STAT+: The FDA plans to regulate far more AI tools as devices. The industry won’t go down without a fight

STAT+: The FDA plans to regulate far more AI tools as devices. The industry won’t go down without a fight Lizzy Lawrence

Health tech companies are in a tizzy: After years of letting companies roll out software tools to guide patient care with little oversight, the Food and Drug Administration is taking a tougher stance.

In September, the FDA announced its intentions to regulate many of these AI-powered clinical decision support (CDS) tools as devices — which regulators say has always been their plan and within their purview. But the industry says it was blindsided by the move. In a fierce rebuttal, the Clinical Decision Support Coalition filed a petition earlier this month asking the FDA to withdraw the final CDS guidance, arguing regulators are overstepping their bounds by trying to police medical practice. They also claim the FDA’s move violates the 21st Century Cures Act, a 2016 law that says tools that “provide limited clinical decision support” don’t count as medical devices.

“FDA is not listening to Congress,” said Bradley Merill Thompson, the CDS Coalition’s general counsel and attorney at Epstein Becker Green. “They are not following the statute that Congress wrote. That’s our concern.”

Meanwhile, the FDA maintains that the final guidance is consistent with the agency’s historical enforcement and interpretation of the Cures Act, and is designed to give developers more clarity and context on how the FDA defines devices.

“We’re focused on helping developers get the clarity they need to move these important technologies forward, and that really does include helping developers identify and make any product adjustments that may be needed if they want to ensure that a product meets the criteria in the law,” Brendan O’Leary, deputy director of the FDA’s Digital Health Center of Excellence, told STAT.

That clarity, though, ultimately means that more technologies will be subject to closer regulatory scrutiny.

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