Significant risk device

A significant risk study needs an approved IDE from FDA as well as IRB approval before it starts. The sponsor proposes the risk level, the IRB decides, and FDA has the final word if asked through a study risk determination.

Significant risk device means 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.

21 CFR, 812.3