Overview of Human Subjects Research and the IRB

< i > Medical Device Approvals

PreMarket Approval (PMA)
- Similar to an NDA for a drug
- Studies Required - IRB involved
510K
- Determined by FDA
- "this new device is substantially equivalent to that other device that is legally marketed without a PMA."
- If do research, then must go to an IRB
Humanitarian Device Exemption (HDE)
- Used in <4,000 patients per year