在美国食品和药物管理局数据库中追踪软件作为医疗设备的存在:回顾性数据分析
Aaron Ceross1, Jeroen Bergmann1
1Natural Interaction Lab, Department of Engineering Science, University of Oxford, Oxford, United Kingdom.
JMIR biomedical engineering
|June 22, 2024
概括
软件作为医疗设备 (SaMD) 的增长一直很温和,不良事件占报告总数的一小部分. SaMD设备通常被归类为中度至高风险,类似于其他医疗设备.
科学领域:
- 医疗器械规则 医疗器械规则
- 医疗信息学 医疗信息学
- 数字健康数字健康
背景情况:
- 软件作为医疗设备 (SaMD) 越来越多地被监管机构认可用于诊断和治疗应用.
- 关于SAMD流行和监管行动的有限数据阻碍了全面的理解.
- 了解SaMD市场透率对于有效的监管策略至关重要.
研究的目的:
- 实证地评估SaMD的市场批准和许可.
- 识别和分析与SaMD相关的不良事件.
- 为SaMD监管环境提供数据驱动的洞察力.
主要方法:
- 自2016年以来,利用美国食品和药物管理局 (FDA) 数据库进行SaMD注册数据.
- 使用产品代码来跟踪SaMD分类路径.
- 记录和分析SaMD.的不良事件数据.
主要成果:
- SaMD的注册率与其他医疗器械相美.
- 与SaMD相关的不良事件占所有报告事件的很小一部分.
- 与更广泛的医疗保健趋势相比,数字健康革命在SaMD的影响似乎不那么明显.
结论:
- 虽然在文献中指出了SaMD的增长,但一直很温和.
- 大多数SaMD设备被归类为中度至高风险,遵循特定的监管途径.
- 在医疗器械市场中SaMD的整合在很大程度上反映了传统医疗器械的整合.
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