Last April, in what can only be described as a mic-drop moment for clinical laboratories, a federal judge in Texas struck down the FDA’s bold (and arguably baffling) move to reclassify laboratory-developed tests (LDTs) as medical devices. It was a legal slapdown decades in the making—and the FDA didn’t even bother to appeal. The deadline came and went on May 30, and the silence was deafening.
So now, we’re right back where we’ve been for over 40 years. LDTs are staying put under the oversight of CLIA (Clinical Laboratory Improvement Amendments) and CMS, not the FDA. And honestly? That’s exactly where they belong.
For the uninitiated: LDTs are tests that labs design, run, and interpret in-house. They help diagnose everything from cancer to rare genetic conditions. They are services, not mass-produced gadgets. You can’t buy one from Amazon or pick it up at CVS. They’re tailored to specific patients, ordered by real doctors, and analyzed by experts.
Under CLIA, labs are already required to follow strict rules to ensure accuracy, reliability, and quality. The FDA? They regulate devices, as in stuff you can hold, ship, or plug in. That small but crucial difference? It became the central issue in this 20-year regulatory saga.
FDA’s LDT Obsession has been a two-decade-long (and painful) story. The FDA has been trying to regulate LDTs since the 1990s. They’d float a proposal, get buried in public backlash, and back off. Rinse and repeat. They claimed “enforcement discretion,” winked at Congress, and wrote thousands of pages of guidance that never stuck.
In 2024, the FDA finally decided to go all in. They finalized a rule that would treat all LDTs as medical devices under the FDCA. Labs would need to submit to the FDA’s slow, expensive review process—something designed for pacemakers, not pathology reports. The resources needed to enforce compliance with the new rule were astronomical and unrealistic. The FDA framed it as a patient safety move. Labs, doctors, and professional societies called it a nightmare for innovation, cost, and access.
The court didn’t mince words. The judge vacated the rule using the following arguments:
- FDA Doesn’t Have the Legal Power – The FDA can regulate physical products. LDTs are services.
- Congress Had Its Chance – If lawmakers wanted the FDA to take over LDTs, they would’ve said so. They didn’t.
- You Can’t Redefine Reality – Running a test in a lab is not “manufacturing a device.” That’s like calling a recipe a toaster.
- You Waited 30 Years to Change the Rules? – Labs built entire business models on the FDA’s past hands-off approach. Changing the game now? Unfair.
With the rule tossed and the FDA out of the picture (again), LDTs will stay under CLIA oversight—just like they have since 1988. CMS and labs continue to ensure safety and accuracy without the FDA’s extra layers of bureaucracy. After two decades of chasing shadows, it looks like the FDA has finally given up the ghost.
