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FDA Federal Register Notices - Archives

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FDA Federal Register Notices - 2007 Releases
Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the list of Recognized Standards, Recognition List Number: 019
 December 19, 2007
Federal Register: Medical Devices, Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
 December 19, 2007
Federal Register: Guidance for Industry and Food and Drug Administration Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle; Availability
 November 30, 2007
Federal Register: Medical Devices; Hematology and Pathology Devices: Reclassification of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle
 November 30, 2007
Federal Register: Agency Information Collection Activities: Submission for Office of Management and Budget Review; Comment Request; Medical Devices Third-Party Review Under the Food and Drug Administration Modernization Act
 November 19, 2007
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Recommended Glossary and Educational Outreach to Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
 November 19, 2007
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program
 November 9, 2007
Federal Register: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 November 9, 2007
Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 November 6, 2007
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions and Answers; Availability (PDF)
 October 26, 2007
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Device Studies--Frequently Asked Questions; Availability (Notice)
 October 25, 2007
Federal Register: Guidance for Industry, Food and Drug Administration, and Foreign Governments; Fiscal Year 2008 Medical Device User Fee Small Business Qualification and Certification; Availability
 October 23, 2007
Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Remote Medication Management System; Availability
 October 19, 2007
Federal Register: Medical Devices; General Hospital and Personal Use Devices; Classification of Remote Medication Management System
 October 19, 2007
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidances Document: Electrocardiograph Electrodes; Availability Correction
 October 15, 2007
Federal Register: Medical Device User Fee Rates for Fiscal Year 2008
 October 15, 2007
Federal Register: Medical Device User Fee and Modernization Act; Notice to Public of Web Location of 2008 Proposed Guidance Development; Establishment of a Public Docket
 October 10, 2007
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes; Availability
 October 4, 2007
Federal Register: Guidance for Industry and Food and Drug Administration Staff; Biological Indicator Premarket Notification Submissions; Availability
 October 4, 2007
Federal Register: Medical Devices; Cardiovascular Devices; Electrocardiograph Electrode; Designation of Special Controls
 October 4, 2007
Federal Register: Agency Emergency Processing Under OMB Review; Medical Device User Fee Amendent of 2007; Foreign Small Bussiness Qualification Certication Form FDA 3602A
 October 2, 2007
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Current Good Manufacturing Practice Quality System Regulations
 September 20, 2007
Federal Register: Draft Guidance for Industry, Clinical Laboratories, and Food and Drug Administration Staff on In Vitro Diagnostic Multivariate Index Assays; Reopening of the Comment Period
 September 17, 2007
Federal Register: Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents: Frequently Asked Questions; Availability
 September 14, 2007
Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
 September 13, 2007
Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 September 12, 2007
Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 018
 September 12, 2007
Federal Register: National Mammography Quality Assurance Advisory Committee; Notice of Meeting
 September 11, 2007
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Recommended Glossary and Educational Outreach to Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
 August 31, 2007
Federal Register: Medical Devices 101: An Educational Forum; Public Workshop
 August 21, 2007
Federal Register: Processing Methods for Orthopedic, Cardiovascular, and Skin Allografts; Public Workshop
 August 16, 2007
Federal Register: Clinical Developent Programs for Human Drugs, Biological Products, and Medical Devices for the Treatment and Prevention of Osteoarthritis; Request for Assistance
 August 14, 2007
Federal Register: Medical Devices: Immunology and Microbiology Devices: Classification of In Vitro Human Immunodeficiency Virus Drug Resistance Genotype Assay
 August 8, 2007
Federal Register: Guidance for Industry and Food and Drug Administration Staff;Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology
 August 3, 2007
Federal Register: Medical Devices; General and Plastic Surgery Devices; Classification of Absorbable Poly(hydorxybutyrate)Surgical Suture Produced by Recombinant DNA Technology
 August 3, 2007
Federal Register: Assuring Radiation Protection; Cooperative Agreement; Request for Applications: RFA-FDA-CDRH-07-004; Catalog of Federal Domestic Assistance Number: 93.103
 July 30, 2007
Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 July 27, 2007
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Multivariate Index Assays; Availability
 July 26, 2007
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Premarket Notification Submissions for Medical Devices that Include Antimicrobial Agents; Availability
 July 19, 2007
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Pulse Oximeters--Premarket Notification Submissions [510(k)s]; Availability
 July 19, 2007
Federal Register: Global Harmonization Task Force, Study Groups 1 and 5; New Proposed and Final Documents; Availability
 July 13, 2007
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Current Good Manufcaturing Practice Quality System Regulations
 July 9, 2007
Federal Register: Draft Guidance for Industry: Preparation of Investigational Device Exemptions and Investigational New Drug Applications for Products Inteded to Repair or Replace Knee Cartilage; Availability
 July 9, 2007
