FDA Regulatory Insights

FDA Software as a Medical Device (SaMD): A Practical Interpretive Guide

**FDA regulates Software as a Medical Device (SaMD)—software performing medical functions independently on general-purpose platforms like smartphones or cloud servers—under a risk-based framework, with exclusions for administrative tools, wellness apps, and clinical decision support meeting strict criteria. Companies must navigate multiple regulatory instruments including FDA's 2019 AI/ML guidance and 2023 predetermined change control plan guidance to determine premarket clearance requirements.**