On 19 September, the US Food and Drug Administration (FDA) chose to axe its 鈥楩inal Rule鈥� from May 2024, bringing to an end a long-running agency-industry dispute around the proposed classification of laboratory-developed tests (LDTs) as medical devices.
The FDA鈥檚 action follows its Final Rule being struck down in a Texas court in March 2025. The lawsuit, brought jointly by the American Clinical Laboratory Association (ACLA), member company HealthTrackRx, and the Association for Molecular Pathology (AMP) at the US District Court for the Eastern District of Texas in 2024, asserted that the use of the medical device framework as mooted in the FDA鈥檚 Final Rule was 鈥渋nappropriate and ill-suited鈥� for regulating LDTs.
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