On March 31, 2025, the U.S. District Court for the Eastern District of Texas struck down the FDA’s Final Rule regulating laboratory-developed tests (LDTs) as medical devices. Judge Sean D. Jordan granted the plaintiffs’ Motion for Summary Judgment, vacating the rule in its entirety and remanding the matter to the Secretary of Health and Human Services. In his ruling, Judge Jordan found that the FDA lacks authority under the FDCA and CLIA to regulate LDTs in this manner and criticized the agency’s reliance on enforcement discretion. While the decision limits the FDA’s ability to regulate LDTs as medical devices, it does not necessarily bar oversight.

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