2023-06786: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning-Enabled Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions." This draft guidance demonstrates FDA's commitment to developing innovative approaches to the regulation of machine learning- enabled medical devices and describes an approach that would often be the least burdensome and would support iterative improvement through modifications to machine learning-enabled device software functions (herein referred to as ML-DSF) while continuing to ensure device safety and effectiveness. This draft guidance provides recommendations on the information to be included in a Predetermined Change Control Plan (PCCP) in a marketing submission for an ML-DSF. Such a plan describes the anticipated ML-DSF modifications and the associated methodology to implement those modifications, which would be reviewed in the marketing submission to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for each modification described in the PCCP. This draft guidance is not final nor is it for implementation at this time.

The agency’s own summary, as published.