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Code · REGISTER · 2004-07-09 · Food and Drug Administration, HHS · Notices

Notices. Notice

11,998 words·~55 min read·/register/2004/07/09/04-15660

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4160-01-S 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://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 Substances and Drug Products Stephen M. Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6210. Design, Installation and Operation of Heating, Ventilation and Air 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 Same as above
(Do)Compliance Program 7341.002—Inspection of Tissue Establishments Do Compliance Program 7342.001—Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors Do Compliance Program 7342.002—Inspection of Source Plasma Establishments Do Compliance Program 7342.008—Inspections of Licensed Viral Marker Test Kits Do Compliance Program 7345.001—Inspection of Center for Biologics Evaluation and Research-Regulated Biological Drug Products Do CATEGORY—CELLULAR, TISSUE, AND GENE THERAPY Submission of Information for the National Xenotransplantation Database Do Guidance for Reviewers: Instructions and Template for Chemistry, Manufacturing, and Controls Reviewers of Human Gene Therapy Investigational New Drug Applications Do Submission of Information for Adverse Event and Annual Reports for Gene Therapy Investigational New Drug Applications Do Eligibility Determination for Donors of Human Cells, Tissue and Cellular and Tissue-Based Products Do 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 Hepatitis C Virus; Testing, Product Disposition, Donor Deferral and Re-entry Do Efficacy, Pharmokinetic, and Safety Studies to Support Marketing of Immune Globulin Intravenous (Human) as a Replacement Therapy for Primary Humoral Immunodeficiency Do Guidance on the Content of Premarket Submissions for Center for Biologics Evaluation and Research-Regulated Automated Instruments and Associated Software Systems for Donor Blood Collection and Screening Do CATEGORY—VACCINES Characterization and Qualification of Cell Substances and Viral Seeds Used to Produce Viral Vaccines Do Preclinical Toxicity Studies for Prophylactic Vaccines Do Immunization Human Plasma Donors to Obtain Source Plasma for Preparation of Specific Immune Globulins Do Content and Format of Chemistry, Manufacturing, and Controls Information and Establishment Description Information for a Vaccine or Related Product Do Content and Format of Chemistry, Manufacturing, and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test Do 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 File Action Do Multi-Product Manufacturing With Spore-Forming Microorganisms Do Good Review Practices—Track IV Do Submission of Chemistry, Manufacturing, and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products Do Submission of Chemistry, Manufacturing, and Control Information for a Therapeutic Recombinant Deoxyribonucleic Acid-Derived Product or a Monoclonal Antibody for In-Vivo Use Do III. CENTER FOR DEVICES AND RADIOLOGICAL HEALTH Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria: Guidance for Industry, FDA Staff and Third Parties John F. Stigi, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-0806 Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry, and Third Parties Do Mutual Recognition Agreement Between the European Union and the United States of America: Confidence Building Programme: Overview and Procedure; Medical Device Annex, Version 7, June 29, 2000; Draft Christine Nelson, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-0806 Regulation of Medical Devices; Background Information for International Officials (Entire Document Available on Disk) Ron Parr, Center for Devices and 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 Programs Under the Sectoral Annex on Medical Devices to the Agreement on Mutual Recognition Between the United States of America and the European Community John F. Stigi, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-0806 Medical Device Appeals and Complaints: A Guidance on Dispute Resolution Do Overview of Food and Drug Administration Modernization Act of 1997 Medical Device Provisions (Food and Drug Administration Modernization Act) Do Medical Device Reporting for Manufacturers Do In Vitro Diagnostic Devices: Guidance for the Preparation of Premarket Notification Submissions (FDA 97-4224) Do Medical Device Quality Systems Manual: A Small Entity Compliance Guide Do Comparison Chart: 1996 Quality System Reg vs. 1978 Good Manufacturing Practices Reg vs. ANSI/ISO/ASQC Q9001 and ISO/DI 13485:1996 (Include 126) Do Premarket Notification: 510(k)—Regulatory Requirements for Medical Devices (FDA 95-4158) Do Labeling—Regulatory Requirements for Medical Devices (FDA 89-4203) Paula G. Silberberg, Center for Devices 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 Devices Intended for Professional Use (Draft) Lily Ng, Center for Devices and 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 Single-Use Devices by Third-Party and Hospital Reprocessors; Three Additional Questions Do Frequently Asked Questions About the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors; Final Guidance for Industry and FDA Staff Paula G. Silberberg, Center for Devices and Radiological Health (HFZ-230), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1217 Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers Do Center for Devices and Radiological Health Manual for the Good Guidance Practices Regulations; Final Guidance for FDA Staff Ron D. Kaye, Center for Devices and Radiological Health (HFZ-205), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3265 Medical Device Use—Safety: Incorporating Human Factors Engineering Into Risk Management; Guidance for Industry and FDA Premarket and Design Control Reviewers Center for Devices and Radiological Health (HFZ-230), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1217 Human Factors Points to Consider for Investigational Device Exemption Devices Alvin W. Thomas, Center for Devices and 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 Devices Walter l. Scott, Center for Devices and 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 Modifications and Additions to Policy Guidance Help System #8 (Incorporated into Policy Guidance Help Systems) Do The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #6; Guidance for Industry and FDA (Incorporated into Policy Guidance Help System) Do The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #7; Guidance for Industry and FDA (Incorporated into Policy Guidance Help System) Do The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #5; Guidance for Industry and FDA (Incorporated into Policy Guidance Help System) Do The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #4; Guidance for Industry and FDA (Incorporated into Policy Guidance Help System) Do Compliance Guidance—The Mammography Quality Standards Act Final Regulations—Preparing for Mammography Quality Standards Act Inspections (Incorporated into Policy Guidance Help System) Do The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #3; Guidance for Industry and FDA (Incorporated into Policy Guidance Help System) Do The Mammography Quality Standards Act Final Regulations 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) Do The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #4; Guidance for Industry and FDA (Incorporated into Policy Guidance Help System) Do The Mammography Quality Standards Act Final Regulations; Modifications and Additions to Policy Guidance Help System #2; Final Guidance for Industry and FDA (Incorporated into Policy Guidance Help System) Do Compliance Guidance—Mammography Facility Survey, Equipment Evaluation and Medical Physicist Qualification Requirements Under MQSA; Final (Incorporated into Policy Guidance Help System) Do Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #3 (Incorporated into Policy Guidance Help System) Do The Mammography Quality Standards Act Final Regulations Modifications to the Policy Guidance Help System #1; Guidance for Industry and FDA (Incorporated into Policy Guidance Help System) Do Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #2 (Incorporated into Policy Guidance Help System) Do Compliance Guidance: The Mammography Quality Standards Act Final Regulations Quality Assurance Documentation (Incorporated into Policy Guidance Help System) Do Guidance for Request and Issuance of Interim Notice Letters for Mammography Facilities Under the Mammography Quality Standards Act (42 U.S.C. 263(b)) (Incorporated into Policy Guidance Help System) Do Compliance Guidance: The Mammography Quality Standards Act Final Regulations Motion of Tube-Image Receptor Assembly (Incorporated into Policy Guidance Help System) Do Guidance: The Mammography Quality Standards Act Final Regulations Document #1 (Incorporated into Policy Guidance Help System) Do Guidance for Industry—Requalification for Interpreting Physician's Continuing Experience Requirement (Incorporated into Policy Guidance Help System) Do Policy and Standard Operating Procedures When Mammography Facilities in States That Have Accreditation Bodies Intend to Change Accreditation Bodies (Incorporated into Policy Guidance Help System) Do Guidance for Review of Requests for Reconsideration of Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Act (42 U.S.C. 263(b)) (April 8, 1998) (Incorporated into Policy Guidance Help System) Paula G. Silberberg, Center for Devices and Radiological Health (HFZ-230), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1217 Guidance for Submission of Request for Reconsideration of Adverse 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) Do Continuing Education Credit for Reading/Writing Articles/Papers and Presenting Courses/Lectures (Incorporated into the Policy Guidance Help System) Do Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations to State and Local Agencies Thomas E. Cardamone, Center for Devices 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 Certification—Guidance for Industry and FDA Joanne R. Less, Center for Devices and 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 for Industry and FDA Staff Heather S. Rosecrans, Center for Devices 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 FDA Staff Joanne R. Less, Center for Devices and Radiological Health (HFZ-403), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190 Premarket Approval Application Filing Review—Guidance for Industry and FDA Staff Center for Devices and Radiological Health (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 Business Qualification Worksheet and Certification Do Assessing User Fees: Premarket Approval Application Supplement 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 Do Determination of Intended Use for 510(k) Devices; Guidance for Center for Devices and Radiological Health Staff Do The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles: Final Guidance for FDA and Industry Thninh Nguyen, Center for Devices and 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 Industry and FDA Robert R. Gatling, Center for Devices and 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 Connection With Center for Devices and Radiological Health Open Public Panel Meetings; Draft Guidance for Industry and FDA Staff Nancy J. Pluhowski, Center for Devices and Radiological Health (HFZ-400), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2022 Humanitarian Device Exemptions Regulation: Questions and Answers; Final Guidance for Industry Heather S. Rosecrans, Center for Devices 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 Investigation; Final Guidance for Industry and Center for Devices and Radiological Health Staff Donna-Bea Tillman, Center for Devices and Radiological Health (HFZ-400), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2022 Early Collaboration Meetings Under the FDA Modernization Act; Final Guidance for Industry and for Center for Devices and Radiological Health Staff Do Deciding When to Submit a 510(k) for a Change to an Existing Wireless Telemetry Medical Device; Final Guidance for FDA Reviewers and Industry Karen F. Warbuton, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1744 Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997 Nicole Wolanski, Center for Devices and 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 Determinations; Final Heather S. Rosecrans, Center for Devices 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 (Except In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry; Final Nicole Wolanski, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186 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 Contained in Medical Devices; Final Do Guidance to Industry Supplements to Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review; Final Do A New 510(k) Paradigm—Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications Do Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices Joanne R. Less, Center for Devices and 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 Supplements for Manufacturing Method or Process Changes, Guidance for Industry and Center for Devices and Radiological Health (Docket 98D-0080); Final Heather S. Rosecrans, Center for Devices and Radiological Health (HFZ-230), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190 Guidance on Premarket Approval Application Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies—for Use by Center for Devices and Radiological Health and Industry; Final Thninh Nguyen, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186 New Section 513(f)(2)—Evaluation of Automatic Class III Designation: Guidance for Industry and Center for Devices and Radiological Health Staff; Final Do Procedures for Class II Device Exemptions From Premarket Notification Guidance for Industry and Center for Devices and Radiological Health Staff; Final Do Guidance on Investigational Device Exemption Policies and Procedures; Final Heather S. Rosecrans, Center for Devices 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 Application Summary of Safety and Effectiveness Data Packages Do Kit Certification for Premarket Notifications Do Convenience Kits Interim Regulatory Guidance Do Real-Time Review Program for Premarket Approval Application Supplements Do Deciding When to Submit a Premarket Notification for a Change to an Existing Device (K97-1) Do Questions and Answers for the FDA Reviewer Guidance: Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities Do Memorandum of Understanding Regarding Patient Labeling Review (blue book memo #G96-3) Do Continued Access to Investigational Devices During Premarket Approval Application Preparation and Review (blue book memo) (D96-1) Do Format for Investigational Device Exemption Progress Reports Do Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance Do Premarket Notification Quality Review Program (blue book memo) Do Suggested Content for Original Investigational Device Exemption Application Cover Letter Do Indications for Use Statement Do Cover Letter: Premarket Notification Requirements During Firm-Initiated Recalls; Attachment A: Guidance on Recall and Premarket Notification Review Procedures During Firm-Initiated Recalls of Legally Marketed Devices (blue book memo #K95-1) Do #D95-2, Attachment A (Interagency Agreement Between FDA & Health Care Financing Administration Do #D95-2, Attachment B (Criteria for Categorization of Investigational Devices Health Care Financing Administration Do Health Care Financing Administration Reimbursement Categorization Determinations for FDA-Approved Investigational Device Exemptions Do Implementation of the FDA/Health Care Financing Administration 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) Do Goals and Initiatives for the Investigational Device Exemption Program #D95-1 (blue book