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Creating 21st Century Medical Devices: Development Needs and Issues
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Editors: Nelson E. Parker
Book Description:
In order to be legally manufactured in the U.S., medical devices must be approved by the Food and Drug Administration (FDA), the agency responsible for protecting the public health by assuring the safety, efficacy, and security of human medical devices and other products. The regulation of medical devices can affect their cost, quality, and availability in the health care system. This book discusses the legislative history of medical device regulation, describes the FDA's approval process for medical devices, and provides an overview of the medical device related legislative issues facing Congress.

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Table of Contents:

High-Confidence Medical Devices: Cyber-Physical Systems for 21st Century Health Care
(Networking and Information Technology Research and Development Program (NITRD) pp.1-90

FDA Should Take Steps to Ensure that High-Risk Device Types are Approved through the Most Stringent Premarket Review Process pp.91-134

Medical Device User Fees and User Fee Acts
(Erin D. Williams, Specialist in Public Health and Bioethics pp.135-164

The Medical Device Approval Process and Related Legislative Issues
(Erin D. William, Specialist in Public Health and Bioethics pp.165-192

Index pp.192-206

      Medical Devices and Equipment
   Binding: Hardcover
   Pub. Date: 2011 - 1st Quarter
   Pages: 206.pp
   ISBN: 978-1-60876-773-1
   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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Creating 21st Century Medical Devices: Development Needs and Issues