- What is a Medical Device?
- How does the FDA classify a Medical Device?
- Class I Devices
- Class II Devices
- Class III Devices
- Examples of Medical Devices
- What is a Premarket Notification – 510(k) Submission?
- What is a Premarket Approval (PMA)
- What is a Humanitarian Use Device (HUD) and Humanitarian Device Exemption (HDE)?
- Key Information about HUDs?
- Requirements for an HUD Submission
- What regulations apply to Medical Device Clinical Exemptions?
- What types of device studies do the IDE Regulations (21 CFR Part 812) cover?
- Significant Risk Devices (SR)
- Non-Significant Risk Devices (NSR)
- Institutional Review Board (IRB) Review Responsibilities for NSR
- Exempt Studies
- IRB Review Responsibilities
- Making Risk Determinations: IRB Considerations
- IRB Responsibilities
- FAQ on Devices
- Emergency Use/ Expanded Access
- Compassionate Use
- Custom Device
- USC Device Applications
Clinical Trials with Medical Devices Boot Camp 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.
Accompanying text created by Khyati Ashtekar | Graduate Student, Regulatory Science, USC School of Pharmacy | firstname.lastname@example.org