memo) Joanne R. Less, Center for Devices and Radiological Health (HFZ-403), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190 Memorandum: Electromagnetic Compatibility for Medical Devices: Issues and Solutions Heather S. Rosecrans, Center for Devices 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 Medical Devices Part 1: Evaluation and Testing7rsquo; (Replaces #G87-1 #8294) (blue book memo) Do Premarket Approval Application Closure #P94-2 (blue book memo) Do Premarket Notification Sign-Off Procedures #K94-2 (blue book memo) Do Letter to Industry, Powered Wheelchair/Scooter or Accessory/Component Manufacturer From Susan Alpert Do Premarket Notification Refuse to Accept Procedures #K94-1 (blue book memo) Do Investigational Device Exemption Refuse to Accept Procedures #D94-1 (blue book memo) Do Preamendments Class III Strategy Premarket Notification Status Request Form Do Documentation and Resolution of Differences of Opinion on Product Evaluations #G93-1 (blue book memo) Do Premarket Notification Additional Information Procedures #K93-1 (blue book memo) Do Center for Devices and Radiological Health's Investigational Device Exemption Refuse to Accept Policy Do Center for Devices and Radiological Health's Premarket Notification Refuse to Accept Policy—(Updated Checklist for March 14, 1995) Do Classified Convenience Kits Do Telephone Communications Between Office of Device Evaluation Staff and Manufacturers #I93-1 (blue book memo) Do Preamendment Class III Devices Do Nondisclosure of Financially Sensitive Information #I92-1 (blue book memo) Do Document Review Processing #I91-1 (blue book memo) Do Integrity of Data and Information Submitted to Office of Device Evaluation #I91-2 (blue book memo) Do Panel Review of Premarket Approval Applications #P91-2 (blue book memo) Do Premarket Approval Application Compliance Program #P91-3 (blue book memo) Do Shelf Life of Medical Devices Do Device Labeling Guidance #G91-1 (blue book memo) Do Consolidated Review of Submissions for Diagnostic Ultrasound Equipment, Accessories and Related Measurement Devices #G90-2 (blue book memo) Do Consolidated Review of Submissions for Lasers and Accessories #G90-1 (blue book memo) Do Assignment of Review Documents #I90-2 (blue book memo) Do Policy Development and Review Procedures #I90-1 (blue book memo) Do Substantial Equivalence Decision Making Documentation ATTACHED: ‘SE’ Decision Making Process (Detailed) (i.e., the decision making tree) Do Threshold Assessment of the Impact of Requirements for Submission of Premarket Approval Applications for 31 Medical Devices Marketed Prior to May 28, 1976 Do Meetings With the Regulated Industry #I89-3 (blue book memo) Do Toxicology Risk Assessment Committee #G89-1 (blue book memo) Do Review of IDEs for Feasibility Studies #D89-1 (blue book memo) Do Premarket Notification—Consistency of Reviews #K89-1 (blue book memo) Do Review of Laser Submissions #G88-1 (blue book memo) Do Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test Do 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 Information Do Guideline on General Principles of Process Validation Do Industry Representatives on Scientific Panel Do Guidance on the Center for Devices and Radiological Health's Premarket Notification Review Program #K86-3 (blue book memo) Do Panel Report and Recommendations on PMA Approvals #P86-5 (blue book memo) Do Points to Consider in the Characterization of Cell Lines Used to Produce Biological Products Do Application of the Device Good Manufacturing Practice Regulation to the Manufacture of Sterile Devices Do Methods for Conducting Recall Effectiveness Checks Do Guidance for Submitting Reclassification Petition Do Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications Do Bundling Multiple Devices or Multiple Indications in a Single Submission—Guidance for Industry and FDA Staff Do FDA and Industry Actions on Premarket Approval Applications: Effect on FDA Review Clock and Performance Assessment Do Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme; Draft Do Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA Do Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCo <sup>2</sup> and Oxygen (PcO <sup>2</sup> ) Monitors; Guidance for Industry and FDA Do Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA Do Heated Humidifier Review Guidance Do Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing of Dental Restorations; Guidance for Industry and FDA Anthony Watson, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-824-1287 Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA Do Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices; Guidance for Industry and FDA Reviewers Do Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Abutments; Draft Guidance for Industry and FDA Do Overview of Information Necessary for Premarket Notification Submissions for Endosseous Implants; Final Do Guidance for the Preparation of Premarket Notifications for Dental Composites Do Dental Cements—Premarket Notification; Final Do Dental Impression Materials—Premarket Notification; Final Do Over-the-Counter Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits; Final Do Information Necessary for Premarket Notification Submissions for Screw-Type Endosseous Implants Kevin Mulry, Center for Devices and 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 Application for an Endosseous Implant for Prosthetic Attachment Do Premarket Notification Submissions for Chemical Indicators; Guidance for Industry and FDA Staff Do Draft Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Precious Metal Alloys Do Draft Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Base Metal Alloys Do Supplementary Guidance on Premarket Notifications for Medical Devices With Sharps Injury Prevention Features; Guidance for Industry and FDA Do Guidance on Premarket Notifications for Intravascular Administration Sets Do Neonatal and Neonatal Transport Incubators—Premarket Notifications; Final Do Guidance on the Content of Premarket Notification Submissions for Protective Restraints Do Guidance on Premarket Notification Submissions for Short-Term and Long-Term Intravascular Catheters Do Guidance on the Content of Premarket Notification Submissions for Hypodermic Single Lumen Needles Do Guidance on the Content of Premarket Notification Submissions for Piston Syringes Do Guidance on the Content of Premarket Notification Submissions for Clinical Electronic Thermometers Do Guidance on the Content of Premarket Notification Submissions for External Infusion Pumps Do Guidance on Premarket Notification Submissions for Implanted Infusion Ports Do 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 Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA Do Premarket Notification Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA Do Premarket Notifications for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities; Draft Guidance for Industry and FDA Reviewers Elias Mallis, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8517 Premarket Approval Applications for Sharps Needle Destruction Devices; Final Guidance for Industry and FDA Do Guidance on the Content and Format of Premarket Notification Submissions for Liquid Chemical Sterilants and High Level Disinfectants; Final Do Premarket Notification Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products; Final Do Center for Devices and Radiological Health Regulatory Guidance for Washers and Washer-Disinfectors Intended for Use in Processing Reusable Medical Devices Do Testing for Sensitizing Chemicals in Natural Rubber Latex Medical Devices (Addendum to 944) Do Addendum to: Guidance on Premarket Notification Submissions for Sterilizers Intended for Use in Health Care Facilities Dina Fleisher, Center for Devices and 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 Submissions for Sharps Containers Do Guidance on Premarket Notification Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities Do Guidance on