April 1, 2025—The U.S. District Court for the Eastern District of Texas ruled on March 31 in favor of the laboratory plaintiffs in the two consolidated cases challenging the validity of the Food and Drug Administration’s final rule on laboratory-developed tests.
The plaintiffs in the cases were the American Clinical Laboratory Association, Association for Molecular Pathology, HealthTrackRX, and pathologist Michael Laposata, MD.
The ruling by Judge Sean D. Jordan ordered that the plaintiffs’ motions for summary judgment be granted. The final rule that would have regulated LDTs as medical devices under the Federal Food, Drug and Cosmetic Act was vacated.
“Neither side disputes that, if a laboratory makes a test kit for commercial distribution, it is manufacturing a device,” the court wrote in its opinion. “But when laboratory professionals use a series of tools to perform a test, or when they develop new test protocols that call for the use of such tools, they are not manufacturing devices, they are conceiving and carrying out professional services.”
FDA’s contrary view, the court wrote, “implicates limitless FDA oversight of all surgical procedures and physical examinations that use ‘devices.’” It cited the example of a radiologist who reads an x-ray and in so doing provides a service that depends on a device—the x-ray machine. “But the radiologist is rendering a service and is not subject to regulation” under the Food, Drug and Cosmetic Act.
“Similarly, when a heart surgeon conducts an operation to repair a valve or insert a pacemaker, the surgical procedure does not become a ‘device’ merely because it involves the use of surgical instruments, sutures, and other medical equipment,” the court added.
Under the FDA’s reading of the term “device,” the court continued, the radiologist’s x-ray analysis and the heart surgeon’s valve repair or pacemaker insertion operation would constitute “manufacturing” a medical “device, thereby implicating FDA oversight. Doing so would give the term ‘device’ an extraordinary, expansive meaning with far-reaching consequences, rather than the ordinary and normal meaning required by Supreme Court precedent. The Court will not go down that road.”
The court noted that Congress had already considered in CLIA the issues that laboratory-developed testing procedures raise and decided to address them by vesting regulatory authority in the Centers for Medicare and Medicaid Services. “Through the final rule, it appears that FDA is attempting to circumvent that legislative decision. It has no authority to do so,” the court ruled.