------------------
  Preamendment Class III Devices                                      Do
----------------------------------------------------------------------------------------------------------------

[[Page 41518]]


  Nondisclosure of Financially Sensitive Information I92-1   Do
   (blue book memo)
----------------------------------------------------------------------------------------------------------------
  Document Review Processing I91-1 (blue book memo)          Do
----------------------------------------------------------------------------------------------------------------
  Integrity of Data and Information Submitted to Office of Device     Do
   Evaluation I91-2 (blue book memo)
----------------------------------------------------------------------------------------------------------------
  Panel Review of Premarket Approval Applications P91-2      Do
   (blue book memo)
----------------------------------------------------------------------------------------------------------------
  Premarket Approval Application Compliance Program P91-3    Do
   (blue book memo)
----------------------------------------------------------------------------------------------------------------
  Shelf Life of Medical Devices                                       Do
----------------------------------------------------------------------------------------------------------------
  Device Labeling Guidance G91-1 (blue book memo)            Do
----------------------------------------------------------------------------------------------------------------
  Consolidated Review of Submissions for Diagnostic Ultrasound        Do
   Equipment, Accessories and Related Measurement Devices < greek-
   i>G90-2 (blue book memo)
----------------------------------------------------------------------------------------------------------------
  Consolidated Review of Submissions for Lasers and Accessories       Do
   G90-1 (blue book memo)
----------------------------------------------------------------------------------------------------------------
  Assignment of Review Documents I90-2 (blue book memo)      Do
----------------------------------------------------------------------------------------------------------------
  Policy Development and Review Procedures I90-1 (blue book  Do
   memo)
----------------------------------------------------------------------------------------------------------------
  Substantial Equivalence Decision Making Documentation ATTACHED:     Do
   `SE' Decision Making Process (Detailed) (i.e., the decision
   making tree)
----------------------------------------------------------------------------------------------------------------
  Threshold Assessment of the Impact of Requirements for Submission   Do
   of Premarket Approval Applications for 31 Medical Devices
   Marketed Prior to May 28, 1976
----------------------------------------------------------------------------------------------------------------
  Meetings With the Regulated Industry I89-3 (blue book      Do
   memo)
----------------------------------------------------------------------------------------------------------------
  Toxicology Risk Assessment Committee G89-1 (blue book      Do
   memo)
----------------------------------------------------------------------------------------------------------------
  Review of IDEs for Feasibility Studies D89-1 (blue book    Do
   memo)
----------------------------------------------------------------------------------------------------------------
  Premarket Notification--Consistency of Reviews K89-1       Do
   (blue book memo)
----------------------------------------------------------------------------------------------------------------
  Review of Laser Submissions G88-1 (blue book memo)         Do
----------------------------------------------------------------------------------------------------------------
  Guideline on Validation of the Limulus Amebocyte Lysate Test as an  Do
   End-Product Endotoxin Test
----------------------------------------------------------------------------------------------------------------
  Limulus Amebocute Lysate; Reduction of Samples for Testing          M. Sussan Runer, Center for Devices and
                                                                       Radiological Health (HFZ-480), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-827-5283
----------------------------------------------------------------------------------------------------------------
  Master Files Part III; Guidance on Scientific and Technical         Do
   Information
----------------------------------------------------------------------------------------------------------------
  Guideline on General Principles of Process Validation               Do
----------------------------------------------------------------------------------------------------------------
  Industry Representatives on Scientific Panel                        Do
----------------------------------------------------------------------------------------------------------------
  Guidance on the Center for Devices and Radiological Health's        Do
   Premarket Notification Review Program K86-3 (blue book
   memo)
----------------------------------------------------------------------------------------------------------------
  Panel Report and Recommendations on PMA Approvals P86-5    Do
   (blue book memo)
----------------------------------------------------------------------------------------------------------------
  Points to Consider in the Characterization of Cell Lines Used to    Do
   Produce Biological Products
----------------------------------------------------------------------------------------------------------------
  Application of the Device Good Manufacturing Practice Regulation    Do
   to the Manufacture of Sterile Devices
----------------------------------------------------------------------------------------------------------------
  Methods for Conducting Recall Effectiveness Checks                  Do
----------------------------------------------------------------------------------------------------------------
  Guidance for Submitting Reclassification Petition                   Do
----------------------------------------------------------------------------------------------------------------
  Guidance for Industry and FDA: User Fees and Refunds for Premarket  Do
   Approval Applications
----------------------------------------------------------------------------------------------------------------
  Bundling Multiple Devices or Multiple Indications in a Single       Do
   Submission--Guidance for Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------

[[Page 41519]]


  FDA and Industry Actions on Premarket Approval Applications:        Do
   Effect on FDA Review Clock and Performance Assessment
----------------------------------------------------------------------------------------------------------------
  Reprocessing and Reuse of Single-Use Devices: Review                Do
   Prioritization Scheme; Draft
----------------------------------------------------------------------------------------------------------------
  Class II Special Controls Guidance Document: Apnea Monitors;        Do
   Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
  Class II Special Controls Guidance Document: Cutaneous Carbon       Do
   Dioxide (PcCo2 and Oxygen (PcO2) Monitors; Guidance for Industry
   and FDA
----------------------------------------------------------------------------------------------------------------
  Class II Special Controls Guidance Document: Indwelling Blood Gas   Do
   Analyzers; Final Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
  Heated Humidifier Review Guidance                                   Do
----------------------------------------------------------------------------------------------------------------
  Class II Special Controls Guidance Document: Optical Impression     Anthony Watson, Center for Devices and
   Systems for Computer Assisted Design and Manufacturing of Dental    Radiological Health (HFZ-480), Food and
   Restorations; Guidance for Industry and FDA                         Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-824-1287
----------------------------------------------------------------------------------------------------------------
  Class II Special Controls Guidance Document: Intraoral Devices for  Do
   Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and
   FDA
----------------------------------------------------------------------------------------------------------------
  Class II Special Controls Guidance Document: Dental Sonography and  Do
   Jaw Tracking Devices; Guidance for Industry and FDA Reviewers
----------------------------------------------------------------------------------------------------------------
  Class II Special Controls Guidance Document: Root-Form Endosseous   Do
   Dental Implants and Abutments; Draft Guidance for Industry and
   FDA
----------------------------------------------------------------------------------------------------------------
  Overview of Information Necessary for Premarket Notification        Do
   Submissions for Endosseous Implants; Final
----------------------------------------------------------------------------------------------------------------
  Guidance for the Preparation of Premarket Notifications for Dental  Do
   Composites
----------------------------------------------------------------------------------------------------------------
  Dental Cements--Premarket Notification; Final                       Do
----------------------------------------------------------------------------------------------------------------
  Dental Impression Materials--Premarket Notification; Final          Do
----------------------------------------------------------------------------------------------------------------
  Over-the-Counter Denture Cushions, Pads, Reliners, Repair Kits,     Do
   and Partially Fabricated Denture Kits; Final
----------------------------------------------------------------------------------------------------------------
  Information Necessary for Premarket Notification Submissions for    Kevin Mulry, Center for Devices and
   Screw-Type Endosseous Implants                                      Radiological Health (HFZ-480), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-827-5283
----------------------------------------------------------------------------------------------------------------
  Guidance Document on Dental Handpieces                              Do
----------------------------------------------------------------------------------------------------------------
  Guidance for the Arrangement and Content of a Premarket Approval    Do
   Application for an Endosseous Implant for Prosthetic Attachment
----------------------------------------------------------------------------------------------------------------
  Premarket Notification Submissions for Chemical Indicators;         Do
   Guidance for Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
  Draft Guidance for Industry and FDA Staff; Class II Special         Do
   Controls Guidance Document: Dental Precious Metal Alloys
----------------------------------------------------------------------------------------------------------------
  Draft Guidance for Industry and FDA Staff; Class II Special         Do
   Controls Guidance Document: Dental Base Metal Alloys
----------------------------------------------------------------------------------------------------------------
  Supplementary Guidance on Premarket Notifications for Medical       Do
   Devices With Sharps Injury Prevention Features; Guidance for
   Industry and FDA
----------------------------------------------------------------------------------------------------------------
  Guidance on Premarket Notifications for Intravascular               Do
   Administration Sets
----------------------------------------------------------------------------------------------------------------
  Neonatal and Neonatal Transport Incubators--Premarket               Do
   Notifications; Final
----------------------------------------------------------------------------------------------------------------
  Guidance on the Content of Premarket Notification Submissions for   Do
   Protective Restraints
----------------------------------------------------------------------------------------------------------------
  Guidance on Premarket Notification Submissions for Short-Term and   Do
   Long-Term Intravascular Catheters
----------------------------------------------------------------------------------------------------------------

[[Page 41520]]


  Guidance on the Content of Premarket Notification Submissions for   Do
   Hypodermic Single Lumen Needles
----------------------------------------------------------------------------------------------------------------
  Guidance on the Content of Premarket Notification Submissions for   Do
   Piston Syringes
----------------------------------------------------------------------------------------------------------------
  Guidance on the Content of Premarket Notification Submissions for   Do
   Clinical Electronic Thermometers
----------------------------------------------------------------------------------------------------------------
  Guidance on the Content of Premarket Notification Submissions for   Do
   External Infusion Pumps
----------------------------------------------------------------------------------------------------------------
  Guidance on Premarket Notification Submissions for Implanted        Do
   Infusion Ports
----------------------------------------------------------------------------------------------------------------
  Surgical Masks--Premarket Notification Submissions; Draft Guidance  Bram D. Zuckerman, Center for Devices and
                                                                       Radiological Health (HFZ-450), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-443-8320
----------------------------------------------------------------------------------------------------------------
  Regulatory Status of Disinfectants Used to Process Dialysate        Do
   Delivery Systems and Water Purification Systems for Hemodialysis;
   Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
  Premarket Notification Submissions for Medical Sterilization        Do
   Packaging Systems in Health Care Facilities; Draft Guidance for
   Industry and FDA
----------------------------------------------------------------------------------------------------------------
  Premarket Notifications for Biological Indicators Intended to       Elias Mallis, Center for Devices and
   Monitor Sterilizers Used in Health Care Facilities; Draft           Radiological Health (HFZ-450), Food and
   Guidance for Industry and FDA Reviewers                             Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-443-8517
----------------------------------------------------------------------------------------------------------------
  Premarket Approval Applications for Sharps Needle Destruction       Do
   Devices; Final Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
  Guidance on the Content and Format of Premarket Notification        Do
   Submissions for Liquid Chemical Sterilants and High Level
   Disinfectants; Final
----------------------------------------------------------------------------------------------------------------
  Premarket Notification Submissions for Testing for Skin             Do
   Sensitization to Chemicals in Natural Rubber Products; Final
----------------------------------------------------------------------------------------------------------------
  Center for Devices and Radiological Health Regulatory Guidance for  Do
   Washers and Washer-Disinfectors Intended for Use in Processing
   Reusable Medical Devices
----------------------------------------------------------------------------------------------------------------
  Testing for Sensitizing Chemicals in Natural Rubber Latex Medical   Do
   Devices (Addendum to 944)
----------------------------------------------------------------------------------------------------------------
  Addendum to: Guidance on Premarket Notification Submissions for     Dina Fleisher, Center for Devices and
   Sterilizers Intended for Use in Health Care Facilities              Radiological Health (HFZ-450), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-443-8517
----------------------------------------------------------------------------------------------------------------
  Guidance on the Content and Format of Premarket Notification        Do
   Submissions for Sharps Containers
----------------------------------------------------------------------------------------------------------------
  Guidance on Premarket Notification Submissions for Automated        Do
   Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended
   for Use in Health Care Facilities
----------------------------------------------------------------------------------------------------------------
  Guidance on Premarket Notification Submissions for Surgical Gowns   Do
   and Surgical Drapes
----------------------------------------------------------------------------------------------------------------
  Guidance on Premarket Notification for Sterilizers Intended for     Ashley Boam, Center for Devices and
   Use in Health Care Facilities                                       Radiological Health (HFZ-450), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-443-8243
----------------------------------------------------------------------------------------------------------------
  Battery Guidance                                                    Megan Moynaham, Center for Devices and
                                                                       Radiological Health (HFZ-450), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-443-8517
----------------------------------------------------------------------------------------------------------------
  Policy for Expiration Dating (DCRND RB92-G)                         Do
----------------------------------------------------------------------------------------------------------------
  Balloon Valvuloplasty Guidance for the Submission of an             A. Doyle Gantt, Center for Devices and
   Investigational Device Exemption Application and a Premarket        Radiological Health (HFZ-450), Food and
   Approval Application                                                Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-443-8262
----------------------------------------------------------------------------------------------------------------

