The anticipation of a Republican-controlled government with Donald Trump serving a second term as president has left some women fearful over access to reproductive healthcare. On the day after Trump's ...

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 ...

Millions of Americans could soon have access over-the-counter contraception without any out-of-pocket costs. Women without one currently pay as much as $50 for one box of Plan B. "The proposed rule we ...

On December 3, 2024, the US Food and Drug Administration (FDA) published final guidance titled, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence ...

Just before the holidays, a patient was in my office for what I thought was going to be a routine appointment. After completing the exam, however, we started talking about what was really on her mind.

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 ...