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# LDT Court Ruling As Soon As Possible, Judge Says
- URL: https://www.fdaweb.com/ldt-court-ruling-as-soon-as-possible-judge-says/
- Published: 2025-02-20T12:00:00.000Z
- Updated: 2026-09-14T14:53:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158691

Texas federal court judge **Sean Jordan** says a ruling will be issued in the consolidated suits against FDA over its final rule regulating laboratory-developed tests (LDTs) “as soon as the court can.” In a *LinkedIn* [post](https://www.linkedin.com/pulse/aclas-amps-suits-over-ldt-final-rule-summary-judgement-bump-h3nyc/?trackingId=855Wqu%2B8TFiUGTDTSMy8ZQ%3D%3D&ref=fdaweb.com), regulatory attorney **Christine Bump**, who attended the three-hour hearing on the suits, summarizes the arguments that were presented by the American Clinical Laboratory Association, Association for Molecular Pathology, and FDA.

She says much of the session was devoted to differing definitions of LDTs and describes how the definitions shaped each side’s arguments. She lists these key points of emphasis and dispute:

- whether the definition of “device” under the Federal Food, Drug, and Cosmetic Act includes LDTs;
- whether LDTs are actually physical objects introduced into interstate commerce for commercial distribution;
- the burden imposed by the final rule and its potential impact on healthcare and public health;
- whether the Clinical Laboratory Improvement Act requires clinical validity;
- whether the “major questions doctrine” (stating that regulatory authority for issues of great economic and political significance must be expressly granted by Congress to an agency) applies; an
- dueling surgical analogies.