On March 30, the U.S. Food and Drug Administration (FDA) published draft guidance that proposes recommendations on the types of information that should be included in a Predetermined Change Control ...

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 ...

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

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 ...

This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. Recommended Reading FDA posts guidance on how to simplify ...

The Food and Drug Administration’s device center clarified how manufacturers should approach artificial intelligence in a draft guidance issued on Monday. The document outlines recommendations for ...

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 ...

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 ...

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 ...