Federal Judge Vacates FDA’s Final Rule Reclassifying Laboratory-Developed Tests as Medical Devices
A Federal judge recently vacated a Final Rule proposed by the U.S. Food and Drug Administration (FDA) that sought to reclassify laboratory-developed tests (LDTs) as medical devices, thus regulating the LDTs under the Federal Food, Drug, and Cosmetic Act (FDCA). The rule was first proposed by the FDA on October 3, 2024, and a final rule was added to the Federal Register on May 6, 2024. Prior to the Final Rule, the FDA exercised general enforcement discretion for LDTs, with action only taken against an LDT if it was thought to have resulted in inaccurate diagnoses.
LDTs are generally not sold to other laboratories and are used internally to help provide diagnoses from samples sent to the laboratory by a healthcare provider. LDTs are subjected to robust testing to ensure they are accurate and reliable before they are used for diagnostic purposes, and laboratories were already regulated by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
The Final Rule reclassified LDTs as medical devices, which means that they would initially be subject to the same reporting requirements as medical devices and the subsequent reporting requirements applicable to medical devices. The first phase of the implementation of the Final Rule, the end to the general enforcement discretion approach and the requirement for laboratories to comply with post-marketing reporting for LDTs as medical devices, was due to commence on May 6, 2025. The Final Rule required premarket reviews for most LDTs from May 6, 2028.
One of the consequences of the additional regulatory requirements would be a substantial increase in the cost of LDTs. Laboratories would be required to secure premarket clearance or premarket approval, and the increased cost could potentially impede access to newly developed and useful diagnostic tests. The FDA’s Final Rule attracted considerable criticism and legal challenges. The American Clinical Laboratory Association and the Association for Molecular Pathology argued in their legal challenge that LDTs do not fall within the definition of a medical device under the FDCA and therefore could not be subject to the same regulatory requirements as medical devices. LDTs are created by clinical professionals to analyze samples purely for diagnostic purposes, with the lawsuit claiming that the FDA exceeded its legal authority under the FDCA by regulating LDTs as medical devices.
On March 31, 2025, a federal judge ruled in favor of the plaintiffs, ruling that the FDA’s asserted jurisdiction over LDTs as medical devices “defies bedrock principles of statutory, common sense, and longstanding industry practice.” Further, Congress had already considered issues raised by LDTs in CLIA and had given the CMS regulatory authority over LDTs, not the FDA.
The court vacated the Final Rule and remanded the case to the FDA for further consideration, which means the first phase of the final rule, due to commence on May 6, 2025, is no longer in effect, which means laboratories do not need to start submitting safety reports under medical device regulations. The decision also means the FDA may no longer regulate the existing LDTs offered in-house by around 1,200 U.S. laboratories. The FDA may appeal the court’s decision; however, in the meantime, laboratories should ensure they continue to comply with CLIA requirements.
