significant risk device

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significant risk device2016-12-28T06:35:22+00:00

significant risk device 

PATIENT SAFETY

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 patient;

(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

Examples, significant risk devices Artificial skin, catheters, extended-wear contact lenses, prosthetic heart valves, ventilators 

Reference www.fda.gov/cdrh/devadvice/ide/index.shtml  

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