FDA Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Draft
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Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Draft[附网盘链接]是Food And Drug Administration于不久之前发布的FDA标准，适用于US。标准截图
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标准文档类型为Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Draft[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
Draft – Not for Implementation 67 Content of Premarket Submissions for 68 Management of Cybersecurity in 69 Medical Devices 70 ______________________________________________________________________________ 71 Draft Guidance for Industry and 72 Food and Drug Administration Staff 73
74 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 75 Administration (FDA or Agency) on this topic. It does not establish any rights for any person 76 and is not binding on FDA or the public. You can use an alternative approach if it satisfies 77 the requirements of the applicable statutes and regulations. To discuss an alternative 78 approach, contact the FDA staff or Office responsible for this guidance as listed on the title 79 page. 80
81 I. Introduction 82
83 The need for effective cybersecurity to ensure medical device functionality and safety has 84 become more important with the increasing use of wireless, Internet- and network- connected 85 devices, portable media (e.g. USB or CD), and the frequent electronic exchange of medical 86 device-related health information. In addition, cybersecurity threats to the healthcare sector have 87 become more frequent, more severe, and more clinically impactful. Cybersecurity incidents have 88 rendered medical devices and hospital networks inoperable, disrupting the delivery of patient 89 care across healthcare facilities in the US and globally. Such cyberattacks and exploits can delay 90 diagnoses and/or treatment and may lead to patient harm. 91
92 This guidance is intended to provide recommendations to industry regarding cybersecurity 93 device design, labeling, and the documentation that FDA recommends be included in premarket 94 submissions for devices with cybersecurity risk. These recommendations can facilitate an 95 efficient premarket review process and help ensure that marketed medical devices are 96 sufficiently resilient to cybersecurity threats. 97
98 Although FDA issued final guidance addressing premarket expectations in 2014, the rapidly 99 evolving landscape, and the increased understanding of the threats and their potential 100 mitigations, necessitates an updated approach. This guidance has been developed by the FDA to 101 assist industry by identifying issues related to cybersecurity that manufacturers should address in 102 the design and development of their medical devices as well as in preparing premarket 4
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