May 8, 2009 |
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Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Shortages Data Collection System (formerly "Emergency Medical Device Shortages Program Survey") |
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May 7, 2009 |
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Class I Medical Device Recall: Biosite Incorporated, Triage Cardiac Panel |
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Consumer Information on: REPEL-CV® Bioresorbable Adhesion Barrier - P070005 |
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May 6, 2009 |
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Federal Register: Implementation of Post-Approval Studies for Medical Devices; Public Workshop |
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May 4, 2009 |
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CDRH White Oak Move |
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Federal Register: Pediatric Device Consortia Grant Program |
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May 1, 2009 |
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PMA Final Decisions for March 2009 |
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April 30, 2009 |
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Neurological Devices Panel Advisory Meeting, May 14, 2009 - Waivers for Conflicts of Interest |
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April 29, 2009 |
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Ophthalmic Devices Panel Advisory Meeting, March 27, 2009 - Transcript |
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Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, March 31, 2009 - Transcript |
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April 28, 2009 |
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Federal Register: Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting |
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Letter of Authorization: Emergency Use of the Swine Influenza Virus Real-time RT-PCR Detection Panel |
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Federal Register: Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting |
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Report to Congress: Premarket Approval of Pediatric Uses of Devices - FY 2008 |
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April 27, 2009 |
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Circulatory System Devices Panel Advisory Meeting, April 23, 2009 - Agenda, Roster, Briefing, Questions, Brief Summary |
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Federal Register: Computational Modeling for Cardiovascular Devices; Public Workshop |
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April 22, 2009 |
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Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Financial Disclosure by Clinical Investigators |
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April 17, 2009 |
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Consumer Information on: ARCHITECT® CORE Reagent Kit, Calibrator and Controls - P080023 |
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Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption Guidance for Retinal Prostheses |
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Consumer Information on: Medtronic® Attain Ability™ Model 4196 Lead - P080006 |
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April 16, 2009 |
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Draft Guidance for Industry and FDA Staff: Investigational Device Exemption (IDE) Guidance for Retinal Prostheses |
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FDA / NHLBI / NSF Workshop on Computer Methods for Cardiovascular Devices, June 1-2, 2009 |
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April 15, 2009 |
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Class I Medical Device Recall: Teleflex Medical, Arrow International Inc. 30, 40, and 50 cc Intra-Aortic Balloons |
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April 13, 2009 |
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Summary Information for: Cervista™ HPV 16/18 |
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Consumer Information on: Cervista™ HPV 16/18 - P080015 |
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Consumer Information on: CervistaTM HPV HR and GenfindTM DNA Extraction Kit - P080014 |
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Summary Information for: CervistaTM HPV HR and GenfindTM DNA Extraction Kit |
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Consumer Information on: FC2 Female Condom - P080002 |
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Consumer Information on: Synvisc-One (hylan GF-20) - P940015S012 |
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