Significant Risk (SR) medical device study

A study that involves an investigational device that may present serious risk to the health, safety, or welfare of a participant(s). 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. SR studies must follow all the IDE regulations at 21 CFR 812 and requires an approved IDE application before the study can begin. FDA: 21 CFR 812.3, Definitions; FDA: Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors, Significant Risk and Nonsignificant Risk medical Device Studies