Lexology December 27, 2024
As a streamlined method for obtaining U.S. Food and Drug Administration (“FDA”) authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control Plan in marketing submissions for intended modifications of artificial intelligence (“AI”)-enabled devices.
On December 3, 2024, FDA issued final guidance that outlines FDA’s recommendations on the content of a marketing submission for a Predetermined Change Control Plan—a plan outlining a change that a manufacturer will implement—for medical devices that include one or more AI software function(s). Because the agency recognizes that medical devices that incorporate AI are continuously building, testing, and learning, FDA will review these plans “to ensure the continued safety and effectiveness of the device without necessitating additional...
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