PDF(Pubmed)
Abstract：
BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
背景：作为医疗设备的软件（SaMD）已经引起了医疗设备监管机构的关注，因为用于诊断和治疗环境的独立软件的前景已经增加。然而,到目前为止,监管机构尚未提供与SaMD有关的数据，这限制了人们对这些设备的普遍程度以及应该采取什么行动来规范它们的理解。
目的：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。
方法：使用由美国医疗器械监管机构管理的数据库，美国食品和药物管理局（FDA），我们通过使用产品代码确定了自2016年以来在FDA注册的SaMD计数，映射SaMD朝向分类的路径，并记录不良事件。
结果：SaMD的注册率似乎与其他医疗器械不同；因此，SaMD的不良事件仅占报告总数的一小部分.
结论：尽管在文献中已将SaMD确定为发展领域，我们的分析表明，这种增长是温和的。这些设备绝大多数被归类为中等至高风险，他们采取了非常特殊的方式来分类。当考虑到与SaMD有关的证据时，医疗保健的数字革命就不那么明显了。总的来说,将SaMD加入医疗器械市场似乎模仿了其他医疗器械。
目的：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。
方法：使用由美国医疗器械监管机构管理的数据库，美国食品和药物管理局（FDA），我们通过使用产品代码确定了自2016年以来在FDA注册的SaMD计数，映射SaMD朝向分类的路径，并记录不良事件。
结果：SaMD的注册率似乎与其他医疗器械不同；因此，SaMD的不良事件仅占报告总数的一小部分.
结论：尽管在文献中已将SaMD确定为发展领域，我们的分析表明，这种增长是温和的。这些设备绝大多数被归类为中等至高风险，他们采取了非常特殊的方式来分类。当考虑到与SaMD有关的证据时，医疗保健的数字革命就不那么明显了。总的来说,将SaMD加入医疗器械市场似乎模仿了其他医疗器械。
