Medical Device Regulation: Fda-Cdrh Manufacturing, Policies and Regulation Handbook

By Elijah Wreh

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.

• Format: Paperback
• Language: English
• ISBN: 0323953549
• ISBN13: 9780323953542
• Release Date: March 2023
• Publisher: Academic Press
• Length: 678 Pages
• Weight: 2.53 lbs.
• Dimensions: 1.4" x 7.5" x 9.3"