{"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":"directives-de-la-fda-sur-les-dispositifs-medicaux-lies-au-covid-19","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/fda-covid-19-medical-device-guidance\/","title":{"rendered":"La FDA publie des directives d\u00e9finitives pour aider au plan de transition\u2026"},"content":{"rendered":"<div>\n<div>Les directives de transition finales fournissent des recommandations et des \u00e9claircissements aux fabricants de dispositifs m\u00e9dicaux qui peuvent ou non vouloir continuer \u00e0 distribuer leurs dispositifs apr\u00e8s l&#039;expiration de la d\u00e9claration d&#039;autorisation d&#039;utilisation d&#039;urgence (EUA) du dispositif concern\u00e9 li\u00e9e \u00e0 la COVID-19 en vertu de l&#039;article 564 de la loi f\u00e9d\u00e9rale sur les aliments, les m\u00e9dicaments et les cosm\u00e9tiques ou apr\u00e8s que les politiques d&#039;application de certaines directives relatives aux dispositifs COVID-19 (voir \u00ab Liste 1 \u00bb) ne soient plus en vigueur.<\/div>\n<div><\/div>\n<div>Selon <a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">La FDA<\/a>, les fabricants de dispositifs qui pr\u00e9voient demander une autorisation de mise sur le march\u00e9 pour leur dispositif qui a re\u00e7u une EUA li\u00e9e \u00e0 la COVID-19, ou qui rel\u00e8ve d&#039;une politique d&#039;application \u00e9mise pendant l&#039;urgence de sant\u00e9 publique COVID-19 (voir la \u00ab Liste 1 \u00bb), doivent commencer \u00e0 travailler sur leur soumission de mise sur le march\u00e9, y compris leur plan de mise en \u0153uvre de la transition, comme d\u00e9crit dans les directives de transition.<\/div>\n<\/div>\n<div><\/div>\n<div>Besoin d\u2019en savoir plus sur les changements r\u00e9glementaires relatifs aux dispositifs m\u00e9dicaux ? <a href=\"https:\/\/regask.com\/fr\/contact-2\/\" target=\"_blank\" rel=\"noopener\">Contactez les experts de RegASK.<\/a><\/div>\n<div><\/div>\n<a href=\"https:\/\/regask.com\/fr\/contact-2\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contactez RegASK pour plus de d\u00e9tails<\/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>En savoir plus<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-219897499\">\n\n\t<div id=\"col-1428698384\" 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\/fr\/etudes-de-cas\/ressources-etudes-de-cas-dispositifs-medicaux\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lire les \u00e9tudes de cas sur le secteur des dispositifs m\u00e9dicaux<\/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>Les directives de transition finales fournissent des recommandations et des \u00e9claircissements aux fabricants de dispositifs m\u00e9dicaux qui peuvent ou non vouloir continuer \u00e0 distribuer leurs dispositifs apr\u00e8s l&#039;expiration de la d\u00e9claration d&#039;autorisation d&#039;utilisation d&#039;urgence (EUA) du dispositif concern\u00e9 li\u00e9e \u00e0 la COVID-19 en vertu de l&#039;article 564 de la loi f\u00e9d\u00e9rale sur les aliments, les m\u00e9dicaments et les cosm\u00e9tiques ou des politiques d&#039;application de certaines directives relatives aux dispositifs COVID-19 (voir\u2026<\/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 v27.6 (Yoast SEO v27.7) - 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. 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