[[Page 41521]]


  Class II Special Controls Guidance Document: Arrhythmia Detector    Do
   and Alarm
----------------------------------------------------------------------------------------------------------------
  Cardiac Ablation Catheters Generic Arrhythmia Indications for Use;  Do
   Guidance for Industry
----------------------------------------------------------------------------------------------------------------
  Investigational Device Exemption Study Enrollment for Cardiac       Do
   Ablation of Typical Atrial Flutter; Final Guidance for Industry
   and FDA Reviewers
----------------------------------------------------------------------------------------------------------------
  Recommended Clinical Study Design for Ventricular Tachycardia       Neil R. Ogden, Center for Devices and
   Ablation                                                            Radiological Health (HFZ-410), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-1307
----------------------------------------------------------------------------------------------------------------
  Nonautomated Sphygmomanometer (Blood Pressure Cuff) Guidance        Do
   Version 1; Final
----------------------------------------------------------------------------------------------------------------
  Noninvasive Blood Pressure Monitor Guidance                         Do
----------------------------------------------------------------------------------------------------------------
  Electrocardiograph Electrode                                        Do
----------------------------------------------------------------------------------------------------------------
  Electrocardiograph Lead Switching Adapter                           Do
----------------------------------------------------------------------------------------------------------------
  Electrocardiograph Surface Electrode Tester                         Do
----------------------------------------------------------------------------------------------------------------
  Clinical Study Designs for Percutanwous Catheter Ablation for       Do
   Treatment of Atrial Fibrillation--Guidance for Industry and FDA
   Staff
----------------------------------------------------------------------------------------------------------------
  Guidance for Annuloplasty Rings Premarket Notification              Barbara Zimmerman, Center for Devices and
   Submissions; Final Guidance for Industry and FDA Staff              Radiological Health (HFZ-410), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-2036
----------------------------------------------------------------------------------------------------------------
  Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter      Do
   Premarket Notification Submissions; Final Guidance for Industry
   and FDA
----------------------------------------------------------------------------------------------------------------
  Guidance for Extracorporeal Blood Circuit Defoamer Premarket        Do
   Notification Submissions; Final Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
  Guidance for Cardiopulmonary Bypass Oxygenators Premarket           Do
   Notification Submissions; Final Guidance for Industry and FDA
   Staff
----------------------------------------------------------------------------------------------------------------
  Guidance for the Preparation of the Annual Report to the Premarket  Do
   Approval Application Approved Heart Valve Prostheses
----------------------------------------------------------------------------------------------------------------
  Coronary and Cerebrovascular Guidewire Guidance                     Do
----------------------------------------------------------------------------------------------------------------
  Guidance for the Submission of Research and Marketing Applications  Do
   for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor
   Premarket Notification Submissions
----------------------------------------------------------------------------------------------------------------
  Implantable Pacemaker Testing Guidance                              Do
----------------------------------------------------------------------------------------------------------------
  Guidance Document for Vascular Prostheses Premarket Notification    Do
   Submissions
----------------------------------------------------------------------------------------------------------------
  Guidance for Cardiovascular Intravascular Filter Premarket          Do
   Notification Submissions; Final
----------------------------------------------------------------------------------------------------------------
  Carotid Stent--Suggestions for Content of Submissions to the Food   Do
   and Drug Administration in Support of Investigational Devices
   Exemption Applications
----------------------------------------------------------------------------------------------------------------
  Class II Special Controls Guidance Document: Vascular and           Do
   Neurovascular Embolization Devices--Draft Guidance for Industry
   and FDA Staff
----------------------------------------------------------------------------------------------------------------
  Guidance Document for Powered Suction Pump Premarket Notifications  Steven Rhodes, Center for Devices and
                                                                       Radiological Health (HFZ-410), Food and
                                                                       Drug Administration 9200 Corporate Blvd.,
                                                                       Rockville, MD 20850, 301-594-3090
----------------------------------------------------------------------------------------------------------------
  Guidance Document for Surgical Lamp Premarket Notification; Final   Do
----------------------------------------------------------------------------------------------------------------
  Guidelines for Reviewing Premarket Notifications That Claim         Do
   Substantial Equivalence to Evoked Response Stimulators
----------------------------------------------------------------------------------------------------------------
  Guidance Document for the Preparation of Premarket Notification     Do
   Applications for Electromyograph Needle Electrodes
----------------------------------------------------------------------------------------------------------------

[[Page 41522]]


  Guidance on the Content and Organization of a Premarket             Do
   Notification for a Medical Laser
----------------------------------------------------------------------------------------------------------------
  Guidance for the Preparation of a Premarket Notification for        Do
   Extended Laparoscopy Devices
----------------------------------------------------------------------------------------------------------------
  Class II Special Controls Guidance Document: Knee Joint             Do
   Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated
   Uncemented Prostheses; Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
  Class II Special Controls Guidance Document:                        Do
   Polymethylmethacrylate Bone Cement; Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
  Class II Special Controls Guidance Document: Hip Joint Metal/       Theodore R. Stevens, Center for Devices
   Polymer Constrained Cemented or Uncemented Prosthesis               and Radiological Health (HFZ-410), Food
                                                                       and Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-1296
----------------------------------------------------------------------------------------------------------------
  Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/   Do
   Metal Nonconstrained or Semiconstrained Porous-Coated Uncemented
   Prosthesis Guidance for Spinal System Premarket Notifications
----------------------------------------------------------------------------------------------------------------
  Guidance Document for the Preparation of Investigational Device     Do
   Exemptions for Spinal Systems
----------------------------------------------------------------------------------------------------------------
  ORDB Premarket Notification Sterility Review Guidance               Do
----------------------------------------------------------------------------------------------------------------
  Reviewers Guidance Checklist for Intramedullary Rods                Do
----------------------------------------------------------------------------------------------------------------
  Reviewers Guidance Checklist for Orthopedic External Fixation       Do
   Devices
----------------------------------------------------------------------------------------------------------------
  Premarket Notification Information Needed for Hydroxyapatite        Do
   Coated Orthopedic Implants
----------------------------------------------------------------------------------------------------------------
  Guidance Document for Testing Biodegradable Polymer Implant         Do
   Devices
----------------------------------------------------------------------------------------------------------------
  Guidance Document for Testing Bone Anchor Devices                   Do
----------------------------------------------------------------------------------------------------------------
  Guidance Document for Testing Non-Articulating, `Mechanically       Do
   Locked', Modular Implant Components
----------------------------------------------------------------------------------------------------------------
  Guidance Document for the Preparation of Premarket Notification     Do
   for Ceramic Ball Hip Systems
----------------------------------------------------------------------------------------------------------------
  Guidance Document for Testing Orthopedic Implants With Modified     Do
   Metallic Surfaces Apposing Bone or Bone Cement
----------------------------------------------------------------------------------------------------------------
  Guidance Document for the Preparation of Investigational Device     Do
   Exemption and Premarket Approval Applications for Intra-Articular
   Prosthetic Knee Ligament Devices
----------------------------------------------------------------------------------------------------------------
  Class II Special Controls Guidance Document: Surgical Sutures;      Evertte T. Bears, Center for Devices and
   Guidance for Industry and FDA                                       Radiological Health (HFZ-460), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-2018
----------------------------------------------------------------------------------------------------------------
  Guidance for Saline, Silicone Gel, and Alternative Breast           Do
   Implants; Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
  Class II Special Controls Guidance Document: Human Dura Mater;      Do
   Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
  Guidance for Resorbable Adhesion Barrier Devices for Use in         Do
   Abdominal and/or Pelvic Surgery; Guidance for Industry
----------------------------------------------------------------------------------------------------------------
  Guidance Document for Dura Substitute Devices; Final Guidance for   Do
   Industry
----------------------------------------------------------------------------------------------------------------
  Guidance for Neurological Embolization Devices                      Do
----------------------------------------------------------------------------------------------------------------
  Guidance for the Preparation of a Premarket Notification            Do
   Application for Processed Human Dura Mater; Final
----------------------------------------------------------------------------------------------------------------
  Guidance for Dermabrasion Devices; Final                            Do
----------------------------------------------------------------------------------------------------------------

[[Page 41523]]


  Guidance for the Preparation of a Premarket Notification            Do
   Application for a Surgical Mesh; Final
----------------------------------------------------------------------------------------------------------------
  Guidance for Content of Premarket Notifications for Esophageal and  Eric A, Mann, Center for Devices and
   Tracheal Prostheses; Final                                          Radiological Health (HFZ-460), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-2080
----------------------------------------------------------------------------------------------------------------
  Guidance for Testing Magnetic Resonance Interaction With Aneurysm   Do
   Clips
----------------------------------------------------------------------------------------------------------------
  Class II Special Controls Guidance Document: Resorbable Calcium     Do
   Salt Bone Void Filler Device; Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
  Cyanoacrylate Tissue Adhesive for the Topical Approzimation of      Do
   Ski--Premarket Approval Applications--Guidance for Industry and
   FDA Staff
----------------------------------------------------------------------------------------------------------------
  Saline, Silicone Gel, and Alternative Breast Implants--Draft        Kesia Alexander, Center for Devices and
   Guidance for Industry                                               Radiological Health (HFZ-460), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-2053
----------------------------------------------------------------------------------------------------------------
  Guidance Document for Powered Muscle Stimulator Premarket
   Notifications; Final
----------------------------------------------------------------------------------------------------------------
  Guidance Document for the Preparation of Premarket Notification     Do
   Applications for Therapeutic Massagers and Vibrators
----------------------------------------------------------------------------------------------------------------
  Guidance Document for the Preparation of Premarket Notification     Do
   Applications for Beds
----------------------------------------------------------------------------------------------------------------
  Guidance Document for the Preparation of Premarket Notification     Do
   Applications for Communications Systems (Powered and Nonpowered)
   and Powered Environmental Control Systems
----------------------------------------------------------------------------------------------------------------
  Guidance Document for the Preparation of Premarket Notification     Do
   Applications for Exercise Equipment
----------------------------------------------------------------------------------------------------------------
  Guidance Document for the Preparation of Premarket Notification     Do
   Applications for Heating and Cooling Devices
----------------------------------------------------------------------------------------------------------------
  Guidance Document for the Preparation of Premarket Notification     Do
   Applications for Immersion Hydrobaths
----------------------------------------------------------------------------------------------------------------
  Guidance Document for the Preparation of Premarket Notification     Carolyn Y. Neuland, Center for Devices and
   Applications for Powered Tables and Multifunctional Physical        Radiological Health (HFZ-470), Food and
   Therapy Tables                                                      Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-1220
----------------------------------------------------------------------------------------------------------------
  Guidance Document for the Preparation of Premarket Notification     Do
   Applications for Submerged (Underwater) Exercise Equipment
----------------------------------------------------------------------------------------------------------------
  Guidance Document for the Preparation of Premarket Notification     Do
   Applications for Mechanical and Powered Wheelchairs, and
   Motorized Three-Wheeled Vehicles
----------------------------------------------------------------------------------------------------------------
  Guidance for Studies for Pain Therapy Devices--General              Do
   Consideration in the Design of Clinical Studies for Pain-
   Alleviating Devices
----------------------------------------------------------------------------------------------------------------
  Guidance Document for Nonprescription Sunglasses; Final             Do
   Ophthalmoscope Guidance
----------------------------------------------------------------------------------------------------------------
  Retinoscope Guidance; Final                                         Do
----------------------------------------------------------------------------------------------------------------
  Slit Lamp Guidance; Final                                           Do
----------------------------------------------------------------------------------------------------------------
  Third Party Review Guidance for Phacofragmentation System Device    Do
   Premarket Notification
----------------------------------------------------------------------------------------------------------------
  Third Party Review Guidance for Vitreous Aspiration and Cutting     Collin M. Pollard, Center for Devices and
   Device Premarket Notification                                       Radiological Health (HFZ-470), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-1180
----------------------------------------------------------------------------------------------------------------
  Checklist of Information Usually Submitted in an Investigational    Do
   Device Exemptions Application for Refractive Surgery Lasers
   (Excimer)
----------------------------------------------------------------------------------------------------------------
  Implantable Middle Ear Hearing Device; Guidance for Industry and    Do
   FDA
----------------------------------------------------------------------------------------------------------------

