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Meeting Notice: February 18, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will…
Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices
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Public Workshop – Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy, January 25, 2016
The Food and Drug Administration (FDA) is announcing the following public workshop entitled “Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy.” The purpose of this workshop is to discuss and receive input from stakeholders regarding approaches to the analytical and clinical validation of point of care (POC) Prothrombin Time/International Normalized Ratio…
Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150010 added)
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Meeting Minutes posted for FDA-Industry MDUFA IV Reauthorization Meeting, November 18, 2015
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Letter to Genomic Express, Inc. concerning pharmacogenomic tests
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Letter to Healthspek LLC concerning the Healthspek PGT test for genes affecting drug metabolism
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GEN1500807: Letter to Healthspek LLC concerning the Healthspek PGT test for genes affecting drug metabolism
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Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings
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