Healthcare IT News December 4, 2024
The agency said it will review developers’ modified Predetermined Change Control Plans for artificial intelligence and machine learning submissions that have already been approved without triggering the need for new marketing submissions.
The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices.
The document – Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions – aims to provide a “forward-thinking approach to promote the development of safe and effective AI-enabled devices,” the agency said in a statement Tuesday.
WHY IT MATTERS
The guidance offers recommendations on the information to include in a marketing submission for a device with one or more AI-enabled device software functions....
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