The FDA published early January 2025, a long-awaited guidance about Artificial Intelligence Enabled device software functions. This guidance contains FDA's recommendations on how to document an AI-enabled device in marketing submissions.
Almost 70 pages long, this guidance is a monster!
Friday, 7 February 2025
FDA Guidance on Artificial Intelligence enabled device software functions
By Mitch on Friday, 7 February 2025, 13:53 - Regulations
