Court Strikes Down FDA’s Final Rule on Laboratory-Developed Tests

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On March 31, the U.S. District Court for the Eastern District of Texas issued a significant in the case of ACLA et al. v. FDA. This case was brought by laboratory organizations challenging a released by the FDA last year, which aimed to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).

The FDA’s final rule amended the regulatory definition of “in vitro diagnostic products” to include tests manufactured by laboratories, thereby subjecting LDTs to FDA’s medical device regulatory framework. The rule also introduced a phased enforcement approach over four years and created carveouts for certain categories of tests.

The court found that the FDA lacked the statutory authority to regulate LDTs as medical devices, stating that these tests should be regulated exclusively by CMS under the Clinical Laboratory Improvement Amendments (CLIA). Consequently, the court granted the plaintiffs’ motions for summary judgment, denied the government’s cross-motion for summary judgment, and vacated the final rule.

American Clinical Laboratory Ass’n et al. v. U.S. Food and Drug Admin., Civil No. 4:24-CV-479-SDJ (E.D. Tex., Mar. 31, 2025).

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