Welle Cristin, Krauthamer Victor
Center for Devices and Radiological Health, FDA, Silver Spring, Maryland, USA. cristin.welle@ fda.hhs.gov
IEEE Pulse. 2012 Mar;3(2):37-41. doi: 10.1109/MPUL.2011.2181022.
The U.S. Food and Drug Administration (FDA) is charged with assuring the safety and effectiveness of medical devices. Before any medical device can be brought to market, it must comply with all federal regulations regarding FDA processes for clearance or approval. Navigating the FDA regulatory process may seem like a daunting task to the innovator of a novel medical device who has little experience with the FDA regulatory process or device commercialization. This review introduces the basics of the FDA regulatory premarket process, with a focus on issues relating to chronically implanted recording devices in the central or peripheral nervous system. Topics of device classification and regulatory pathways, the use of standards and guidance documents, and optimal time lines for interaction with the FDA are discussed. Additionally, this article summarizes the regulatory research on neural implant safety and reliability conducted by the FDA's Office of Science and Engineering Laboratories (OSEL) in collaboration with Defense Advanced Research Projects Agency (DARPA) Reliable Neural Technology (RE-NET) Program. For a more detailed explanation of the medical device regulatory process, please refer to several excellent reviews of the FDA's regulatory pathways for medical devices [1]-[4].
美国食品药品监督管理局（FDA）负责确保医疗器械的安全性和有效性。任何医疗器械在上市之前，都必须符合所有关于FDA审批或批准程序的联邦法规。对于几乎没有FDA监管程序或器械商业化经验的新型医疗器械创新者而言，应对FDA监管程序似乎是一项艰巨的任务。本综述介绍了FDA监管上市前程序的基础知识，重点关注与中枢或外周神经系统中长期植入式记录设备相关的问题。讨论了器械分类和监管途径、标准和指导文件的使用以及与FDA互动的最佳时间线等主题。此外，本文总结了FDA科学与工程实验室办公室（OSEL）与国防高级研究计划局（DARPA）可靠神经技术（RE-NET）项目合作开展的关于神经植入物安全性和可靠性的监管研究。有关医疗器械监管程序的更详细解释，请参考关于FDA医疗器械监管途径的几篇优秀综述[1]-[4]。
