Oral Arguments Heard in Lawsuit Challenging FDA Regulation of LDTs

Oral arguments were heard on Feb. 19 in the ongoing lawsuit challenging the U.S. Food and Drug Administration regulation of laboratory-developed tests (LDTs) as medical devices.

The plaintiffs in the case, the American Clinical Laboratory Association and the Association for Molecular Pathology, urged the federal judge in the U.S. District Court in Eastern Texas to rule against FDA rulemaking and vacate the rule before the first stage of its implementation is effective on May 6.

The FDA continued to defend the rulemaking, reiterating that the rule does not exceed the agency’s authority and complements the authority of the Centers for Medicare and Medicaid Services to regulate LDTs under the Clinical Laboratory Improvement Amendments of 1988.

The final rule would regulate LDTs as medical devices under the Food, Drug, and Cosmetics Act. The plaintiffs’ lawsuits were consolidated on Sept. 9, 2024, with the shared objective of challenging the statutory validity and ultimately achieving vacatur of the final rule.

Source:

https://www.cap.org/advocacy/latest-news-and-practice-data/february-19-2025