The Investigational Device Exemption permits clinical investigation of medical devices that are not yet approved or cleared for commercial distribution in the United States. Analogous to the IND for drugs, the IDE provides regulatory oversight of device studies while enabling the collection of clinical data necessary for marketing applications. The IDE requirements ensure that clinical investigations are conducted safely, with appropriate informed consent and IRB oversight, while not imposing the full regulatory requirements applicable to marketed devices.

IDE requirements vary based on the risk classification of the device and the nature of the study. Significant risk device studies, involving devices that present potential for serious harm, require FDA approval of an IDE application before the study can begin. The application must describe the device, the proposed clinical protocol, manufacturing information, investigator qualifications, and risk analysis. Nonsignificant risk device studies may proceed after IRB approval without formal IDE submission to FDA, though they must still comply with IDE regulations regarding informed consent, labeling, and record-keeping.

The distinction between significant and nonsignificant risk is based on an assessment of the device's potential to cause harm. Significant risk devices include those that are implants, life-supporting or life-sustaining, or otherwise present unreasonable risk of illness or injury. For studies requiring IDE approval, the FDA review evaluates whether the investigation presents unreasonable risks, whether the research design is adequate to meet the study objectives, and whether adequate protections are in place for human subjects. IDE approval permits initiation of the clinical study, with ongoing requirements for safety reporting and progress updates.