Rethinking Lab Test Regulation

In today’s episode, we’re diving into a pretty big shift in how lab-developed tests are regulated in the United States. If you’re up on FDA developments, you may have heard that there’s an effort to regulate these tests as medical devices. But a recent federal court ruling in Texas just flipped the script.

Instead of agreeing with the FDA, the court basically said, “Nope, lab-developed tests aren’t devices—they’re services.” And services aren’t under the FDA’s jurisdiction.

Read the full article:

• FDA’s Authority Over Lab-Developed Tests Overturned: What the Court’s Decision Means for Lab Testing

About the authors:

• L. Christine Lawson
• Katie Clowers 

Transcript

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Host 1:

In today’s episode, we’re diving into a pretty big shift in how lab-developed tests are regulated in the United States. If you’re up on FDA developments, you may have heard that there’s an effort to regulate these tests as medical devices. But a recent federal court ruling in Texas just flipped the script.

Instead of agreeing with the FDA, the court basically said, “Nope, lab-developed tests aren’t devices—they’re services.” And services aren’t under the FDA’s jurisdiction.

Host 2:

And that’s a huge distinction, so let’s unpack that a little. Why were these lawsuits brought in the first place?

Host 1:

Well, labs argued that treating these tests like devices would lead to massive compliance costs. Think expensive FDA reviews, longer turnaround times, and potentially limited access for patients. 

And the court agreed. They pointed to the Federal Food, Drug, and Cosmetic Act and the Clinical Laboratory Improvement Amendments, more commonly known as CLIA. Together, those laws suggest that lab-developed tests fall under CLIA, not FDA.

Host 2:

Right. Which means labs can keep developing and offering specialized tests without going through FDA’s premarket review. That’s a big win for innovation and speed. But it also shifts a lot of responsibility onto the labs themselves, doesn’t it? Without FDA oversight, they have to ensure their tests are scientifically sound and biologically accurate.

Host 1:

Exactly. And that’s where things get interesting. These tests aren’t just measuring numbers, they’re measuring biology. Like troponin levels during a heart attack or cytokines during inflammation. So the tests have to reflect real-time physiological changes. That’s not something you can fake with a device-style checklist.

Host 2:

And designing these takes deep physiological insight, doesn’t it? Measuring insulin accurately means understanding hepatic clearance, receptor-binding kinetics, and molecular half-life, for example.

Host 1:

That’s a lot of science. And it doesn’t stop at design. Sample handling is just as critical. If blood sits too long at room temperature, proteins degrade, pH shifts, cells rupture—it can all mess with the results.

Previously, the FDA had protocols to standardize that. Now, labs have to rely on CLIA standards, internal training, and continuous monitoring.

Host 2:

Would that be enough? I mean, without FDA oversight, could we see inconsistencies between labs?

Host 1:

It’s possible. But CLIA does require accreditation and proficiency testing. So there’s still a framework in place—it’s just more decentralized. 

And maybe more flexible, too. Especially as lab-developed tests get more advanced. We’re talking cell-free DNA sequencing, microbiome profiling, pharmacogenomics…

Host 2:

Yeah, the future of lab testing is incredibly sophisticated. And aligning regulation with molecular science is key to keeping that innovation going.

So what’s the takeaway here?

Host 1:

The court’s decision shifts oversight from the FDA to the scientific community. Labs and clinicians now bear the responsibility for ensuring tests reflect real biology—not just regulatory checkboxes. 

And any future policy should build on that foundation. Support innovation, safeguard accuracy, and keep patients at the center.

Host 2:

Well said. That’s it for today’s episode of Womble Perspectives. If you found this helpful, share it with a colleague or subscribe for more insights. Thanks for listening—and we’ll catch you next time.

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