Tracking the Presence of Software as a Medical Device in US Food and Drug Administration Databases: Retrospective Data Analysis.

Abstract

Software as a medical device (SaMD) has gained the attention of medical device regulatory bodies as the prospects of standalone software for use in diagnositic and therapeutic settings have increased. However, to date, figures related to SaMD have not been made available by regulators, which limits the understanding of how prevalent these devices are and what actions should be taken to regulate them. The aim of this study is to empirically evaluate the market approvals and clearances related to