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Creating 21st Century Medical Devices: Development Needs & Issues

Creating 21st Century Medical Devices: Development Needs & Issues

9781608767731
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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 FDAs approval process for medical devices, and provides an overview of the medical device related legislative issues facing Congress.
Product Details
Nova Science Publishers Inc
73058
9781608767731
9781608767731

Data sheet

Publication date
2011
Issue number
1
Cover
hard cover
Pages count
206
Dimensions (mm)
260.00 x 180.00
Weight (g)
548
  • Preface; High-Confidence Medical Devices:: Cyber-Physical Systems for 21st Century Health Care; FDA Should Take Steps to Ensure that High-Risk Device Types are Approved through the Most Stringent Premarket Review Process; Medical Device User Fees & User Fee Acts; The Medical Device Approval Process & Related Legislative Issues; Index.
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