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FDA Oversight of Medical Devices: Efforts and Developments: Efforts & Developments (M - Hardcover

 
9781622570898: FDA Oversight of Medical Devices: Efforts and Developments: Efforts & Developments (M
Hardcover
ISBN 10: 1622570898 ISBN 13: 9781622570898
Verlag: Nova Science Publishers Inc, 2012

Inhaltsangabe

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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Verlag
Nova Science Publishers Inc
Erscheinungsdatum
2012
Sprache
Englisch
ISBN 10 
1622570898
ISBN 13 
9781622570898
Einband
Gebundene Ausgabe
Auflage
1
Anzahl der Seiten
150
Herausgeber
Hill Matthew W., Torres Daniel E.
Kontakt zum Hersteller
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Verantwortliche Person
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