A Significant Risk (SR) Device Study involves an investigational device that:

• Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject.  

• Is represented to be for use supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject.  

• 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  

• Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.  

Non-Significant Risk (NSR) Device Study:

• An NSR device study is one that does not meet the definition for an SR device study.

Basis for determination:

Risk determination is based on the use of the device in an investigational study. In a situation where the FDA has not made a risk determination  then it will be up to the IRB to determine the risk when submitted by the sponsor who is responsible for making the initial risk determination and presenting it to the IRB. FDA is also available to assist the Sponsor and IRB with risk determination.

‍