[[Page 41524]]


  Guidance for Manufacturers Seeking Marketing Clearance of Ear,      Do
   Nose, and Throat Endoscope Sheaths Used as Protective Barriers;
   Final
----------------------------------------------------------------------------------------------------------------
  Tympanostomy Tubes, Submission Guidance for a Premarket             Do
   Notification; Final
----------------------------------------------------------------------------------------------------------------
  Guidance For The Arrangement and Content of a Premarket Approval    Do
   Application For A Cochlear Implant in Children Ages 2 to 17 Years
----------------------------------------------------------------------------------------------------------------
  Guideline for the Arragement and Content of a Premarket Approval    Do
   Application for a Cochlear Implant in Adults at Least 18 Years of
   Age
----------------------------------------------------------------------------------------------------------------
  Guideline for the Arrangement and Content of a Premarket Approval   Do
   Application for a Cochlear Implant in Adults at Least 18 Years of
   Age
----------------------------------------------------------------------------------------------------------------
  Guidance on Submissions for Keratoprostheses; Final                 Do
----------------------------------------------------------------------------------------------------------------
  Aqueous Shunts--Premarket Notification Submissions; Final           Do
----------------------------------------------------------------------------------------------------------------
  FDA Guidelines for Multifocal Intraocular Lens Investigational      Do
   Device Exemptions Studies and Premarket Approval Applications
----------------------------------------------------------------------------------------------------------------
  Important Information About Rophae Intraocular Lenses               Do
----------------------------------------------------------------------------------------------------------------
  Guidance for Premarket Submissions of Orthokeratology Rigid Gas     Do
   Permeable Contact Lenses; Final
----------------------------------------------------------------------------------------------------------------
  Revised Procedures for Adding Lens Finishing Laboratories to        Do
   Approved Premarket Approval Applications for Class III Rigid Gas
   Permeable Contact Lenses for Extended Wear; Final
----------------------------------------------------------------------------------------------------------------
  Premarket Notification Guidance for Contact Lens Care Products      Do
----------------------------------------------------------------------------------------------------------------
  Premarket Notification Guidance Document for Class II Daily Wear    Do
   Contact Lenses
----------------------------------------------------------------------------------------------------------------
  New FDA Recommendations and Results of Contact Lens Study (7-Day    Do
   Letter)
----------------------------------------------------------------------------------------------------------------
  Class II Special Controls Guidance Document; Ingestible Telemetric  Do
   Gastrointestinal Capsule Imaging System; Final Guidance for
   Industry and FDA
----------------------------------------------------------------------------------------------------------------
  Class II Special Controls Guidance Document: Tissue Culture Media   Janine M. Morris, Center for Devices and
   for Human Ex Vivo Tissue and Cell Culture Processing                Radiological Health (HFZ-470), Food and
   Applications; Final Guidance for Industry and FDA Reviewers         Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-2194
----------------------------------------------------------------------------------------------------------------
  Guidance for Investigational Device Exemptions for Solutions for    Do
   Hypothermic Flushing, Transport, and Storage of Organs for
   Transplantation; Final Guidance for Industry and FDA Reviewers
----------------------------------------------------------------------------------------------------------------
  Guidance for Industry and the Center for Devices and Radiological   Do
   Health Reviewers on the Content of Premarket Notifications for
   Hemodialysis Delivery Systems; Final
----------------------------------------------------------------------------------------------------------------
  Guidance for the Content of Premarket Notification for              Do
   Conventional and High Permeability Hemodialyzers; Final
----------------------------------------------------------------------------------------------------------------
  Guidance for the Content of Premarket Notifications for Metal       Do
   Expandable Biliary Stents; Final
----------------------------------------------------------------------------------------------------------------
  Guidance for the Content of Premarket Notifications for Water       Do
   Purification Components and Systems for Hemodialysis
----------------------------------------------------------------------------------------------------------------
  Class II Special Controls Guidance Document: Breast Lesion          Do
   Documentation System--Guidance for Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
  Class II Special Controls Guidance for Home Uterine Activity        Do
   Monitors; Final Guidance for Industry and FDA Reviewers
----------------------------------------------------------------------------------------------------------------
  Class II Special Controls Guidance Document for Clitoral            Do
   Engorgement Devices
----------------------------------------------------------------------------------------------------------------
  Latex Condoms for Men--Information for Premarket Notifications:     Do
   Use of Consensus Standards for Abbreviated Submissions
----------------------------------------------------------------------------------------------------------------
  Uniform Contraceptive Labeling; Final                               Do
----------------------------------------------------------------------------------------------------------------
  Letter to Manufacturers of Prescription Home Monitors for Non-      Do
   Stress Tests
----------------------------------------------------------------------------------------------------------------

[[Page 41525]]


  Letter to Manufacturers of Falloposcopes                            Do
----------------------------------------------------------------------------------------------------------------
  Thermal Endometrial Ablation Devices (Submission Guidance for an    Do
   Investigational Device Exemption)
----------------------------------------------------------------------------------------------------------------
  Hysteroscopes and Gynecology Laparoscopes--Submission Guidance for  Do
   a Premarket Notification
----------------------------------------------------------------------------------------------------------------
  Premarket Applications for Digital Mammography Systems; Final       Do
   Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
  Guidance for the Submission of Premarket Notifications for Photon-  Do
   Emitting Brachytherapy Sources
----------------------------------------------------------------------------------------------------------------
  Guidance for the Submission of Premarket Notifications for Medical  Do
   Image Management Devices
----------------------------------------------------------------------------------------------------------------
  Guidance for the Submission of Premarket Notification for Solid     Do
   State X-Ray Imaging Devices; Final
----------------------------------------------------------------------------------------------------------------
  Guidance for the Submission of Premarket Notifications for          Do
   Emission Computed Tomography Devices and Accessories and Nuclear
   Tomography Systems; Final
----------------------------------------------------------------------------------------------------------------
  Guidance for the Submission of Premarket Notifications for          Do
   Radionuclide Dose Calibrators; Final
----------------------------------------------------------------------------------------------------------------
  Harmonic Imaging With/Without Contrast--Premarket Notification;     Do
   Final
----------------------------------------------------------------------------------------------------------------
  Guidance for the Submission of Premarket Notifications for          Do
   Magnetic Resonance Diagnostic Devices; Final
----------------------------------------------------------------------------------------------------------------
  Information for Manufacturers Seeking Marketing Clearance of        Do
   Diagnostic Ultrasound Systems and Transducers
----------------------------------------------------------------------------------------------------------------
  Letter: Notice to Manufacturers of Bone Mineral Densitometers       Do
----------------------------------------------------------------------------------------------------------------
  Simplified Premarket Notification Procedures for Certain Radiology  Avis T. Danishefsky, Center for Devices
   Devices: December 21, 1993, Letter From L Yin, Office of Device     and Radiological Health (HFZ-440), Food
   Evaluation, Division of Reproduction, Abdominal, and Radiological   and Drug Administration, 9200 Corporate
   Devices, to National Electrical Manufacturers Association           Blvd., Rockville, MD 20850, 301-594-1243
----------------------------------------------------------------------------------------------------------------
  Reviewer Guidance for Automatic X-Ray Film Processor Premarket      Do
   Notification
----------------------------------------------------------------------------------------------------------------
  Guidance for the Content of Premarket Notifications for             Do
   Extracorporeal Shock Wave Lithotripters Indicated for the
   Fragmentation of Kidney and Ureteral Calculi
----------------------------------------------------------------------------------------------------------------
  Guidance for the Content of Premarket Notifications for Penile      Do
   Rigidity Implants; Final
----------------------------------------------------------------------------------------------------------------
  Guidance for the Content of Premarket Notifications for             Do
   Intracorporeal Lithotripters; Final
----------------------------------------------------------------------------------------------------------------
  Center for Devices and Radiological Health Interim Regulatory       Do
   Policy for External Penile Rigidity Devices
----------------------------------------------------------------------------------------------------------------
  Checklist for Mechanical Lithotripters and Stone Dislodgers Used    Do
   in Gastroenterology and Urology
----------------------------------------------------------------------------------------------------------------
  Premarket Notification Checklist for Sterile Lubricating Jelly      Do
   Used With Transurethral Surgical Instruments
----------------------------------------------------------------------------------------------------------------
  Guidance for the Content of Premarket Notifications for             Do
   Conventional and Antimicrobial Foley Catheters
----------------------------------------------------------------------------------------------------------------
  Guidance for the Content of Premarket Notifications for Urodynamic/ Do
   Uroflowmetry Systems
----------------------------------------------------------------------------------------------------------------
  Guidance for the Content of Premarket Notifications for Urine       Do
   Drainage Bags
----------------------------------------------------------------------------------------------------------------
  Guidance for the Content of Premarket Notifications for Biopsy      Do
   Devices Used in Gastroenterology and Urology
----------------------------------------------------------------------------------------------------------------
  Guidance for the Content of Premarket Notifications for Ureteral    Do
   Stents
----------------------------------------------------------------------------------------------------------------
  Perspectives on Clinical Studies for Medical Device Submissions     Do
   (Statistical)
----------------------------------------------------------------------------------------------------------------

[[Page 41526]]


