{"id":40690,"date":"2017-06-02T19:28:05","date_gmt":"2017-06-02T19:28:05","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-extends-udi-compliance-date-for-class-i-devices-to-2020\/"},"modified":"2020-02-07T14:06:11","modified_gmt":"2020-02-07T14:06:11","slug":"fda-extends-udi-compliance-date-for-class-i-devices-to-2020","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/es\/fda-extends-udi-compliance-date-for-class-i-devices-to-2020\/","title":{"rendered":"FDA Extiende la Fecha de Cumplimiento UDI para Dispositivos Clase I hasta 2020"},"content":{"rendered":"<p>El 2 de Junio de 2017, la U.S. Food and Drug Administration (FDA) <a href=\"https:\/\/www.fda.gov\/downloads\/MedicalDevices\/ResourcesforYou\/Industry\/UCM561575.pdf?source=govdelivery&amp;utm_medium=email&amp;utm_source=govdelivery\" target=\"_blank\" rel=\"noopener noreferrer\">emiti\u00f3 una carta<\/a> anunciando que la agencia intenta extender las fechas de cumplimiento para la Identificaci\u00f3n \u00danica de Dispositivos (UDI) para dispositivos clase I y dispositivos no clasificados (excepto dispositivos implantables, de mantenimiento o soporte vital) hasta el 24 de Septiembre de 2020 (dos a\u00f1os despu\u00e9s a la fecha de cumplimiento original). FDA planea reafirmar esta extensi\u00f3n con un documento de orientaci\u00f3n sobre su aplicaci\u00f3n a discreci\u00f3n, sin embargo, la Agencia busca informar a la industria de su decisi\u00f3n a la brevedad posible.<\/p>\n<p>Los <a href=\"https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2016\/03\/UDI_Who_Is_The_Labeler_2016_Final.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Etiquetadores de Dispositivos<\/a> son responsables de la implementaci\u00f3n de los requerimientos UDI de la FDA. De acuerdo con la carta, son varios los etiquetadores que solicitaron a FDA una extensi\u00f3n al darse cuenta de que la cantidad de tiempo necesario que toma el proceso es substancial.\u00a0 La carta tambi\u00e9n menciona que \u201cproveer soporte preciso y a tiempo a etiquetadores tambi\u00e9n ha sido desafiante, debido al gran n\u00famero y diversidad de dispositivos\u201d, lo cual nos hace creer que varios etiquetadores est\u00e1n teniendo dificultades para completar este proceso por su cuenta.<\/p>\n<p>Con esto en mente, es prudente que los etiquetadores de dispositivos comiencen a prepararse para la fecha de cumplimiento UDI en 2020 tan pronto como sea posible para asegurar que cumplen los requerimientos en tiempo. Los Especialistas Regulatorios de Registrar Corp pueden ayudarle en el proceso UDI, incluyendo la obtenci\u00f3n del n\u00famero DUNS, <a href=\"https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2016\/03\/How_Many_FDA_UDIs_Do_I-Need.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">calculando cu\u00e1ntos UDIs usted necesita<\/a>, y mucho m\u00e1s. Para obtener asistencia simplemente complete la siguiente forma:<\/p>\n<p class=\"gform_not_found\">\u00a1Vaya! No hemos podido localizar tu formulario.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>El 2 de Junio de 2017, la U.S. Food and Drug Administration (FDA) emiti\u00f3 una carta anunciando que la agencia intenta extender las fechas de cumplimiento para la Identificaci\u00f3n \u00danica de Dispositivos (UDI) para dispositivos clase I y dispositivos no clasificados (excepto dispositivos implantables, de mantenimiento o soporte vital) hasta el 24 de Septiembre de<\/p>\n","protected":false},"author":30,"featured_media":403,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"content-type":"","om_disable_all_campaigns":false,"inline_featured_image":false,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[61],"tags":[],"class_list":["post-40690","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medical-devices-es","entry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.9 (Yoast SEO v25.5) - 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