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The Food and Drug Administration on Thursday released a new plan allowing developers of medical devices that rely on artificial intelligence to automatically update products already being used in the clinic.

The agency’s draft guidance outlines a new process in which the makers of AI tools could get approval for modifications in advance by submitting a document describing how the changes will be implemented and tested.


“If what you’re going to do looks right, we can bless the plan,” Jeffrey Shuren, head of the FDA’s Center for Devices and Radiological Health, told STAT. “Then you can move forward, make those changes as long as you follow the plan and you don’t have to come back to the FDA.”

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