{"id":4197,"date":"2023-04-10T09:53:47","date_gmt":"2023-04-10T01:53:47","guid":{"rendered":"https:\/\/regask.com\/?p=4197"},"modified":"2024-09-26T03:23:05","modified_gmt":"2024-09-25T19:23:05","slug":"fda-leitfaden-fur-covid-19-medizinprodukte","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/fda-covid-19-medical-device-guidance\/","title":{"rendered":"FDA gibt endg\u00fcltige Leitlinien zur Unterst\u00fctzung des \u00dcbergangsplans heraus \u2026"},"content":{"rendered":"<div>\n<div>Die endg\u00fcltigen \u00dcbergangsrichtlinien enthalten Empfehlungen und Klarheit f\u00fcr Hersteller medizinischer Ger\u00e4te, die ihre Ger\u00e4te m\u00f6glicherweise weiterhin vertreiben m\u00f6chten, nachdem die entsprechende EUA-Erkl\u00e4rung f\u00fcr das Ger\u00e4t im Zusammenhang mit COVID-19 gem\u00e4\u00df Abschnitt 564 des Federal Food, Drug, and Cosmetic Act erloschen ist oder die Durchsetzungsrichtlinien in bestimmten Richtlinien f\u00fcr COVID-19-Ger\u00e4te (siehe \u201eListe 1\u201c) nicht mehr in Kraft sind.<\/div>\n<div><\/div>\n<div>Entsprechend <a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">FDA<\/a>Ger\u00e4tehersteller, die eine Marktzulassung f\u00fcr ihr Ger\u00e4t beantragen m\u00f6chten, f\u00fcr das eine EUA im Zusammenhang mit COVID-19 ausgestellt wurde oder das unter eine w\u00e4hrend des COVID-19-Gesundheitsnotstands erlassene Durchsetzungsrichtlinie f\u00e4llt (siehe \u201eListe 1\u201c), sollten mit der Arbeit an ihrem Marktzulassungsantrag beginnen, einschlie\u00dflich ihres \u00dcbergangsimplementierungsplans, wie in den \u00dcbergangsrichtlinien beschrieben.<\/div>\n<\/div>\n<div><\/div>\n<div>M\u00f6chten Sie mehr \u00fcber \u00c4nderungen der Vorschriften f\u00fcr Medizinprodukte erfahren? <a href=\"https:\/\/regask.com\/de\/kontakt\/\" target=\"_blank\" rel=\"noopener\">Nehmen Sie Kontakt mit den Experten von RegASK auf.<\/a><\/div>\n<div><\/div>\n<a href=\"https:\/\/regask.com\/de\/kontakt\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Kontaktieren Sie RegASK f\u00fcr weitere Details<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/www.fda.gov\/medical-devices\/medical-devices-news-and-events\/fda-issues-final-guidances-assist-transition-plans-covid-19-related-medical-devices\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Mehr lesen<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-973698995\">\n\n\t<div id=\"col-1566069294\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/de\/fallstudien\/ressourcen-fallstudien-medizinprodukte\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lesen Sie Fallstudien aus der Medizinger\u00e4tebranche<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Die endg\u00fcltigen \u00dcbergangsrichtlinien enthalten Empfehlungen und Klarheit f\u00fcr Hersteller von Medizinprodukten, die ihre Produkte m\u00f6glicherweise weiterhin vertreiben m\u00f6chten, nachdem die entsprechende EUA-Erkl\u00e4rung f\u00fcr das Produkt im Zusammenhang mit COVID-19 gem\u00e4\u00df Abschnitt 564 des Federal Food, Drug, and Cosmetic Act erloschen ist oder die Durchsetzungsrichtlinien in bestimmten Richtlinien zu COVID-19-Produkten (siehe \u2026) erloschen sind.<\/p>","protected":false},"author":39,"featured_media":2976,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[40],"class_list":["post-4197","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-devices-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA&#039;s Final Guidance on COVID-19 Medical Devices | RegASK<\/title>\n<meta name=\"description\" content=\"The FDA releases final guidance to help with transition plans for COVID-19 related medical devices. Stay compliant with RegASK.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/de\/fda-leitfaden-fur-covid-19-medizinprodukte\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Issues Final Guidances to Assist with Transition Plans for COVID-19-Related Medical Devices\" \/>\n<meta property=\"og:description\" content=\"The FDA releases final guidance to help with transition plans for COVID-19 related medical devices. 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