FDA Oversight of Medical Devices : Efforts & Developments
Book Details
Format
Hardback or Cased Book
ISBN-10
1622570898
ISBN-13
9781622570898
Publisher
Nova Science Publishers Inc
Imprint
Nova Science Publishers Inc
Country of Manufacture
US
Country of Publication
GB
Publication Date
Nov 14th, 2012
Print length
150 Pages
Weight
388 grams
Dimensions
16.20 x 23.60 x 1.70 cms
Product Classification:
Public administrationRegulation of medicines & medical devices
Ksh 28,800.00
Not available
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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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