On November 18, 2016, the U.S. Food and Drug Administration (FDA or Agency) announced that it would not finalize the draft guidance entitled Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (Draft Guidance) prior to the end of the Obama administration.
As we previously reported, FDA issued the Draft Guidance on October 3, 2014. The document describes the Agency’s shift from enforcement discretion policy for LDTs to a risk-based framework under which LDTs would be regulated as medical devices pursuant to the Federal Food, Drug, and Cosmetic Act (FDCA). In particular, the Draft Guidance outlined a phased-in approach for both premarket review and postmarket requirements, including registration and listing, medical device reporting, and Quality System Regulation (QSR) requirements.
Section 1143 of the Food and Drug Administration Safety and Innovation Act (FDASIA) required FDA to provide notification to Congress of its intent to finalize the Draft Guidance at least 60 days prior to the issuance of a final guidance. Although agency officials had stated that FDA would finalize the Draft Guidance by the end of 2016, the Agency had not provided this notification to Congress. Had the Obama administration intended to move forward with a final guidance before the end of the administration, the notification required by FDASIA would had to have been issued by November 19, 2016. At the same time, lawmakers had threatened to use the Congressional Review Act to block FDA from finalizing guidance documents imposing the FDCA on LDTs.
On Friday, an FDA spokesperson confirmed that the Agency would not finalize the Draft Guidance during the Obama administration:
“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 test results can harm individual patients. We have been working to develop a new oversight policy for laboratory developed tests, one that balances patient protection with continued access and innovation, 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. It is our hope that such an approach will help guide continued discussions.”
We will continue to monitor legislative and regulatory developments relating to LDTs.