First mentioned in a 2019 discussion paper entitled “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD),” the idea of a defined set of FDA expectations for AI/ML-based SaMDs centering on the use of a “Predetermined Change Control Plan” (or PCCP) has been widely discussed by industry for years. In January 2021, FDA committed to publishing PCCP guidance in the Agency’s “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan.”...