Ceross Aaron, Bergmann Jeroen
Natural Interaction Lab, Department of Engineering Science, University of Oxford, Oxford, United Kingdom.
JMIR Biomed Eng. 2021 Nov 3;6(4):e20652. doi: 10.2196/20652.
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 SaMD and identify adverse incidents related to these devices.
Using databases managed by the US medical device regulator, the US Food and Drug Administration (FDA), we identified the counts of SaMD registered with the FDA since 2016 through the use of product codes, mapped the path SaMD takes toward classification, and recorded adverse events.
SaMD does not seem to be registered at a rate dissimilar to that of other medical devices; thus, adverse events for SaMD only comprise a small portion of the total reported number.
Although SaMD has been identified in the literature as an area of development, our analysis suggests that this growth has been modest. These devices are overwhelmingly 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 related to SaMD is considered. In general, the addition of SaMD to the medical device market seems to mimic that of other medical devices.
随着独立软件在诊断和治疗环境中使用的前景增加，软件即医疗器械（SaMD）已引起医疗器械监管机构的关注。然而，迄今为止，监管机构尚未提供与SaMD相关的数据，这限制了人们对这些设备的普遍程度以及应采取何种监管措施的了解。
本研究的目的是实证评估与SaMD相关的市场批准和许可，并确定与这些设备相关的不良事件。
利用美国医疗器械监管机构美国食品药品监督管理局（FDA）管理的数据库，我们通过使用产品代码确定了自2016年以来在FDA注册的SaMD数量，绘制了SaMD的分类路径，并记录了不良事件。
SaMD的注册率似乎与其他医疗器械没有差异；因此，SaMD的不良事件仅占报告总数的一小部分。
尽管SaMD在文献中已被确定为一个发展领域，但我们的分析表明这种增长较为适度。这些设备绝大多数被归类为中度至高度风险，并且它们的分类过程非常特殊。当考虑与SaMD相关的证据时，医疗保健领域的数字革命并不明显。总体而言，SaMD进入医疗器械市场的情况似乎与其他医疗器械类似。
