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FDA Oversight of Medical Devices: Efforts and Developments
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Editors: Matthew W. Hill and Daniel E. Torres
Book Description:
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 premarket 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. (Imprint: Nova Biomedical)

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Table of Contents:
Preface pp. i-viii

Medical Devices: FDA Has Met Most Performance Goals but Device Reviews are Taking Longer
(GAO)pp. 1-50

Pediatric Medical Devices: Provisions Support Development, but Better Data Needed for Required Reporting
(GAO)pp. 51-96

Medical Devices: FDA's Premarket Review and Postmarket Safey Efforts. Testimony of Marcia Crosse, Government Accountability Office delivered at the Hearing on "A Delicate Balance: FDA and the Reform of the Medical Device Approval Process" pp. 97-114

Statement of William Maisel, Deputy Director for Science, Center for Devices and Radiological Health, Food and Drug Administration. Hearing on "A Delicate Balance: FDA and the Reform of the Medical Device Approval Process" pp. 115-128

Testimony of David Nexon, Senior Executive Vice President, Advanced Medical Technology Association. Hearing on "A Delicate Balance: FDA and the Reform of the Medical Device Approval Process" pp. 129-144

Index pp. 145-150

   Series:
      Medical Devices and Equipment
      Government Procedures and Operations
   Binding: Hardcover
   Pub. Date: 2012-September
   Pages: 158, 6 x 9 (NBC - G)
   ISBN: 978-1-62257-089-8
   Status: AV
  
Status Code Description
AN Announcing
FM Formatting
PP Page Proofs
FP Final Production
EP Editorial Production
PR At Prepress
AP At Press
AV Available
  
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FDA Oversight of Medical Devices: Efforts and Developments