{"id":4443,"date":"2017-07-16T12:10:06","date_gmt":"2017-07-16T10:10:06","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=4443\/"},"modified":"2023-01-24T14:59:47","modified_gmt":"2023-01-24T13:59:47","slug":"usa-new-guidance-about-medical-device-usability-published","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2017\/07\/16\/usa-new-guidance-about-medical-device-usability-published\/","title":{"rendered":"USA: new guidance about medical device usability  published"},"content":{"rendered":"<p>On February 3, 2016 FDA published a new version of the usability guidance \u201cApplying human factors and usability engineering to medical devices\u201d. This document shows the Agency has great care of the medical device safety, trying to prevent errors and dangers during use.<\/p>\n<p>Main content of this guidance is the usability requirements of the device user interface and include all possible interactions between the product and the user (i.e. display, controls, packaging, labels, instructions for use).<\/p>\n<p>CDRH recommends manufacturers of some device categories listed in the guidance \u201cList of highest priority devices for human factors review\u201d to include usability specifications into the pre-market approval or pre-market notification applications.<\/p>\n<p>For further information:<br \/>\n<a href=\"http:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/ucm259760.pdf?source=govdelivery&amp;utm_medium=email&amp;utm_source=govdelivery\">http:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/ucm259760.pdf?source=govdelivery&amp;utm_medium=email&amp;utm_source=govdelivery<\/a><br \/>\n<a href=\"http:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/UCM484097.pdf\">http:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/UCM484097.pdf<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On February 3, 2016 FDA published a new version of the usability guidance \u201cApplying human factors and usability engineering to medical  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"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-4443","post","type-post","status-publish","format-standard","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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