On March 31, 2025, Judge Sean D Jordan of the US District Court for the Eastern District of Texas vacated the FDA rule that would have regulated laboratory developed tests (LDTs) as medical devices under the Federal Food, Drug and Cosmetic Act.
The rule – issued by the FDA on May 6, 2024, following years of consultations – angered many in the pathology community. Eric Q Konnick, the Association of Molecular Pathology (AMP) Professional Relations Committee Chair, said, “The FDA LDT rule would have created an undue burden on laboratories tasked with keeping patients healthy and safe, and would have led to extensive additional requirements in addition to the existing Clinical Laboratory Improvement Amendments (CLIA) regulations.”
The American Clinical Laboratory Association and AMP both responded by filing lawsuits against the FDA, requesting the court to rescind the rule on the basis of “the agency’s lack of authority to regulate LDTs and to avert the significant and harmful disruption to laboratory medicine.”
Following that, in October, the ASCP and four other medical specialty societies filed an amicus curiae brief seeking to overturn the Final Rule. ASCP followed this in November with a letter to Linda McMahon and Howard Lutnick, co-chairs of the Trump transition team, seeking support for overturning the rule. It argued that existing CLIA regulations were adequate for ensuring LDT quality without compromising patient care
In its ruling, the court sided with the stakeholders, stating that the Federal Food, Drug, and Cosmetic Act and CLIA “make clear that FDA lacks the authority to regulate” LDTs.
AMP’s President, Jane S Gibson, said, “AMP is extremely pleased with the court’s clear and decisive ruling in our favor, and we hope this will finally end the FDA’s attempts to exert an unwarranted overreach of authority of LDTs. This judgment is a significant victory for our members and for patients across the country. The decision to vacate the FDA rule will avoid adding billions of dollars to healthcare costs and protect access to high-quality care for hundreds of millions of Americans.”
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