We Have an LDT Proposed Rule!

It’s the moment we’ve all been waiting for, dreading, anticipating . . . .

Today, FDA released a copy of a proposed rule to regulate laboratory-developed tests (LDTs), which is scheduled to be published in the Federal Register on October 3rd.  The proposed rule has a 60-day comment period for stakeholders.

This proposed rule is a long-time coming.  For more than 30 years, FDA has asserted that it has jurisdiction to regulate LDTs as medical devices and clinical laboratories as manufacturers.  As we have blogged about extensively over the years, FDA has initiated, but not completed, many efforts through different means to create a regulatory framework for LDTs.  FDA previously attempted to regulate LDTs via guidance (see posts here, here, and here) and Congress has engaged in multiple attempts to pass the VALID Act (see posts here and here).  After Congress failed to enact VALID in December 2022, as part of user fee reauthorization, CDRH declared its intention to promulgate LDT regulations.

This proposed rule, if finalized, would phase out the Agency’s general enforcement discretion approach for LDTs, so that in vitro diagnostics (IVDs) “manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs.”  As described in the proposed rule, FDA believes increased oversight is necessary to ensure the safety and effectiveness of IVDs.  The proposed rule cites the current “bifurcated system,” in which companies will initially launch their diagnostic assays as LDTs or offer them as LDTs following failure to obtain clearance or approval.  These LDTs are performed in clinical laboratories regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).  Nevertheless, the Agency believes this bifurcated system presents public health risks, and needs to be corrected by bringing LDTs under the FDA’s general IVD regulatory framework.

Indeed, there are thousands of LDTs offered in the U.S. which are offered for a wide variety of clinical applications from consumer health testing to cancer screening.  Many of these tests, in particular those for rare diseases, are not available as commercial IVDs.  The implementation of a regulatory framework and phasing out of LDT enforcement discretion will have a massive impact on a wide range of stakeholders – including clinical laboratories, healthcare providers, and patients – the ramifications of which will take time to fully assess.

Watch this space for further blog posts analyzing the proposed rule and its potential implications for stakeholders, and indeed for public health, in the coming days and weeks.