Premarket Notification Submissions for Surgical Gowns and Surgical Drapes Do Guidance on Premarket Notification for Sterilizers Intended for Use in Health Care Facilities Ashley Boam, Center for Devices and 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 Investigational Device Exemption Application and a Premarket Approval Application A. Doyle Gantt, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8262 Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm Do Cardiac Ablation Catheters Generic Arrhythmia Indications for Use; Guidance for Industry Do Investigational Device Exemption Study Enrollment for Cardiac Ablation of Typical Atrial Flutter; Final Guidance for Industry and FDA Reviewers Do Recommended Clinical Study Design for Ventricular Tachycardia Ablation Neil R. Ogden, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1307 Nonautomated Sphygmomanometer (Blood Pressure Cuff) Guidance Version 1; Final Do 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 Treatment of Atrial Fibrillation—Guidance for Industry and FDA Staff Do Guidance for Annuloplasty Rings Premarket Notification Submissions; Final Guidance for Industry and FDA Staff Barbara Zimmerman, Center for Devices and 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 Premarket Notification Submissions; Final Guidance for Industry and FDA Do Guidance for Extracorporeal Blood Circuit Defoamer Premarket Notification Submissions; Final Guidance for Industry and FDA Do Guidance for Cardiopulmonary Bypass Oxygenators Premarket Notification Submissions; Final Guidance for Industry and FDA Staff Do Guidance for the Preparation of the Annual Report to the Premarket Approval Application Approved Heart Valve Prostheses Do Coronary and Cerebrovascular Guidewire Guidance Do Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor Premarket Notification Submissions Do Implantable Pacemaker Testing Guidance Do Guidance Document for Vascular Prostheses Premarket Notification Submissions Do Guidance for Cardiovascular Intravascular Filter Premarket Notification Submissions; Final Do Carotid Stent—Suggestions for Content of Submissions to the Food and Drug Administration in Support of Investigational Devices Exemption Applications Do Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices—Draft Guidance for Industry and FDA Staff Do 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 Substantial Equivalence to Evoked Response Stimulators Do Guidance Document for the Preparation of Premarket Notification Applications for Electromyograph Needle Electrodes Do Guidance on the Content and Organization of a Premarket Notification for a Medical Laser Do Guidance for the Preparation of a Premarket Notification for Extended Laparoscopy Devices Do Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA Do Class II Special Controls Guidance Document: Polymethylmethacrylate Bone Cement; Guidance for Industry and FDA Do Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis Theodore R. Stevens, Center for Devices 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/Metal Nonconstrained or Semiconstrained Porous-Coated Uncemented Prosthesis Guidance for Spinal System Premarket Notifications Do Guidance Document for the Preparation of Investigational Device Exemptions for Spinal Systems Do ORDB Premarket Notification Sterility Review Guidance Do Reviewers Guidance Checklist for Intramedullary Rods Do Reviewers Guidance Checklist for Orthopedic External Fixation Devices Do Premarket Notification Information Needed for Hydroxyapatite Coated Orthopedic Implants Do Guidance Document for Testing Biodegradable Polymer Implant Devices Do Guidance Document for Testing Bone Anchor Devices Do Guidance Document for Testing Non-Articulating, ‘Mechanically Locked’, Modular Implant Components Do Guidance Document for the Preparation of Premarket Notification for Ceramic Ball Hip Systems Do Guidance Document for Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone or Bone Cement Do Guidance Document for the Preparation of Investigational Device Exemption and Premarket Approval Applications for Intra-Articular Prosthetic Knee Ligament Devices Do Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA Evertte T. Bears, Center for Devices and 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 Implants; Guidance for Industry and FDA Do Class II Special Controls Guidance Document: Human Dura Mater; Guidance for Industry and FDA Do Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Guidance for Industry Do Guidance Document for Dura Substitute Devices; Final Guidance for Industry Do Guidance for Neurological Embolization Devices Do Guidance for the Preparation of a Premarket Notification Application for Processed Human Dura Mater; Final Do Guidance for Dermabrasion Devices; Final Do Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; Final Do Guidance for Content of Premarket Notifications for Esophageal and Tracheal Prostheses; Final Eric A, Mann, Center for Devices and 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 Clips Do Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA Do Cyanoacrylate Tissue Adhesive for the Topical Approzimation of Ski—Premarket Approval Applications—Guidance for Industry and FDA Staff Do Saline, Silicone Gel, and Alternative Breast Implants—Draft Guidance for Industry Kesia Alexander, Center for Devices and 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 Applications for Therapeutic Massagers and Vibrators Do Guidance Document for the Preparation of Premarket Notification Applications for Beds Do Guidance Document for the Preparation of Premarket Notification Applications for Communications Systems (Powered and Nonpowered) and Powered Environmental Control Systems Do Guidance Document for the Preparation of Premarket Notification Applications for Exercise Equipment Do Guidance Document for the Preparation of Premarket Notification Applications for Heating and Cooling Devices Do Guidance Document for the Preparation of Premarket Notification Applications for Immersion Hydrobaths Do Guidance Document for the Preparation of Premarket Notification Applications for Powered Tables and Multifunctional Physical Therapy Tables Carolyn Y. Neuland, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1220 Guidance Document for the Preparation of Premarket Notification Applications for Submerged (Underwater) Exercise Equipment Do Guidance Document for the Preparation of Premarket Notification Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles Do Guidance for Studies for Pain Therapy Devices—General Consideration in the Design of Clinical Studies for Pain-Alleviating Devices Do Guidance Document for Nonprescription Sunglasses; Final Ophthalmoscope Guidance Do Retinoscope Guidance; Final Do Slit Lamp Guidance; Final Do Third Party Review Guidance for Phacofragmentation System Device Premarket Notification Do Third Party Review Guidance for Vitreous Aspiration and Cutting Device Premarket Notification Collin M. Pollard, Center for Devices and 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 Device Exemptions Application for Refractive Surgery Lasers (Excimer) Do Implantable Middle Ear Hearing Device; Guidance for Industry and FDA Do Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers; Final Do Tympanostomy Tubes, Submission Guidance for a Premarket Notification; Final Do Guidance For The Arrangement and Content of a Premarket Approval Application For A Cochlear Implant in Children Ages 2 to 17 Years Do Guideline for the Arragement and Content of a Premarket Approval Application for a Cochlear Implant in Adults at Least 18 Years of Age Do Guideline for the Arrangement and Content of a Premarket Approval Application for a Cochlear Implant in Adults at Least 18 Years of Age Do Guidance on Submissions for Keratoprostheses; Final Do Aqueous Shunts—Premarket Notification Submissions; Final Do FDA Guidelines for Multifocal Intraocular Lens Investigational Device Exemptions