LAS VEGAS — The Food and Drug Administration announced Tuesday that it will ease regulations on digital health products, following through on the Trump administration’s promises to deregulate artificial intelligence and promote its widespread use.
FDA Commissioner Marty Makary said one of the agency’s priorities is to foster an investor-friendly environment and that FDA regulations must evolve “at the pace of Silicon Valley.” He announced the changes during a speech to conference attendees at the Consumer Electronics Show.
The agency will soften your approach to the regulation of clinical decision support software, which includes AI-based products that help doctors navigate diagnoses and treatment options. The agency previously considered products that provided a single recommendation to be FDA-regulated medical devices. Now, these products can enter the market without FDA review, provided they meet the agency’s other criteria for evading regulation.
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