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FDA Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

蒋千琴 12/28/2021 浏览 321 FDA U.S

标准简介

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices [附网盘链接]是Food&Drug Administration于不久前发布的FDA标准，适用于U.S。

标准截图

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices [附网盘链接]
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices [附网盘链接](截图)

 

标准文档说明

标准文档类型为Content of Premarket Submissions for Management of Cybersecurity in Medical Devices [附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

标准部分原文

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. 1. Introduction The need for effective cybersecurity to assure medical device functionality and safety has become more important with the increasing use of wireless, Internet- and network- connected devices, and the frequent electronic exchange of medical device-related health information. This guidance has been developed by the FDA to assist industry by identifying issues related to cybersecurity that manufacturers should consider in the design and development of their medical devices as well as in preparing premarket submissions for those devices. The recommendations contained in this guidance document are intended to supplement FDA’s “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/u

cm089543.htm) and “Guidance to Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software” (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/u

cm077812.htm).

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