Federal Register: Medical Devices: The Mammography Quality Standards Act of 1992 and Subsequent Mammography Quality Standards Reauthorization Act and Amendments; Inspection Fees
 July 6, 2007
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin; Availability
 July 3, 2007
Federal Register: General and Plastic Surgery Devices; Reclassification of the Tissue Adhesive for Topical Approximation of Skin Device
 July 3, 2007
Federal Register: Medical Devices; Cardiovascular Devices; Denial of Request for Change in Classification of Impedance Plethysmograph
 July 3, 2007
Federal Register: Medical Devices; General Hospital and Personal Use Devices; Classification of the Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies
 July 3, 2007
Federal Register: Medical Devices; General Hospital and Personal Use Devices; Classification of the Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies; Availability
 July 3, 2007
Federal Register: Neurological Devices; Denial of Request for Change in Classification of Cutaneous Electrode
 July 3, 2007
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Pre-market Approval of Medical Devices
 June 28, 2007
Federal Register: June 19, 2007 (Volume 72, Number 117)
 June 19, 2007
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Pilot Program for Medical Products (Formally Medical Device Adverse Event Reporting Program) (Notice)
 June 13, 2007
Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Intervertebral Body Fusion Device; Availability
 June 12, 2007
Federal Register: Orthopedic Devices; Reclassification of the Intervertegral Body Fusion Device
 June 12, 2007
Federal Register: Guidance for Industry and Food and Drug Administration Staff; Assayed and Unassayed Quality Control Material; Availability
 June 7, 2007
Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications (Notice)
 June 7, 2007
Federal Register: Determination of Regulatory Review Period for Purposes of Patent Extension; GEM 21S GROWTH-FACTOR ENHANCED MATRIX
 June 1, 2007
Federal Register: Determination of Regulatory Review Period for Purposes of Patent Extension; PHAKIC INTRAOCULAR LENSES
 June 1, 2007
Federal Register: Determination of Regulatory Review Period for Purposes of Patent Extension; X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
 June 1, 2007
Federal Register: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 May 29, 2007
Federal Register: Determination of Regulatory Review Period for Purposes of Patent Extension; KDR 401 and 403 PACEMAKERS
 May 25, 2007
Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 017
 May 21, 2007
Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 May 10, 2007
Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis; Availability
 May 9, 2007
Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of Gene Expression Profiling Test System for Breast Cancer Prognosis
 May 9, 2007
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Hemostatic Device; Availability; Reopening of Comment Period
 May 8, 2007
Federal Register: General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device; Reopening of Comment Period
 May 8, 2007
Federal Register: Medical Device User Fee and Modernization Act; Public Meeting; Correction
 April 27, 2007
Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems; Availability
 April 24, 2007
Federal Register: Medical Devices; Obstetrical and Gynecological Devices; Classification of Computerized Labor Monitoring System
 April 24, 2007
Federal Register: Medical Device User Fee and Modernization Act; Public Meeting
 April 18, 2007
Federal Register: General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 April 9, 2007
Federal Register: Medical Devices; Technical Amendment
 April 9, 2007
Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays; Availability
 April 3, 2007
Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
April 3, 2007
Federal Register: Microbiology Devices; Reclassification of Herpes Simplex Virus Types 1 and 2 Serological Assays
 April 3, 2007
Federal Register: Determination of Regulatory Review Period for Purposes of Patent Extension; Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device
 March 28, 2007
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Modifications to Devices Subject to Premarket Approval--The Premarket Approval Supplement Decision-Making Process; Availability
 March 27, 2007
Federal Register: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 March 26, 2007
Federal Register: Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee; Notice of Meeting
 March 22, 2007
Federal Register: Guidance for Industry and Food and Drug Administration Staff; Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests; Availability
 March 14, 2007
Federal Register: The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and Suppliers; Public Seminar
 March 1, 2007
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document; Oxygen Pressure Regulators and Oxygen Conserving Devices; Availability (notice)
 February 27, 2007
Federal Register: Proposed Rules: Anesthesiology Devices; Oxygen Pressure Regulators and Oxygen Conserving Devices
 February 27, 2007
Federal Register: Global Harmonization Task Force, Study Groups 1, 2, and 4; New Proposed and Final Documents; Availability
 February 6, 2007
Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
 January 26, 2007
Federal Register: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 January 24, 2007
Federal Register: Patient Examination and Surgeons' Gloves; Test Procedures and Acceptance Criteria; Correction
 January 19, 2007
Federal Register: Orthopedic Devices; Reclassification of Non-Invasive Bone Growth Stimulator
 January 18, 2007
Federal Register: Reprocessed Single-Use Devices; Requirement for Submission of Validation Data; Withdrawal
 January 12, 2007
Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays; Availability
 January 10, 2007
Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of Quality Control Material for Cystic Fibrosis Nucleic Acid Assays
 January 10, 2007
Federal Register: In Vitro Diagnostic Multivariate Index Assays; Public Meeting
 January 9, 2007
Federal Register: Medical Devices 101: An Educational Forum; Public Workshop
 January 9, 2007
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