STAT+: FDA proposes a new plan to streamline updates to medical devices that use AI
The FDA has released a new plan allowing developers of medical devices that rely on artificial intelligence to automatically update their products already being used in the clinic.
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The agency’s draft guidance outlines a new process in which the makers of AI tools could get approval for modifications in advance by submitting a document describing how the changes will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.
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