Medical Device Regulation

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

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• Regulamento de medicamentos e dispositivos médicos

A premarket notification, or 510(k) submission, is the mechanism through which most medical devices obtain United States marketing clearance. A 510(k) submission is required for any device intended for human use unless the device is exempt by regulation (most class I and select class II devices) or is a class III device; And examination of specimens taken from the human body; And reagents used to perform the tests; But also the products intended for use in the collection; CDRH; CFR; Device modification; FDA