MEDICAL DEVICE REGULATION FDA-CDRH Manufacturing, Policies and Regulation Handbook

• Main Author: Wreh, Elijah (Author)
• Format: Book
• Language: English
• Published: Oxford, United Kingdom Elsevier 2023
• Subjects: Equipment and supplies > Standards; Equipment design; Device approval > legislation & jurisprudence; Government Regulation; United States
• Online Access: Click Here to View Status and Holdings.

 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.