FDA Issues Long-Awaited Action Plan for Artificial Intelligence/Machine Learning-Based Software As a Medical Device

On January 12, 2021, the FDA issued its long-awaited action plan concerning the regulation of artificial intelligence (AI) and machine learning (ML)-based Software As a Medical Device (SaMD).  The plan comes on the heels of an April 2019 FDA white paper, which provided an initial proposed regulatory framework for SaMD, as well as an open comment period in which the FDA solicited stakeholder feedback.  The action plan outlines five primary goals and commitments to advance the FDA’s interest in facilitating the innovation of SaMD while developing proper oversight, as follows. Continue reading “FDA Issues Long-Awaited Action Plan for Artificial Intelligence/Machine Learning-Based Software As a Medical Device”