FDA's LDT Regulations Struck Down by Texas Court
Yesterday, 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.
According to Susan Van Meter, speaking for the ACLA (one of the two plaintiffs in the lawsuit challenging FDA’s LDT regulations), the court stated that “devices” under the FDCA “are articles of commerce, not the kinds of services performed by doctors and laboratories.”
NILA/AAB’s attorney, Mike Hawrylchak, Esq., led a group of 5 laboratory organizations in filing an “amicus” brief in support of ACLA’s lawsuit. Mr. Hawrylchak is studying the opinion, but 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.'”
It is now up to Dr. Marty Makary, the new head of FDA, to decide whether FDA will appeal the court’s decision.
Additional analyses of the court's decision will be forwarded as they become available.