| Federal Register: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Devices; Humanitarian Use Devices |
December 30, 2005 |
|
| Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Mammography Quality Standards Act Final Regulations; Modifications and Additions to Policy Guidance Help System #9 |
December 30, 2005 |
|
| Federal Register: Biological Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices |
December 27, 2005 |
|
| Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, and Distributor Reporting |
December 23, 2005 |
|
| Federal Register: Advisory Committees; Tentative Schedule of Meetings for 2006 |
December 22, 2005 |
|
| Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Public Health Notification (formerly known as Safety Alert/Public Health Advisory) Readership Survey |
December 22, 2005 |
|
| Federal Register: Hand-Held, Doppler Ultrasound Prenatal Listening Devices Meeting on March 29, 2006 |
December 22, 2005 |
|
| Federal Register: Regulatory Process for Pediatric Mechanical Circulatory Support Devices (Ventricular Assist Devices) |
December 21, 2005 |
|
| Federal Register: Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reprocessed Single-Use Device Labeling |
December 15, 2005 |
|
| Federal Register: Draft Guidance for Industry and Food and Drug Administration; Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens; Availability |
December 8, 2005 |
|
| Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authority |
December 1, 2005 |
|
| Federal Register: Environmental Assessment; Categorical Exclusions - Final Rule |
November 15, 2005 |
|
| Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex; Availability |
November 15, 2005 |
|
| Federal Register: Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom With Spermicidal Lubricant |
November 15, 2005 |
|
| Federal Register: Medical Devices; A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff; Availability |
November 11, 2005 |
|
| Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tinnitus Masker Devices; Availability |
November 9, 2005 |
|
| Federal Register: Ear, Nose, and Throat Devices; Tinnitus Masker; Designation of Special Controls |
November 9, 2005 |
|
| Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 013 |
November 9, 2005 |
|
| Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner; Availability |
November 8, 2005 |
|
| Federal Register: Medical Devices; General and Plastic Surgery Devices; Classification of the Low Energy Ultrasound Wound Cleaner |
November 8, 2005 |
|
| Federal Register: Proposed Collection; Comment Request; Emergency Shortages Data Collection System (Formerly the Emergency Medical Device Shortage Program Survey) |
November 4, 2005 |
|
| Federal Register:Guidance for Industry and Food and Drug Administration
Staff; Class II Special Controls Guidance Document: Cystic Fibrosis
Transmembrane Conductance Regulator Gene Mutation Detection Systems;
Availability |
October 27 , 2005 |
|
| Federal Register: Medical Devices; Immunology and Microbiology Devices;
Classification of Cystic Fibrosis Transmembrane Conductance Regulator Gene
Mutation Detection System |
October 27 , 2005 |
|
| Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Functional Indications for Implantable Cardioverter Defibrillators; Availability |
October 7 , 2005 |
|
| Federal Register: The Essentials of Food and Drug Administration Device Regulations: A Primer for Manufacturers and Suppliers; Public Workshop |
October 7 , 2005 |
|
| Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: AFP-L3% Immunological Test Systems; Availability |
October 5 , 2005 |
|
| Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of AFP-L3% Immunological Test Systems |
October 5 , 2005 |
|
| Federal Register: Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002; Public Meeting |
October 5 , 2005 |
|
| Federal Register: Agency Information Collection Activities; Proposed
Collection; Comment Request; Reprocessed Single-Use Device Labeling. |
September 30 , 2005 |
|
| Federal Register: Medical Devices; Reprocessed Single-Use Devices;
Termination of Exemptions from Premarket Notification; Requirement for
Submission of Validation Data. |
September 30 , 2005 |
|
| Federal Register: International Preparation for International Conference on
Harmonization Meetings in Chicago, Illinois; Public Meeting. |
September 26 , 2005 |
|
| Federal Register: Medical Devices; Needle-Bearing Devices; Withdrawal of
Advance Notice of Proposed Rulemaking. |
September 23 , 2005 |
|
| Federal Register: Industry Exchange Workshop on Food and Drug Administration
Clinical Trial Requirements; Public Workshop. |
September 22 , 2005 |
|
| Federal Register: Guidance for Industry and Food and Drug Administration
Staff; Class II Special Controls Guidance Document: Oral Rinse to Reduce the
Adhesion of Dental Plaque; Availability. |
September 21 , 2005 |
|
| Federal Register: Medical Devices; Dental Devices; Classification of Oral
Rinse to Reduce the Adhesion of Dental Plaque. |
September 21 , 2005 |
|
| Federal Register: Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting |
September 16 , 2005 |
|
| Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order; Availability |
September 16 , 2005 |
|
| Federal Register: Guidance-Accredited Third Parties; Requests for Inspection by an Accredited Person Under the Inspections by Accredited Persons Program Authorized by the Medical Device User Fee and Modernization Act of 2002; Availability |
September 16 , 2005 |
|
| Federal Register: Medical Devices; Needle-Bearing Devices; Withdrawal of
Advance Notice of Proposed Rulemaking. |
September 9 , 2005 |
|
| Federal Register: CDRH 200145. Draft Guidance for Industry and Food and Drug
Administration Staff: Recommendations for Clinical Laboratory Improvement
Amendments of 1988 Waiver Applications; Availability |
September 8 , 2005 |
|
| Federal Register: Medical Devices; Immunology and Microbiology Devices;
Classification of the Endotoxin Assay; Technical Amendment. |
September 8 , 2005 |
|
| Federal Register: Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications |
September 7 , 2005 |
|
| Federal Register: Agency Information Collection Activities; Proposed
Collection; Comment Request; Medical Device Recall Authority |
September 6 , 2005 |
|
| Federal Register: General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting |
September 1 , 2005 |
|
| Federal Register: Agency Information Collection Activities; Proposed
Collection; Comment Request; Financial Disclosure by Clinical Investigators. |
August 26 , 2005 |
|
| Federal Register: Medical Devices; Immunology and Microbiology Devices:
Classification of Ribonucleic Acid Preanalytical Systems.
