Nonsignificant Risk (NSR) medical device study

A study that involves an investigational device that does not present serious risk to the health, safety, or welfare of a participant(s) (known as a Nonsignificant Risk (NSR) medical device). The sponsor is responsible for making the initial risk determination and presenting it to the Institutional Review Board (IRB) with the appropriate rationale. The risk determination is based on the proposed use of a device in an investigation, and not on the device alone. NSR medical device studies must follow abbreviated requirements at 21 CFR 812.2(b), including labeling, IRB approval, Informed Consent (IC), monitoring, records, reports, and prohibition against promotion, and do not require an Investigational Device Exemption (IDE) application approved by the Food and Drug Administration (FDA). The IRB serves as the FDA’s surrogate for review, approval, and continuing review of NSR medical device studies and IRB approval of an NSR device does not have to be reported to the FDA. FDA: Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors, Significant Risk and Nonsignificant Risk medical Device Studies