Studies and Premarket Approval Applications Do Important Information About Rophae Intraocular Lenses Do Guidance for Premarket Submissions of Orthokeratology Rigid Gas Permeable Contact Lenses; Final Do Revised Procedures for Adding Lens Finishing Laboratories to Approved Premarket Approval Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear; Final Do Premarket Notification Guidance for Contact Lens Care Products Do Premarket Notification Guidance Document for Class II Daily Wear Contact Lenses Do New FDA Recommendations and Results of Contact Lens Study (7-Day Letter) Do Class II Special Controls Guidance Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA Do Class II Special Controls Guidance Document: Tissue Culture Media for Human Ex Vivo Tissue and Cell Culture Processing Applications; Final Guidance for Industry and FDA Reviewers Janine M. Morris, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2194 Guidance for Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport, and Storage of Organs for Transplantation; Final Guidance for Industry and FDA Reviewers Do Guidance for Industry and the Center for Devices and Radiological Health Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems; Final Do Guidance for the Content of Premarket Notification for Conventional and High Permeability Hemodialyzers; Final Do Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents; Final Do Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis Do Class II Special Controls Guidance Document: Breast Lesion Documentation System—Guidance for Industry and FDA Staff Do Class II Special Controls Guidance for Home Uterine Activity Monitors; Final Guidance for Industry and FDA Reviewers Do Class II Special Controls Guidance Document for Clitoral Engorgement Devices Do Latex Condoms for Men—Information for Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions Do Uniform Contraceptive Labeling; Final Do Letter to Manufacturers of Prescription Home Monitors for Non-Stress Tests Do Letter to Manufacturers of Falloposcopes Do Thermal Endometrial Ablation Devices (Submission Guidance for an Investigational Device Exemption) Do Hysteroscopes and Gynecology Laparoscopes—Submission Guidance for a Premarket Notification Do Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDA Do Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources Do Guidance for the Submission of Premarket Notifications for Medical Image Management Devices Do Guidance for the Submission of Premarket Notification for Solid State X-Ray Imaging Devices; Final Do Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories and Nuclear Tomography Systems; Final Do Guidance for the Submission of Premarket Notifications for Radionuclide Dose Calibrators; Final Do Harmonic Imaging With/Without Contrast—Premarket Notification; Final Do Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Final Do Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Do Letter: Notice to Manufacturers of Bone Mineral Densitometers Do Simplified Premarket Notification Procedures for Certain Radiology Devices: December 21, 1993, Letter From L Yin, Office of Device Evaluation, Division of Reproduction, Abdominal, and Radiological Devices, to National Electrical Manufacturers Association Avis T. Danishefsky, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1243 Reviewer Guidance for Automatic X-Ray Film Processor Premarket Notification Do Guidance for the Content of Premarket Notifications for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi Do Guidance for the Content of Premarket Notifications for Penile Rigidity Implants; Final Do Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters; Final Do Center for Devices and Radiological Health Interim Regulatory Policy for External Penile Rigidity Devices Do Checklist for Mechanical Lithotripters and Stone Dislodgers Used in Gastroenterology and Urology Do Premarket Notification Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments Do Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters Do Guidance for the Content of Premarket Notifications for Urodynamic/Uroflowmetry Systems Do Guidance for the Content of Premarket Notifications for Urine Drainage Bags Do Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology Do Guidance for the Content of Premarket Notifications for Ureteral Stents Do Perspectives on Clinical Studies for Medical Device Submissions (Statistical) Do Premarket Approval Application Review Statistical Checklist Do Statistical Guidance for Clinical Trials of Nondiagnostic Medical Devices Do Medical Device Reporting Guidance Document: Remedial Action Exemption; Final Do Guidance on Adverse Event Reporting for Hospitals That Reprocess Devices Intended by the Original Equipment Manufacturer for Single Use Do Medical Device Reporting Guidance Document No. 1—Intraocular lenses—E1996004; Final Do 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 Form 3500A (MEDWATCH) (Medical Device Reporting); Final Do MEDWATCH FDA Form 3500A For Use By User Facilities, Distributors and Manufacturers for Mandatory Reporting (Medical Device Reporting); Final Do Variance from Manufacturer Report Number Format (Medical Device Reporting Letter); Final Do Instructions for Completing Form 3417: Medical Device Reporting Baseline Report (Medical Device Reporting); Final Do Medical Device Reporting—Alternative Summary Reporting Program; Guidance for Industry Do Addendum to the Instructions for Completing FDA Form 3500A With Coding Manual (MEDWATCH) (Medical Device Reporting); Final Do Needlesticks—Medical Device Reporting Guidance Do Guidance on Criteria and Approaches for Postmarket Surveillance Do Guidance on Procedures to Determine Application of Postmarket Surveillance Strategies (Food and Drug Administration Modernization Act); Final Do Guidance on Procedures for Review of Postmarket Surveillance Submissions (Food and Drug Administration Modernization Act); Final Do Guidance for Industry and FDA Staff—Safe Medical Devices Act 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 Do Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Do Office of In Vitro Diagnostic Device Evaluation and Safety
(OIVD)Analyte Specific Reagents; Small Entity Compliance Guidance; Guidance for Industry Do Assessing the Safety/Effectiveness of Home-Use In Vitro Diagnostic Devices: Draft Points to Consider Regarding Labeling and Premarket Submissions Do Data for Commercialization of Original Equipment Manufacturer, Secondary and Generic Reagents for Automated Analyzers Do Determination of Intended Use for Premarket Notification Devices; Guidance for the Center for Devices and Radiological Health Staff Do Guidance for Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization Do Guidance for Clinical Laboratory Improvement Amendments of 1988 Criteria for Waiver; Draft Guidance for Industry and FDA Do Guidance for Industry—Abbreviated Premarket Notification Submissions for In Vitro Diagnostic Calibrators; Final Do Letter to In-Vitro Device Manufacturers on Streamlined Premarket Approval Applications; Final Do Points to Consider for Collection of Data in Support of In-Vitro Device Submissions for Premarket Notification Clearance Do Points to Consider for Review of Calibration and Quality Control Labeling for In Vitro Diagnostic Devices/Cover Letter Dated March 14, 1996 Do Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material; Draft Do Premarket Approval Application Filing Review—Guidance for Industry and FDA Staff Do Breath Nitric Oxide Test System—Class II Special Controls Guidance Document Do Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers Do Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA Do Draft Guidance for Prescription Use of Drugs of Abuse Assays Premarket Notifications Do Draft Guidance on the Labeling for Over-the-Counter Sample Collection Systems for Drugs of Abuse Testing Do Guidance for Premarket Notifications on Cholesterol Tests for Clinical