Advancing Regulatory Science With Computational Modeling for Medical Devices at the FDA's Office of Science and Engineering Laboratories
Advancing Regulatory Science With Computational Modeling for Medical Devices at the FDA's Office of Science and Engineering Laboratories
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DOI：
10.3389/fmed.2018.00241
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发表时间：
2018-09-25
影响因子：
3.9
通讯作者：
Margerrison, Edward
中科院分区：
文献类型：
--
作者：
Morrison, Tina M.;Pathmanathan, Pras;Margerrison, Edward
保护和促进公众健康是美国食品和药物管理局（FDA）的使命。FDA的器械和放射健康中心（CDRH）负责监管在美国上市的医疗器械，该中心将自己定位为医疗器械创新和监管科学领域的全球领导者——开发新的方法、标准和方法来评估医疗器械的安全性、有效性、质量和性能。传统上，台架试验、动物研究和临床试验一直是美国医疗器械上市的主要证据来源。然而，近年来，计算模型已经成为评估医疗器械的一个越来越强大的工具，补充了台架、动物和临床方法。此外，计算建模方法越来越多地被用于软件平台，作为临床决策支持工具，并被嵌入到医疗设备中。由于它的范围和巨大的潜力，计算建模已经被CDRH和FDA的领导确定为优先事项。因此，科学与工程实验室办公室（OSEL）——cdrh的研究机构——投入了大量资源，将计算建模从一种有价值的科学工具转变为一种有价值的监管工具，并开发更多依赖数字证据而不是其他证据的机制。本文介绍了计算建模在医疗设备中的作用，描述了OSEL正在进行的研究g，并概述了近年来工业界如何在向CDRH提交的监管文件中使用计算建模的证据（即数字证据）。最后讨论了计算建模和数字证据在医疗设备中的潜在未来作用。
Protecting and promoting public health is the mission of the U.S. Food and Drug Administration (FDA). FDA's Center for Devices and Radiological Health (CDRH), which regulates medical devices marketed in the U.S., envisions itself as the world's leader in medical device innovation and regulatory science-the development of new methods, standards, and approaches to assess the safety, efficacy, quality, and performance of medical devices. Traditionally, bench testing, animal studies, and clinical trials have been the main sources of evidence for getting medical devices on the market in the U.S. In recent years, however, computational modeling has become an increasingly powerful tool for evaluating medical devices, complementing bench, animal and clinical methods. Moreover, computational modeling methods are increasingly being used within software platforms, serving as clinical decision support tools, and are being embedded in medical devices. Because of its reach and huge potential, computational modeling has been identified as a priority by CDRH, and indeed by FDA's leadership. Therefore, the Office of Science and Engineering Laboratories (OSEL)-the research arm of CDRH-has committed significant resources to transforming computational modeling from a valuable scientific tool to a valuable regulatory tool, and developing mechanisms to rely more on digital evidence in place of other evidence. This article introduces the role of computational modeling for medical devices, describes OSEL's ongoing research g, and overviews how evidence from computational modeling (i.e., digital evidence) has been used in regulatory submissions by industry to CDRH in recent years. It concludes by discussing the potential future role for computational modeling and digital evidence in medical devices.