{"id":14837,"date":"2020-06-29T13:11:59","date_gmt":"2020-06-29T11:11:59","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=14837"},"modified":"2023-01-24T15:02:03","modified_gmt":"2023-01-24T14:02:03","slug":"fda-eua-authorisations-for-medical-devices-during-covid-19","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2020\/06\/29\/fda-eua-authorisations-for-medical-devices-during-covid-19\/","title":{"rendered":"FDA: EUA authorisations for medical devices during COVID-19"},"content":{"rendered":"\n<p>FDA has issued exceptional <strong>emergency use authorisations<\/strong> <strong>(EUA) <\/strong>to ensure that patients and healthcare professionals have timely and continuous access to <strong>medical devices <\/strong>used to diagnose, prevent and treat COVID-19. <br>Below, it is shown how FDA authorizes the use of these devices through FDA<strong> <\/strong>EUA authorisations.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/06\/FDA-autorizzazioni-EUA-DM-pandemia-covid-19-1024x536.png\" alt=\"FDA EUA authorisations for medical devices during COVID-19 test\" class=\"wp-image-14804\"\/><figcaption>FDA: EUA authorisations for medical devices during COVID-19<\/figcaption><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>FDA EUA authorisations for two types of COVID-19 tests: diagnostic and antibodies <\/strong><\/h2>\n\n\n\n<p>In vitro\ndiagnostic tests are carried out on samples taken from human body to detect\ndiseases and monitor a person\u2019s general health. On February 4, 2020, the\nSecretary of Health and Human Services (HHS) ruled that, due to the ongoing\nhealth emergency, the use of in vitro diagnostics for the detection and\/or\ndiagnosis of the new COVID-19 is authorized.<\/p>\n\n\n\n<p>In the United\nStates a wide availability of <strong>tests<\/strong>\nis required to be able to control the emergence of this disease quickly. For\nthis reason, FDA authorized two different types of tests: <strong>diagnostic and antibodies. <\/strong>As indicated in the <strong>\u201cPolicy for\nCoronavirus Disease-2019 Tests\u201d<\/strong> document, these tests must be validated by\nthe developer before they are offered for clinical use. <strong>FDA has issued over 100 EUA authorizations <\/strong>to allow the use of such\ntests during the COVID-19 emergency. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>FDA EUA authorizations for medical equipment and PPE<\/strong><\/h2>\n\n\n\n<p>Given the <strong>extreme need for ventilators<\/strong> to control\nor assist the patient\u2019s breathing, <strong>FDA\nissued a EUA that authorizes the use of certain ventilators and accessories <\/strong>for\nthe treatmentof patients with\nCOVID-19. <\/p>\n\n\n\n<p>As regards\npersonal protective equipment (<strong>PPE<\/strong>),\nwhich includes gloves, surgical masks, respirators and other devices, <strong>FDA has established regulations on quality\nsystems as well as good manufacturing practices <\/strong>to ensure that they are <strong>safe<\/strong> and <strong>effective<\/strong>. Moreover, FDA has published <strong>conservation strategies for use<\/strong> by health organisations and staff. <strong>&nbsp;<\/strong><\/p>\n\n\n\n<p><strong>FDA has also issued EUA approvals for respiratory <\/strong>and for systemsthat can decontaminate certain types of N95 respiratory for re-use\nby hospital staff in a healthcare environment. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Other actions implemented by FDA in response to COVID-19<\/strong><\/h2>\n\n\n\n<p>In order to <strong>protect public health <\/strong>during the\npandemic caused by COVID-19, FDA has implemented other actions, such as: active\nmonitoring for the supply of health and food products and the measures taken to\n<strong>stop the sale of fraudulent products<\/strong>.\n<\/p>\n\n\n\n<p>To stay up to\ndate, visit our website <a href=\"https:\/\/www.thema-med.com\/en\/\">www.thema-med.com<\/a>!<\/p>\n\n\n\n<p><em>Source:<\/em> <\/p>\n\n\n\n<p><a href=\"https:\/\/www.fda.gov\/medical-devices\/emergency-situations-medical-devices\/medical-devices-and-covid-19-pandemic\">https:\/\/www.fda.gov\/medical-devices\/emergency-situations-medical-devices\/medical-devices-and-covid-19-pandemic<\/a> <\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA has issued exceptional emergency use authorisations (EUA) to ensure that patients and healthcare professionals have timely and continuous access to  [&#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":[2,1513],"tags":[],"class_list":["post-14837","post","type-post","status-publish","format-standard","hentry","category-news-en","category-us-agent-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA: EUA authorisations for medical devices during COVID-19<\/title>\n<meta name=\"description\" content=\"FDA has issued exceptional emergency use authorisations (EUA) for medical devices used to diagnose, prevent and treat COVID-19...\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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