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On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback