Main description:

This book sheds light on the importance of regulations and standards for manufacturers' development of medical devices. Based on the author's practical experience with the US Food and Drug Administration (FDA) and industry, it provides a concise, practical guide on key issues and processes in developing new medical devices to meet the FDA regulatory requirements and standards. The book is designed to help medical device manufacturers navigate FDA regulation, carefully consider the parameters for medical device patient safety, anticipate problems with medical device, and efficiently manage medical device throughout the total product life cycle.

The book contains perspectives from industry and FDA professionals and academics providing a comprehensive look of FDA regulation of medical devices in the United States, best practices for medical device product development, FDA current thinking on medical device regulation, and the dynamics of implementation of new product introduction. Various chapters advise manufacturers on how to achieve marketing approval and clearance for all types of medical device classification, including Class 1 (low to moderate risk), Class 2 (moderate to high risk), and Class 3 (high risk). In addition, the book describes compliance for medical device and their software and discusses legal issues and case studies surrounding medical devices, the impact of medical device failures on patient safety, mobile medical applications, cybersecurity, and wireless coexistence. It brings forth relevant challenges and demonstrates how medical device manufacturers can foster increased clinical and non-clinical data to support their marketing application to the FDA and the bottom line by translating the regulatory impact on operational requirements.

Contents:

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. Humanitarian Devices

8. In Vitro Diagnostics

9. Clinical Studies for Medical Device

10. Medical Device Labeling

11. FDA Advisory Committees

12. Human Factors and Medical Devices

13. Mobile Medical Applications

14. Software, Cybersecurity and Wireless Coexistence

15. Postmarket Activities and Requirements

16. Compliance and Enforcement

17. Quality System Regulation (QRS)

18. Risk Management

19. Meeting and Collaboration with FDA

20. Future of Medical Device Regulation

Appendix A: FDA Guidance Documents (Medical Devices)

Appendix B: Regulatory Affairs Certification (Devices) Practice Exam Questions

Glossary