IDE Approval Process- IDE Exempt Investigations

All clinical investigations of devices must have an approved IDE or be exempt from the IDE regulation. Studies exempt from the IDE regulation include:

1. a legally marketed device when used in accordance with its labeling
2. a diagnostic device if it complies with the labeling requirements and if the testing:


1. is noninvasive;
2. does not require an invasive sampling procedure that presents significant risk;
3. does not by design or intention introduce energy into a subject; and
4. is not used as a diagnostic procedure without confirmation by another medically established diagnostic product or procedure; Additional guidance for an in vitro diagnostic device studies can be found in "Regulating In Vitro Diagnostic Device (IVD) Studies."


3. consumer preference testing, testing of a modification, or testing of a combination of devices if the device(s) are legally marketed device(s) [that is, the devices have an approved PMA, cleared Premarket Notification 510(k), or are exempt from 510(k)] AND if the testing is not for the purpose of determining safety or effectiveness and does not put subjects at risk;
4. a device intended solely for veterinary use;
5. a device shipped solely for research with laboratory animals and contains the labeling "CAUTION – Device for investigational use in laboratory animals or other tests that do not involve human subjects."

Depending upon the nature of the investigation, those studies which are exempt from the requirements of the IDE regulation may or may not be exempt from the requirements for IRB review and approval under Part 56 and the requirements for obtaining informed consent under Part 50.