{"id":30927,"date":"2023-10-20T17:25:49","date_gmt":"2023-10-20T15:25:49","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=30927"},"modified":"2023-10-20T17:26:48","modified_gmt":"2023-10-20T15:26:48","slug":"ee-uu-solicitudes-510k-solo-con-el-portal-estar","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/es\/2023\/10\/20\/ee-uu-solicitudes-510k-solo-con-el-portal-estar\/","title":{"rendered":"EE.UU.: solicitudes 510(k) s\u00f3lo con el portal eSTAR"},"content":{"rendered":"<h2>El 2 de octubre de 2023, la FDA public\u00f3 una actualizaci\u00f3n de la gu\u00eda <a href=\"https:\/\/www.fda.gov\/media\/152429\/download\"><em>Electronic Submission Template for Medical Device 510(k) Submissions<\/em><\/a>:<a href=\"https:\/\/www.fda.gov\/media\/152429\/download\"><em> Orientaciones para la industria y el personal de la FDA<\/em><\/a> debido a que a partir del 1 de octubre de 2023, todas las solicitudes 510(k), a menos que est\u00e9n exentas, tendr\u00e1n que presentarse utilizando el <strong>portal eSTAR<\/strong> (electronic Submission Template And Resource).<\/h2>\n<p>&nbsp;<\/p>\n<p>De hecho, los solicitantes deben aplicar los requisitos de la <strong>Secci\u00f3n 745A(b)(B) de la Ley FD&amp;C<\/strong> que exige que todas las solicitudes 510(k) <em>-tradicionales<\/em>, <em>especiales<\/em> y <em>abreviadas-<\/em> y los suplementos o modificaciones posteriores, salvo que est\u00e9n exentos en virtud de la Secci\u00f3n VI, se presenten a trav\u00e9s de eSTAR.<\/p>\n<p>La directriz del cuadro 1 ofrece una visi\u00f3n general de alto nivel de la <strong>estructura <\/strong>de la plantilla de presentaci\u00f3n electr\u00f3nica actual para los expedientes 510(k) y un <strong>resumen<\/strong> del contenido previsto de la presentaci\u00f3n.<\/p>\n<p>&nbsp;<\/p>\n<p>El formato eSTAR, comparado con su predecesor eSubmitter, presenta varias <strong>ventajas<\/strong> , entre ellas un software <strong>f\u00e1cil de usar<\/strong> que no requiere formaci\u00f3n especial, funciones m\u00e1s din\u00e1micas como la compatibilidad con im\u00e1genes y mensajes con hiperv\u00ednculos, compatibilidad con dispositivos m\u00f3viles y la posibilidad de que los usuarios a\u00f1adan comentarios a los documentos PDF. Adem\u00e1s, el contenido de eSTAR refleja plenamente las plantillas internas utilizadas por los revisores, lo que favorece la exhaustividad del contenido de la solicitud y facilita su revisi\u00f3n.<\/p>\n<p>Por lo tanto, la FDA identific\u00f3 <strong>el 1 de octubre de 2023<\/strong> como la fecha de entrada en vigor de los requisitos para el env\u00edo electr\u00f3nico de solicitudes 510(k) a trav\u00e9s del portal eSTAR.<\/p>\n<p>&gt;&gt; A trav\u00e9s de los servicios de\u00a0<a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/consulenza-strategico-regolatoria-dispositivi-medici-medical-devices\/\"><strong>consultor\u00eda estrat\u00e9gica-normativa<\/strong><\/a>y redacci\u00f3n de <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/registrazioni-internazionali-extra-ue-dispositivi-medici-dm-e-medico-diagnostici-in-vitro-ivd\/\"><strong>notificaciones previas a la comercializaci\u00f3n 510(k), De Novo y aprobaci\u00f3n previa a la comercializaci\u00f3n (PMA)<\/strong><\/a> Thema puede apoyarle para comercializar productos sanitarios en los EE.UU. cumpliendo con los requisitos de la Administraci\u00f3n de Alimentos y Medicamentos (FDA).<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Fuente<\/strong>:<\/p>\n<p><a href=\"https:\/\/www.fda.gov\/media\/152429\/download\"><em>Electronic Submission Template for Medical Device 510(k) Submissions:<\/em><\/a><a href=\"https:\/\/www.fda.gov\/media\/152429\/download\"><em> Guidance for Industry and FDA Staff<\/em><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>El 2 de octubre de 2023, la FDA public\u00f3 una actualizaci\u00f3n de la gu\u00eda Electronic Submission Template for Medical Device 510(k)  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":30923,"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-30927","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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