United States Food and Drug Administration Regulation of Clinical Software in the Era of Artificial Intelligence and Machine Learning

The U.S. Food and Drug Administration (FDA) has been regulating medical devices since 1976. The introduction of novel medical devices including software as a medical device (SaMD) has led to more recent challenges given the rapid evolution of laws, technologies, and review pathways.1 The FDA defines medical devices as an “instrument, apparatus, implement, machine, appliance, implant, reagent for invitro use, software, or material” that can be used in the “diagnosis, cure, mitigation, treatment, and prevention of diseases.”2 This definition excludes medical devices which primarily achieve their intended purpose through pharmacological, immunological, or metabolic means, but devices may be assisted in their function by these means.