FDA’s LDT Regulations Struck Down by Texas Court

On March 31, 2025, a Texas District Court vacated the FDA’s rule regulating Laboratory Tests (LDTs) in its entirety, holding that the FDA’s attempt to regulate laboratory services as medical devices exceeds the agency’s statutory authority under the Food, Drug, and Cosmetic Act (FDCA). The court's decision can be viewed at the bottom of this Alert.

NILA/AAB’s attorney, Mike Hawrylchak, Esq., led a group of 5 laboratory organizations in filing an “amicus” brief in support of the American Clinical Laboratory Association's (ACLA's) lawsuit challenging the FDA regulations. Mr. Hawrylchak says the key holdings are “the text, structure, and history of the FDCA and CLIA make clear that FDA lacks the authority to regulate laboratory-developed test services” and “the proper remedy is vacatur (nullification and cancellation) of the final rule and remand to FDA for “'further consideration in light of this opinion.'” See Mr. Hawrylchak's summary at the bottom of this Alert.

It is now up to Dr. Marty Makary, the new head of FDA, to decide whether FDA will appeal the court’s decision.

Click here to view/download the Texas Court's decision.

Click here to view/downlaod Michael Hawrylchak's Summary of the decision in ACLA/AMP v. FDA.