  Premarket Approval Application Review Statistical Checklist         Do
----------------------------------------------------------------------------------------------------------------
  Statistical Guidance for Clinical Trials of Nondiagnostic Medical   Do
   Devices
----------------------------------------------------------------------------------------------------------------
  Medical Device Reporting Guidance Document: Remedial Action         Do
   Exemption; Final
----------------------------------------------------------------------------------------------------------------
  Guidance on Adverse Event Reporting for Hospitals That Reprocess    Do
   Devices Intended by the Original Equipment Manufacturer for
   Single Use
----------------------------------------------------------------------------------------------------------------
  Medical Device Reporting Guidance Document No. 1--Intraocular       Do
   lenses--E1996004; Final
----------------------------------------------------------------------------------------------------------------
  Common Problems: Baseline Reports and Medwatch Form 3500A           Do
----------------------------------------------------------------------------------------------------------------
  Medical Device Reporting: An Overview; Final                        Do
----------------------------------------------------------------------------------------------------------------
  Instructions for Completing FDA Form 3500A With Coding Manual for   Do
   Form 3500A (MEDWATCH) (Medical Device Reporting); Final
----------------------------------------------------------------------------------------------------------------
  MEDWATCH FDA Form 3500A For Use By User Facilities, Distributors    Do
   and Manufacturers for Mandatory Reporting (Medical Device
   Reporting); Final
----------------------------------------------------------------------------------------------------------------
  Variance from Manufacturer Report Number Format (Medical Device     Do
   Reporting Letter); Final
----------------------------------------------------------------------------------------------------------------
  Instructions for Completing Form 3417: Medical Device Reporting     Do
   Baseline Report (Medical Device Reporting); Final
----------------------------------------------------------------------------------------------------------------
  Medical Device Reporting--Alternative Summary Reporting Program;    Do
   Guidance for Industry
----------------------------------------------------------------------------------------------------------------
  Addendum to the Instructions for Completing FDA Form 3500A With     Do
   Coding Manual (MEDWATCH) (Medical Device Reporting); Final
----------------------------------------------------------------------------------------------------------------
  Needlesticks--Medical Device Reporting Guidance                     Do
----------------------------------------------------------------------------------------------------------------
  Guidance on Criteria and Approaches for Postmarket Surveillance     Do
----------------------------------------------------------------------------------------------------------------
  Guidance on Procedures to Determine Application of Postmarket       Do
   Surveillance Strategies (Food and Drug Administration
   Modernization Act); Final
----------------------------------------------------------------------------------------------------------------
  Guidance on Procedures for Review of Postmarket Surveillance        Do
   Submissions (Food and Drug Administration Modernization Act);
   Final
----------------------------------------------------------------------------------------------------------------
  Guidance for Industry and FDA Staff--Safe Medical Devices Act to    Do
   Food and Drug Administration Modernization Act: Guidance on FDA's
   Transition Plan for Existing Postmarket Surveillance Protocols
   (Food and Drug Administration Modernization Act); Final
----------------------------------------------------------------------------------------------------------------
  Guidance for Industry on the Testing of Metallic Plasma Sprayed     Do
   Coatings on Orthopedic Implants to Support Reconsideration of
   Postmarket
================================================================================================================
Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
================================================================================================================
  Analyte Specific Reagents; Small Entity Compliance Guidance;        Do
   Guidance for Industry
----------------------------------------------------------------------------------------------------------------
  Assessing the Safety/Effectiveness of Home-Use In Vitro Diagnostic  Do
   Devices: Draft Points to Consider Regarding Labeling and
   Premarket Submissions
----------------------------------------------------------------------------------------------------------------
  Data for Commercialization of Original Equipment Manufacturer,      Do
   Secondary and Generic Reagents for Automated Analyzers
----------------------------------------------------------------------------------------------------------------
  Determination of Intended Use for Premarket Notification Devices;   Do
   Guidance for the Center for Devices and Radiological Health Staff
----------------------------------------------------------------------------------------------------------------
  Guidance for Administrative Procedures for Clinical Laboratory      Do
   Improvement Amendments of 1988 Categorization
----------------------------------------------------------------------------------------------------------------
  Guidance for Clinical Laboratory Improvement Amendments of 1988     Do
   Criteria for Waiver; Draft Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
  Guidance for Industry--Abbreviated Premarket Notification           Do
   Submissions for In Vitro Diagnostic Calibrators; Final
----------------------------------------------------------------------------------------------------------------

[[Page 41527]]


  Letter to In-Vitro Device Manufacturers on Streamlined Premarket    Do
   Approval Applications; Final
----------------------------------------------------------------------------------------------------------------
  Points to Consider for Collection of Data in Support of In-Vitro    Do
   Device Submissions for Premarket Notification Clearance
----------------------------------------------------------------------------------------------------------------
  Points to Consider for Review of Calibration and Quality Control    Do
   Labeling for In Vitro Diagnostic Devices/Cover Letter Dated March
   14, 1996
----------------------------------------------------------------------------------------------------------------
  Points to Consider Guidance Document on Assayed and Unassayed       Do
   Quality Control Material; Draft
----------------------------------------------------------------------------------------------------------------
  Premarket Approval Application Filing Review--Guidance for          Do
   Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
  Breath Nitric Oxide Test System--Class II Special Controls          Do
   Guidance Document
----------------------------------------------------------------------------------------------------------------
  Class II Special Control Guidance Document for B-Type Natriuretic   Do
   Peptide Premarket Notifications; Final Guidance for Industry and
   FDA Reviewers
----------------------------------------------------------------------------------------------------------------
  Class II Special Controls Guidance Document: Cyclosporine and       Do
   Tacrolimus Assays; Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
  Draft Guidance for Prescription Use of Drugs of Abuse Assays        Do
   Premarket Notifications
----------------------------------------------------------------------------------------------------------------
  Draft Guidance on the Labeling for Over-the-Counter Sample          Do
   Collection Systems for Drugs of Abuse Testing
----------------------------------------------------------------------------------------------------------------
  Guidance for Premarket Notifications on Cholesterol Tests for       Do
   Clinical Laboratory, Physicians' Office Laboratory, and Home Use
----------------------------------------------------------------------------------------------------------------
  Guidance for Industry In Vitro Diagnostic Bicarbonate/Carbon        Do
   Dioxide Test System; Final
----------------------------------------------------------------------------------------------------------------
  Guidance for Industry In Vitro Diagnostic Chloride Test System;     Do
   Final
----------------------------------------------------------------------------------------------------------------
  Guidance for Industry In Vitro Diagnostic Creatinine Test System;   Do
   Final
----------------------------------------------------------------------------------------------------------------
  Guidance for Industry In Vitro Diagnostic Glucose Test System;      Do
   Final
----------------------------------------------------------------------------------------------------------------
  Guidance for Industry In Vitro Diagnostic Potassium Test System;    Do
   Final
----------------------------------------------------------------------------------------------------------------
  Guidance for Industry In Vitro Diagnostic Sodium Test System;       Do
   Final
----------------------------------------------------------------------------------------------------------------
  Guidance for Industry In Vitro Diagnostic Urea Nitrogen Test        Do
   System; Final
----------------------------------------------------------------------------------------------------------------
  Guidance for Industry-In Vitro Diagnostic C-Reactive Protein        Do
   Immunological Test System
----------------------------------------------------------------------------------------------------------------
  Guidance for Over-the-Counter Human Chorionic Gonadotropin          Do
   Premarket Notifications
----------------------------------------------------------------------------------------------------------------
  Guidance for Over-the-Counter Ovulation Predictor Premarket         Do
   Notifications
----------------------------------------------------------------------------------------------------------------
  Over the Counter Screening Tests for Drugs of Abuse: Guidance for   Do
   Premarket Notifications
----------------------------------------------------------------------------------------------------------------
  Points to Consider for Portable Blood Glucose Monitoring Devices    Do
   Intended for Bedside Use in the Neonate Nursery
----------------------------------------------------------------------------------------------------------------
  Review Criteria for Assessment of In Vitro Diagnostic Devices for   Do
   Drugs of Abuse Assays Using Various Methodologies
----------------------------------------------------------------------------------------------------------------
  Review Criteria for Assessment of Portable Blood Glucose In Vitro   Do
   Diagnostic Devices Using Glucose Oxidase, Dehydrogenase, or
   Hexokinase Methodology
----------------------------------------------------------------------------------------------------------------
  Review Criteria for Assessment of Professional Use Human Chorionic  Laura A. Alonge, Center for Devices and
   Gonadotropin In Vitro Diagnostic Devices                            Radiological Health (HFZ-510), Food and
                                                                       Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-594-0648
----------------------------------------------------------------------------------------------------------------
  Premarket Notification Submissions for Coagulation Instruments--    Do
   Guidance for Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
  Class II Special Control Guidance Document for Anti-Saccharomyces   Do
   Cerevisia (S. cerevisiae) Antibody Premarket Notifications
----------------------------------------------------------------------------------------------------------------

[[Page 41528]]


  Class II Special Controls Guidance Document: Premarket              Do
   Notifications for Automated Differential Cell Counters for
   Immature or Abnormal Blood Cells; Final Guidance for Industry and
   FDA
----------------------------------------------------------------------------------------------------------------
  Document for Special Controls for Erythropoietin Assay Premarket    Do
   Notifications; Final
----------------------------------------------------------------------------------------------------------------
  Draft Guidance Document for Premarket Notification Submission of    Do
   Fecal Occult Blood Tests
----------------------------------------------------------------------------------------------------------------
  Draft Guidance Document for Premarket Notification Submission of    Do
   Glycohemoglobin (Glycated or Glycosylated) Hemoglobin for In
   Vitro Diagnostic Devices
----------------------------------------------------------------------------------------------------------------
  Draft Guidance Document for Premarket Notification Submission of    Do
   Immunoglobulins A,G,M,D and E Immunoglobulin System In-Vitro
   Devices
----------------------------------------------------------------------------------------------------------------
  Draft Guidance for Premarket Notification Submission of Lymphocyte  Do
   Immunophenotyping In Vitro Diagnostic Devices Using Monoclonal
   Antibodies
----------------------------------------------------------------------------------------------------------------
  Draft Guidance for Premarketing Approval Review Criteria for        Do
   Premarket Approval of Estrogen or Progesterone Receptors In Vitro
   Diagnostic Devices Using Steroid Hormone Binding With Dextran-
   Coated Charcoal Separation, Histochemical Receptor Bind
----------------------------------------------------------------------------------------------------------------
  Guidance Document for the Submission of Tumor Associated Antigen    Do
   Premarket Notification to FDA
----------------------------------------------------------------------------------------------------------------
  Guidance for Submission of Immunohistochemistry Applications to     Do
   FDA; Final
----------------------------------------------------------------------------------------------------------------
  In Vitro Diagnostic Fibrin Monomer Paracoagulation Test; Final      Do
----------------------------------------------------------------------------------------------------------------
  Multiplex Tests for Heritable Deoxyribonucleic Acid Markers,        Do
   Mutations and Expression Patterns; Draft Guidance for Industry
   and FDA Reviewers
----------------------------------------------------------------------------------------------------------------
  Points to Consider for Cervical Cytology Devices                    Do
----------------------------------------------------------------------------------------------------------------
  Points to Consider for Hematology Quality Control Materials         Do
----------------------------------------------------------------------------------------------------------------
  Radioallergosorbent Test Methods for Allergen-Specific              Do
   Immunoglobulin E (IgE) Premarket Notifications; Final Guidance
   for Industry and FDA
----------------------------------------------------------------------------------------------------------------
  Review Criteria for Assessment of Alpha-Fetoprotein In Vitro        Do
   Diagnostic Devices for Fetal Open Neural Tube Defects Using
   Immunological Test Methodologies
----------------------------------------------------------------------------------------------------------------
  Review Criteria for Assessment of Cytogenetic Analysis Using        Do
   Automated and Semiautomated Chromosome Analyzers
----------------------------------------------------------------------------------------------------------------
  Review Criteria for Assessment of Rheumatoid Factor In Vitro        Casper E. Uldriks, Center for Devices and
   Diagnostic Devices Using Engzyme-Linked Immunoassay, Enzyme         Radiological Health (HFZ-300), Food and
   Linked Immunosorbent Assay, Particle Agglutination Tests, and       Drug Administration, 9200 Corporate
   Laser and Rate Nephelometry                                         Blvd., Rockville, MD 20850, 301-594-4692
----------------------------------------------------------------------------------------------------------------
  Review Criteria for Blood Culture Systems                           Do
----------------------------------------------------------------------------------------------------------------
  Review Criteria for In Vitro Diagnostic Devices for Detection of    Do
   Immunoglobulin Class M Antibodies to Viral Agents
----------------------------------------------------------------------------------------------------------------
  Review Criteria for In Vitro Diagnostic Devices for the Assessment  Do
   of Thyroid Autoantibodies Using Indirect Immunofluorescence
   Assay, Indirect Hemagglutination Assay, Radioimmunoasay, and
   Enzyme Linked Immunosorbent Assay
----------------------------------------------------------------------------------------------------------------
  Review Criteria for In Vitro Diagnostic Devices that Utilize        Do
   Cytogenetic In Situ Hybridization Technology for the Detection of
   Human Genetic Mutations (Germ Line and Somatic)
----------------------------------------------------------------------------------------------------------------
  Review Criteria for the Assessment of Anti-Nuclear Antibodies In-   Do
   Vitro Diagnostic Devices Using Class II Special Controls Guidance
   Document: Antimicrobial Susceptibility Test Systems; Guidance for
   Industry and FDA
----------------------------------------------------------------------------------------------------------------
  Draft Review Criteria for Nucleic Acid Amplification Based In       Do
   Vitro Diagnostic Devices for Direct Detection of Infectious
   Microorganisms
----------------------------------------------------------------------------------------------------------------
  Premarket Approval Applications for In Vitro Diagnostic Devices     Do
   Pertaining to Hepatitis C Viruses
----------------------------------------------------------------------------------------------------------------

