On April 3, 2023, U.S. Food and Drug Administration (FDA) issued its much anticipated draft guidance, "Marketing Submission Recommendations for a Predetermined Change Control Plan for.
FDA expects manufacturers to commit to transparency and real-world performance monitoring, to periodically update FDA on changes implemented as part of the approved pre-specifications and algorithm change protocol and follow Good Machine Learning Practice guiding principles
Our latest briefing dives into new local laws about AI and how it affects both employment and insurance industries, the launch of NIST’s Trustworthy & Responsible Artificial.