FDA Issues Discussion Paper on Possible Regulatory Approach for Laboratory Developed Tests

FDA Issues Discussion Paper on Possible Regulatory Approach for Laboratory Developed Tests

January 17, 2017, Covington Alert

On January 13, 2017, the U.S. Food and Drug Administration (FDA or Agency) released a discussion paper synthesizing public feedback on FDA’s 2014 draft guidance documents and outlining a possible approach to regulation of laboratory developed tests (LDTs) (Discussion Paper). This approach is intended to “advance the public discussion by providing a possible approach to spur further dialogue” and “to respond to stakeholder feedback and attempt to balance patient protection with continued access and innovation.”