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