The FDA’s Draft Guidance on AI- and ML-Enabled Device Software Functions

In 2019, the U.S. Food and Drug Administration (FDA) first described its preliminary approach to premarket reviews for Artificial Intelligence/Machine Learning-driven software modifications in the discussion paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learn (AI/ML)-Based Software as a Medical Device (SaMD).”

Since this time, the FDA has received an increasing number of marketing submissions and pre-submissions leveraging ML technologies, and more specifically, from Clients wishing to utilize Predetermined Change Control Plans (PCCP) for AI/ML-enabled medical devices. As a result, the FDA published the PCCP Guidance, “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan” in January 2021 and Draft Guidance: “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions” in March 2023.

With these recent changes and deepened focus on AI/ML and PCCPs by the FDA, what does it mean for industry, where are potential concerns and what should manufacturers be doing now?

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