Issue Date: August 11, 2014
FDA To Act On Diagnostic Tests
FDA is taking steps to increase its oversight of certain tests, used to diagnose and treat patients, to ensure the accuracy and reproducibility of the tests. A draft proposal released on July 31 takes aim at diagnostic tests that are developed and used in a single laboratory, such as genetic tests used by medical professionals to guide treatment for a particular patient. Under the draft proposal, tests that pose high or moderate risks to patients would be subject to premarket approval, which requires clinical studies. Historically, FDA has not required clinical studies for this category of diagnostics. As a result, some of these tools have entered the market without safety data and are directly competing with FDA-approved diagnostics. Under the draft proposal, FDA would consider diagnostics high risk if they have the same intended use as tests that are already FDA approved.
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