Regulatory aspects of artificial intelligence and machine learning-enabled software as medical devices (SaMD)

With the introduction of artificial intelligence (AI) and machine learning (ML) in healthcare and the development of an increasing number of commercial products based on software as medical device (SaMD), regulatory processes need to evolve in parallel. This book chapter aims to provide a high-level overview of the history of SaMD and reviews some of the various regulatory aspects associated with this group of medical devices. Although we aim to cover the regulations globally, the main focus is on markets dependent on the Food and Drug Administration (FDA) based review process mostly due to the early stages of regulations in other geographies.