What statute and regulations apply to medical device clinical investigations?


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.

About the Author
Proxima CRO Team
Taylor Lunsford
Regulatory Affairs Associate

Taylor Lunsford is a Regulatory Affairs Associate from Houston, Texas and holds degrees from the University of Houston and the Defense Language Institute. Before working with Proxima, he served in the Army as a Mandarin Chinese translator and intelligence analyst.

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