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
An approval by the FDA for a device that permits its use in a clinical study to collect the safety and effectiveness data required for an application to market the device.
a regulatory category and process in which the U.S. Food and Drug Administration (FDA) allows specified use of an unapproved health device in controlled settings for purposes of collecting data on safety and efficacy/effectiveness; this information may be used subsequently in a premarketing approval application.
A formal application to the Food and Drug Administration to obtain an exemption to use an unapproved device in a clinical trial in the United States. The IDE ensures that the study will appropriately select and exclude subjects, obtain informed consent, employ qualified investigators, and monitor and collect data.
A FDA regulatory status which permits the human use of an unapproved medical device for the purposes of collecting clinical data under strictly controlled conditions.
Exemption from FD & C Act to study investigational medical devices.
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a PMA or 510(k) submission to FDA.
An application to the FDA to conduct clinical trials of an investigational device.