On March 31, 2025, the U.S. District Court for the Southern District of Texas vacated the FDA’s Final Rule on laboratory-developed tests (LDTs), holding that the agency lacks authority to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The core of the court’s opinion is that Congress created a distinct regulatory scheme in 1988 through the Clinical Laboratory Improvement Amendments (CLIA), vesting oversight authority for laboratory testing with the Centers for Medicare & Medicaid Services (CMS), not the FDA. The court found that the FDA’s attempt to regulate LDTs under the FDCA as medical “devices” was inconsistent with the structure and legislative history of both statutes.
As we previously reported in our May 2024 analysis, the Final Rule proposed to phase out FDA’s longstanding enforcement discretion policy over a four-year period, introducing compliance obligations in five stages. This decision by the Texas federal court now halts that regulatory trajectory and marks a significant setback for FDA’s efforts to assert broader oversight on LDTs.
The FDA has 60 days to appeal the district court’s decision. However, an appeal appears unlikely, as the Final Rule was issued during the prior administration and may not be a policy priority for the current administration. Because the rule was vacated in full, the phased compliance deadlines are no longer operative. At this time, no parallel litigation regarding LDT regulation has been identified in other jurisdictions, though future cases could lead to conflicting outcomes and create a potential circuit split.
The ruling reinforces the separation of regulatory authority between FDA and CMS and raises questions about what, if any, future role FDA can play in LDT oversight without congressional action. Our experienced Food and Drug Law team can help you monitor compliance and regulatory actions from FDA and CMS in this area, and help you track the pulse of congressional action on LDTs.