![]() ![]() (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 (1) Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject Significant risk device means an investigational device that: An approved IDE means that the IRB (and FDA for significant risk devices) has approved the sponsor’s study application and all the requirements under 21 CFR 812 are met. Investigational device exemption (IDE) IDE refers to the regulations under 21 CFR 812. The device is approved for marketing but is being clinically evaluated for a new indication.The device is not approved for marketing in the United States or.A medical device is considered investigational if either condition applies: Investigational device means a device, including a transitional device, that is the object of an investigation. intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes (21 U.S.C.intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or. ![]()
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