{"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":"guia-de-la-fda-sobre-dispositivos-medicos-contra-el-covid-19","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/fda-covid-19-medical-device-guidance\/","title":{"rendered":"La FDA emite directrices finales para ayudar con los planes de transici\u00f3n\u2026"},"content":{"rendered":"<div>\n<div>Las pautas de transici\u00f3n finales brindan recomendaciones y claridad para los fabricantes de dispositivos m\u00e9dicos que quieran o no continuar distribuyendo sus dispositivos despu\u00e9s de que finalice la declaraci\u00f3n de EUA del dispositivo relevante relacionada con COVID-19 seg\u00fan la secci\u00f3n 564 de la Ley Federal de Alimentos, Medicamentos y Cosm\u00e9ticos o las pol\u00edticas de cumplimiento en ciertas pautas de dispositivos COVID-19 (ver \u201cLista 1\u201d) ya no est\u00e9n vigentes.<\/div>\n<div><\/div>\n<div>De acuerdo a <a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">FDA<\/a>Los fabricantes de dispositivos que planean solicitar una autorizaci\u00f3n de comercializaci\u00f3n para su dispositivo al que se le emiti\u00f3 una EUA relacionada con COVID-19, o que se encuentra dentro de una pol\u00edtica de cumplimiento emitida durante la emergencia de salud p\u00fablica de COVID-19 (ver \u201cLista 1\u201d), deben comenzar a trabajar en su presentaci\u00f3n de comercializaci\u00f3n, incluido su plan de implementaci\u00f3n de transici\u00f3n, como se describe en la gu\u00eda de transici\u00f3n.<\/div>\n<\/div>\n<div><\/div>\n<div>\u00bfNecesita saber m\u00e1s sobre los cambios en la regulaci\u00f3n de dispositivos m\u00e9dicos? <a href=\"https:\/\/regask.com\/es\/contacto\/\" target=\"_blank\" rel=\"noopener\">Ponte en contacto con los expertos de RegASK.<\/a><\/div>\n<div><\/div>\n<a href=\"https:\/\/regask.com\/es\/contacto\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contacte con RegASK para m\u00e1s detalles<\/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>Leer m\u00e1s<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-1941837955\">\n\n\t<div id=\"col-910460991\" 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\/es\/estudios-de-caso\/recursos-casos-de-estudio-dispositivos-medicos\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lea estudios de casos de la industria de dispositivos m\u00e9dicos<\/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>Las pautas de transici\u00f3n finales brindan recomendaciones y claridad para los fabricantes de dispositivos m\u00e9dicos que quieran o no continuar distribuyendo sus dispositivos despu\u00e9s de que finalice la declaraci\u00f3n de autorizaci\u00f3n de uso de emergencia (EUA) del dispositivo relevante relacionada con COVID-19 seg\u00fan la secci\u00f3n 564 de la Ley Federal de Alimentos, Medicamentos y Cosm\u00e9ticos o las pol\u00edticas de cumplimiento en ciertas pautas de dispositivos COVID-19 (ver\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 v27.8 (Yoast SEO v27.9) - 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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