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FDA Commissioner Dr. Marty Makary joins ‘Varney & Co.’ to discuss the agency’s new approach to AI health tools, wearable technology and the future of medical innovation.
FDA Commissioner Marty Makary announced Tuesday that portable devices the provision of 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 guidelines, that if their device or software simply provides information, they can do so without FDA regulation,” Dr. Makary said.Varney & Co.”
“The only condition is that they claim something is medical grade, like a clinical grade blood pressure measurement, clinically appropriate. We don’t want people changing their medications based on something that is just a screening tool or an estimate of a physiological parameter,” he added.
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A Dexcom G6 continuous glucose monitoring (CGM) system is attached to a patient’s arm at a medical clinic based at the University of Bristol on April 8, 2019. (Ben Birchall/PA Images via Getty Images / Getty Images)
The move aims to provide clearer guidance to the sector 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 that the FDA must be “proactive.”
When asked whether these wearable devices provide accurate measurements, Makary said the decision should be left to the non-medical grade device market.
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The ChatGPT logo appears on a smartphone screen in this photo in Reno on Jan. 3, 2025. Makary said the government is not looking to crack down on AI platforms. (Jaque Silva/NurPhoto via Getty Images / Getty Images)
“If they don’t claim they’re medical grade, let’s let the market decide. Let’s let doctors choose from a competitive market which ones to recommend to their patients. A lot of these AI medical devices and software-based technologies get better over time. So for us to use an old FDA model to just approve something isn’t really appropriate for a changing market,” he explained.
Makary also noted that the FDA announced new guidance on Tuesday regarding support tools such as Google and ChatGPT.
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“If something simply provides information like ChatGPT or Google, we’re not going to outrun this lion. We’re not going to go out there and say, ‘There’s a result that’s inaccurate, so we need to stop it,'” he said.
“We need to promote these products and, at the same time, guard against major safety issues.”
