Regulatory Science Symposium: Clinical Trials with Medical Devices Session 3: IRB Reviews on Medical Device Trials (2019)

1. What is a Medical Device?
2. How does the FDA classify a Medical Device?
3. Class I Devices
4. Class II Devices
5. Class III Devices
6. Examples of Medical Devices
7. What is a Premarket Notification – 510(k) Submission?
8. What is a Premarket Approval (PMA)
9. What is a Humanitarian Use Device (HUD) and Humanitarian Device Exemption (HDE)?
10. Key Information about HUDs?
11. Requirements for an HUD Submission
12. What regulations apply to Medical Device Clinical Exemptions?
13. What types of device studies do the IDE Regulations (21 CFR Part 812) cover?
14. Significant Risk Devices (SR)
15. Non-Significant Risk Devices (NSR)
16. Institutional Review Board (IRB) Review Responsibilities for NSR
17. Exempt Studies
18. IRB Review Responsibilities
19. Making Risk Determinations: IRB Considerations
20. IRB Responsibilities
21. FAQ on Devices
22. Emergency Use/ Expanded Access
23. Compassionate Use
24. Custom Device
25. USC Device Applications

Accompanying text created by Khyati Ashtekar | Graduate Student, Regulatory Science, USC School of Pharmacy | ashtekar@usc.edu