Medical Device Regulation: FDA-CDRH Manufacturing, Policies and Regulation Handbook

  • ISBN 9780323953542
  • Author: Wreh, Elijah (Adjunct Professor, Case Western Rese
  • Publ Date: 2023-02-01
  • Edition: 1
  • Binding: Paperback / softback

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Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices.
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