[[Page 41529]]


  Assays Intended for Diagnosis, Prognosis, or Monitoring of          Do
   Hepatitis C Virus Infection, Hepatitis C, or Other Hepatitis C-
   Associated Disease; Draft Guidance for Industry FDA
----------------------------------------------------------------------------------------------------------------
  Review Criteria for Assessment of Antimicrobial Susceptibility      Do
   Test Discs
----------------------------------------------------------------------------------------------------------------
  Review Criteria for Assessment of In Vitro Diagnostic Devices for   Do
   Direct Detection of Chlamydiae in Clinical Specimens
----------------------------------------------------------------------------------------------------------------
  Review Criteria for Assessment of In Vitro Diagnostic Devices for   Do
   Direct Detection of Mycobacterium spp. (Tuberculosis)
----------------------------------------------------------------------------------------------------------------
  Review Criteria for Assessment of Laboratory Tests for the          Do
   Detection of Antibodies to Helicobacter Pylori
----------------------------------------------------------------------------------------------------------------
  Review Criteria for Devices Assisting in the Diagnosis of           Do
   Clostriduim Difficile Associated Diseases
----------------------------------------------------------------------------------------------------------------
  Review Criteria for Devices Intended for the Detection of           Do
   Hepatitis B `e' Antigen and Antibody to Hepatitis B `e'
----------------------------------------------------------------------------------------------------------------
  Review Criteria For Premarket Approval of In Vitro Diagnostic       Do
   Devices for Detection of Antibodies to Parvovirus B19
================================================================================================================
Office of Surveillance and Biometrics
================================================================================================================
  Perspectives on Clinical Studies for Medical Device Submissions     Do
   (Statistical)
----------------------------------------------------------------------------------------------------------------
  Premarket Approval Application Review Statistical Checklist         Do
----------------------------------------------------------------------------------------------------------------
  Statistical Aspects of Submissions to FDA: A Medical Device         Do
   Perspective (Also Includes as Appendix the Article ``Observed
   Uses and Abuses of Statistical Procedures in Medical Device
   Submissions'')
----------------------------------------------------------------------------------------------------------------
  Statistical Guidance for Clinical Trials of Nondiagnostic Medical   Do
   Devices
----------------------------------------------------------------------------------------------------------------
  Statistical Guidance on Reporting Results From Studies Evaluating   Do
   Diagnostic Tests; Draft
----------------------------------------------------------------------------------------------------------------
  Medical Device Reporting Guidance Document: Remedial Action         Do
   Exemption; Final
----------------------------------------------------------------------------------------------------------------
  Guidance on Adverse Event Reporting for Hospitals That Reprocess    Do
   Devices Intended by the Original Equipment Manufacturer for
   Single Use
----------------------------------------------------------------------------------------------------------------
  Medical Device Reporting Guidance Document No. 1--Intraocular       Do
   Lenses--E1996004; Final
----------------------------------------------------------------------------------------------------------------
  Common Problems: Baseline Reports and Medwatch Form 3500A           Do
----------------------------------------------------------------------------------------------------------------
  Medical Device Reporting: An Overview; Final                        Do
----------------------------------------------------------------------------------------------------------------
  Instructions for Completing FDA Form 3500A With Coding Manual for   Do
   Form 3500A (MEDWATCH) (Medical Device Reporting); Final
----------------------------------------------------------------------------------------------------------------
  MEDWATCH FDA Form 3500A For Use By User Facilities, Distributors    Do
   and Manufacturers for Mandatory Reporting; Final
----------------------------------------------------------------------------------------------------------------
  Variance From Manufacturer Report Number Format (Medical Device     Do
   Reporting Letter); Final
----------------------------------------------------------------------------------------------------------------
  Instructions for Completing Form 3417: Medical Device Reporting     Do
   Baseline Report (Medical Device Reporting); Final
----------------------------------------------------------------------------------------------------------------
  Medical Device Reporting--Alternative Summary Reporting Program;    Do
   Guidance for Industry
----------------------------------------------------------------------------------------------------------------
  Addendum to the Instructions for Completing FDA Form 3500A With     Do
   Coding Manual (MEDWATCH) (Medical Device Reporting); Final
----------------------------------------------------------------------------------------------------------------
  Needlesticks--Medical Device Reporting Guidance                     Do
----------------------------------------------------------------------------------------------------------------
  Guidance to Sponsors on the Development of a Discretionary          Do
   Postmarket Surveillance Study for Permanent Implantable Cardiac
   Pacemaker Electrodes (Leads)
----------------------------------------------------------------------------------------------------------------

[[Page 41530]]


  Guidance on Criteria and Approaches for Postmarket Surveillance     Do
----------------------------------------------------------------------------------------------------------------
  Guidance on Procedures to Determine Application of Postmarket       Do
   Surveillance Strategies (Food and Drug Administration
   Modernization Act); Final
----------------------------------------------------------------------------------------------------------------
  Guidance on Procedures for Review of Postmarket Surveillance        Do
   Submissions (Food and Drug Administration Modernization Act);
   Final
----------------------------------------------------------------------------------------------------------------
  Guidance for Industry and FDA Staff-- Safe Medical Devices Act of   Do
   1990 to Food and Drug Administration Modernization Act: Guidance
   on FDA's Transition Plan for Existing Postmarket Surveillance
   Protocols (Food and Drug Administration Modernization Act); Final
----------------------------------------------------------------------------------------------------------------
  Amendment to Guidance on Discretionary Postmarket Surveillance on   Do
   Pacemaker Leads; Final
----------------------------------------------------------------------------------------------------------------
  Guidance for Industry on the Testing of Metallic Plasma Sprayed     Do
   Coatings on Orthopedic Implants to Support Reconsideration of
   Postmarket
================================================================================================================
Office of Compliance
================================================================================================================
  Perspectives on Clinical Studies for Medical Device Submissions     Do
   (Statistical)
----------------------------------------------------------------------------------------------------------------
  Commercial Distribution/Exhibit Letter                              Do
----------------------------------------------------------------------------------------------------------------
  FDA Guide for Validation of Biological Indicator Incubation Time    Do
----------------------------------------------------------------------------------------------------------------
  Guide for Establishing and Maintaining a Calibration Constancy      Do
   Intercomparison System for Microwave Oven Compliance Survey
   Instruments (FDA 88-8264)
----------------------------------------------------------------------------------------------------------------
  General Principles of Software Validation; Draft Guidance           Do
----------------------------------------------------------------------------------------------------------------
  Guidance on Medical Device Tracking (Food and Drug Administration   Do
   Modernization Act); Guidance for Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
  Compliance Program Guidance Manual: Inspection of Medical Devices;  Do
   Draft
----------------------------------------------------------------------------------------------------------------
  Procedures for Laboratory Compliance Testing of Television          Do
   Revivers--Part of Television Packet
----------------------------------------------------------------------------------------------------------------
  Guidance on Quality System Regulation Information for Various       Do
   Premarket Submissions; Draft
----------------------------------------------------------------------------------------------------------------
  Surveillance and Detention without Physical Examination of          Do
   Surgeons' and/or Patient Examination Gloves; Guidance for
   Industry
----------------------------------------------------------------------------------------------------------------
  Manufacturers/Assemblers of Diagnostic X-Ray Systems: Enforcement   Do
   Policy for Positive-Beam Limitation Requirements in 21 CFR
   1020.31 g)
----------------------------------------------------------------------------------------------------------------
  Guidance for the Submission of Initial Reports on Diagnostic X-Ray  Do
   Systems and Their Major Components
----------------------------------------------------------------------------------------------------------------
  Exemption From Reporting and Recordkeeping Requirements for         Do
   Certain Sunlamp Product Manufacturers
----------------------------------------------------------------------------------------------------------------
  Letter to Medical Device Industry on Endoscopy and Laparoscopy      Do
   Accessories (Galdi)
----------------------------------------------------------------------------------------------------------------
  Clarification of Radiation Control Regulations for Diagnostic X-    Do
   Ray Equipment (FDA 89-8221)
----------------------------------------------------------------------------------------------------------------
  Compliance Policy Guide 7133.19: Retention of Microwave Oven Test   Do
   Record/Cover Letter: August 24, 1981, Retention of Records
   Required by 21 CFR Part 1002
----------------------------------------------------------------------------------------------------------------
  Guidance for the Submission of Abbreviated Radiation Safety         Do
   Reports on Cephalometric X-Ray Devices: Defined as Dental Units
   With an Attachment for Mandible Work That Holds a Cassette and
   Beam Limiting Device
----------------------------------------------------------------------------------------------------------------
  A Guide for the Submission of an Abbreviated Radiation Safety       Do
   Report on X-Ray Tables, Cradles, Film Changers or Cassette
   Holders Intended for Diagnostic Use
----------------------------------------------------------------------------------------------------------------
  A Guide for the Submission of Abbreviated Radiation Safety Reports  Do
   on Image Receptor Support Devices for Mammography X-Ray Systems
----------------------------------------------------------------------------------------------------------------

[[Page 41531]]


  Compliance Program Guidance Manual: Field Compliance Testing of     Do
   Diagnostic (Medical) X-Ray Equipment; Guidance for FDA Staff
----------------------------------------------------------------------------------------------------------------
  Information Disclosure by Manufacturers to Assemblers for           Do
   Diagnostic X-Ray Systems; Final Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
  Guide for Submission of Information on Accelerators Intended to     Do
   Emit X-Radiation Required Under 21 CFR 1002.10
----------------------------------------------------------------------------------------------------------------
  Abbreviated Report on Radiation Safety for Microwave Products       Do
   (Other Than Microwave Ovens) (e.g., Microwave Heating, Microwave
   Diathermy, Rheumatoid Factor Sealers, Induction, Dielectric
   Heaters, Security Systems)
----------------------------------------------------------------------------------------------------------------
  Guide for Preparing Reports on Radiation Safety of Microwave Ovens  Do
----------------------------------------------------------------------------------------------------------------
  Guide for Filing Annual Reports for X-Ray Components and Systems    Do
----------------------------------------------------------------------------------------------------------------
  Reporting and Compliance Guide for Television Products Including    Do
   Product Report, Supplemental Report, Radiation Safety Abbreviated
   Report, Annual Report, Information and Guidance
----------------------------------------------------------------------------------------------------------------
  Revised Guide for Preparing Annual Reports on Radiation Safety      Do
   Testing of Laser and Laser Light Show Products (Replaces FDA 82-
   8127)
----------------------------------------------------------------------------------------------------------------
  Guide for Preparing Abbreviated Reports of Microwave and            Howard W. Cyr, Center for Devices and
   Rheumatoid Factor-Emitting Electronic Products Intended for         Radiological Health (HFZ-114), Food and
   Medical Use                                                         Drug Administration, 9200 Corporate
                                                                       Blvd., Rockville, MD 20850, 301-796-0297
----------------------------------------------------------------------------------------------------------------
  Letter to Manufacturers and Importers of Microwave Ovens:           Do
   Information Requirements for Cookbooks and User and Service
   Manuals
----------------------------------------------------------------------------------------------------------------
  Abbreviated Report on Radiation Safety of Non-Medical Ultrasonic    Do
   Products
----------------------------------------------------------------------------------------------------------------
  Guide for Preparing Product Reports for Medical Ultrasound          Do
   Products
----------------------------------------------------------------------------------------------------------------
  Letter to Manufacturers, Distributors and Importers of Condom       Do
   Products
----------------------------------------------------------------------------------------------------------------
  Letter to Manufacturers, Importers, and Repackagers of Condoms for  Do
   Contraception or Sexually-Transmitted Disease Prevention (Holt)
----------------------------------------------------------------------------------------------------------------
  Letter to Condom Manufacturers and Distributors                     Do
----------------------------------------------------------------------------------------------------------------
  Letter to Manufacturers/Repackers Using Cotton                      Do
----------------------------------------------------------------------------------------------------------------
  Guide for Preparing Product Reports for Lasers and Products         Do
   Containing Lasers
----------------------------------------------------------------------------------------------------------------
  Compliance Guide for Laser Products (FDA 86-8260)                   Do
----------------------------------------------------------------------------------------------------------------
  Condoms: Inspection and Sampling at Domestic Manufacturers and of   Do
   All Repackers; Sampling From All Importers (Damaska Memo to Field
   on April 8, 1987)
----------------------------------------------------------------------------------------------------------------
  Dental Hand Piece Sterilization (Dear Doctor Letter)                Do
----------------------------------------------------------------------------------------------------------------
  Latex Labeling Letter (Johnson)                                     Do
----------------------------------------------------------------------------------------------------------------
  Pesticide Regulation Notice 94-4:Interim Measures for the           Do
   Registration of Antimicrobial Products/Liquid Chemical Germicides
   With Medical Device Use Claims Under the Memorandum of
   Understanding Between the Environmental Protection Agency and the
   Food and Drug Administration
----------------------------------------------------------------------------------------------------------------
  Guide for Preparing Product Reports for Lasers and Products         ..........................................
   Containing Lasers
----------------------------------------------------------------------------------------------------------------
  Letter to Industry, Powered Wheelchair Manufacturers From RM        Do
   Johnson
----------------------------------------------------------------------------------------------------------------
  Hazards of Volume Ventilators and Heated Humidifiers                Do
----------------------------------------------------------------------------------------------------------------
  Manufacturers and Initial Distributors of Sharps Containers and     Do
   Destroyers Used by Health Care Professionals
----------------------------------------------------------------------------------------------------------------
  Ethylene Oxide; Ethylene Chlorohydrin; and EthyleneGlycol:          Do
   Proposed Maximum Residue Limits and Maximum Levels of Exposure
----------------------------------------------------------------------------------------------------------------
  Letter to: Manufacturers and Users of Lasers for Refractive         Do
   Surgery (Excimer)
----------------------------------------------------------------------------------------------------------------

