Investigational Device Exemption (IDE)

An IDE is obtained when it is necessary to conduct clinical trials on a device to collect safety and efficacy data. This data is mostly used to support the PMA or in very few cases, the 510k. IDE documents are approved by the Institutional Review Board (IRB), a committee designated to review and approve/deny and monitor study involving humans. In cases involving significant risk devices, the FDA is also required to review the IDE. All clinical studies of investigational devices, unless exempt, must have an approved IDE for the study.

An IDE approval requires
* informed consent from all subjects;
* clear labeling that states that the device is to be used for investigational purpose only;
* monitoring of all studies;
* maintenance of all data, records and reports.