significant risk device
significant risk device
An FDA term of art for 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.
FDA-approval is required for investigation of significant risk devices, which include artificial skin, catheters, extended-wear contact lenses, prosthetic heart valves, and ventilators.