Morrison Tina M, Pathmanathan Pras, Adwan Mariam, Margerrison Edward
Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, United States.
Front Med (Lausanne). 2018 Sep 25;5:241. doi: 10.3389/fmed.2018.00241. eCollection 2018.
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, 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.
保护和促进公众健康是美国食品药品监督管理局（FDA）的使命。FDA的器械与放射健康中心（CDRH）负责监管在美国市场销售的医疗器械，其目标是成为全球医疗器械创新和监管科学领域的领导者——开发用于评估医疗器械安全性、有效性、质量和性能的新方法、标准和途径。传统上，台架测试、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，计算建模已成为评估医疗器械的一种越来越强大的工具，对台架、动物和临床方法起到了补充作用。此外，计算建模方法越来越多地应用于软件平台，用作临床决策支持工具，并被嵌入到医疗器械中。由于其影响力和巨大潜力，计算建模已被CDRH乃至FDA领导层确定为优先事项。因此，CDRH的科研部门——科学与工程实验室办公室（OSEL）已投入大量资源，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，并建立更多依赖数字证据而非其他证据的机制。本文介绍了计算建模在医疗器械方面的作用，描述了OSEL正在进行的研究，并概述了近年来计算建模证据（即数字证据）在行业向CDRH提交的监管申报材料中的使用情况。文章最后讨论了计算建模和数字证据在医疗器械领域未来可能发挥的作用。
