Summary of FDA Statement on Laboratory Developed Tests Released - January 13, 2017

    View Authors January 2017

    On January 13, 2017, the Food and Drug Administration (FDA) issued a discussion paper on laboratory developed tests (LDT), synthesizing the regulatory dialogue that FDA and stakeholders have had since 2010 and outlining future regulatory possibilities for LDTs. FDA and a majority of stakeholders support a complimentary approach to regulating LDTs that combines FDA’s experience in pre- and post-market matters for medical devices themselves with the Centers for Medicare and Medicaid’s (CMS) experience in laboratories’ processes and procedures.

    The discussion paper advances FDA’s points on the common topics that have been brought up in the discussion for regulating LDTs and makes proposals for a future program.