FDA Issues Draft Guidance For Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions

The US Food and Drug Administration (FDA or the Agency) recently issued its draft guidance titled "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions." The draft guidance follows the passage of the Food and Drug Omnibus Reform Act of 2022 (FDORA), which explicitly authorized the Agency to approve or clear Predetermined Change Control Plans (PCCPs) for devices that require premarket approval (PMA) or premarket notification (510(k)).¹ While the FDORA provision covers all devices subject to a PMA or 510(k), the draft guidance specifically applies to machine learning-enabled device software functions (ML-DSFs) that a manufacturer intends to modify over time.