FDA Releases Draft Guidance for Planned Modifications to AI/ML Software

The U.S. Food and Drug Administration (FDA) released draft guidance — Marketing Submission Recommendations for a Predetermined Change Control Plan (PCCP) for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions — with public comments due July 3.

The document describes information provided by manufacturers that would enable FDA consideration of planned AI/ML software modifications during device marketing submissions. The PCCP enables downstream improvements to AI/ML software functionality without necessitating additional submissions, provided the future modifications are implemented in accordance with the FDA-vetted plan.

The American College of Radiology® (ACR®) is reviewing the draft guidance. Members interested in providing feedback for potential inclusion in ACR’s future comments should contact Michael Peters, ACR Senior Government Affairs Director.