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

by Elijah Wreh

Book Details

Format Paperback / Softback

ISBN-10 0323953549

ISBN-13 9780323953542

Publisher Elsevier Science & Technology

Imprint Academic Press Inc

Country of Manufacture NL

Country of Publication GB

Publication Date Feb 24th, 2023

Print length 678 Pages

Weight 1,338 grams

Dimensions 19.00 x 23.50 x 3.80 cms

Product Classification: Regulation of medicines & medical devices

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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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