FDA Commissioner Marty Makary announced Tuesday that wearable devices providing non-medical-grade information will not be subject to FDA regulation as the agency moves to clarify its approach to digital health and artificial intelligence.
“We want to let companies know, with very clear guidance, that if their device or software is simply providing information, they can do that without FDA regulation,” Dr. Makary told “Varney & Co.”
“The only stipulation is if they make claims of something being medical grade, like a clinically appropriate, clinical grade blood pressure measurement. We don’t want people changing their medicines based on something that’s just a screening tool or an estimate of a physiologic parameter,” he added.
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The move is intended to provide clearer guidance for the industry and greater predictability for investors.
Makary said the clarification comes as government agencies grapple with the rapid pace of artificial intelligence and technological advancements, arguing the FDA must be “proactive.”
When asked whether such wearables provide accurate measurements, Makary said that decision should be left to the market for non-medical-grade devices.
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“If they’re not making claims that they are medical grade, let’s let the market decide. Let’s let doctors choose from a competitive marketplace which ones they recommend for their patients. Many of these AI medical devices and software-based technologies are improving over time. So, for us to use an old model at the FDA to simply put a rubber stamp on something isn’t really appropriate for an evolving marketplace,” he explained.
Makary also noted that the FDA announced new guidance Tuesday regarding support tools such as Google and ChatGPT.
“If something is simply providing information like ChatGPT or Google, we’re not going to outrun that lion. We’re not going to go in there and say, ‘There’s one result that is inaccurate, therefore we’ve got to shut this down,'” he said.
“We have to promote these products and, at the same time, just guard against major safety concerns.”
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