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” ...

On April 3, 2023, the US Food and Drug Administration (FDA) published its draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial ...

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 U.S. FDA’s approach to predetermined change control plans (PCCP) for medical devices has been widely viewed through the lens of artificial intelligence software, but the potential scope of PCCP is ...

I'm looking for some good change control software that's web based and utilizes SQL server. I used one a couple of years ago and can't recall the name. Google didn't turn up much that looked ...

Most everyone knows networked multifunction printers can pose a dangerous weak link within an enterprise, but not everyone agrees on just how to secure them. Printer manufacturer Sharp upped the ante ...

Michael J. Davern has received funding from CPA Australia and Chartered Institute of Management Accountants (CIMA) for research on the impacts of AI. Ida Someh receives research funding from the ...

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 ...