Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions (DSF)

3 April 2023 – the FDA published the draft guidance on marketing submission recommendations for AI/ML-enabled devices. Submit comments by 3 July 2023.

This draft guidance describes a least burdensome approach to support iterative improvement through modifications to an ML-DSF while continuing to provide a reasonable assurance of device safety and effectiveness. The draft guidance provides recommendations on the information to be included in a Predetermined Change Control Plan (PCCP) provided in a marketing submission for ML-DSF.