Accepted for/Published in: JMIR Biomedical Engineering
Date Submitted: May 25, 2020
Date Accepted: Sep 28, 2021
Evaluating the presence of software-as-a-medical-device in FDA registrations
ABSTRACT
Software-as-a-medical-device (SaMD) has gained popularity as a type of medical device. However, to date, empirical analysis of SaMD trends have been lacking. Using databases managed by the US medical device regulator (the Food and Drug Administration), we map the path SaMD takes towards classification and recorded adverse events. The findings show that while SaMD has been identified in literature as an area of development, the data analysis suggests that this growth has been modest. These devices are overwhelming classified as moderate to high risk and they take a very particular path to that classification. The digital revolution in health care is less pronounced when evidence is considered of SaMD. In general, the trend for software registration mimics that of medical devices.
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