On March 31, 2025, U.S. District Judge Sean D. Jordan ordered that FDA's Laboratory Developed Tests (LDT) Final Rule be vacated and set aside, in its entirety. That Rule sought to codify FDA's view that LDTs are medical devices subject to FDA regulation under the Food, Drug, and Cosmetic Act (FDCA) and then phase out, over a four-year period, FDA's purported policy of "enforcement discretion" for such tests.
Plaintiffs Association for Molecular Pathology (AMP) and Dr. Michael Laposata (both represented by Hyman, Phelps & McNamara, P.C.) had sued FDA, HHS, the FDA Commissioner, and the Secretary of Health and Human Services last year, alleging that the LDT Rule conflicted with the text, history, and structure of the Federal Food, Drug, and Cosmetic Act (FDCA) and the Clinical Laboratories Improvement Amendments (CLIA). Their case was later consolidated with a similar lawsuit filed by the American Clinical Laboratory Association (ACLA) and HealthTrackRX Indiana, Inc.
The Court ruled in favor of all Plaintiffs and against the federal defendants. In the Court's words:
The final rule contemplates expanding FDA's jurisdiction to cover laboratory-developed test services as medical "devices" under the FDCA. That expansion is foreclosed by the text, structure, and history of the FDCA and CLIA. Congress considered the unique regulatory issues raised by clinical laboratories and the tests they develop and perform. It addressed those issues through the comprehensive but distinct statutory regime of CLIA, not through the FDCA. And Congress vested authority over those regulations in CMS, not in FDA.
This decision is a clear win not only for the Plaintiffs, but for the laboratories that the now-vacated Rule threatened to shutter, and most importantly the patients who would have lost access to countless cutting-edge tests.
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