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Recent Additions In CDRH

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* Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption Guidance for Retinal Prostheses Text PDF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* Draft Guidance for Industry and FDA Staff: Investigational Device Exemption (IDE) Guidance for Retinal Prostheses Text PDF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

Updated May 11, 2009

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