{"id":22057,"date":"2022-07-26T14:57:57","date_gmt":"2022-07-26T12:57:57","guid":{"rendered":"https:\/\/www.thema-med.eu\/?p=22057"},"modified":"2022-07-27T08:48:41","modified_gmt":"2022-07-27T06:48:41","slug":"ee-uu-progreso-de-la-plataforma-para-la-presentacion-del-510k","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2022\/07\/26\/ee-uu-progreso-de-la-plataforma-para-la-presentacion-del-510k\/","title":{"rendered":"USA: progreso de la plataforma para la presentaci\u00f3n del 510(k)"},"content":{"rendered":"<p>La FDA est\u00e1 reclutando constantemente operadores para probar las funcionalidades del Portal de <strong>Colaboraci\u00f3n con el Cliente (CCP)<\/strong>, un portal que ya est\u00e1 activo para ver el estado de los expedientes, pero que pronto se implementar\u00e1 para <strong>cargar<\/strong> los expedientes de autorizaci\u00f3n previa a la comercializaci\u00f3n de productos sanitarios, incluidos los expedientes 510(k), tradicionales, abreviados o especiales. Esta operaci\u00f3n se realizar\u00e1 tanto en formato<strong> eSTAR<\/strong> como en formato <strong>eCopy<\/strong>.<\/p>\n<p>Uno de los requisitos fundamentales que quiere cumplir la FDA es la <strong>seguridad del portal<\/strong>: la plataforma est\u00e1 dise\u00f1ada de tal manera que la informaci\u00f3n sobre el desarrollo s\u00f3lo puede ser visible para el corresponsal oficial, es decir, el titular de la cuenta para el seguimiento y la carga.<\/p>\n<p><strong>\u00bfCu\u00e1les son las ventajas de cargar archivos?<\/strong><\/p>\n<p>Con un <strong>formato estandarizado<\/strong>, los fabricantes podr\u00e1n confiar en la integridad de sus presentaciones de 510(k), mientras que los revisores de la FDA podr\u00e1n realizar las comprobaciones pertinentes con mayor rapidez y eficacia. En particular, el uso de la <strong>plantilla electr\u00f3nica eSTAR<\/strong> mejorar\u00e1 sustancialmente la calidad de las presentaciones del 510(k).<\/p>\n<h3><strong>&gt;&gt;&gt; \u00bfNecesita ayuda para comercializar dispositivos en los Estados Unidos?<\/strong><\/h3>\n<p>Con su servicio de <strong><u>asesoramiento estrat\u00e9gico en materia de reglamentaci\u00f3n<\/u><\/strong> y su apoyo a la <strong><u>presentaci\u00f3n de solicitudes<\/u><\/strong> <strong>previas a la comercializaci\u00f3n en los Estados Unidos<\/strong>, incluido el <strong><u>procedimiento 510(k)<\/u><\/strong>, Thema puede apoyarle en el cumplimiento de todos los requisitos previos y posteriores a la comercializaci\u00f3n del 21 CFR y de la reglamentaci\u00f3n federal, lo que permite una colocaci\u00f3n y distribuci\u00f3n del dispositivo sin problemas y de forma eficiente.<\/p>\n<p>Adem\u00e1s, con el servicio de <strong><u>agente local de EE.UU.<\/u><\/strong> y de <strong><u>importador inicial de EE.UU.<\/u><\/strong>, necesario para el registro del establecimiento, podr\u00e1 comercializar los dispositivos con la <strong>m\u00e1xima independencia<\/strong>.<\/p>\n<p><strong><u>P\u00f3ngase en contacto con nuestro Servicio de Atenci\u00f3n al Cliente<\/u><\/strong> para obtener informaciones.<\/p>\n<p>Fuentes:<\/p>\n<p><a href=\"https:\/\/www.fda.gov\/news-events\/fda-voices\/how-cdrhs-digital-transformation-initiative-will-strengthen-premarket-review-program\">https:\/\/www.fda.gov\/news-events\/fda-voices\/how-cdrhs-digital-transformation-initiative-will-strengthen-premarket-review-program<\/a><\/p>\n<p><a href=\"https:\/\/www.fda.gov\/medical-devices\/industry-medical-devices\/tracking-your-premarket-submissions-progress-progress-tracker\">https:\/\/www.fda.gov\/medical-devices\/industry-medical-devices\/tracking-your-premarket-submissions-progress-progress-tracker<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>La FDA est\u00e1 reclutando constantemente operadores para probar las funcionalidades del Portal de Colaboraci\u00f3n con el Cliente (CCP), un portal que  [&#8230;]<\/p>\n","protected":false},"author":114,"featured_media":21999,"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":[3],"tags":[],"class_list":["post-22057","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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