Federal Court Vacates FDA Rule Regulating LDTs

The U.S. District Court for the Eastern District of Texas, on March 31, ruled that the U.S. Food and Drug Administration (FDA) exceeded its statutory authority under the Federal Food, Drug, and Cosmetic Act by seeking to regulate laboratory developed tests (LDTs) as medical devices and ordered that the 2024 final rule be vacated and set aside in its entirety.

The ruling halted the implementation of the regulation shortly before it was slated to go into effect with a first compliance deadline of May 6. The American Clinical Laboratory Association and the Association of Molecular Pathology, plaintiffs in the cases decided this week, filed lawsuits challenging the FDA's authority in May 2024 and August 2024 respectively, and the two suits were later consolidated administratively.

The AAMC, in its 2023 comments to the FDA's proposed rule, urged the agency not to regulate LDTs developed and performed by academic medical centers, warning of the "immediate and detrimental effect on the ability of academic medical centers to provide specialized and patient-centric medical care" [refer to Washington Highlights, Dec. 8, 2023].