{"id":24248,"date":"2022-10-21T09:25:30","date_gmt":"2022-10-21T07:25:30","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=24248"},"modified":"2023-01-24T15:08:55","modified_gmt":"2023-01-24T14:08:55","slug":"usa-fda-publica-un-template-electronico-para-el-510k","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/","title":{"rendered":"USA: FDA publica un template electr\u00f3nico para el 510(k)"},"content":{"rendered":"<h2>El 22 de septiembre, la FDA public\u00f3 <a href=\"https:\/\/media-exp1.licdn.com\/dms\/document\/D561FAQEWUqd8Er1xLw\/feedshare-document-pdf-analyzed\/0\/1663773076462?e=1665619200&amp;v=beta&amp;t=fGkDYhOS0U7hYDSw5T1dJ01WrkCTdKz2aT3Zvma2Ibg\"><em>Electronic Submission Template for Medical Device 510(k) Submissions<\/em><\/a><em>,<\/em> un documento que proporciona especificaciones sobre los procedimientos de <strong>presentaci\u00f3n electr\u00f3nica de 510(k)<\/strong> para mejorar la consistencia de la presentaci\u00f3n y la eficiencia del proceso de revisi\u00f3n.<\/h2>\n<p>El documento complementa la versi\u00f3n anterior del a\u00f1o pasado, proporcionando <strong>est\u00e1ndares<\/strong> adicionales para la presentaci\u00f3n en l\u00ednea y criterios para las <strong>derogaci\u00f3nes y exenciones<\/strong> de los requisitos. El documento de orientaci\u00f3n, <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/providing-regulatory-submissions-medical-devices-electronic-format-submissions-under-section-745ab\"><em>\u201cProviding Regulatory Submissions for Medical Devices in Electronic Format \u2014 Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act<\/em><em>\u201d<\/em><\/a>, proporciona un proceso para desarrollar templates que faciliten la <strong>preparaci\u00f3n<\/strong>, <strong>presentaci\u00f3n<\/strong> y <strong>revisi\u00f3n<\/strong> de solicitudes de Dispositivos M\u00e9dicos en formato electr\u00f3nico solamente. La FDA tiene la intenci\u00f3n de aplicar los requisitos 754A(b)(3) de la Ley FD&amp;C con <strong>orientaciones individuales<\/strong> que especifiquen los formatos de las <strong>solicitudes individuales<\/strong> y los <strong>plazos<\/strong> de aplicaci\u00f3n.<\/p>\n<p>En febrero de 2020, el CDRH (<a href=\"https:\/\/www.thema-med.com\/2018\/08\/29\/cosa-si-occupa-cdrh\/\"><em>Center for Devices and Radiological Health<\/em><\/a>), en apoyo de la transici\u00f3n a las presentaciones electr\u00f3nicas de 510(k), desarroll\u00f3 y lanz\u00f3 el programa piloto eSTAR (Electronic Submission Template And Resource), un servicio que est\u00e1 disponible desde junio de 2022. El template eSTAR tiene caracter\u00edsticas similares a las del anterior <strong>eSubmitter<\/strong>.<\/p>\n<p>A diferencia de eSubmitter, el formato eSTAR presenta <strong>varias ventajas<\/strong>, como el uso de un software muy f\u00e1cil de utilizar que no requiere una formaci\u00f3n especial, caracter\u00edsticas m\u00e1s din\u00e1micas como la compatibilidad con im\u00e1genes y mensajes con hiperv\u00ednculos, soporte para la edici\u00f3n, 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 los templates internos utilizados por los revisores, lo que favorece la <strong>exhaustividad<\/strong> del contenido de las presentaciones y facilita una <strong>revisi\u00f3n m\u00e1s eficiente<\/strong>.<\/p>\n<p>Con el siguiente resumen, queremos recordarle que:<\/p>\n<ul>\n<li><strong>Antes del 1 de octubre de 2023<\/strong>, los 510(k) pueden presentarse por correo o a trav\u00e9s del portal del CDRH en formato eSTAR o eCopy.<\/li>\n<li><strong>A partir del 1 de octubre de 2023<\/strong>, todas las solicitudes 510(k), a menos que est\u00e9n <strong>exentas<\/strong>*, deber\u00e1n presentarse electr\u00f3nicamente utilizando eSTAR.<\/li>\n<li>La FDA ha identificado el 1 de octubre de 2023 como la fecha en la que exigir\u00e1 que las presentaciones de 510(k) se presenten electr\u00f3nicamente. La FDA tiene la intenci\u00f3n de aceptar las presentaciones 510(k) guardadas en un medio de almacenamiento electr\u00f3nico y enviadas a la FDA si las recibe <strong>antes del<\/strong> <strong>1 de octubre de 2023<\/strong>.<\/li>\n<\/ul>\n<p>*Como se indica en la gu\u00eda final, <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/electronic-submission-template-medical-device-510k-submissions\"><em>Electronic Submission Template for Medical Device 510(k) Submissions: Guidance for Industry and FDA Staff<\/em><\/a>,\u00a0 incluidas las solicitudes 510(k) originales tradicionales, especiales y abreviadas y los suplementos y enmiendas posteriores, y cualquier solicitud posterior a una solicitud original, a menos que est\u00e9n <strong>exentas<\/strong> en la secci\u00f3n <em>VI.A Waivers and Exemptions From Electronic Submission Requirements<\/em> de la gu\u00eda, deben presentarse electr\u00f3nicamente. El template de presentaci\u00f3n electr\u00f3nica, eSTAR, es el \u00fanico template de presentaci\u00f3n electr\u00f3nica disponible actualmente para facilitar la preparaci\u00f3n de solicitudes electr\u00f3nicas de 510(k).