Under the Microscope - Biomarker and Diagnostic Tests as FDA-Regulated Devices

April 27, 2016

The technological boom in recent years has led to an explosion of biomarker and genetic mutation tests. This boom has raised issues regarding the conduct of FDA-regulated clinical investigations. In this paper,  our authors discuss the roles of the FDA, the sponsor, and the IRB in determining if a biomarker test is considered FDA-regulated medical device research when it is conducted as part of a clinical investigation. 

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