|
August 26 , 2005 |
|
| Federal Register: Definition of Primary Mode of Action of a Combination
Product. |
August 26 , 2005 |
|
| Federal Register: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. |
August 25 , 2005 |
|
| Federal Register: Request for Nominations for Voting Members on Public Advisory Panels or Committees. |
August 25 , 2005 |
|
| Federal Register: Request for Nominations for Voting Consumer Representative
Members on Public Advisory Committees. |
August 18 , 2005 |
|
| Federal Register: National Mammography Quality Assurance Advisory Committee; Notice of Meeting |
August 3 , 2005 |
|
| Federal Register: Medical Device User Fee Rates for Fiscal Year 2006; Delay in Publication |
August 1 , 2005 |
|
| Federal Register: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting |
July 27, 2005 |
|
| Federal Register: General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting |
July 22, 2005 |
|
| Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications |
July 15, 2005 |
|
| Federal Register: Request for Nominations for Nonvoting Members Representing Industry Interests on Public Advisory Panels or Committees; Medical Devices Advisory Committee |
July 8, 2005 |
|
| Federal Register: Memorandum of Understanding Between the U.S. Food and Drug Administration and the State of South Carolina, Department of Health and Environmental Control, Bureau of Radiological Health. |
July 7, 2005 |
|
| Federal Register: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Device Labeling Regulations. |
July 1, 2005 |
|
| Agenda, Roster, Questions and Briefing Information for the June 23, 2005 Obstetrics and Gynecology Devices Panel Meeting |
June 23, 2005 |
|
| Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Dissemination of Information on unapproved/New Uses for Marketed Drugs, Biologics, and Devices |
June 18, 2005 |
|
| Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Humanitarian Use Devices |
June 18, 2005 |
|
| Federal Register: Electronic Products; Performance Standard for Diagnostic X-ray Systems and Their Major Components. |
June 10, 2005 |
|
| Federal Register: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Devices; Medical Device Tracking |
May 20, 2005 |
|
| Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. |
May 16, 2005 |
|
| Federal Register: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting |
May 16, 2005 |
|
| Federal Register: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. |
May 10 , 2005 |
|
| Federal Register: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. |
May 6 , 2005 |
|
| Federal Register: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Device Registration and Listing |
May 3 , 2005 |
|
| Federal Register: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Third-Party Review Under the Food and Drug Administration Modernization Act, Third-Party Premarket Submission Review, and Quality System |
May 3, 2005 |
|
| Federal Register: Dental Devices; Reclassification of Tricalcium Phosphate Granules and Classification of Other Bone Grafting Material for Dental Bone Repair |
April 28, 2005 |
|
| Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices; Availability |
April 28, 2005 |
|
| Federal Register: Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. |
April 21, 2005 |
|
| Federal Register: Guidance for Industry and Food and Drug Administration Staff on Application User Fees for Combination Products; Availability. |
April 21, 2005 |
|
| Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Need for Online Medical Device Information. |
April 19, 2005 |
|
| Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Regulations |
April 1 , 2005 |
|
| Federal Register: Food and Drug Administration/Drug Information Association Cross Labeling; Public Meeting; Combination Products and Mutually Conforming Labeling |
March 28 , 2005 |
|
| Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems; Availability. |
March 23 , 2005 |
|
| Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of the Automated Fluorescence in situ Hybridization Enumeration Systems. |
March 23 , 2005 |
|
| Federal Register: Request for Nominations for Nonvoting Members Representing Industry Interests on Public Advisory Committees |
March 22 , 2005 |
|
| Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting |
March 15 , 2005 |
|
| Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Medical Devices; Device Tracking |
March 4 , 2005 |
|
| Federal Register: Medical Devices; Medical Device Reporting; Companion to Direct Final Rule. |
February 28, 2005 |
|
| Federal Register: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting |
February 28, 2005 |
|
| Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting |
February 28, 2005 |
|
| Federal Register: Medical Devices; Medical Device Reporting |
February 28, 2005 |
|
| Federal Register: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Application for Participation in the Medical Devices Fellowship Program. |
February 24, 2005 |
|
| Federal Register: Annual Comprehensive List of Guidance Documents at the Food and Drug Administration; Correction |
February 14, 2005 |
|
| Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Registration and Listing. |
January 13, 2005 |
|
| 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, Third-Party
Premarket Submission Review, and Quality System Inspections Under the United
States/European Community Mutual Recognition Agreement. |
January
5, 2005 |
|
| Federal
Register: Annual Comprehensive List of Guidance Documents at the Food and
Drug Administration |
January
5, 2005 |
|
| Federal
Register: Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Good Laboratory Practice
Regulations for Nonclinical Studies. |
January
3 , 2005 |
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