WASHINGTON — The Food and Drug Administration has always believed it has the power to regulate tests made in labs. But it was only under President Biden that it began exercising that authority, releasing a policy in April telling labs they have four years to comply with regulatory requirements.
It was a move that sought to restore patient confidence in test quality — and infuriated labs. But the Trump administration is likely to reverse the policy, experts tell STAT, plunging lab tests into a world of continued regulatory uncertainty and leaving patients who order tests online or receive them at the doctor’s office without the protections that come with FDA scrutiny.
“What everyone wants to see is a system where one can have confidence in these tests and not have to question whether they’ve been sufficiently evaluated or not,” said Jeff Allen, CEO of patient group Friends of Cancer Research. “Hopefully that won’t suffer as the policy and political discourse winds its way forward.”
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. Yet labs argue that their tests are not medical devices as the FDA defines them, and should not be subject to regulation. Instead, they say their tests are “professional health care services.”
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