Federal Court Rules FDA Lacks Authority to Regulate Lab-Developed Tests

The regulation of laboratory-developed tests (LDTs) is beyond the legal authority of the U.S. Food and Drug Administration, according to a ruling issued today by a federal judge. 

The U.S. District Court for the Eastern District of Texas determined that the final rule issued by FDA in April 2024, which established a regulatory framework for LDTs, exceeded the FDA’s authority and was, therefore, unlawful. The ruling was in response to consolidated lawsuits filed by the American Clinical Laboratory Association (ACLA) and by the Association for Molecular Pathology (AMP). 

FDA asserted that it had always had the statutory authority to regulate LDTs as medical devices but had declined to do so by exercising enforcement discretion. Under the final rule, LDTs were subject to the regulatory framework governing devices – including adverse event reporting, establishment registration, device listing, labeling requirements, investigational use requirements, quality system requirements and premarket review. ACLA and AMP asserted that the final rule should be vacated because it exceeded FDA’s statutory jurisdiction, authority or limitations, and the court agreed. 

AABB has long supported an alternative approach to regulating LDTs. In previous public statements, AABB noted that LDTs play a critical role in diagnosing and treating conditions such as cancer, rare diseases and infections – and that regulations set forth in the final rule could jeopardize this. AABB also cautioned that the final rule could lead to financial burdens on laboratories, stifle innovation and compromise patient care.

“AABB has been advocating on behalf of our community for FDA to pause implementation of the final rule regulating LDTs as medical devices,” said Meghan Delaney, DO, MPH, AABB president. “The FDA’s final rule would hinder access to diagnostics as well as innovation and advancements in patient care. The laboratory community came together to voice these concerns. Today’s court ruling is beneficial for our patients and donors and allows us to continue to provide high quality testing.”