Definitions for "Investigational Device Exemption"
Exemption from certain regulations found in the Medical Device Amendments that allow shipment of unapproved devices for use in clinical investigations [21 CFR 812.20].
Certain studies of lawfully marketed devices may be exempt under 21 CFR 812.2(c). An 812.2(c)(2) exemption applies only to investigations in which 510(k) products are being used in accordance with the labeling cleared by FDA. Investigation of an off-label use of a 510(k) product takes it outside this exemption. A device subject to 510(k) remains "investigational" until the 501(k) is cleared by FDA and the investigational use is subject to the requirements of the IDE regulation, informed consent and IRB review (21 CFR 50 and 56, respectively).
The application by which a manufacturer requests an exemption from the FD&C Act requirements to study its medical device