U.S. District Court vacates FDA LDT final rule
April 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 HealthTrackRX Indiana, 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.
‘Musts’ for pathologists in AI action plan
Pathologists must have a leadership role in selecting, configuring, deploying, applying, and monitoring the artificial intelligence systems that will be part of the preanalytical, analytical, and postanalytical phases of the laboratory workflow, the CAP said in comments it sent last month to the White House Office of Science and Technology Policy.
Input was requested from all interested parties on an artificial intelligence action plan that was directed by a Jan. 23, 2025 presidential executive order to advance America’s AI leadership.
In the development of a national AI plan, the CAP advised the following:
- Federal regulations on AI should be reasonable and not overly burdensome from a laboratory perspective, prioritize patient safety, ensure clinical validity, allow innovation, and preserve the role of pathologists as physicians and patient advocates. The CAP also recommends that any new regulatory requirements not be duplicative of existing regulations and not infringe on the practice of medicine. And the CAP said payment for AI in pathology and laboratory medicine should appropriately advance its use, promote equity in its clinical application, and recognize the professional role and responsibility of pathologists in its implementation, clinical application, and management.
- Local pathologists will be the best-positioned experts to evaluate the performance of AI systems using their laboratories’ data during development, at the time of deployment, and over time. The best performance of AI in pathology accrues from an optimal blend of human and machine capabilities, yielding augmented rather than artificial intelligence, the CAP said. “A pathologist must be the final decisionmaker regarding all cases,” it said. In addition, to carry out their responsibilities in the lab related to AI, the CAP said, pathologists will need “the techniques (including required transparency) and authority to measure AI performance and respond to performance problems.” This will ensure “the ethical application and clinical validity of the use of AI systems in the laboratory.”
- The Trump administration should employ a standardized, consistent, and uniform cybersecurity approach across the federal government to avoid overlapping and inconsistent requirements. The CAP suggests government enforcement of cybersecurity responsibilities and expectations be based on the levels of risk various entities pose. “We view risk as defined not only in terms of an entity’s size and the number of patients that entity affects,” the CAP said, “but also the risk they pose to the entire health system.” If a small rural private practice gets hacked, for example, the effects of the hack don’t have an impact on the entire U.S. health system in the way that a hack of a large corporate entity could, and thus the government’s cybersecurity enforcement should be measured for a small rural practice as compared with that of a larger corporate entity.
In addition, the federal government’s adoption and implementation approach to cybersecurity protection should not be punitive but instead enable providers to demonstrate they are meeting recommended standards. Incentivization and education are what the CAP suggests as an approach to cybersecurity protection, consisting of educational resources and guidance and financial assistance from federal agencies (grants, increased federal health care program payments) to improve cyberattack protection and response.