A predetermined change control plan (PCCP) is documentation describing what modifications will be made to a device after its initial premarket authorization without requiring a new marketing ...

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 ...

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 ...

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The U.S. FDA’s draft guidance for predetermined change control plans (PCCPs) is one of the more innovative regulatory proposals in recent memory, although the FDA is not statutorily required to limit ...

Beacon Biosignals Inc. can rest easy now that it has received U.S. FDA authorization of its predetermined change control plan for the Dreem 3s, a wearable sleep monitor that conducts ...

Makers of medical devices that use artificial intelligence are clamoring for clarity from the Food and Drug Administration about its approval framework for devices evolving in real time. Manufacturers ...

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 ...

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 ...