U.S. District Court Shuts Down FDA’s Plan to Tightly Regulate Lab-Developed Tests

Big news for the medical testing world! On April 25, 2025, a U.S. District Court in Texas just slammed the brakes on the FDA’s big plan to treat laboratory-developed tests (LDTs) like medical devices. The FDA’s Final Rule, rolled out in May 2024, was gonna put these lab tests under some serious oversight, but the court said, “That’s not happening.” This is a huge win for labs and companies who argued the FDA was overstepping its bounds.

So, what’s the deal with LDTs? These are tests developed in-house by high complexity labs—think genetic screenings or cancer diagnostics. They’re a big part of modern medicine, used in hospitals and clinics to catch diseases early or guide treatments. The FDA wanted to regulate them like they do pacemakers or ventilators, saying it’d ensure tests are safe and accurate. The rule would’ve required labs to jump through hoops like premarket reviews and quality system compliance, which aren’t cheap or quick.  In fact, these requirements would have surely put many third party labs out of business.

The American Clinical Laboratory Association (ACLA) and HealthTrackRx, who sued the FDA, weren’t having it. They argued the FDA doesn’t have the legal power to regulate LDTs as devices since they’re more like services tied to lab expertise, not standalone products. The court, presided over by Judge Rodriguez, agreed, pointing out that Congress never gave the FDA that kind of authority. The ruling leans on a 2022 Supreme Court decision limiting federal agencies’ reach when they try to stretch their powers too far.

This decision’s got folks cheering and grumbling. Labs and test developers are pumped—ACLA called it a “momentous victory” for patients, saying it keeps innovation alive and costs down. Without the FDA’s heavy hand, labs can keep churning out new tests faster. But some, like the American Medical Association, are worried. They say weak oversight could let sketchy tests slip through, putting patients at risk. The FDA’s been banging this drum since 2010, citing cases where faulty LDTs led to misdiagnoses.

For now, LDTs stay under the lighter touch of CLIA (Clinical Laboratory Improvement Amendments), which focuses on lab quality but doesn’t dig into test accuracy like the FDA wanted. The court’s move doesn’t kill the debate, though. Congress could step in with new laws to clarify who’s in charge, or the FDA might try a different angle. Either way, this ruling’s a game-changer, keeping the status quo for labs while the fight over regulation simmers on.

Sources: JD Supra, ACLA Press Release, FDA.gov