CPC Comments on FDA’s “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback”

On May 31, 2019, CPC filed comments on FDA’s “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback” (“Discussion Paper”). While the CPC believes FDA’s proposed approach on AI/ML is well-constructed, we asked that the Agency consider certain general comments/requests, including that FDA: (i) compose any future discussion papers on AI/ML to consider broader and more pressing issues around AI/ML, including use of AI/ML in interpreting real-world and well-controlled clinical data as well as human understanding and interpretation of AI/ML algorithms; (ii) address the critical question of when a continuously adaptive AI/ML may require a premarket submission, as the proposed framework currently addresses only incremental learning algorithms with gating mechanisms for updates; and (iii) provide clarity on what least burdensome AI/ML submissions from industry look like throughout the product lifecycle. We also provided specific responses to the questions posed by FDA in the Discussion Paper.