Clinical Study with Medical Devices

A significant risk device study, a sponsor must:
Clinical studies with medical devices that pose a significant risk require both FDA and an Institutional Review Board (IRB) approval prior to initiation of a clinical study. FDA approval is obtained by submitting an IDE application to FDA (§812.20).

• Submit a complete IDE application  (§812.20) to FDA for review and obtain FDA approval of the IDE; submit the investigational plan and report of prior investigations(§812.25 and §812.27) to the IRB at each institution where the investigation is to be conducted for review and approval; and

• Select qualified investigators, provide them with all necessary information on the investigational plan and report of prior investigations, and obtain signed investigator agreements from them.

An IDE application is considered approved 30 days after it has been received by FDA, unless FDA otherwise informs the sponsor prior to 30 calendar days from the date of receipt, that the IDE is approved, approved with conditions, or disapproved. 

Nonsignificant Risk Device
Nonsignificant risk devices are devices that do not pose a significant risk to the human subjects. Examples include most daily-wear contact lenses and lens solutions, ultrasonic dental scalers, and foley catheters.

• A nonsignificant risk device study requires only IRB approval prior to initiation of a clinical study. Sponsors of studies involving nonsignificant risk devices are not required to submit an IDE application to FDA for approval.

IDE Exempt Investigations
All clinical investigations of devices must have an approved IDE or be exempt from the IDE regulation. Investigations that are exempted from 21 CFR 812 are described in §812.2(c) of the IDE regulation. Studies exempt from the IDE regulation include

• a legally marketed device when used in accordance with its labeling
• a diagnostic device if it complies with the labeling requirements in §809.10(c) and if the testing:
• is noninvasive;
• oes not require an invasive sampling procedure that presents significant risk;
• does not by design or intention introduce energy into a subject; and
• is not used as a diagnostic procedure without confirmation by another medically established diagnostic product or procedure; "Regulating In Vitro Diagnostic Device (IVD) Studies."

• consumer preference testing, testing of a modification, or testing of a combination of devices if the device(s) are legally marketed device(s) with 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;

• a device intended solely for veterinary use;

•  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.