IDE

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Investigational Device Exemption (IDE)

An Investigational Device Exemption (IDE) application is submitted to the FDA to allow for the conduct of a clinical investigation using a significant risk device that is new or not approved for a given use.

When Do You Need an IDE?

Significant vs. Non-significant Risk Devices

The following categories of devices are exempt from IDE requirements:

Devices in commercial distribution before 5/28/1976

Devices determined by FDA to be substantially equivalent to a device in commercial distribution before 5/28/1976

Diagnostic devices that are noninvasive or do not require an invasive sampling procedure that presents significant risk, do not introduce energy into a subject or are not used as a diagnostic procedure without the confirmation of another medically established diagnostic product or procedure

Devices used for consumer preference testing or for any test that is not intended to determine safety or effectiveness and does not expose subjects to risk

Devices exclusively used for veterinary indications

Devices to be shipped exclusively for research on laboratory animals

Custom devices unless these are used to assess safety or effectiveness for commercial distribution

UUSOP-12: Investigational Device Exemption Applications in FDA-Regulated Research

Please contact us with any questions

Contact Us for IND/IDE Support

CRSO.FDAsupport@hsc.utah.edu

PHONE: (307) 709-0119