Yesterday, the U.S. District Court for the Eastern District of Texas vacated the U.S. Food and Drug Administration’s 2024 rule that aimed to regulate laboratory-developed tests (LDTs) as medical devices, deciding it is outside the agency's statutory authority.
In the combined cases of American Clinical Laboratory Association v. FDA and Association for Molecular Pathology v. FDA, the District Court found that LDTs are “professional services” subject to the existing regulatory framework under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), not "devices" under the Food, Drug, and Cosmetic Act (FDCA).
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