Significant Risk Device (SR)

This is defined [21 CFR 812.3(m)] as a study of a device that presents the potential for serious risk to the health, safety or welfare of a subjects and 1) is an implant; or 2) is used in supporting or sustaining human life; or 3) is of substantial importance in diagnosing, curing, mitigating or treating disease, or otherwise prevents impairment of human health; or 4) otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

Nonsignificant Risk Device (NSR)

This is one that does not meet the definition for a significant risk study. NSR device studies, however, should not be confused with "minimal risk", a term utilized to identify certain studies that may be approved through the expedited review process.

Distinguishing between SR and NSR device studies as described in federal regulations:

The effect of the SR vs NSR decision is very important to research sponsors and investigators. SR device studies are governed by the IDE regulations (21 CFR part 812). NSR device studies have fewer regulatory controls than SR studies and are governed by abbreviated requirements (21 CFR 812.2(b)). The major differences are in the approval process and in the record keeping and reporting requirements. The SR vs NSR decision is also important because the IRB serves as the Agency's surrogate with respect to review and approval of NSR studies. FDA is usually not apprised of the existence of approved NSR studies because sponsors and IRBs are not required to report NSR device study approvals to 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 study is NSR and approves the study, the investigation may begin at that institution immediately, without submission of an IDE application to FDA. If an IRB believes that a device is SR, the investigation may not begin until both IRB and the FDA approve the investigation. To help in the determination of the risk status of conducted with the device, the proposed investigational plan, a description of subject selection criteria and monitoring procedures. The sponsor should provide the IRB with a risk assessment and the rationale used in making its risk determinations (21 CFR 812.150(b)(10)).