A federal judge in Texas quashed the Food and Drug Administration’s plan to regulate lab-developed tests on Monday, ruling in favor of lab trade groups that said the agency was overstepping its bounds.
“The Court VACATES and SETS ASIDE, in its entirety, the FDA’s Final Rule titled Medical Devices; Laboratory Developed Tests,” the ruling reads. “The Court remands this matter to the Secretary of Health and Human Services for further consideration.”
The FDA has always believed it has the power to regulate lab-developed tests as medical devices, but it has not exercised that authority historically. It was only under President Biden that the agency announced its plans to actively regulate the tests, giving labs until 2028 to comply. The move came after Congress tried and failed to give FDA more explicit authority in 2022.
The American Clinical Laboratory Association and the Association for Molecular Pathology promptly sued, claiming that only Congress can give FDA the power to regulate the tests as medical devices.
“AMP is extremely pleased with the court’s clear and decisive ruling in our favor, and we hope this will finally end the FDA’s attempts to exert an unwarranted overreach of authority of LDTs,” AMP president Jane Gibson said in a statement.
When the FDA started regulating medical devices in 1976, lab tests were simple and given to local patient populations. Today, they’re far more complex and commercialized, with greater potential for patient harm via misdiagnosis.
Laboratory scientists develop all kinds of tests, including ones looking for rare diseases or cancer, or examining prenatal genetics. Labs argue that their tests are not medical devices, but rather “professional health care services” that should not be subject to regulation.
Before President Trump took office, experts speculated that his administration might try to roll back the rule anyway given Trump’s deregulatory bent. But the U.S. Department of Justice attorney assigned to the Texas case robustly defended the LDT rule, indicating that the Trump administration was willing to stand by it.
The judge’s decision may have implications for FDA’s broader authority when it comes to regulating medical devices. The government may appeal the case to the U.S. Court of Appeals for the Fifth Circuit.
The Health and Human Services Department did not respond immediately to request for comment.
“While rulemaking may not have been the preferred path for all, the intention is to improve transparency in test performance,” said Jeff Allen, CEO of patient group Friends of Cancer Research. “If FDA chooses not to appeal, it underscores the need for congressional action to establish a consistent and reliable framework to ensure diagnostic test accuracy.”
