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

November 9, 2017 at 9:21 PM
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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