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The court's decision vacates FDA's 2024 rule over LDTs, pointing to oversight authority by Clinical Laboratory Improvement Amendments

On March 31, the U.S. District Court for the Eastern District of Texas  on laboratory-developed tests (LDTs). The decision halts the agency's enforcement plans, scheduled to begin in May, with significant implications for the clinical laboratory and healthcare industries regarding these tests and their legal oversight. The  — including the American Clinical Laboratory Association, HealthTrackRx, and the Association for Molecular Pathology — finding that FDA lacks the authority to oversee LDTs under the  (FD&C Act).

Establishing regulatory authority for laboratory-developed tests

FDA issued its rule on LDTs in May 2024 after pursuing other measures, including the release of guidance and the support of related legislative actions. LDTs — in vitro tests designed and manufactured by individual laboratories for use exclusively within those laboratories — are championed for their use in innovative, specialized testing applications, such as when health conditions cannot be addressed by existing commercial testing or when new scientific discoveries enable the pursuit of bespoke clinical approaches. However, FDA has  over "potentially inaccurate, unsafe, ineffective or poor quality" LDTs that could ultimately harm patients.

While the FD&C Act of 1938 granted FDA the authority to regulate medical devices, food, drugs, and cosmetics, the Centers for Medicare & Medicaid Services (CMS) is charged with regulating quality and safety standards for all U.S. lab testing related to human specimens, including blood, tissue, and body fluid, as a result of the  (CLIA). Under its new rule, FDA had classified LDTs as "medical devices," rather than methodologies, in an effort to establish its authority over them, but the U.S. District Court found that the "text, structure, and history" of the FD&C Act and CLIA "make clear that FDA lacks the authority to regulate" LDTs.

What does this mean for clinical laboratories?

The District Court's ruling vacates FDA's rule and proposed 2028 timeline for phasing in regulatory compliance over LDTs, allowing U.S. clinical laboratories to continue to incorporate LDTs into their services without implementing the additional requirements outlined in the rule, such as the first set of new requirements that would have come into effect on May 6 of this year: medical device reporting (MDR), correction and removal, and quality system requirements. U.S. District Court Judge Sean Jordan, who wrote the opinion in the case, identified the CMS as the authority to administer CLIA and oversee LDTs, stressing that the "CLIA and its regulations reflect that performing and interpreting laboratory tests requires significant scientific and technical knowledge, training, experience, and judgment."

However, clinical laboratories and other industry stakeholders will want to watch closely for further developments. Judge Jordan, in his decision, remanded the matter to the U.S. Department of Health and Human Services for further consideration, and FDA has 60 days from the date of the decision to appeal — now a little over a month. Additionally, U.S. Congressional involvement is possible in determining the ultimate oversight of LDTs moving forward.