WASHINGTON — The Food and Drug Administration has always believed it had the authority to regulate laboratory testing. But it was only under President Biden that he began actively exercising this authority, publish a policy in April, informing laboratories that they have four years to comply with regulatory requirements.
It was a move aimed at restoring patient confidence in the quality of testing – and making labs furious. But the Trump administration is likely to reverse its 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 accompany FDA control.
“What everyone wants is a system where we can have confidence in these tests and not have to worry about whether or not they have been sufficiently evaluated,” said Jeff Allen, CEO of the patient group Friends of Cancer Research. “I hope it doesn’t suffer as politics and political discourse move forward.”
When the FDA began regulating medical devices in 1976, laboratory tests were simple and available to local patient populations. Today, they are much more complex and commercialized, with greater potential for harm to the patient due to incorrect diagnosis. Yet the 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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