backOn March 31, 2025, U.S. District Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas set aside and vacated the U.S. Food and Drug Administration’s final rule attempting to regulate professional laboratory developed testing procedures as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). Until the court issued its decision, the FDA had planned to begin enforcing its final rule on May 6, 2025.
In American Clinical Laboratory Association et al. v. FDA, the district court ruled in favor of the American Clinical Laboratory Association, accepting its arguments that FDA had exceeded its statutory authority. The opinion recognized that “accepting FDA’s interpretation of the FDCA, as articulated in the final rule, would mean that the entire clinical laboratory sector, a significant part of the healthcare system, has been breaking the law for nearly fifty years, and possibly much longer. And it would mean that, going forward, the entire profession is operating unlawfully and can be subject to civil and criminal penalties at any time.”
The American Clinical Laboratory Association represents the leading laboratories that deliver essential diagnostic health information to patients and providers in the United States.
The King & Spalding team includes Ashley Parrish, Paul Alessio Mezzina, Alexander Kazam, Edward Fernandes and Christopher Taylor.