STAT+: FDA announces sweeping changes to oversight of wearables, AI-enabled devices

LAS VEGAS — The Food and Drug Administration announced Tuesday that it will ease regulation of digital health products, following through on the Trump administration’s promises to deregulate artificial intelligence and promote its widespread use.

FDA Commissioner Marty Makary indicated that one of the agency’s priorities is fostering an environment that’s good for investors, and that FDA regulation needs to move “at Silicon Valley speed.” He announced the changes during an address to conference attendees at the Consumer Electronics Show.

The agency will soften its approach to the regulation of clinical decision support software, which include AI-enabled products that help doctors navigate diagnoses and treatment options. The agency previously considered products that delivered a single recommendation as FDA-regulated medical devices. Now, those products can enter the market without FDA review as long as they fulfill the agency’s other criteria for escaping regulation. 

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