<\/p>\n<h3><strong>Derogaci\u00f3nes y exenciones<\/strong><\/h3>\n<p>Todas las solicitudes 510(k), incluidas las traditional, special y abbreviated, as\u00ed como los suplementos y enmiendas posteriores, a menos que est\u00e9n exentas en la secci\u00f3n VI.A del documento de la FDA, deben presentarse electr\u00f3nicamente. Una solicitud 510(k) no presentada electr\u00f3nicamente no ser\u00e1 recibida a menos que se aplique una exenci\u00f3n. De hecho, los requisitos de presentaci\u00f3n electr\u00f3nica del 510(k) est\u00e1n exentos:<\/p>\n<ul>\n<li>Respuestas de revisi\u00f3n interactivas;<\/li>\n<li>Enmiendas;<\/li>\n<li>Recursos\/solicitudes de revisi\u00f3n;<\/li>\n<li>Solicitudes de resumen sustantivo;<\/li>\n<li>Cambios en las enmiendas correspondientes;<\/li>\n<li>Cambios posteriores a la decisi\u00f3n final.<\/li>\n<\/ul>\n<p>Dada la amplia disponibilidad de programas inform\u00e1ticos para el uso del actual PDF 510(k) eSTAR, la FDA no ha identificado actualmente ninguna circunstancia especial que justifique una exenci\u00f3n de los requisitos de presentaci\u00f3n electr\u00f3nica del 510(k) y no tiene intenci\u00f3n de atender ninguna solicitud de exenci\u00f3n.<\/p>\n<h3><strong>Plazos<\/strong><\/h3>\n<p>La FDA ha se\u00f1alado el 1 de octubre de 2023 como fecha de entrada en vigor de los requisitos para la presentaci\u00f3n electr\u00f3nica de las solicitudes 510(k) a trav\u00e9s del portal. Esta fecha incluye un periodo de transici\u00f3n de al menos un a\u00f1o. Las solicitudes 510(k) guardadas en un medio de almacenamiento electr\u00f3nico y enviadas a la FDA s\u00f3lo se aceptar\u00e1n si se reciben antes del 1 de octubre de 2023.<\/p>\n<p><strong>&gt;&gt; \u00bfNecesita apoyo para la comercializaci\u00f3n de dispositivos en los Estados Unidos?<\/strong><\/p>\n<p>Con servicios de <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/consultoria-estrategico-regulatoria\/\">consulencia estrat\u00e9gico-regulatoria<\/a> y apoyo al <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/\">registro<\/a> <strong>en los Estados Unidos<\/strong>, incluido el <a href=\"https:\/\/www.thema-med.com\/es\/2017\/07\/18\/que-es-la-510k\/\">procedimiento 510(k),<\/a> Thema puede apoyarle en el cumplimiento de todos los requisitos previos y posteriores a la comercializaci\u00f3n del 21 CFR y de las normativas federales, lo que permite la entrada y distribuci\u00f3n de dispositivos sin problemas y de forma eficiente.<\/p>\n<p>Adem\u00e1s, con nuestros servicios de representante local, <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/representante-local\/\">U.S. Agent<\/a> e <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/representante-local\/servicio-de-us-initial-importer\/\">U.S. Initial Importer<\/a>, que son obligatorios para el registro de establecimientos, podr\u00e1 comercializar sus dispositivos con la <strong>m\u00e1xima independencia y autonom\u00eda.<\/strong><\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/es\/contactanos-2\/\">P\u00f3ngase en contacto con nosotros<\/a> para m\u00e1s informaci\u00f3n.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>El 22 de septiembre, la FDA public\u00f3 Electronic Submission Template for Medical Device 510(k) Submissions, un documento que proporciona especificaciones sobre  [&#8230;]<\/p>\n","protected":false},"author":114,"featured_media":24218,"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-24248","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 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>USA: FDA publica un template electr\u00f3nico para el 510(k)<\/title>\n<meta name=\"description\" content=\"El 22 de septiembre, la FDA public\u00f3 Electronic Submission Template for Medical Device 510(k) Submissions, un documento que proporciona...\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"USA: FDA publica un template electr\u00f3nico para el 510(k)\" \/>\n<meta property=\"og:description\" content=\"El 22 de septiembre, la FDA public\u00f3 Electronic Submission Template for Medical Device 510(k) Submissions, un documento que proporciona...