On December 4, 2024, FDA finalized its guidance entitled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions” ...

The Food and Drug Administration issued a much-anticipated update on Tuesday detailing how it plans to regulate changes to artificial intelligence-enabled medical devices after the agency has ...

At long last, the U.S. FDA finalized guidance on using predetermined change control plans in submissions for medical devices that include artificial intelligence. The guidance, “Marketing Submission ...

On August 18, 2025, the Food and Drug Administration (FDA) issued guidance (Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device ...

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BOSTON, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Beacon Biosignals is proud to announce FDA authorization of the Predetermined Change Control Plan (PCCP) for the Dreem 3S, a groundbreaking wearable EEG ...

The Food and Drug Administration (FDA) has released guidance providing recommendations on what information should be included in a predetermined change control plan (PCCP) tailored to marketing ...