Significant Risk (SR) medical device

An investigational device that:

1. Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
2. is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;
3. is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or
4. otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

Examples of SR devices include internal sutures, cardiac pacemakers, hydrocephalus shunts, and orthopedic implants.

FDA: 21 CFR 812.3, Definitions; FDA: Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors, Significant Risk and Nonsignificant Risk Medical Device Studies