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IDE Exempt Investigations

All clinical investigations of devices must have an approved IDE or be exempt from the IDE regulation.

21 CFR 812.2(c) describes investigations that are exempt. Exempt studies include:

  • A legally marketed device used in accordance with its labeling
  • A diagnostic device, if it complies with the labeling requirements in 21 CFR 819.19(c) and if the testing:
    • Is noninvasive
    • Does not involve an invasive sampling procedure that presents significant risk
    • Does not by design or intention introduce energy into a subject
    • Is not used as a diagnostic procedure without confirmation by another medically established diagnostic product or procedure.
      (The guidance for an in vitro diagnostic device can be found in the FDA document "Regulating In Vitro Diagnostic Device (IVD) Studies.")
  • Consumer preference testing, testing of a modification, or testing of a combination of devices, if all such device(s) are legally marketed device(s).
  • Device intended solely for veterinary use.
  • Device shipped solely for research with laboratory animals and contains the label "CAUTION - Device for investigational use in laboratory animals or other tests that do not involve human subjects."

Depending upon the nature of the investigation, those studies that are exempt from the requirements of the IDE regulation may or may not require CPHS review and approval and the obtaining of informed consent. Please contact the CPHS and/or the FDA at (301) 594-1190.

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