[[Page 41532]]


  Shielded Trocars and Needles Used for Abdominal Access During       Do
   Laparoscopy Surveillance and Detention Without Physical
   Examination of Condoms; Guidance for Industry; Draft
----------------------------------------------------------------------------------------------------------------
  All U.S. Condom Manufacturers, Importers and Repackagers            Do
----------------------------------------------------------------------------------------------------------------
  Manufacturers and Initial Distributors of Hemodialyzers             Do
----------------------------------------------------------------------------------------------------------------
  Laser Light Show Safety--Who's Responsible? (FDA 86-8262)           Do
----------------------------------------------------------------------------------------------------------------
  Suggested State Regulations for Control of Radiation--Volume II     Do
   Nonionizing Radiation--Lasers (FDA Publication No. 83-8220)
----------------------------------------------------------------------------------------------------------------
  Letter to All Foreign Manufacturers and Importers of Electronic     Do
   Products for Which Applicable FDA Performance Standards Exist
----------------------------------------------------------------------------------------------------------------
  Guide for Submission of Information on Industrial X-Ray Equipment   Do
   Required Under 21 CFR 1002.10
----------------------------------------------------------------------------------------------------------------
  Guidance for the Submission of Cabinet X-Ray System Reports Under   Do
   21 CFR 1020.40
----------------------------------------------------------------------------------------------------------------
  Guide for Preparing Annual Reports on Radiation Safety Testing of   Do
   Electronic Products (General)
----------------------------------------------------------------------------------------------------------------
  Computerized Devices/Processes Guidance--Application of the         Do
   Medical Device Good Manufacturing Practice to Computerized
   Devices and Manufacturing Processes
----------------------------------------------------------------------------------------------------------------
  Guide for Preparing Product Reports for Ultrasonic Therapy          Do
   Products (Physical Therapy Only)
----------------------------------------------------------------------------------------------------------------
  Guide for Submission of Information on Industrial Radiofrequency    Do
   Dielectric Heater and Sealer Equipment Unter 21 CFR 1002.10 and
   1002.12 (FDA 81-8137)
----------------------------------------------------------------------------------------------------------------
  Guide for Preparing Annual Reports for Ultrasonic Therapy Products  Do
----------------------------------------------------------------------------------------------------------------
  Guide for Preparing Annual Reports on Radiation Safety Testing of   Do
   Sunlamps and Sunlamp Products (Replaces FDA 82-8127)
----------------------------------------------------------------------------------------------------------------
  Guide for Preparing Annual Reports on Radiation Safety Testing of   Do
   Mercury Vapor (Replaces FDA 82-8127) Quality Control Guide for
   Sunlamp Products (FDA 88-8234)
----------------------------------------------------------------------------------------------------------------
  Guide for the Submission of Initial Reports on Computed Tomography  Do
   X-Ray Systems
----------------------------------------------------------------------------------------------------------------
  Guide for Preparing Product Reports on Sunlamps and Sunlamp         Do
   Products (21 CFR Part 1002)
----------------------------------------------------------------------------------------------------------------
  Letter: Policy on Maximum Timer Interval and Exposure Schedule for  Do
   Sunlamp Products
----------------------------------------------------------------------------------------------------------------
  Reporting Guide for Product Reports on High Intensity Mercury       Do
   Vapor Discharge Lamps (21 CFR Part 1002)
----------------------------------------------------------------------------------------------------------------
  Quality Control Practices for Compliance With the Federal Mercury   Do
   Vapor Lamp Performance Standard
----------------------------------------------------------------------------------------------------------------
  Keeping Up With the Microwave Revolution (FDA Publication No. 91-   Do
   4160)
----------------------------------------------------------------------------------------------------------------
  Quality Assurance Guidelines for Hemodialysis Devices               Do
----------------------------------------------------------------------------------------------------------------
  Letter to Manufacturers and Importers of Microwave Ovens--Open      Do
   Door Operation of Microwave Ovens as a Result of Oven Miswiring
----------------------------------------------------------------------------------------------------------------
  Reporting of New Model Numbers to Existing Model Families           Do
----------------------------------------------------------------------------------------------------------------
  Import: Radiation-Producing Electronic Products (FDA 89-8008)       Do
----------------------------------------------------------------------------------------------------------------
  Unsafe Patient Lead Wires and Cables                                Do
----------------------------------------------------------------------------------------------------------------
  Application of a Variance from 21 CFR 1040.11(c) for a Laser Light  Do
   Show, Display, or Device (Form FDA 3147)
----------------------------------------------------------------------------------------------------------------
  Letter to Trade Association: Reuse of Single-Use or Disposable      Do
   Medical Devices
----------------------------------------------------------------------------------------------------------------

[[Page 41533]]


  Design Control Guidance for Medical Device Manufacturers            Do
----------------------------------------------------------------------------------------------------------------
  Keeping Medical Devices Safe From Electromagnetic Interference      Do
----------------------------------------------------------------------------------------------------------------
  Safety of Electrically Powered Products: Letter to Medical Devices  Do
   and Electronic Products Manufacturers From Lilliam Gill and Bruce
   H. Burlington Correction Memo
----------------------------------------------------------------------------------------------------------------
  Enforcement Priorities for Single-Use Deices Reprocessed by Third   Do
   Parties and Hospitals: Guidance for Industry and for FDA Staff
----------------------------------------------------------------------------------------------------------------
  Labeling for Electronic Anti-Theft Systems; Guidance for Industry;  Do
   Final
----------------------------------------------------------------------------------------------------------------
  Wireless Medical Telemetry Risks and Recommendations, Guidance for  Do
   Industry; Final
----------------------------------------------------------------------------------------------------------------
  Policy on Warning Label Required on Sunlamp Products                Do
----------------------------------------------------------------------------------------------------------------
  Policy on Lamp Compatibility (Sunlamps)                             Do
================================================================================================================
Office of Science and Technology
================================================================================================================
  Perspectives on Clinical Studies for Medical Device Submissions     Do
   (Statistical)
----------------------------------------------------------------------------------------------------------------
  Guidance on Frequently Asked Questions on Recognition of Consensus  Do
   Standards (Food and Drug Administration Modernization Act)
----------------------------------------------------------------------------------------------------------------
  Guidance on the Recognition and Use of Consensus Standards/         Do
   Appendix A (Food and Drug Administration Modernization Act)
----------------------------------------------------------------------------------------------------------------
  Center for Devices and Radiological Health Standard Operating       Do
   Procedures for the Identification and Evaluation of Candidate
   Consensus Standard for Recognition
----------------------------------------------------------------------------------------------------------------
  Guidance for Industry and FDA Reviewers: Guidance on                Do
   Immunotoxicity Testing

                               IV. CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

CATEGORY--ADVERTISING
================================================================================================================
  Promotion of Combination Oral Contraceptive Products                Nancy E. Derr, Center for Drug Evaluation
                                                                       and Research (HFD-5), Food and Drug
                                                                       Administration, 5515 Security Lane,
                                                                       Rockville, MD 20852, 301-594-5400
================================================================================================================
CATEGORY--CHEMISTRY
================================================================================================================
  Documentation for Antibiotics and Other Cellular Metabolites        Do
   Produced by Microorganisms Modified Using Recombinant DNA
   Technology
================================================================================================================
CATEGORY--CLINICAL/MEDICAL
================================================================================================================
  Acne Vulgaris                                                       Do
----------------------------------------------------------------------------------------------------------------
  Ankylosing Spondylitis                                              Do
----------------------------------------------------------------------------------------------------------------
  Antifungal                                                          Do
----------------------------------------------------------------------------------------------------------------
  Chemoprevention of Sporadic Colorectal Adenomas                     Do
----------------------------------------------------------------------------------------------------------------
  Clinical Evaluation of Analgesic Drug Products                      Do
----------------------------------------------------------------------------------------------------------------
  Clinical Evaluation of Drugs for Neuropathic Pain                   Do
----------------------------------------------------------------------------------------------------------------
  Clinical Evaluation of Drugs for Neuropathy                         Do
----------------------------------------------------------------------------------------------------------------
  Clinical Evaluation of Opiate Analgesic Drug Products               Do
----------------------------------------------------------------------------------------------------------------
  Clinical Trial Design for the Treatment of Allergic Conjunctivitis  Do
----------------------------------------------------------------------------------------------------------------
  Clinical Trial Design for the Treatment of Bacterial Blepharitis    Do
----------------------------------------------------------------------------------------------------------------
  Clinical Trial Design for the Treatment of Bacterial                Do
   Conjunctivitis
----------------------------------------------------------------------------------------------------------------
  Clinical Trial Design for the Treatment of Choroidal                Do
   Neovascularization
----------------------------------------------------------------------------------------------------------------
  Clinical Trial Design for the Treatment of Diabetic Macular Edema   Do
----------------------------------------------------------------------------------------------------------------

[[Page 41534]]


