FDA Synthesizes Feedback on LDTs in New Discussion Paper

Following up its decision not to issue final guidance in 2016 regarding oversight of laboratory developed tests (LDTs), the U.S. Food and Drug Administration released a discussion paper Friday, Jan. 13, 2017. The paper synthesizes the feedback it has received on its 2014 draft guidance and offers a possible alternative approach to regulating LDTs. The FDA expressly stated however that this discussion paper and the proposal included isn’t a final version of the 2014 guidance and “does not represent the formal position of the FDA, nor is it enforceable. We hope to simply advance the public discussion by providing a possible approach to spur further dialogue.”