Advocacy - Lab Advocate
On March 31, 2025, the U.S. District Court for the Eastern District of Texas vacated the U.S. Food and Drug Administration’s (FDA) final rule that sought to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act. The court determined that FDA exceeded its statutory authority, reaffirming that LDTs are professional medical services, not products subject to device regulation. As a result, the rule’s initial compliance deadline of May 6, 2025 is no longer in effect.
This decision is a significant victory for the clinical laboratory community. The court emphasized that oversight of LDTs falls under the Clinical Laboratory Improvement Amendments (CLIA), administered by the Centers for Medicare & Medicaid Services (CMS), not the FDA.
ADLM played an active role in this case, joining other leading laboratory and healthcare organizations in submitting an amicus brief supporting the challenge to FDA’s rule. The brief underscored the critical role of LDTs in patient care and the importance of preserving a regulatory framework that promotes innovation while maintaining quality and access.
The Department of Health and Human Services (HHS) has 60 days from the ruling to file an appeal, though early indications suggest an appeal is unlikely at this time. However, broader discussions around LDT oversight—such as potential congressional action—remain ongoing.
ADLM continues to monitor these developments and advocate for a policy environment that supports high-quality laboratory testing, patient access, and the advancement of diagnostic science. The association is committed to keeping members informed and engaged as this important issue evolves.