E-mailSignificant risk (SR) device studies are subject to regulations found in [21 CFR part 812]. Non-significant risk (NSR) device studies are subject to the 'abbreviated requirements' found in [21 CFR part 812.2 (b)]. The major differences between these two device categories are in the approval, record keeping, and reporting processes. The decision as to whether or not a device is a SR device is important to the FDA because, in some respects, the IRB serves as their surrogate with respect to the review and approval of such studies. FDA is not usually notified of the existence of NSR studies because sponsors and IRBs are not required to report these approvals to the FDA. If an investigator or a sponsor proposes the initiation of a claimed NSR investigation to an IRB, and if the IRB agrees that the device is NSR and approves the study, the investigation may begin immediately at that institution, and does not require submission of an IDE application to the FDA.
The determination of whether or not a device is SR vs. NSR is initially made by the sponsor. If the sponsor considers the device NSR, they must then provide the reviewing IRB with an explanation of who this determination was made. The sponsor should also provide the reviewing IRB with a description of the actual device, reports of previous investigations with the device, the proposed investigational plan, a description of patient selection criteria, a description of proposed monitoring procedures, and any other information that the IRB requires to make its decision. The sponsor must inform the IRB whether another IRB has reviewed the proposed study and what determination was made. If the FDA assessed the device and made a determination regarding classification, the sponsor must also inform the IRB of the Agency's decision.