Medical Device Regulation : A Guidebook for Medical Device Manufacturers book cover
1st Edition

Medical Device Regulation
A Guidebook for Medical Device Manufacturers

  • Available for pre-order. Item will ship after May 31, 2021
ISBN 9789814877640
May 31, 2021 Forthcoming by Jenny Stanford Publishing
1400 Pages

SAVE ~ $120.00
was $600.00
USD $480.00

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Book 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.

Table of 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


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Elijah N. Wreh is an accomplished regulatory affairs leader with a proven track record of success in the medical device industry. He is also industry representative, FDA Neurological Devices Panel Advisory Committee. In 2011, the Medical Device Fellowship Program appointed him as a staff fellow at the FDA Center for Devices and Radiological Health, Office of the Center Director (Dr. Jeffrey Shuren). He was part of the FDA team of experts that wrote the FDA guidance document on "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." Wreh is an adjunct professor at Case Western Reserve University; part-time lecturer at Northeastern University, College of Professional Studies; and guest lecturer at Cleveland State University and the University of Akron. He holds an MS in regulatory science from the University of St. Thomas (Minnesota), a certificate in Healthcare Compliance from Seton Hall Law School (New Jersey), and a Risk Analysis certificate from Harvard T.H. Chan School of Public Health (Massachusetts). He is also a board member of CommStar Credit Union, Elyria, Ohio.