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# FDA Loses on Regulating Lab-Developed Tests
- URL: https://www.fdaweb.com/fda-loses-on-regulating-lab-developed-tests/
- Published: 2025-03-31T12:00:00.000Z
- Updated: 2026-09-14T14:56:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158927

An FDA final rule regulating laboratory-developed tests (LDTs) has been vacated by a Texas federal court. Eastern Texas federal judge **Sean Jordan** [ruled 3/31](http://www.fdaweb.com/download.php?file=LDT%5F3-31-25.pdf) in favor of plaintiffs American Clinical Laboratory Association and Association for Molecular Pathology, agreeing that the rule is in “excess of \[FDA’s\] statutory jurisdiction, authority, or limitations” and is “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”

FDA has maintained that the final rule is well within its authority under the Food Drug and Cosmetic Act (FDCA) and does not otherwise violate the Administrative Procedure Act. “In sum, Congress has considered but declined to enact several bills over the past two decades that would have reshaped the regulatory framework over laboratory-developed test services,” Jordan ruled. “Under the circumstances, agencies cannot circumvent, and courts must enforce, the statutory framework Congress enacted as it exists under the FDCA and CLIA \[Clinical Laboratory Improvement Amendments\].”

Jordan remanded the rule to FDA for further consideration.