FDA Week - 11/10/2017

FDA Lowers Marketing Hurdles For Direct-To-Consumer Genetic Tests

November 09, 2017
FDA announced Monday (Nov. 6) that the agency would exempt from premarket review all in vitro tests marketed to consumers for detecting genetic risk of developing a disease, so long as manufacturers have received a first-time FDA marketing authorization for their systems. Coupled with the move to allow these devices to come to market more easily, FDA also outlined a number of special controls meant to ensure the tests' accuracy, reliability and clinical relevance. The agency Monday also took a...

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