FDA Defers Decision on LDT Guidance

Last Friday’s announcement by the Food and Drug Administration (FDA) that it would not finalize guidance regulating laboratory developed tests (LDTs) provides a reprieve to the laboratory community, which was concerned the agency would release the policy before the new Administration takes office in January.  Just recently, AACC learned that the FDA submitted the guidance to the Office of Management and Budget (OMB) for review.  OMB clearance is required before a regulation or guidance is published.  In announcing that it would not finalize the guidance, the FDA seems to have taken seriously Congress’ warning to the Obama Administration not to institute any new regulations in the lame-duck session. The Agency rather stated that it will outline a new “risk-based approach in the near future.” 

Given President-elect Trump’s call for reduced federal regulation, and congressional threats to stop the FDA from advancing this policy initiative, it seems unlikely the agency will implement a new policy regulating LDTs without legislative authorization.  House Energy and Commerce Chair Fred Upton issued a statement praising the FDA’s decision and stating that he looks forward to working with stakeholders next year to craft a legislative solution.  AACC will continue to work with Congress, the federal agencies and other stakeholders to ensure that patients continue to have access to high quality, innovative tests.