STAT+: FDA announces sweeping changes to oversight of wearables, AI-enabled devices
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LAS VEGAS \u2014 The Food and Drug Administration announced Tuesday that it will ease regulation of digital health products, following through on the Trump administration\u2019s promises to deregulate artificial intelligence and promote its widespread use.<\/p>\n
FDA Commissioner Marty Makary indicated that one of the agency\u2019s priorities is fostering an environment that\u2019s good for investors, and that FDA regulation needs to move \u201cat Silicon Valley speed.\u201d He announced the changes during an address to conference attendees at the Consumer Electronics Show.<\/p>\n
The agency will soften its approach<\/a> 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\u2019s other criteria for escaping regulation.\u00a0<\/p>\n Continue to STAT+ to read the full story\u2026<\/a><\/p>\n<\/div>\n