Clinical studies of medical devices must comply with:

• FDA’s human subject protection requirements (21 CFR 50)
• Institutional Review Board requirements (21 CFR 56)
• Investigational Device Exemptions requirements (21 CFR 812)
• Financial Disclosure for Clinical Investigations requirements (21 CFR 54)
• Any other applicable regulations, including pertinent sections of In Vitro Diagnostic Devices for Human Use (21 CFR 809)

States may have their own laws, regulations, and guidelines.