Healthcare IT News January 6, 2025
After resolving how it will review updates to previously approved artificial intelligence-enabled medical devices, the agency will release its full draft proposal for market submissions.
To support the continued development and marketing of safe and effective medical devices enhanced by artificial intelligence, the U.S. Food and Drug Administration will offer marketing submission recommendations, including the documentation and information needed throughout their total product life cycles for regulatory oversight of the safety and efficacy, on Tuesday.
WHY IT MATTERS
Following its release last month of the final predetermined change control plan guidance for AI and machine learning submissions – defining what is required to maintain the AI/ML components and submitting that for regulatory review without triggering an entirely new marketing submission...
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