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

BackgroundSoftware 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 avai...

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Bibliographic Details
Main Authors: Aaron Ceross, Jeroen Bergmann
Format: Article
Language:English
Published: JMIR Publications 2021-11-01
Series:JMIR Biomedical Engineering
Online Access:https://biomedeng.jmir.org/2021/4/e20652