{"id":6669,"date":"2018-01-24T17:07:00","date_gmt":"2018-01-24T16:07:00","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=6669"},"modified":"2023-01-24T14:59:36","modified_gmt":"2023-01-24T13:59:36","slug":"usa-clinical-evaluation-of-software-as-medical-device","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2018\/01\/24\/usa-clinical-evaluation-of-software-as-medical-device\/","title":{"rendered":"USA: clinical evaluation of software as a medical device"},"content":{"rendered":"<p>The FDA published the final guidance for the <strong>clinical evaluation of software<\/strong> classified as a medical device (SaMD &#8211; Software as Medical Device).<\/p>\n<p>The clinical evaluation should be understood as a <strong>continuous action<\/strong> belonging to the medical devices quality management system and aiming to ensure the designed software safety, effectiveness and performance.<\/p>\n<p>The essential conditions for a correct clinical evaluation are the relationship between the software itself and a specific clinical condition, an analytical validation of input and output data processing, and the verification of the device clinical effectiveness during the course of therapy.<\/p>\n<p>For more information:<\/p>\n<p><a href=\"https:\/\/www.fda.gov\/downloads\/medicaldevices\/deviceregulationandguidance\/guidancedocuments\/ucm524904.pdf?utm_campaign=New%20FDA%20Guidances%20and%20Public%20Workshop%20on%20Digital%20Health%20Now%252\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/downloads\/medicaldevices\/deviceregulationandguidance\/guidancedocuments\/ucm524904.pdf?utm_campaign=New%20FDA%20Guidances%20and%20Public%20Workshop%20on%20Digital%20Health%20Now%2<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA published the final guidance for the clinical evaluation of software classified as a medical device (SaMD &#8211; Software as  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","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-6669","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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