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Are there investigational medical devices that are exempt from FDA IDE regulations?

April 26, 2017Devices exempt fda IDE Implant investigational IUD medical nsr regulations

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Are there investigational medical devices that are exempt from FDA IDE regulations?

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There are five possible device studies that are exempt from the FDA regulations on IDEs. These exemptions apply only so long as the investigator remains qualified to conduct the research (see FDA regulations, 21 CFR 812.119 for Disqualification).