Medical Device Regulation

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.

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