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
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