Laboratory, Physicians' Office Laboratory, and Home Use Do Guidance for Industry In Vitro Diagnostic Bicarbonate/Carbon Dioxide Test System; Final Do Guidance for Industry In Vitro Diagnostic Chloride Test System; Final Do Guidance for Industry In Vitro Diagnostic Creatinine Test System; Final Do Guidance for Industry In Vitro Diagnostic Glucose Test System; Final Do Guidance for Industry In Vitro Diagnostic Potassium Test System; Final Do Guidance for Industry In Vitro Diagnostic Sodium Test System; Final Do Guidance for Industry In Vitro Diagnostic Urea Nitrogen Test System; Final Do Guidance for Industry-In Vitro Diagnostic C-Reactive Protein Immunological Test System Do Guidance for Over-the-Counter Human Chorionic Gonadotropin Premarket Notifications Do Guidance for Over-the-Counter Ovulation Predictor Premarket Notifications Do Over the Counter Screening Tests for Drugs of Abuse: Guidance for Premarket Notifications Do Points to Consider for Portable Blood Glucose Monitoring Devices Intended for Bedside Use in the Neonate Nursery Do Review Criteria for Assessment of In Vitro Diagnostic Devices for Drugs of Abuse Assays Using Various Methodologies Do Review Criteria for Assessment of Portable Blood Glucose In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase, or Hexokinase Methodology Do Review Criteria for Assessment of Professional Use Human Chorionic Gonadotropin In Vitro Diagnostic Devices Laura A. Alonge, Center for Devices and Radiological Health (HFZ-510), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-0648 Premarket Notification Submissions for Coagulation Instruments—Guidance for Industry and FDA Staff Do Class II Special Control Guidance Document for Anti-Saccharomyces Cerevisia (S. cerevisiae) Antibody Premarket Notifications Do Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA Do Document for Special Controls for Erythropoietin Assay Premarket Notifications; Final Do Draft Guidance Document for Premarket Notification Submission of Fecal Occult Blood Tests Do Draft Guidance Document for Premarket Notification Submission of Glycohemoglobin (Glycated or Glycosylated) Hemoglobin for In Vitro Diagnostic Devices Do Draft Guidance Document for Premarket Notification Submission of Immunoglobulins A,G,M,D and E Immunoglobulin System In-Vitro Devices Do Draft Guidance for Premarket Notification Submission of Lymphocyte Immunophenotyping In Vitro Diagnostic Devices Using Monoclonal Antibodies Do Draft Guidance for Premarketing Approval Review Criteria for Premarket Approval of Estrogen or Progesterone Receptors In Vitro Diagnostic Devices Using Steroid Hormone Binding With Dextran-Coated Charcoal Separation, Histochemical Receptor Bind Do Guidance Document for the Submission of Tumor Associated Antigen Premarket Notification to FDA Do Guidance for Submission of Immunohistochemistry Applications to FDA; Final Do In Vitro Diagnostic Fibrin Monomer Paracoagulation Test; Final Do Multiplex Tests for Heritable Deoxyribonucleic Acid Markers, Mutations and Expression Patterns; Draft Guidance for Industry and FDA Reviewers Do Points to Consider for Cervical Cytology Devices Do Points to Consider for Hematology Quality Control Materials Do Radioallergosorbent Test Methods for Allergen-Specific Immunoglobulin E
(IgE)Premarket Notifications; Final Guidance for Industry and FDA Do Review Criteria for Assessment of Alpha-Fetoprotein In Vitro Diagnostic Devices for Fetal Open Neural Tube Defects Using Immunological Test Methodologies Do Review Criteria for Assessment of Cytogenetic Analysis Using Automated and Semiautomated Chromosome Analyzers Do Review Criteria for Assessment of Rheumatoid Factor In Vitro Diagnostic Devices Using Engzyme-Linked Immunoassay, Enzyme Linked Immunosorbent Assay, Particle Agglutination Tests, and Laser and Rate Nephelometry Casper E. Uldriks, Center for Devices and Radiological Health (HFZ-300), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-4692 Review Criteria for Blood Culture Systems Do Review Criteria for In Vitro Diagnostic Devices for Detection of Immunoglobulin Class M Antibodies to Viral Agents Do Review Criteria for In Vitro Diagnostic Devices for the Assessment of Thyroid Autoantibodies Using Indirect Immunofluorescence Assay, Indirect Hemagglutination Assay, Radioimmunoasay, and Enzyme Linked Immunosorbent Assay Do Review Criteria for In Vitro Diagnostic Devices that Utilize Cytogenetic In Situ Hybridization Technology for the Detection of Human Genetic Mutations (Germ Line and Somatic) Do Review Criteria for the Assessment of Anti-Nuclear Antibodies In-Vitro Diagnostic Devices Using Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test Systems; Guidance for Industry and FDA Do Draft Review Criteria for Nucleic Acid Amplification Based In Vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms Do Premarket Approval Applications for In Vitro Diagnostic Devices Pertaining to Hepatitis C Viruses Do Assays Intended for Diagnosis, Prognosis, or Monitoring of Hepatitis C Virus Infection, Hepatitis C, or Other Hepatitis C-Associated Disease; Draft Guidance for Industry FDA Do Review Criteria for Assessment of Antimicrobial Susceptibility Test Discs Do Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Chlamydiae in Clinical Specimens Do Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Mycobacterium spp. (Tuberculosis) Do Review Criteria for Assessment of Laboratory Tests for the Detection of Antibodies to *Helicobacter Pylori* Do Review Criteria for Devices Assisting in the Diagnosis of *Clostriduim Difficile* Associated Diseases Do Review Criteria for Devices Intended for the Detection of Hepatitis B ‘e’ Antigen and Antibody to Hepatitis B ‘e’ Do Review Criteria For Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19 Do Office of Surveillance and Biometrics Perspectives on Clinical Studies for Medical Device Submissions (Statistical) Do Premarket Approval Application Review Statistical Checklist Do Statistical Aspects of Submissions to FDA: A Medical Device Perspective (Also Includes as Appendix the Article “Observed Uses and Abuses of Statistical Procedures in Medical Device Submissions”) Do Statistical Guidance for Clinical Trials of Nondiagnostic Medical Devices Do Statistical Guidance on Reporting Results From Studies Evaluating Diagnostic Tests; Draft Do Medical Device Reporting Guidance Document: Remedial Action Exemption; Final Do Guidance on Adverse Event Reporting for Hospitals That Reprocess Devices Intended by the Original Equipment Manufacturer for Single Use Do Medical Device Reporting Guidance Document No. 1—Intraocular Lenses—E1996004; Final Do 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 Form 3500A (MEDWATCH) (Medical Device Reporting); Final Do MEDWATCH FDA Form 3500A For Use By User Facilities, Distributors and Manufacturers for Mandatory Reporting; Final Do Variance From Manufacturer Report Number Format (Medical Device Reporting Letter); Final Do Instructions for Completing Form 3417: Medical Device Reporting Baseline Report (Medical Device Reporting); Final Do Medical Device Reporting—Alternative Summary Reporting Program; Guidance for Industry Do Addendum to the Instructions for Completing FDA Form 3500A With Coding Manual (MEDWATCH) (Medical Device Reporting); Final Do Needlesticks—Medical Device Reporting Guidance Do Guidance to Sponsors on the Development of a Discretionary Postmarket Surveillance Study for Permanent Implantable Cardiac Pacemaker Electrodes (Leads) Do Guidance on Criteria and Approaches for Postmarket Surveillance Do Guidance on Procedures to Determine Application of Postmarket Surveillance Strategies (Food and Drug Administration Modernization Act); Final Do Guidance on Procedures for Review of Postmarket Surveillance Submissions (Food and Drug Administration Modernization Act); Final Do Guidance for Industry and FDA Staff— Safe Medical Devices Act of 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 Do Amendment to Guidance