{"id":8251,"date":"2018-11-14T13:59:50","date_gmt":"2018-11-14T12:59:50","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=8251"},"modified":"2023-01-25T16:55:08","modified_gmt":"2023-01-25T15:55:08","slug":"usa-fda-medical-devices-cybersecurity-guidance-update","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2018\/11\/14\/usa-fda-medical-devices-cybersecurity-guidance-update\/","title":{"rendered":"USA: Medical devices cybersecurity Guidance update"},"content":{"rendered":"<p><span lang=\"EN-US\"><img decoding=\"async\" class=\"size-medium wp-image-8323 alignnone\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/11\/USA-cybersecurity-300x173.jpg\" alt=\"\" width=\"300\" height=\"173\" \/><\/span><\/p>\n<p><span lang=\"EN-US\">To allow a more efficient pre-market review process and more effective protection of marketed medical devices against cybersecurity vulnerabilities, FDA issued on October 18 the draft of the latest edition of the<\/span> <a href=\"https:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/UCM623529.pdf\" target=\"_blank\" rel=\"noopener\"><em>&#8220;Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. <\/em><em>Draft Guidance for Industry and Food and Drug Administration Staff\u201d<\/em><\/a>.<\/p>\n<p>The 2018 edition brings the following additions:<\/p>\n<ul>\n<li><span lang=\"EN-US\">new and\/or updated definitions of key terms<\/span>;<\/li>\n<li><span lang=\"EN-US\">a two-tier cybersecurity risk assessment approach for medical devices<\/span>:\n<ol>\n<li><span lang=\"EN-US\">Tier 1 (higher risk) includes devices that can connect to another medical or non-medical product, a network or the Internet and\/or which may cause direct damage to the patient<\/span>;<\/li>\n<li><span lang=\"EN-US\">Tier 2 (standard risk) includes the remaining devices<\/span>;<\/li>\n<\/ol>\n<\/li>\n<li><span lang=\"EN-US\">the concept of &#8220;trustworthy device&#8221;, meaning a medical device containing hardware, software, and\/or programmable logic that is reasonably effective and secure in terms of cybersecurity<\/span>;<\/li>\n<li><span lang=\"EN-US\">recommendations for the labeling of medical devices with cybersecurity risks<\/span>.<\/li>\n<\/ul>\n<p><span lang=\"EN-US\">The new version of the guideline aims to place <b>greater emphasis on controls during the design and development\u00a0<\/b>of medical devices subject to cybersecurity risks, before being placed on the market. Once finalized, it will replace the <a href=\"https:\/\/www.fda.gov\/downloads\/medicaldevices\/deviceregulationandguidance\/guidancedocuments\/ucm356190.pdf\" target=\"_blank\" rel=\"noopener\">previous version<\/a> issued on October 2014<\/span>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>To allow a more efficient pre-market review process and more effective protection of marketed medical devices against cybersecurity vulnerabilities, FDA issued  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":23503,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-8251","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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