FDA Challenges Direct-To-Consumer Genetic Tests

Law360, New York (March 22, 2016, 11:47 AM EDT) -- Nancy K. Stade

Torrey A. Cope

Ryan J. Kaat Although the U.S. Food and Drug Administration policy of "enforcement discretion" for laboratory developed tests (LDTs) remains in place for the time being, this policy has not stayed the FDA's hand in taking action against genetic tests marketed direct-to-consumer (DTC). The FDA has made clear that DTC tests do not fall within that policy,[1] which means that manufacturers of such tests are subject to enforcement action if they do not submit information about their tests to the FDA for premarket review and do not comply with other FDA regulatory controls, even if...

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