JD Supra

Streamlining Device Changes with Predetermined Change Control Plans (PCCPs)

In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement ...
JD Supra

Predetermined Change Control Plans (PCCPs) for Medical Devices: FDA Issues Draft Guidance

On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA ...
MarketWatch

FDA Authorizes Beacon's Dreem 3S as First Sleep Wearable with Predetermined Change Control Plan, Paving the Way for Continuous Algorithm Enhancements in Sleep Monitoring

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 ...
WGN Radio

Moon Surgical Receives FDA Clearance for Maestro™ Connectivity and Predetermined Change Control Plan for AI-Powered ScoPilot®

PARIS and SAN FRANCISCO, July 2, 2025 /PRNewswire/ -- Moon Surgical, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for two major advancements to its Maestro System: ...
Morningstar

FDA Authorizes Beacon’s Dreem 3S as First Sleep Wearable with Predetermined Change Control Plan, Paving the Way for Continuous Algorithm Enhancements in Sleep Monitoring

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 ...