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

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. Offers a unique focus on the regulatory affairs industry, specifically targeted at regulatory affairs professionals and those seeking certification Puts regulations in the context of contemporary design Includes case studies and applications of regulations INDICE: 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 Section 2: Postmarket Activities and FDA Collaboration 14. Postmarket Activities and Requirements 15. Compliance and Enforcement 16. Quality System Regulation (QRS) 17. Risk Management 18. Meeting and Collaboration with FDA 19. Future of Medical Device Regulation Appendix A: FDA Guidance Documents (Medical Devices) B: Regulatory Affairs Certification (Devices) Practice Exam Questions C: Quality Management System (QMS) Manual

• ISBN: 978-0-323-95354-2
• Editorial: Academic Press
• Encuadernacion: Rústica
• Páginas: 350
• Fecha Publicación: 01/01/2023
• Nº Volúmenes: 1
• Idioma: Inglés