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/\" \/>\n<meta property=\"og:site_name\" content=\"Thema - Medical Regulatory Consultancy\" \/>\n<meta property=\"article:published_time\" content=\"2022-10-21T07:25:30+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-01-24T14:08:55+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/10\/NL-tech-articoli-11.png\" \/>\n\t<meta property=\"og:image:width\" content=\"700\" \/>\n\t<meta property=\"og:image:height\" content=\"250\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"ufficiomarketing1\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"ufficiomarketing1\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/\"},\"author\":{\"name\":\"ufficiomarketing1\",\"@id\":\"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/b59b63715293fcd656329797e97821f4\"},\"headline\":\"USA: FDA publica un template electr\u00f3nico para el 510(k)\",\"datePublished\":\"2022-10-21T07:25:30+00:00\",\"dateModified\":\"2023-01-24T14:08:55+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/\"},\"wordCount\":896,\"publisher\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/10\/NL-tech-articoli-11.png\",\"articleSection\":[\"Noticias\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/\",\"url\":\"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/\",\"name\":\"USA: FDA publica un template electr\u00f3nico para el 510(k)\",\"isPartOf\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/10\/NL-tech-articoli-11.png\",\"datePublished\":\"2022-10-21T07:25:30+00:00\",\"dateModified\":\"2023-01-24T14:08:55+00:00\",\"description\":\"El 22 de septiembre, la FDA public\u00f3 Electronic Submission Template for Medical Device 510(k) Submissions, un documento que proporciona...\",\"breadcrumb\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/#breadcrumb\"},\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/#primaryimage\",\"url\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/10\/NL-tech-articoli-11.png\",\"contentUrl\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/10\/NL-tech-articoli-11.png\",\"width\":700,\"height\":250,\"caption\":\"template electr\u00f3nico para el 510(k)\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.thema-med.com\/es\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"USA: FDA publica un template electr\u00f3nico para el 510(k)\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.thema-med.com\/es\/#website\",\"url\":\"https:\/\/www.thema-med.com\/es\/\",\"name\":\"Thema - Medical Regulatory Consultancy\",\"description\":\"Quality and Regulatory Affairs for Medical Devices\",\"publisher\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.thema-med.com\/es\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"es\"},{\"@type\":[\"Organization\",\"Place\"],\"@id\":\"https:\/\/www.thema-med.com\/es\/#organization\",\"name\":\"Thema\",\"alternateName\":\"Thema\",\"url\":\"https:\/\/www.thema-med.com\/es\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\/\/www.thema-med.com\/es\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png\",\"contentUrl\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png\",\"width\":2440,\"height\":2851,\"caption\":\"Thema\"},\"image\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.linkedin.com\/company\/thema-s-r-l-\/\"],\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/b59b63715293fcd656329797e97821f4\",\"name\":\"ufficiomarketing1\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/e97f413dea882bfe71cb5629642221ae2d87068e3446a03fc8d85844fbc25c65?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/e97f413dea882bfe71cb5629642221ae2d87068e3446a03fc8d85844fbc25c65?s=96&d=mm&r=g\",\"caption\":\"ufficiomarketing1\"},\"url\":\"https:\/\/www.thema-med.com\/es\/author\/ufficiomarketing1\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"USA: FDA publica un template electr\u00f3nico para el 510(k)","description":"El 22 de septiembre, la FDA public\u00f3 Electronic Submission Template for Medical Device 510(k) Submissions, un documento que proporciona...","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/","og_locale":"es_ES","og_type":"article","og_title":"USA: FDA publica un template electr\u00f3nico para el 510(k)","og_description":"El 22 de septiembre, la FDA public\u00f3 Electronic Submission Template for Medical Device 510(k) Submissions, un documento que proporciona...","og_url":"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/","og_site_name":"Thema - Medical Regulatory Consultancy","article_published_time":"2022-10-21T07:25:30+00:00","article_modified_time":"2023-01-24T14:08:55+00:00","og_image":[{"width":700,"height":250,"url":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/10\/NL-tech-articoli-11.png","type":"image\/png"}],"author":"ufficiomarketing1","twitter_card":"summary_large_image","twitter_misc":{"Escrito por":"ufficiomarketing1","Tiempo de lectura":"5 