Summary
Outlines U.S. Food and Drug Administration’s proposed actions to advance oversight of Artificial Intelligence/Machine Learning‑based Software as a Medical Device, including issuing guidances (e.g., Predetermined Change Control Plan), fostering Good Machine Learning Practice, and supporting a total product lifecycle approach.
Healthcare Implications
Signals regulatory roadmap that developers and health systems can use to anticipate requirements for AI device validation, updates, and post‑market monitoring.