  Clinical Trial Design for the Treatment of Diabetic Retinopathy     Do
----------------------------------------------------------------------------------------------------------------
  Clinical Trial Design for the Treatment of Dry Eye                  Do
----------------------------------------------------------------------------------------------------------------
  Clinical Trial Design for the Treatment of Elevated Intraocular     Do
   Pressure
----------------------------------------------------------------------------------------------------------------
  Clinical Trail Design for the Treatment of Iritis                   Do
----------------------------------------------------------------------------------------------------------------
  Clinical Trail Design for the Treatment of Macular Edema            Do
   (Secondary to Inflammation)
----------------------------------------------------------------------------------------------------------------
  Clinical Trail Design for the Treatment of Macular Edema            Do
   (Secondary to a Vascular Event)
----------------------------------------------------------------------------------------------------------------
  Clinical Trail Design for the Treatment of Post-Cataract            Do
   Inflammation
----------------------------------------------------------------------------------------------------------------
  Clinical Trail Design for the Treatment of Posterior Uveitis        Do
----------------------------------------------------------------------------------------------------------------
  Clinical Trial Design for the Treatment of Superficial Punctate     Do
   Keratitis
----------------------------------------------------------------------------------------------------------------
  Chemistry, Manufacturing, and Control, Preclinical, and Clinical    Do
   Development of Decorporation Agents for the Treatment of Internal
   Radioactive Contamination
----------------------------------------------------------------------------------------------------------------
  Corticosteroid Induced Adrenal Suppression                          Do
----------------------------------------------------------------------------------------------------------------
  Development of Drugs for Chronic Obstructive Pulmonary Disease      Do
----------------------------------------------------------------------------------------------------------------
  Developing Antiviral Drugs for the Treatment of Smallpox            Do
----------------------------------------------------------------------------------------------------------------
  Drug-Coated Cardiovascular Stents                                   Do
----------------------------------------------------------------------------------------------------------------
  Evaluation of New Treatments for Diabetes Mellitus                  Do
----------------------------------------------------------------------------------------------------------------
  Gingivitis                                                          Do
----------------------------------------------------------------------------------------------------------------
  Intraocular Pressure Lowering                                       Do
----------------------------------------------------------------------------------------------------------------
  Oral Mucositis                                                      Do
----------------------------------------------------------------------------------------------------------------
  Patient Reported Outcomes                                           Do
----------------------------------------------------------------------------------------------------------------
  Periodontitis                                                       Do
----------------------------------------------------------------------------------------------------------------
  Psoriasis                                                           Do
----------------------------------------------------------------------------------------------------------------
  Safety Review of Clinical Data                                      Do
----------------------------------------------------------------------------------------------------------------
  System Lupus Erythematosus                                          Do
----------------------------------------------------------------------------------------------------------------
  Premarketing Risk Assessment                                        Do
----------------------------------------------------------------------------------------------------------------
  Development and Use of Risk Minimization Action Plans               Do
----------------------------------------------------------------------------------------------------------------
  Good Pharmacovigilance Practices and Pharmacoepidemiologic          Do
   Assessment
----------------------------------------------------------------------------------------------------------------
  Coronary Drug-Eluting Stents                                        Do
----------------------------------------------------------------------------------------------------------------
  Pharmacogenomic Combination Products                                Do
----------------------------------------------------------------------------------------------------------------
  42. Centralized Institutional Review Boards in Multi-Center Trials  Do
================================================================================================================
CATEGORY--CLINICAL/PHARMACOLOGY
================================================================================================================
  Clinical Lactation Studies--Study Design, Data Analysis, and        Do
   Recommendations for Labeling
----------------------------------------------------------------------------------------------------------------
  Immediate Release to Modified Release Dosage Forms                  Do
----------------------------------------------------------------------------------------------------------------
  In Vitro Drug Metabolism/Drug Interaction--Guidance for Reviewers   Do
----------------------------------------------------------------------------------------------------------------
  Pharmacokinetics in Pregnancy--Study Design, Data Analysis, and     Do
   Impact on Dosing and Labeling
================================================================================================================
CATEGORY--COMPLIANCE
================================================================================================================

[[Page 41535]]


  Describing How Positron Emission Tomography Drug Products May       Do
   Comply With New Current Good Manufacturing Practice Requirements
----------------------------------------------------------------------------------------------------------------
  Expiration Dating of Unit-Dose Repackaged Drugs                     Do
----------------------------------------------------------------------------------------------------------------
  Maintaining Adequate and Accurate Records During Clinical           Do
   Investigations
----------------------------------------------------------------------------------------------------------------
  Current Good Manufacturing Practice For Investigational New Drug    Do
   and Biological Products--Phase I Testing
================================================================================================================
CATEGORY--ELECTRONIC SUBMISSIONS
================================================================================================================
  Standards for Clinical Data Submissions                             Do
================================================================================================================
CATEGORY--GENERICS
================================================================================================================
  Abbreviated New Drug Applications Suitability Petitions             Do
----------------------------------------------------------------------------------------------------------------
  Bioequivalence Studies with Clinical Endpoints for Vaginal          Do
   Antifungal Drug Products
----------------------------------------------------------------------------------------------------------------
  Defining the Term ``Listed Drug'' With Respect to Amendments and    Do
   Supplements to Abbreviated New Drug Applications and Section
   505(b)(2) Applications
----------------------------------------------------------------------------------------------------------------
  Abbreviated New Drug Applications: Pharmaceutical Solid             Do
   Polymorphism
================================================================================================================
CATEGORY--GOOD REVIEW PRACTICES
================================================================================================================
  General Clinical Review Template                                    Do
================================================================================================================
CATEGORY--INVESTIGATIONAL NEW DRUG APPLICATION
================================================================================================================
  Consumer Product Safety Commission--Tamper Resistant Packaging for  Do
   Investigational New Drugs
----------------------------------------------------------------------------------------------------------------
  End of Phase 2 Meetings                                             Do
----------------------------------------------------------------------------------------------------------------
  Pediatric Safety and Efficacy Data in Investigational New Drugs     Do
----------------------------------------------------------------------------------------------------------------
  Exploratory Investigational New Drugs: Preclinical and Clinical     Do
   Considerations
================================================================================================================
CATEGORY--LABELING
================================================================================================================
  Content and Format of the Clinical Pharmacology Section             Do
----------------------------------------------------------------------------------------------------------------
  Content and Format of the Dosage and Administration Section of the  Do
   Prescription Drug Labeling
----------------------------------------------------------------------------------------------------------------
  Content and Format of the Warnings and Precautions,                 Do
   Contraindications, and Boxed Warning Sections of Prescription
   Drug Labeling
----------------------------------------------------------------------------------------------------------------
  Drug Names and Dosage Forms                                         Do
----------------------------------------------------------------------------------------------------------------
  Implementing the New Content and Format Requirements for            Do
   Prescription Drug Labeling
----------------------------------------------------------------------------------------------------------------
  Labeling Dietary Supplements for Women Who Are or Could Be          Do
   Pregnant
----------------------------------------------------------------------------------------------------------------
  Pregnancy Labeling Revisions                                        Do
----------------------------------------------------------------------------------------------------------------
  Submitting Proprietary Names for Evaluation                         Do
================================================================================================================
CATEGORY--OVER-THE-COUNTER
================================================================================================================
  Actual Use Trials                                                   Do
----------------------------------------------------------------------------------------------------------------
  Labeling Comprehension Studies for Over-the-Counter Drug Products   Do
----------------------------------------------------------------------------------------------------------------
  Labeling for Over-the-Counter Human Drug Products                   Do
----------------------------------------------------------------------------------------------------------------
  Labeling of Over-the-Counter Skin Protectant Products               Do
----------------------------------------------------------------------------------------------------------------
  Labeling Over-the-Counter Human Drug Products; Questions and        Do
   Answers
================================================================================================================
CATEGORY--PHARMACOLOGY/TOXICOLOGY
================================================================================================================

[[Page 41536]]


  Drug-Induced Vascular Injury                                        Do
================================================================================================================
CATEGORY--PROCEDURAL
================================================================================================================
  Assessment of Abuse Potential of Drugs                              Do
----------------------------------------------------------------------------------------------------------------
  Development of a Drug and Pharmacogenetic Test                      Do
----------------------------------------------------------------------------------------------------------------
  Dispute Resolution Involving Pediatric Labeling                     Do
----------------------------------------------------------------------------------------------------------------
  Exocrine Pancreatic Insufficiency Drug Products--Submitting New     Do
   Drug Applications
----------------------------------------------------------------------------------------------------------------
  How to Comply With the Pediatric Research Equity Act                Do
----------------------------------------------------------------------------------------------------------------
  How to Determine if Human Research With a Radioactive Drug Can Be   Do
   Conducted Under a Radioactive Drug Research Committee
----------------------------------------------------------------------------------------------------------------
  Process for Contracts and Written Requests Under the Best           Do
   Pharmaceutical for Children Act
----------------------------------------------------------------------------------------------------------------
  Qualifying for Pediatric Exclusivity Under Section 505A of the      Do
   Federal Food, Drug, and Cosmetic Act

                             V. Center for Food Safety and Applied Nutrition (CFSAN)

CATEGORY--DIETARY SUPPLEMENTS
================================================================================================================
  Labeling Dietary Supplements for Women Who Are or Could Be          Linda Pellicore, Center for Food Safety
   Pregnant                                                            and Applied Nutrition (HFS-810), Food and
                                                                       Drug Administration, 5100 Paint Branch
                                                                       Pkwy., College Park, MD 20740, 301-436-
                                                                       1448, FAX 301-436-2636,
                                                                       Linda.Pellicore@cfsan.fda.gov
----------------------------------------------------------------------------------------------------------------
  Dietary Supplements: 75-Day Premarket Notifications for New         Do
   Dietary Ingredients
----------------------------------------------------------------------------------------------------------------
  Substantiation Health Claims Guidance                               Do
================================================================================================================
CATEGORY--FOOD ADDITIVE SAFETY
================================================================================================================
  Final Guidance on Electronic Submissions of Food and Color          George Pauli, Center for Food Safety and
   Additive Petitions (Level 1)                                        Applied Nutrition (HFS-200), Food and
                                                                       Drug Administration, 5100 Paint Branch
                                                                       Pkwy., College Park, MD 20740
----------------------------------------------------------------------------------------------------------------
  Presence of Unintended Varieties of Bioengineered Plant Foods in    Do
   the Food Supply (Level 1)
----------------------------------------------------------------------------------------------------------------
  Chloropropanols Compliance Policy Guides Guidance                   Do
================================================================================================================
CATEGORY--CONSTITUENT OPERATIONS
================================================================================================================
  Equivalence Level 1 Guidance                                        Cathy Carneval, Center for Food Safety and
                                                                       Applied Nutrition (HFS-550), Food and
                                                                       Drug Administration, 5100 Paint Branch
                                                                       Pkwy., College Park, MD 20740
================================================================================================================
CATEGORY--OFFICE OF COMPLIANCE
================================================================================================================
  Prior Notice of Imported Food Products--Questions and Answers       May Nelson, Center for Food Safety and
                                                                       Applied Nutrition (HFS-22), Food and Drug
                                                                       Administration, 5100 Paint Branch Pkwy.,
                                                                       College Park, MD 20740

                                    VI. CENTER FOR VETERINARY MEDICINE (CVM)

CATEGORY--NEW ANIMAL DRUG APPLICATIONS
================================================================================================================
  Administrative New Animal Drug Application Process (132)   Gail Schmerfeld, Center for Veterinary
                                                                       Medicine (HFV-100), Food and Drug
                                                                       Administration, 7500 Standish Pl., rm.
                                                                       384, Metropark North II, Rockville, MD
                                                                       20855, 301-827-1796, gschmer1@cvm.fda.gov
----------------------------------------------------------------------------------------------------------------

[[Page 41537]]