on Discretionary Postmarket Surveillance on Pacemaker Leads; Final Do Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Do Office of Compliance Perspectives on Clinical Studies for Medical Device Submissions (Statistical) Do Commercial Distribution/Exhibit Letter Do FDA Guide for Validation of Biological Indicator Incubation Time Do Guide for Establishing and Maintaining a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264) Do General Principles of Software Validation; Draft Guidance Do Guidance on Medical Device Tracking (Food and Drug Administration Modernization Act); Guidance for Industry and FDA Staff Do Compliance Program Guidance Manual: Inspection of Medical Devices; Draft Do Procedures for Laboratory Compliance Testing of Television Revivers—Part of Television Packet Do Guidance on Quality System Regulation Information for Various Premarket Submissions; Draft Do Surveillance and Detention without Physical Examination of Surgeons' and/or Patient Examination Gloves; Guidance for Industry Do Manufacturers/Assemblers of Diagnostic X-Ray Systems: Enforcement Policy for Positive-Beam Limitation Requirements in 21 CFR 1020.31 g) Do Guidance for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major Components Do Exemption From Reporting and Recordkeeping Requirements for Certain Sunlamp Product Manufacturers Do Letter to Medical Device Industry on Endoscopy and Laparoscopy Accessories (Galdi) Do Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221) Do Compliance Policy Guide 7133.19: Retention of Microwave Oven Test Record/Cover Letter: August 24, 1981, Retention of Records Required by 21 CFR Part 1002 Do Guidance for the Submission of Abbreviated Radiation Safety Reports on Cephalometric X-Ray Devices: Defined as Dental Units With an Attachment for Mandible Work That Holds a Cassette and Beam Limiting Device Do A Guide for the Submission of an Abbreviated Radiation Safety Report on X-Ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use Do A Guide for the Submission of Abbreviated Radiation Safety Reports on Image Receptor Support Devices for Mammography X-Ray Systems Do Compliance Program Guidance Manual: Field Compliance Testing of Diagnostic (Medical) X-Ray Equipment; Guidance for FDA Staff Do Information Disclosure by Manufacturers to Assemblers for Diagnostic X-Ray Systems; Final Guidance for Industry and FDA Do Guide for Submission of Information on Accelerators Intended to Emit X-Radiation Required Under 21 CFR 1002.10 Do Abbreviated Report on Radiation Safety for Microwave Products (Other Than Microwave Ovens) (e.g., Microwave Heating, Microwave Diathermy, Rheumatoid Factor Sealers, Induction, Dielectric Heaters, Security Systems) Do 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 Product Report, Supplemental Report, Radiation Safety Abbreviated Report, Annual Report, Information and Guidance Do Revised Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products (Replaces FDA 82-8127) Do Guide for Preparing Abbreviated Reports of Microwave and Rheumatoid Factor-Emitting Electronic Products Intended for Medical Use Howard W. Cyr, Center for Devices and Radiological Health (HFZ-114), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-796-0297 Letter to Manufacturers and Importers of Microwave Ovens: Information Requirements for Cookbooks and User and Service Manuals Do Abbreviated Report on Radiation Safety of Non-Medical Ultrasonic Products Do Guide for Preparing Product Reports for Medical Ultrasound Products Do Letter to Manufacturers, Distributors and Importers of Condom Products Do Letter to Manufacturers, Importers, and Repackagers of Condoms for Contraception or Sexually-Transmitted Disease Prevention
(Holt)Do Letter to Condom Manufacturers and Distributors Do Letter to Manufacturers/Repackers Using Cotton Do Guide for Preparing Product Reports for Lasers and Products Containing Lasers Do Compliance Guide for Laser Products (FDA 86-8260) Do Condoms: Inspection and Sampling at Domestic Manufacturers and of All Repackers; Sampling From All Importers (Damaska Memo to Field on April 8, 1987) Do Dental Hand Piece Sterilization (Dear Doctor Letter) Do Latex Labeling Letter (Johnson) Do Pesticide Regulation Notice 94-4:Interim Measures for the 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 Do Guide for Preparing Product Reports for Lasers and Products Containing Lasers Letter to Industry, Powered Wheelchair Manufacturers From RM Johnson Do Hazards of Volume Ventilators and Heated Humidifiers Do Manufacturers and Initial Distributors of Sharps Containers and Destroyers Used by Health Care Professionals Do Ethylene Oxide; Ethylene Chlorohydrin; and EthyleneGlycol: Proposed Maximum Residue Limits and Maximum Levels of Exposure Do Letter to: Manufacturers and Users of Lasers for Refractive Surgery (Excimer) Do Shielded Trocars and Needles Used for Abdominal Access During Laparoscopy Surveillance and Detention Without Physical Examination of Condoms; Guidance for Industry; Draft Do 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 Nonionizing Radiation—Lasers (FDA Publication No. 83-8220) Do Letter to All Foreign Manufacturers and Importers of Electronic Products for Which Applicable FDA Performance Standards Exist Do Guide for Submission of Information on Industrial X-Ray Equipment Required Under 21 CFR 1002.10 Do Guidance for the Submission of Cabinet X-Ray System Reports Under 21 CFR 1020.40 Do Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General) Do Computerized Devices/Processes Guidance—Application of the Medical Device Good Manufacturing Practice to Computerized Devices and Manufacturing Processes Do Guide for Preparing Product Reports for Ultrasonic Therapy Products (Physical Therapy Only) Do Guide for Submission of Information on Industrial Radiofrequency Dielectric Heater and Sealer Equipment Unter 21 CFR 1002.10 and 1002.12 (FDA 81-8137) Do Guide for Preparing Annual Reports for Ultrasonic Therapy Products Do Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products (Replaces FDA 82-8127) Do Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor (Replaces FDA 82-8127) Quality Control Guide for Sunlamp Products (FDA 88-8234) Do Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems Do Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (21 CFR Part 1002) Do Letter: Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products Do Reporting Guide for Product Reports on High Intensity Mercury Vapor Discharge Lamps (21 CFR Part 1002) Do Quality Control Practices for Compliance With the Federal Mercury Vapor Lamp Performance Standard Do Keeping Up With the Microwave Revolution (FDA Publication No. 91-4160) Do Quality Assurance Guidelines for Hemodialysis Devices Do Letter to Manufacturers and Importers of Microwave Ovens—Open Door Operation of Microwave Ovens as a Result of Oven Miswiring Do 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 Show, Display, or Device (Form FDA 3147) Do Letter to Trade Association: Reuse of Single-Use or Disposable Medical Devices Do 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 and Electronic Products Manufacturers From Lilliam Gill and Bruce H. Burlington Correction Memo Do Enforcement Priorities for Single-Use Deices Reprocessed by Third Parties and Hospitals: Guidance for Industry and for FDA Staff Do Labeling for Electronic Anti-Theft Systems; Guidance for Industry; Final Do Wireless Medical Telemetry Risks and Recommendations, Guidance for Industry; Final Do 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 (Statistical) Do Guidance on Frequently Asked Questions on Recognition of Consensus Standards (Food and Drug Administration Modernization Act) Do Guidance on the Recognition and Use of Consensus Standards/Appendix A (Food and Drug Administration Modernization Act) Do Center for Devices and Radiological Health Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standard for Recognition Do Guidance for Industry and FDA Reviewers: