In accordance with section 520(g) and the regulations, clinical studies of medical devices must comply with FDA’s human subject protection requirements (informed consent and additional safeguards for children in research) (21 CFR Part 50), Institutional Review Board (IRB) requirements (21 CFR Part 56), Investigational Device Exemptions (IDE) requirements (21 CFR Part 812), Financial Disclosure for Clinical Investigators requirements (21 CFR Part 54) regulations, as well as any other applicable regulations, including pertinent regulations at 21 CFR Part 809 (In Vitro Diagnostic Devices For Human Use).
Source: USFDA