Fda Oversight of Medical Devices
Hill, Matthew W Torres, Daniel E
ISBN 10: 1622570898 ISBN 13: 9781622570898
Published by NOVA SCIENCE PUBLISHERS INC (11/2012), 2012
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Hardcover
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About this Item
Description:
LIVRE A L?ETAT DE NEUF. EXPEDIE SOUS 3 JOURS OUVRES. NUMERO DE SUIVI COMMUNIQUE AVANT ENVOI, EMBALLAGE RENFORCE. EAN:9781622570898. Seller Inventory # SLIVCN-9781622570898
Synopsis:
The FDA is responsible for overseeing the safety and effectiveness of medical devices sold in the United States. New devices are generally subject to FDA review via the 510(k) process, which determines if a device is substantially equivalent to another legally marketed device, or the more stringent pre-market approval process, which requires evidence providing reasonable assurance that the device is safe and effective. This book examines whether the FDA is sufficiently meeting the performance goals and whether devices are reaching the market in a timely manner.
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Bibliographic Details
Title: Fda Oversight of Medical Devices
Publisher: NOVA SCIENCE PUBLISHERS INC (11/2012)
Publication Date: 2012
Binding: Hardcover
Condition: Used: Like New