Guidance on Immunotoxicity Testing Do 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 Produced by Microorganisms Modified Using Recombinant DNA Technology Do 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 Conjunctivitis Do Clinical Trial Design for the Treatment of Choroidal Neovascularization Do Clinical Trial Design for the Treatment of Diabetic Macular Edema Do 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 Pressure Do Clinical Trail Design for the Treatment of Iritis Do Clinical Trail Design for the Treatment of Macular Edema (Secondary to Inflammation) Do Clinical Trail Design for the Treatment of Macular Edema (Secondary to a Vascular Event) Do Clinical Trail Design for the Treatment of Post-Cataract Inflammation Do Clinical Trail Design for the Treatment of Posterior Uveitis Do Clinical Trial Design for the Treatment of Superficial Punctate Keratitis Do Chemistry, Manufacturing, and Control, Preclinical, and Clinical Development of Decorporation Agents for the Treatment of Internal Radioactive Contamination Do 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 Assessment Do 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 Recommendations for Labeling Do 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 Impact on Dosing and Labeling Do CATEGORY—COMPLIANCE Describing How Positron Emission Tomography Drug Products May Comply With New Current Good Manufacturing Practice Requirements Do Expiration Dating of Unit-Dose Repackaged Drugs Do Maintaining Adequate and Accurate Records During Clinical Investigations Do Current Good Manufacturing Practice For Investigational New Drug and Biological Products—Phase I Testing Do 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 Antifungal Drug Products Do Defining the Term “Listed Drug” With Respect to Amendments and Supplements to Abbreviated New Drug Applications and Section 505(b)(2) Applications Do Abbreviated New Drug Applications: Pharmaceutical Solid Polymorphism Do CATEGORY—GOOD REVIEW PRACTICES General Clinical Review Template Do CATEGORY—INVESTIGATIONAL NEW DRUG APPLICATION Consumer Product Safety Commission—Tamper Resistant Packaging for Investigational New Drugs Do End of Phase 2 Meetings Do Pediatric Safety and Efficacy Data in Investigational New Drugs Do Exploratory Investigational New Drugs: Preclinical and Clinical Considerations Do CATEGORY—LABELING Content and Format of the Clinical Pharmacology Section Do Content and Format of the Dosage and Administration Section of the Prescription Drug Labeling Do Content and Format of the Warnings and Precautions, Contraindications, and Boxed Warning Sections of Prescription Drug Labeling Do Drug Names and Dosage Forms Do Implementing the New Content and Format Requirements for Prescription Drug Labeling Do Labeling Dietary Supplements for Women Who Are or Could Be Pregnant Do 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 Answers Do CATEGORY—PHARMACOLOGY/TOXICOLOGY 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 Drug Applications Do How to Comply With the Pediatric Research Equity Act Do How to Determine if Human Research With a Radioactive Drug Can Be Conducted Under a Radioactive Drug Research Committee Do Process for Contracts and Written Requests Under the Best Pharmaceutical for Children Act Do Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act Do V. Center for Food Safety and Applied Nutrition (CFSAN) CATEGORY—DIETARY SUPPLEMENTS Labeling Dietary Supplements for Women Who Are or Could Be Pregnant Linda Pellicore, Center for Food Safety 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 Dietary Ingredients Do Substantiation Health Claims Guidance Do CATEGORY—FOOD ADDITIVE SAFETY Final Guidance on Electronic Submissions of Food and Color Additive Petitions (Level 1) George Pauli, Center for Food Safety and 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 the Food Supply (Level 1) Do 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* Waivers of *In Vivo* Demonstration of Bioequivalence of Certain Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles (#171) Marilyn Martinez, Center for Veterinary Medicine (HFV-130), Food and Drug 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 Dogs, Cats, and Captive Noncompanion Animal Carnivores and Omnivores (#122) William Burkholder, Center for Veterinary Medicine (HFV-228), Food and Drug 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 (#134) Douglass Oeller, Center for Veterinary 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 (#173) David Newkirk, Center for Veterinary 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 Animal Drug Application or Abbreviated New Drug Applications (#83) Dennis Bensley, Center for Veterinary Medicine (HFV-143), Food and Drug 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 Medicinal Products for Food-Producing Animals With Respect to Antimicrobial Resistance (#144) William T. Flynn, Center for Veterinary Medicine (HFV-2), Food and Drug 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 Drugs in Human Food: Carcinogenicity Testing (#141) Thomas Mulligan, Center for Veterinary 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 Drugs in Human Food: General Approach to Testing (#149) Do GL-36: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological Acceptable Daily Intake (#159) Do GL-37 Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing (#160) Do GL-38 Environmental Impact Assessments for Veterinary Medicinal Products—Phase II (#166) Charles Eirkson, Center for Veterinary 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 Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs for Use in Animals (#123) Linda Wilmot, Center for Veterinary Medicine (HFV-114), Food and Drug 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 (#135) Mary G. Leadbetter, Center for Veterinary 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 Information Assurance; Good Practices in Converting From Paper to Electronic Processes Paul Motise, Division of Compliance Information and Quality Assurance (HFC-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 Access Rudaina Alrefai, Division of Compliance 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, Environmental Protection Agency, and the Organisation for Economic and Cooperative Development Good Laboratory Practices James McCormack, Division of Compliance Policy (HFC-230), Food and Drug Administration, 1350 Piccard Dr., rm. 400Z, Rockville MD 20850, 301-827-0425. CATEGORY—GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION INVESTIGATORS Auditing Nonclinical Laboratory Studies Do CATEGORY—GUIDANCE FOR FOOD AND DRUG ADMINISTRATION INVESTIGATORS Necropsy, Tissue Preparation, and Histology in Nonclinical Laboratory Studies Do CATEGORY—COMPLIANCE POLICY GUIDE Section 394.500, Importation of Television Products, Microwave Ovens, and Inherent Class I Laser Products for Investigation and Evaluation during Design Development (CPG 7133.22) Jeffrey Governale, Division of Compliance Policy (HFC-230), Food and Drug Administration, 1350 Piccard Dr., rm. 410A, Rockville, MD 20850, 301-827-0411 Section 300.500, Reprocessing and Reuse of Single Use Devices (CPG 7124.16) Do Section 310.210, Blood Pressure Measurement Devices (Sphygmomanometers)—Accuracy (CPG 7124.23) Do 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 Boards and Clinical Investigators David Lepay, Good Clinical Practice 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 Clinical Investigators and Sponsor Investigators Do Dated: June 30, 2004. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 04-15660 Filed 7-8-04; 8:45 am]
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  • 21 CFR 1002
  • 21 CFR 58
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cites case law
Notices
Notice
C.F.R.§ 10.115
U.S.C.§ 263
C.F.R.§ 1020.31
C.F.R.§ 1002.10
C.F.R.§ 1020.40
C.F.R.§ 1040.11
Cite21 CFR 1002
Cite21 CFR 58
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