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What is a Significant Risk Device (SR) as defined by the FDA?

Significant risk device is 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 for use in supporting or sustaining human life and represents 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 a subject.