Not Medical Devices: District Court Vacates FDA’s LDT Rule

• April 04, 2025

• Heather Pearson , Bass Berry & Sims PLC
• David Wilson , Bass Berry & Sims PLC

On March 31, 2025, a federal district court in Texas vacated and set aside the Food & Drug Administration’s (FDA’s) 2024 final rule that sought to regulate laboratory-developed tests (LDTs) as medical devices. In American Clinical Laboratory Association v. FDA, the district court held that the FDA lacked statutory authority to regulate LDTs, which are professional services performed by laboratories using various physical tools, as medical devices. This ruling comes just weeks before the first compliance deadline on May 6, 2025. While industry sighs with relief over averting the looming regulatory changes, this case marks an early example of how to successfully challenge an agency’s statutory interpretation post-Chevron.

ARTICLE TAGS

• Life Sciences Practice Group
• Life Sciences