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FDA Federal Register Notices - 2008 Releases
Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300; Availability
 December 23, 2008
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Emergency Shortages Data Collection System (formerly Emergency Medical Device Shortages Program Survey)
 December 22, 2008
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority
 December 22, 2008
Federal Register: Agency Information Collection Activities ; Proposed Collection; Comment Request; Medical Device Recall Authority
 December 19, 2008
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Emergency Shortages Data Collection System (formerly “Emergency Medical Device Shortages Program Survey”)
 December 19, 2008
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Humanitarian Use Devices
 December 16, 2008
Federal Register: Microbiological Testing for Contact Lens Care Products; Public Workshop
 December 16, 2008
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff: Submission and Review of Sterility Information in Premarket Notification Submissions for Devices Labeled as Sterile; Availability
 December 12, 2008
Federal Register: Guidance for Industry and the Food and Drug Administration: Modifications to Devices Subject to Premarket Approval; the Premarket Approval Supplement Decisionmaking Process; Availability
 December 11, 2008
Federal Register: Sex Differences in the Cardiovascular Device Trials; Public Workshop
 November 26, 2008
Federal Register: Global Harmonization Task Force, Study Group 1; Proposed and Final Documents; Availability
 November 19, 2008
Federal Register: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 November 18, 2008
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance; Compliance With the Medical Device User Fee and Modernization Act of 2002, as Amended: Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices
 November 17, 2008
Federal Register: Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 November 13, 2008
Federal Register: Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex
 November 10, 2008
Federal Register: Intrapartum Electronic Fetal Monitoring With Computer Assisted Diagnosis Workshop - Exploring Methods of Evaluation
 October 27, 2008
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Data Collection Using MedWatch\Plus\ Portal and Rational Questionnaire
 October 23, 2008
Federal Register: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 October 15, 2008
Federal Register: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 October 10, 2008
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recall Regulations
 October 9, 2008
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
 October 8, 2008
Federal Register: Medical Devices; Hearing Aids; Technical Data Amendments; Confirmation of Effective Date
 October 8, 2008
Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
 September 26, 2008
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: Food and Drug Administration Medical Products Reporting Program
 September 24, 2008
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence; Availability
 September 19, 2008
Federal Register: Medical Devices; Medical Device Reporting; Baseline Reports; Confirmation of Effective Date
 September 17, 2008
Federal Register: Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ Keratomileusis (LASIK) Devices; Establishing a Docket
 September 12, 2008
Federal Register: Class II Special Controls Guidance Document: Absorbable Hemostatic Device; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening of Comment Period
 September 11, 2008
Federal Register: General and Plastic Surgery Devices: Reclassification of the Absorbable Hemostatic Device; Reopening of Comment Period
 September 11, 2008
Federal Register: Public Advisory Panels or Committees: Request for Industry Organizations Interested in Participating in Selection Process for Nonvoting Industry Representatives
 September 11, 2008
Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 020
 September 9, 2008
Federal Register: FDA Clinical Trial Requirements Regulations, Compliance, and Good Clinical Practice Conference; Public Workshop
 September 8, 2008
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Request for Inspection Under the Inspection by Accredited Persons Program
 August 29, 2008
Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
 August 28, 2008
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674)
 August 25, 2008
Federal Register: FDA Regulations; Technical Amendment
 August 25, 2008
Federal Register: Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices
 August 22, 2008
Federal Register: Medical Devices; Radiology Devices; Reclassification of Bone Sonometers; Correction
 August 14, 2008
Federal Register: Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications
 August 7, 2008
Federal Register: Humanitarian Device Exemption Regulation: Draft Guidance for Exemption Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff; Questions and Answers
 August 5, 2008
Federal Register: Medical Device User Fee Rates for Fiscal Year 2009
 August 1, 2008
Federal Register: Food and Drug Administration Critical Path Workshop on Clinical Trials for Local Treatment of Breast Cancer by Thermal Ablation
 July 21, 2008
Federal Register: Global Harmonization Task Force, Study Groups 1 and 5; Proposed and Final Documents; Availability
 July 11, 2008
Federal Register: Guidance for Industry and Food and Drug Administration Staff; Surveillance and Detention Without Physical Examination of Condoms; Availability
 July 11, 2008
Federal Register: Guidance for Industry and Food and Drug Administration Staff; Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves; Availability
 July 11, 2008
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies
 June 27, 2008
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Regulations
 June 27, 2008
Federal Register: Hematology and Pathology Devices Panel fo the Medical Devices Advisory Committee; Notice of Meeting
 June 26, 2008
Federal Register: Medical Devices; Change of Name; Technical Amendment
 June 24, 2008
Federal Register: Medical Devices; Technical Amendment
 June 19, 2008
Federal Register: Medical Devices; Medical Device Reporting; Baseline Reports (Direct final rule)
 June 13, 2008
Federal Register: Medical Devices; Medical Device Reporting; Baseline Reports; Companion to Direct Final Rule (Proposed rule)
 June 13, 2008
Federal Register: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 June 9, 2008
Federal Register: Medical Devices; Hearing Aids; Technical Data Amendments
 June 2, 2008
Federal Register: Medical Devices; Hearing Aids; Technical Data Amendments
 June 2, 2008
Federal Register: Cardiovascular Devices; Reclassification of Certain Percutaneous Transluminal Coronary Angioplasty Catheters
 May 30, 2008
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty Catheters; Availability
 May 30, 2008
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Full Field Digital Mammography System; Availability
 May 30, 2008
Federal Register: General and Plastic Surgery Devices; Reclassification of the Tissue Adhesive for Topical Approximation of Skin Device
 May 30, 2008
Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin; Availability
 May 30, 2008
Federal Register: Medical Devices; Radiology Devices; Reclassification of Full Field Digital Mammography System
 May 30, 2008
Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
 May 29, 2008
Federal Register: Potential for a Registry of Breast Cancer Treatment Using Thermal Ablation Devices; Request for Comments
 May 28, 2008
Federal Register: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 May 22, 2008
Federal Register: Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 May 22, 2008
Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays; Availability
 May 20, 2008
Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of Plasmodium Species Antigen Detection Assays
 May 20, 2008
Federal Register: Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 May 1, 2008
Federal Register: Towards an Artificial Pancreas: A Food and Drug Administration, National Institutes of Health, Juvenile Diabetes Research Foundation Public Workshop
 April 30, 2008
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Additional Listing Information for Medical Device Registration and Listing
 April 30, 2008
Federal Register: The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and Suppliers; Public Seminar (Notice of public seminar)
 April 1, 2008
Federal Register: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 March 27, 2008
Federal Register: Global Harmonization Task Force, Study Group 4; Final Document; Availability
 March 26, 2008
Federal Register: Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 March 24, 2008
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674)
 March 5, 2008
Federal Register: Draft Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices; Availability
 February 20, 2008
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses; Availability
 February 15, 2008
Federal Register: Devices: General Hospital and Personal Use Devices; Reclassification of Medical Device Data System
 February 8, 2008
Federal Register: Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 February 7, 2008
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Additional Listing Information for Medical Device Registration and Listing
 February 5, 2008
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking
 February 5, 2008
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in the Medical Device Fellowship Program
 February 5, 2008
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification, FDA Form 3601A
 January 15, 2008
Federal Register: Guidance for Industry and Food and Drug Administration Staff; The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations; Availability
 January 8, 2008
Federal Register: Guidance for Industry and Food and Drug Administration Staff; The Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program; Availability
 January 8, 2008
Federal Register: Guidance for Industry and Food and Drug Administration; Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements; Availability
 January 2, 2008
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