FDA Final Rule regulating laboratory developed tests as medical devices vacated by U.S. District Court
On March 31, 2025, the U.S. District Court for the Eastern District of Texas issued its decision in the consolidated challenge of the FDA’s Final Rule brought by the American Clinical Laboratory Association, HealthTrackRx Indiana, Inc., HealthTrackRx, Inc., the Association for Molecular Pathology, and Michael Laposata, M.D. Judge Sean D. Jordan granted the plaintiffs’ Motion for Summary Judgment, vacating and setting aside, in its entirety, the FDA’s Final Rule regulating laboratory developed tests as medical devices. Judge Jordan remanded the matter to the Secretary of Health and Human Services for further consideration.
In his decision, Judge Jordan stated that “the text, structure and history of the FDCA (Food, Drug and Cosmetics Act) and CLIA make clear that FDA lacks the authority to regulate laboratory developed test services.” The court criticized the FDA for taking the “implausible” and “untenable” position that the laboratory industry is operating unlawfully and can be subject to criminal and civil penalties at any time, with its only protection coming from a policy of enforcement discretion that the FDA is free to revoke at any time. Importantly, the court’s decision does not bar the FDA from regulating aspects of the laboratory industry. Rather, this decision is limited to the scope and breadth of the FDA’s Final Rule regulating laboratory-developed tests as medical devices.
McDonald Hopkins LLC is still assessing the court’s opinion and will be monitoring the FDA’s response. At this time, however, laboratories that are not otherwise subject to FDA regulation are not required to comply with the Final Rule’s first phase out of enforcement discretion, which requires laboratories offering laboratory-developed tests to comply with the FDA’s medical device reporting requirements. Laboratories with FDA-approved or cleared tests are still subject to all applicable FDA regulations.
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