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We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights...
That is, the algorithm is essentially locked and cannot change while out in the market, defeating the optimization of AI/ML technology.
On April 3, 2023, FDA released the draft guidance titled "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions"...
A PCCP must be reviewed by FDA and established as part of a marketing authorization prior to a manufacturer's implementing any modifications under the PCCP.
AI-driven company Juniper Networks has unveiled Cloud Metro – a new category of solutions for service providers, optimised for metro transformation an...