April 1, 2025

On Monday, a federal judge in Texas ruled that the FDA overstepped its authority when it issued its Final Rule: Medical Devices; Laboratory Developed Tests in May of 2024, which directed for laboratory-developed tests (LDTs) to be regulated as medical devices. This court decision vacates and sets aside the FDA’s final rule, remanding this matter to the Secretary of Health and Human Services for further consideration.

The lawsuit was brought by the American Clinical Laboratory Association (ACLA), HealthTrackRX, the Association for Molecular Pathology (AMP), and Dr. Michael Laposata. The plaintiffs challenged the FDA’s May 2024 Final Rule, which directed LDTs to be classified and regulated as medical devices. This final rule would have established new regulatory requirements for LDTs, including premarket review and compliance measures, with a phased implementation scheduled to begin in May 2025 and extend through May 2028.

The plaintiffs argued that the FDA does not have the statutory authority to regulate LDTs as medical devices, with their claims focused on two primary points: first, they contended that LDTs do not fall under the definition of medical devices within the FDCA and that any changes to their oversight should come through legislative action; second, they raised concerns about how the rule might affect the development, cost, and availability of LDTs, suggesting that increased regulation could influence patient access to these tests. The ruling acknowledged these concerns, stating that “placing LDTs under the same regulatory framework as traditional medical devices could impose significant burdens on laboratories, potentially limiting innovation and delaying patient access to critical diagnostic tools.”

Additionally, the plaintiffs asserted that the FDA’s rule violated the Administrative Procedure Act (APA) by representing a significant policy shift without explicit congressional authorization. In its decision, the court emphasized that “an agency may not rewrite the law simply because it disagrees with how Congress has chosen to regulate a particular industry.”

The court ruled in favor of the plaintiffs, granting the plaintiffs’ motion for summary judgment, vacating the FDA’s Final Rule and remanding the matter to the Secretary of Health and Human Services for further consideration. The ruling determined that the FDA’s regulatory action exceeded its authority under current law, stating that “given the absence of clear congressional intent to classify LDTs as medical devices, the court finds that the FDA’s Final Rule cannot stand”.

With the court’s decision, LDTs will continue to be overseen under the Clinical Laboratory Improvement Amendments (CLIA), which govern laboratory quality but do not require FDA premarket approval. This maintains the current regulatory framework for LDTs while leaving open the possibility of future legislative or regulatory changes. The decision leaves open potential next steps, including an appeal by the FDA or congressional action to clarify the agency’s authority over LDTs. “Whether the regulation of LDTs should be expanded is a question for Congress, not the courts or an administrative agency acting on its own initiative,” the ruling concluded. Stakeholders, including clinical laboratories, regulatory bodies, and healthcare providers, will be monitoring further developments closely as the regulatory landscape for diagnostic testing continues to evolve.