On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA ...

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 ...

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 ...

At SNHU, we want to make sure you have the information you need to make decisions about your education and your future—no matter where you choose to go to school. That's why our informational articles ...

Imagine walking onto a job site where you’ve worked for decades and suddenly being told that the tools and workflows you’ve trusted are being completely replaced. The promise is a digital ...

To achieve success, organizations of all sizes across industries need to be adaptable to change. While change is constant in almost every organization, managing change is easier said than done.

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: ...