Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015-20): a comparative analysis
Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015-20): a comparative analysis
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DOI：
10.1016/s2589-7500(20)30292-2
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发表时间：
2021-02-22
影响因子：
30.8
通讯作者：
Vokinger, Kerstin N.
中科院分区：
文献类型：
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作者：
Muehlematter, Urs J.;Daniore, Paola;Vokinger, Kerstin N.
人们对基于人工智能和机器学习（AI/ML）的医疗设备的兴趣激增。然而，人们对基于AI/ML的医疗设备在美国和欧洲如何获得批准以及哪些获得批准知之甚少。我们检索了政府和非政府数据库，以识别出在美国获批的222件器械和在欧洲获批的240件器械。自2015年以来，已批准的基于AI/ML的设备数量大幅增加，其中许多已被批准用于放射学。然而，很少有器械被认定为高风险器械。在美国和欧洲通常批准的124种基于AI/ML的设备中，有80种首先在欧洲获得批准。欧洲先于美国获得批准的一个可能原因可能是欧洲对医疗器械的评价可能相对不那么严格。批准的设备数量之多，突出表明有必要确保对这些设备进行严格监管。目前，美国或欧洲没有针对基于AI/ML的医疗器械的特定监管途径。我们建议在如何监管和批准设备方面提高透明度，以实现和提高公众对基于AI/ML的医疗设备的信任、有效性、安全性和质量。需要一个全面的、可公开访问的数据库，其中包含欧洲认证的Conformite Europeene（CE）医疗器械和美国食品药品监督管理局批准的器械的详细信息。
There has been a surge of interest in artificial intelligence and machine learning (AI/ML)-based medical devices. However, it is poorly understood how and which AI/ML-based medical devices have been approved in the USA and Europe. We searched governmental and non-governmental databases to identify 222 devices approved in the USA and 240 devices in Europe. The number of approved AI/ML-based devices has increased substantially since 2015, with many being approved for use in radiology. However, few were qualified as high-risk devices. Of the 124 AI/ML-based devices commonly approved in the USA and Europe, 80 were first approved in Europe. One possible reason for approval in Europe before the USA might be the potentially relatively less rigorous evaluation of medical devices in Europe. The substantial number of approved devices highlight the need to ensure rigorous regulation of these devices. Currently, there is no specific regulatory pathway for AI/ML-based medical devices in the USA or Europe. We recommend more transparency on how devices are regulated and approved to enable and improve public trust, efficacy, safety, and quality of AI/ML-based medical devices. A comprehensive, publicly accessible database with device details for Conformite Europeene (CE)-marked medical devices in Europe and US Food and Drug Administration approved devices is needed.