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

Assists medical device manufacturers both in and out of the U.S. with premarket application and meeting complex FDA regulatory requirements

Elijah Wreh (Author)

9780323953542, Elsevier Science

Paperback / softback, published 24 February 2023

678 pages
23.5 x 19 x 4.1 cm, 1.4 kg

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.

Section 1: How to Study and Market a Medical Device 1. Overview of Medical Device Regulation 2. Regulatory Routes to Market a Medical Device 3. Premarket Notification 510(k) 4. Device Modifications Requiring new 510(k) Submission 5. Premarket Approval (PMA) 6. Investigational Device Exemption (IDE) 7. In Vitro Diagnostics 8. Clinical Studies for Medical Device 9. Medical Device Labeling 10. FDA Advisory Committees 11. Human Factors and Medical Devices 12. Mobile Medical Applications 13. Software, Cybersecurity and Wireless Coexistence

Subject Areas: Engineering: general [TBC]