Last Friday, the FDA halted the finalization of guidance that would have changed the way lab-developed tests (LDTs) are regulated. The reason? The presidential election. The current administration now enters its waning hours and the FDA decided to suspend guidance until the new regime takes office.
As RAPS reported, the press office for the FDA, Tara Goodin, defended this position because the “FDA believes that patients and health care providers need accurate, reliable, and clinically valid tests to make good health care decisions – inaccurate or false tests results can harm individual patients. We have been working to develop a new oversight policy for laboratory developed tests… and realize just how important it is that we continue to work with stakeholders, our new Administration, and Congress to get our approach right. We plan to outline our view of an appropriate risk-based approach in the near future.”
The agency released draft guidelines two years ago outlining a risk-based framework for regulating LDTs that would be phased in over nine years. LDTs have historically been regulated by the Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendments. The FDA’s decision, though praised by some, creates uncertainty for the industry and may leave a lot of companies in limbo. To learn more about this topic, see our industry whitepaper. Need assistance navigating the regulatory guidance for IVDs or LDTs, contact us and our experts can help.