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

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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