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What statute and regulations apply to medical device clinical investigations?

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About the Author
Proxima CRO Team
Taylor Lunsford, MGA
Regulatory Associate II
Taylor is fluent in Mandarin Chinese and has a strong background in medical interpreting and translating medical documents. Before joining Proxima, Taylor served in the Army as an intelligence analyst, instructor, translator and small-unit leader.

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.

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