  Waivers of In Vivo Demonstration of Bioequivalence of Certain       Marilyn Martinez, Center for Veterinary
   Animal Drugs in Soluble Powder Oral Dosage Form Products and Type   Medicine (HFV-130), Food and Drug
   A Medicated Articles (171)                                 Administration, 7500 Standish Pl., rm.
                                                                       332, Metropark North II, Rockville, MD
                                                                       20855, 301-827-7577, mmartin1@cvm.fda.gov
================================================================================================================
CATEGORY--LABELING
================================================================================================================
  Manufacture and Labeling of Raw Meat Diets for Consumption by       William Burkholder, Center for Veterinary
   Dogs, Cats, and Captive Noncompanion Animal Carnivores and          Medicine (HFV-228), Food and Drug
   Omnivores (122)                                            Administration, 7500 Standish Pl., rm.
                                                                       413, Metropark North II, Rockville, MD
                                                                       20855, 301-827-0179, bburkhol@cvm.fda.gov
----------------------------------------------------------------------------------------------------------------
  Content and Format for Labeling of New Animal Drug Products         Douglass Oeller, Center for Veterinary
   (134)                                                      Medicine (HFV-112), Food and Drug
                                                                       Administration, 7500 Standish Pl., rm.
                                                                       324, Metropark North II, Rockville, MD
                                                                       20855, 301-827-0131, doeller@cvm.fda.gov
================================================================================================================
CATEGORY--STATUTORY REQUIREMENTS
================================================================================================================
  Dispute Resolution--FDA Modernization Act (79)             Marcia Larkins, Center for Veterinary
                                                                       Medicine (HFV-1), Food and Drug
                                                                       Administration, 7519 Standish Pl., rm.
                                                                       165, Metropark North IV, Rockville, MD
                                                                       20855, 301-827-4535, mlarkins@cvm.fda.gov
----------------------------------------------------------------------------------------------------------------
  Animal Drug Sponsor Fees Under the Animal Drug User Fee Act         David Newkirk, Center for Veterinary
   (173)                                                      Medicine (HFV-100), Food and Drug
                                                                       Administration, 7500 Standish Pl., rm.
                                                                       390, Metropark North II, Rockville, MD
                                                                       20855, 301-827-6967, dnewkirk@cvm.fda.gov
----------------------------------------------------------------------------------------------------------------
  Chemistry, Manufacturing, and Control Changes to an Approved New    Dennis Bensley, Center for Veterinary
   Animal Drug Application or Abbreviated New Drug Applications        Medicine (HFV-143), Food and Drug
   (83)                                                       Administration, 7500 Standish Pl., rm.
                                                                       320, Metropark North II, Rockville, MD
                                                                       20855, 301-827-6956, dbensley@cvm.fda.gov
================================================================================================================
CATEGORY--INTERNATIONAL HARMONIZATION
================================================================================================================
  GL-27: Preapproval Information for Registration of New Veterinary   William T. Flynn, Center for Veterinary
   Medicinal Products for Food-Producing Animals With Respect to       Medicine (HFV-2), Food and Drug
   Antimicrobial Resistance (144)                             Administration, 7519 Standish Pl., rm.
                                                                       173, Metropark North IV, Rockville, MD
                                                                       20855, 301-827-4514, wflynn@cvm.fda.gov
----------------------------------------------------------------------------------------------------------------
  GL-28: Studies to Evaluate the Safety of Residues of Veterinary     Thomas Mulligan, Center for Veterinary
   Drugs in Human Food: Carcinogenicity Testing (141)         Medicine (HFV-153), Food and Drug
                                                                       Administration, rm. E375, Metropark North
                                                                       II, 7500 Standish Pl., Rockville, MD
                                                                       20855, 301-827-6984, tmulliga@cvm.fda.gov
----------------------------------------------------------------------------------------------------------------
  GL-33: Studies to Evaluate the Safety of Residues of Veterinary     Do
   Drugs in Human Food: General Approach to Testing (149)
----------------------------------------------------------------------------------------------------------------
  GL-36: Studies to Evaluate the Safety of Residues of Veterinary     Do
   Drugs in Human Food: General Approach to Establish a
   Microbiological Acceptable Daily Intake (159)
----------------------------------------------------------------------------------------------------------------
  GL-37 Studies to Evaluate the Safety of Residues of Veterinary      Do
   Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing
   (160)
----------------------------------------------------------------------------------------------------------------
  GL-38 Environmental Impact Assessments for Veterinary Medicinal     Charles Eirkson, Center for Veterinary
   Products--Phase II (166)                                   Medicine (HFV-103), Food and Drug
                                                                       Administration, rm. 137, Metropark North
                                                                       IV, 7500 Standish Pl., Rockville, MD
                                                                       20855, 301-827-8561, ceirkson@cvm.fda.gov
================================================================================================================
CATEGORY--TARGET ANIMAL SAFETY AND EFFECTIVENESS
================================================================================================================

[[Page 41538]]


  Development of Target Animal Safety and Effectiveness Data to       Linda Wilmot, Center for Veterinary
   Support Approval of Non-Steroidal Anti-Inflammatory Drugs for Use   Medicine (HFV-114), Food and Drug
   in Animals (123)                                           Administration, 7500 Standish Pl., rm.
                                                                       N316, Metropark North II, Rockville, MD
                                                                       20855, 301-827-0135, lwilmot@cvm.fda.gov
================================================================================================================
CATEGORY--HUMAN FOOD SAFETY
================================================================================================================
  Dioxin in Minerals Used in Animal Feed (161)               Gloria Dunnavan, Center for Veterinary
                                                                       Medicine (HFV-230), Food and Drug
                                                                       Administration, 7500 Standish Pl., rm.
                                                                       E480, Metropark North II, Rockville, MD
                                                                       20855, 301-827-1168, gdunnava@cvm.fda.gov
----------------------------------------------------------------------------------------------------------------
  Salmonella Contamination of Feeds Compliance Policy Guide           Henry Ekperigin, Center for Veterinary
                                                                       Medicine (HFV-222), Food and Drug
                                                                       Administration, 7500 Standish Pl., rm.
                                                                       E417, Metropark North II, Rockville, MD
                                                                       20855, 301-827-0174, hekperig@cvm.fda.gov
----------------------------------------------------------------------------------------------------------------
  Bovine Spongiform Encephalopathies Compliance Program               Neal Bataller, Center for Veterinary
                                                                       Medicine (HFV-230), Food and Drug
                                                                       Administration, 7500 Standish Pl., rm.
                                                                       E441, Metropark North II, Rockville, MD
                                                                       20855, 301-827-0163, nbatalle@cvm.fda.gov
----------------------------------------------------------------------------------------------------------------
  Validation of Analytical Procedures for Type C Medicated Feed       Mary G. Leadbetter, Center for Veterinary
   (135)                                                      Medicine (HFV-141), Food and Drug
                                                                       Administration, 7500 Standish Pl., rm.
                                                                       E307, Metropark North II, Rockville, MD
                                                                       20855, 301-827-6964, mleadbet@cvm.fda.gov

                                     VII. OFICE OF REGULATORY AFFAIRS (ORA)

CATEGORY--COMPLIANCE AND INSPECTION
================================================================================================================
  Guidance for Investigators: Investigations Operations Manual        Michael Rogers, Division of Field
                                                                       Investigations (HFC-130), Food and Drug
                                                                       Administration, 5600 Fishers Lane, rm. 13-
                                                                       74, Rockville, MD 20857, 301-827-5653
================================================================================================================
CATEGORY--REGULATORY
================================================================================================================
  Guidance for Food and Drug Administration Staff: Regulatory         Paul Motise, Division of Compliance
   Information Assurance; Good Practices in Converting From Paper to   Information and Quality Assurance (HFC-
   Electronic Processes                                                240), Food and Drug Administration, 1350
                                                                       Piccard Dr., Rockville, MD 20850, 301-827-
                                                                       0383
================================================================================================================
CATEGORY--COMPLIANCE AND INSPECTIONS
================================================================================================================
  Concept Paper on Bioterrorism Act Proposed Guidance to Records      Rudaina Alrefai, Division of Compliance
   Access                                                              Information and Quality Assurance (HFC-
                                                                       240), Food and Drug Administration, 1350
                                                                       Piccard Dr., rm. 400L, Rockville, MD
                                                                       20850, 301-827-0413
================================================================================================================
CATEGORY--GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF
================================================================================================================
  21 CFR Part 58: Good Laboratory Practice, Questions and Answers     James McCormack, Division of Compliance
                                                                       Policy (HFC-230), Food and Drug
                                                                       Administration, 1350 Piccard Dr., rm.
                                                                       400Z, Rockville, MD 20850, 301-827-0425
================================================================================================================
  21 CFR Part 58: Closure of Nonclinical Laboratories                 Rodney Allnutt, Division of Compliance
                                                                       Policy (HFC-230), Food and Drug
                                                                       Administration, 1350 Piccard Dr., rm.
                                                                       400Y, Rockville, MD 20850, 301-827-8860
----------------------------------------------------------------------------------------------------------------
  21 CFR Part 58: Comparison of the Food and Drug Administration,     James McCormack, Division of Compliance
   Environmental Protection Agency, and the Organisation for           Policy (HFC-230), Food and Drug
   Economic and Cooperative Development Good Laboratory Practices      Administration, 1350 Piccard Dr., rm.
                                                                       400Z, Rockville MD 20850, 301-827-0425.
================================================================================================================
CATEGORY--GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION INVESTIGATORS
================================================================================================================

[[Page 41539]]


  Auditing Nonclinical Laboratory Studies                             Do
================================================================================================================
CATEGORY--GUIDANCE FOR FOOD AND DRUG ADMINISTRATION INVESTIGATORS
================================================================================================================
  Necropsy, Tissue Preparation, and Histology in Nonclinical          Do
   Laboratory Studies
================================================================================================================
CATEGORY--COMPLIANCE POLICY GUIDE
================================================================================================================
  Section 394.500, Importation of Television Products, Microwave      Jeffrey Governale, Division of Compliance
   Ovens, and Inherent Class I Laser Products for Investigation and    Policy (HFC-230), Food and Drug
   Evaluation during Design Development (CPG 7133.22)                  Administration, 1350 Piccard Dr., rm.
                                                                       410A, Rockville, MD 20850, 301-827-0411
----------------------------------------------------------------------------------------------------------------
  Section 300.500, Reprocessing and Reuse of Single Use Devices (CPG  Do
   7124.16)
----------------------------------------------------------------------------------------------------------------
  Section 310.210, Blood Pressure Measurement Devices                 Do
   (Sphygmomanometers)--Accuracy (CPG 7124.23)
================================================================================================================
CATEGORY--REGULATORY POLICY MANUAL
================================================================================================================
  Subchapter, Disqualification of Clinical Investigators              James McCormack, Division of Compliance
                                                                       Policy (HFC-230), Food and Drug
                                                                       Administration, 1350 Piccard Dr., rm.
                                                                       400Z, Rockville, MD 20850, 301-827-0425
================================================================================================================
CATEGORY--REGULATORY POLICY MANUAL SUBCHAPTER OR STAFF MANUAL GUIDE
================================================================================================================
  Untrue Statements of Material Facts                                 Sharon Sheehan, Division of Compliance
                                                                       Policy (HFC-230), Food and Drug
                                                                       Administration, 1350 Piccard Dr., rm.
                                                                       450, Rockville, MD 20850, 301-827-0412
================================================================================================================
CATEGORY--REGULATORY POLICY MANUAL SUBCHAPTER
================================================================================================================
  Application Integrity Policy                                        Do
================================================================================================================
CATEGORY--REGULATORY PROCEDURES MANUAL
================================================================================================================
  Chapter 9 Imports                                                   Carl Nielsen, Division of Import
                                                                       Operations (HFC-170), Food and Drug
                                                                       Administration, 5600 Fishers Lane, rm. 12-
                                                                       38, Rockville, MD 20857, 301-443-6553

                                      VIII. OFFICE OF THE COMMISSIONER (OC)

CATEGORY--COMPLIANCE
================================================================================================================
  Guidance for Industry Information Sheets for Institutional Review   David Lepay, Good Clinical Practice
   Boards and Clinical Investigators                                   Program (HF-34), Office of Science and
                                                                       Health Coordination, Food and Drug
                                                                       Administration, 5600 Fishers Lane, rm.
                                                                       9C24, Rockville, MD 20857
----------------------------------------------------------------------------------------------------------------
  Guidance for Industry Computerized Systems Used in Clinical Trials  Do
================================================================================================================
CATEGORY--INSPECTION
================================================================================================================
  Guidance for FDA Staff Compliance Program 7348.811, Inspection of   Do
   Clinical Investigators and Sponsor Investigators
----------------------------------------------------------------------------------------------------------------



[[Page 41540]]

    Dated: June 30, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-15660 Filed 7-8-04; 8:45 am]

BILLING CODE 4160-01-S