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Emergency Use Authorizations (February 25
2014 Ebola Virus Emergency Use Authorization 2013 Coronavirus Emergency Use Authorization (Potential Emergency) 2013 H7N9 Influenza Emergency Use Authorization (Potential Emergency) Historical Information, Termination of Declaration Letters and Additional Information 2013 Coronavirus Emergency Use Authorization (Potential Emergency) On May 29, 2013 Secretary Kathleen Sebelius determined that Middle East respiratory syndrome coronavirus (MERS-CoV) poses a significant…
Presentation Slides added to Public Workshop
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Slides added to Overview of Medical Device Data Systems, General Wellness Devices, and Medical Device Accessories
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Meeting Notice: April 17, 2015 Neurological Devices Panel of the Medical Devices Advisory Committee
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Neurological 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 be…
FDA Voice blog: Moving Toward a National Medical Device Postmarket Surveillance System
By: Jeffrey Shuren, M.D., J.D. and Thomas P. Gross, M.D., MPH Jeffrey Shuren, M.D., J.D., Director of FDA’s Center for Devices and Radiological Health Despite rigorous premarket evaluation, what really counts is how well a medical device works when it’s used day-to-day by patients, caregivers and clinicians. Beyond clinical trials, real-life patient experience may reveal…
FDA Voice blog: Bacterial Infections Associated with Duodenoscopes: FDA?s Actions to Better Understand the Problem and What Can be Done to Mitigate It
By: William Maisel, M.D., M.P.H. Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum). Duodenoscopes are used in more than 500,000 procedures, called endoscopic retrograde cholangiopancreatography—or ERCP—in the United States each year. The procedure is the least invasive way of draining fluids…
Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140038 and 130045 added)
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24 Hour Summary posted for Feb. 20, 2015 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
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