Creating 21st Century Medical Devices : Development Needs & Issues
Book Details
Format
Hardback or Cased Book
ISBN-10
1608767736
ISBN-13
9781608767731
Publisher
Nova Science Publishers Inc
Imprint
Nova Science Publishers Inc
Country of Manufacture
US
Country of Publication
GB
Publication Date
Jul 13th, 2011
Print length
206 Pages
Weight
558 grams
Dimensions
25.80 x 18.20 x 1.80 cms
Product Classification:
Medical equipment & techniques
Ksh 33,500.00
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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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