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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 ...

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 ...

It’s rare to hear the private sector applauding a regulatory agency, but the FDA’s Predetermined Change Control Plan (PCCP) deserves recognition. This initiative could be one of the most ...

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 ...

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 ...

In the document, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning-Enabled Device Software Functions," the FDA proposes to ...

The U.S. Food and Drug Administration this week published its first action plan for how it intends to spur development and oversight of safe, patient-centric artificial intelligence and machine ...

The MarketWatch News Department was not involved in the creation of this content. FDA Authorizes Beacon's Dreem 3S as First Sleep Wearable with Predetermined Change Control Plan, Paving the Way for ...