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/#article","isPartOf":{"@id":"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/"},"author":{"name":"ufficiomarketing1","@id":"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/b59b63715293fcd656329797e97821f4"},"headline":"USA: FDA publica un template electr\u00f3nico para el 510(k)","datePublished":"2022-10-21T07:25:30+00:00","dateModified":"2023-01-24T14:08:55+00:00","mainEntityOfPage":{"@id":"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/"},"wordCount":896,"publisher":{"@id":"https:\/\/www.thema-med.com\/es\/#organization"},"image":{"@id":"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/#primaryimage"},"thumbnailUrl":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/10\/NL-tech-articoli-11.png","articleSection":["Noticias"],"inLanguage":"es"},{"@type":"WebPage","@id":"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/","url":"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/","name":"USA: FDA publica un template electr\u00f3nico para el 510(k)","isPartOf":{"@id":"https:\/\/www.thema-med.com\/es\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/#primaryimage"},"image":{"@id":"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/#primaryimage"},"thumbnailUrl":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/10\/NL-tech-articoli-11.png","datePublished":"2022-10-21T07:25:30+00:00","dateModified":"2023-01-24T14:08:55+00:00","description":"El 22 de septiembre, la FDA public\u00f3 Electronic Submission Template for Medical Device 510(k) Submissions, un documento que proporciona...","breadcrumb":{"@id":"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/#breadcrumb"},"inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/#primaryimage","url":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/10\/NL-tech-articoli-11.png","contentUrl":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/10\/NL-tech-articoli-11.png","width":700,"height":250,"caption":"template electr\u00f3nico para el 510(k)"},{"@type":"BreadcrumbList","@id":"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.thema-med.com\/es\/"},{"@type":"ListItem","position":2,"name":"USA: FDA publica un template electr\u00f3nico para el 510(k)"}]},{"@type":"WebSite","@id":"https:\/\/www.thema-med.com\/es\/#website","url":"https:\/\/www.thema-med.com\/es\/","name":"Thema - Medical Regulatory Consultancy","description":"Quality and Regulatory Affairs for Medical Devices","publisher":{"@id":"https:\/\/www.thema-med.com\/es\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.thema-med.com\/es\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"es"},{"@type":["Organization","Place"],"@id":"https:\/\/www.thema-med.com\/es\/#organization","name":"Thema","alternateName":"Thema","url":"https:\/\/www.thema-med.com\/es\/","logo":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/www.thema-med.com\/es\/#\/schema\/logo\/image\/","url":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png","contentUrl":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png","width":2440,"height":2851,"caption":"Thema"},"image":{"@id":"https:\/\/www.thema-med.com\/es\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.linkedin.com\/company\/thema-s-r-l-\/"],"mainEntityOfPage":{"@id":"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/usa-fda-publica-un-template-electronico-para-el-510k\/"}},{"@type":"Person","@id":"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/b59b63715293fcd656329797e97821f4","name":"ufficiomarketing1","image":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/e97f413dea882bfe71cb5629642221ae2d87068e3446a03fc8d85844fbc25c65?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/e97f413dea882bfe71cb5629642221ae2d87068e3446a03fc8d85844fbc25c65?s=96&d=mm&r=g","caption":"ufficiomarketing1"},"url":"https:\/\/www.thema-med.com\/es\/author\/ufficiomarketing1\/"}]}},"_links":{"self":[{"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/posts\/24248","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/users\/114"}],"replies":[{"embeddable":true,"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/comments?post=24248"}],"version-history":[{"count":1,"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/posts\/24248\/revisions"}],"predecessor-version":[{"id":24249,"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/posts\/24248\/revisions\/24249"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/media\/24218"}],"wp:attachment":[{"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/media?parent=24248"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/categories?post=24248"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/tags?post=24248"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}