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

In this series, we will discuss considerations, regulations and resources to utilize when conducting clinical trials with medical devices.


  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 | 

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