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When does an IVD study involve human subjects?

April 26, 2017Human involve IVD study Subjects

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When does an IVD study involve human subjects?

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Under FDA’s current regulations governing the conduct of IVD device studies, the definition of “subject” includes individuals on whose specimens an investigational device is used [see 21 CFR 812.3(p)]. As a result, an IVD study using human specimens involves human subjects.