An Investigational Device Exemption (IDE) is the regulatory authorization that allows a medical device to be studied in humans in the U.S. before marketing approval.
IDE requirements apply to significant-risk device investigations and are governed by 21 CFR Part 812. IRBs review device risk determinations, informed consent materials, monitoring plans, and reporting processes as part of approving a device study. IDE oversight ensures the study includes adequate safeguards, including adverse event reporting and device accountability. Compliance supports participant safety while generating evidence needed for future regulatory submissions.