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 ...
Michael and Kendra Haken watch a city crew on the Pope-Chaucer Bridge clear debris from San Francisquito Creek around 11 a.m. on Jan. 9, 2023. Photo by Magali Gauthier. A new plan to bolster flood ...
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 ...
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” ...
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 ...
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