{"id":33116,"date":"2024-09-19T16:24:59","date_gmt":"2024-09-19T14:24:59","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/"},"modified":"2024-09-19T16:28:34","modified_gmt":"2024-09-19T14:28:34","slug":"fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/","title":{"rendered":"FDA: se anuncia la fecha de aplicaci\u00f3n de eSTAR para las solicitudes De Novo en una gu\u00eda actualizada"},"content":{"rendered":"<h2>La Administraci\u00f3n de Alimentos y Medicamentos de EE.UU. (FDA) anunci\u00f3 recientemente en una gu\u00eda publicada el 23 de agosto de 2024 titulada <strong>&#8216;<em>Electronic Submission Template for Medical Device De Novo Requests<\/em>&#8216; <\/strong>que, a <strong>partir<\/strong> <strong>del 1 de octubre de 2025<\/strong>, los fabricantes de dispositivos m\u00e9dicos tendr\u00e1n que utilizar \u00fanicamente el formulario electr\u00f3nico <strong>eSTAR<\/strong> para presentar solicitudes De Novo. El procedimiento De Novo permite clasificar los nuevos productos sanitarios de riesgo bajo o moderado para los que no existe ya ninguna clasificaci\u00f3n.<\/h2>\n<h2><strong>Aplicaci\u00f3n de eSTAR y del procedimiento De Novo<\/strong><\/h2>\n<p>El sistema eSTAR, introducido en febrero de 2020 para las solicitudes 510(k), reduce el riesgo de errores de compilaci\u00f3n al ofrecer orientaci\u00f3n y validaci\u00f3n autom\u00e1ticas. Este sistema mejora la revisi\u00f3n y digitalizaci\u00f3n de las solicitudes reglamentarias. El uso de eSTAR para las solicitudes 510(k) ya es obligatorio a partir del 1 de octubre de 2023. Para las solicitudes De Novo, hasta ahora ha sido opcional (de forma voluntaria) y ser\u00e1 obligatorio a partir del 1 de octubre de 2025.<\/p>\n<p>El procedimiento De Novo permite clasificar los productos sanitarios innovadores<strong> de riesgo bajo o moderado<\/strong> sin equivalentes previos. Si un fabricante no puede encontrar un dispositivo \u00abpredicado\u00bb para la presentaci\u00f3n del 510(k), puede recurrir a la solicitud De Novo. La FDA recomienda hacer una solicitud previa para obtener una resonancia antes de presentar la solicitud.<\/p>\n<h2><strong>Novedades en la gu\u00eda de aplicaci\u00f3n De Novo <\/strong><\/h2>\n<p>La gu\u00eda actualizada, publicada el 23 de agosto de 2024 y titulada <strong>\u00ab<em>Electronic Submission Template for Medical Device De Novo Requests<\/em>\u00ab<\/strong>, sustituye a un borrador publicado en septiembre de 2023 e introduce cambios significativos. En resumen:<\/p>\n<ul>\n<li><strong>Uso obligatorio de eSTAR<\/strong>: a partir del 1 de octubre de 2025, eSTAR ser\u00e1 el \u00fanico formato aceptado para las solicitudes De Novo, sustituyendo a los m\u00e9todos anteriores.<\/li>\n<\/ul>\n<ul>\n<li><strong>Normas para la preparaci\u00f3n de solicitudes:<\/strong> se especifican las normas generales y los detalles sobre c\u00f3mo utilizar eSTAR, incluido el contenido y la forma de compilarlas.<\/li>\n<li><strong>Procedimientos t\u00e9cnicos de selecci\u00f3n y revisi\u00f3n:<\/strong> La FDA realizar\u00e1 un examen t\u00e9cnico en un plazo de 15 d\u00edas a partir de la recepci\u00f3n de la solicitud y las tasas. Si la solicitud est\u00e1 incompleta, el remitente recibir\u00e1 una notificaci\u00f3n por correo electr\u00f3nico y dispondr\u00e1 de 180 d\u00edas para corregir el formulario eSTAR; de lo contrario, la solicitud se considerar\u00e1 retirada.<\/li>\n<\/ul>\n<h2><strong>Conclusiones<\/strong><\/h2>\n<p>La nueva gu\u00eda representa un paso importante hacia la digitalizaci\u00f3n completa de las presentaciones reglamentarias a la FDA. Adem\u00e1s, los procedimientos de De Novo son cruciales para sacar al mercado <strong>dispositivos innovadores<\/strong> que no tienen un equivalente ya clasificado, por lo que esta actualizaci\u00f3n es especialmente pertinente para las empresas que desarrollan tecnolog\u00edas de vanguardia.<br \/>\nComo tambi\u00e9n se indica en la gu\u00eda, es aconsejable que todas las empresas empiecen a utilizar eSTAR <strong>lo antes posible<\/strong> para evitar retrasos en futuras presentaciones.<\/p>\n<p><strong>&gt;&gt;&gt; <\/strong>Los expertos de Thema (oficina italiana) y <a href=\"https:\/\/www.thema-med.com\/en\/usa\/\">Thema Corp<\/a> (oficina estadounidense) est\u00e1n a su disposici\u00f3n para guiarle paso a paso en el proceso de obtenci\u00f3n de la clasificaci\u00f3n De Novo y otros procesos reglamentarios previos a la comercializaci\u00f3n necesarios para que los productos sanitarios entren en el mercado estadounidense.<\/p>\n<p><strong><br \/>\nFUENTE:<br \/>\n<\/strong><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/electronic-submission-template-medical-device-de-novo-requests\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/electronic-submission-template-medical-device-de-novo-requests<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>La Administraci\u00f3n de Alimentos y Medicamentos de EE.UU. (FDA) anunci\u00f3 recientemente en una gu\u00eda publicada el 23 de agosto de 2024  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":33094,"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-33116","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>FDA: se anuncia la fecha de aplicaci\u00f3n de eSTAR para las solicitudes De Novo en una gu\u00eda actualizada - Thema - Medical Regulatory Consultancy<\/title>\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\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA: se anuncia la fecha de aplicaci\u00f3n de eSTAR para las solicitudes De Novo en una gu\u00eda actualizada - Thema - Medical Regulatory Consultancy\" \/>\n<meta property=\"og:description\" content=\"La Administraci\u00f3n de Alimentos y Medicamentos de EE.UU. (FDA) anunci\u00f3 recientemente en una gu\u00eda publicada el 23 de agosto de 2024 [...]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/\" \/>\n<meta property=\"og:site_name\" content=\"Thema - Medical Regulatory Consultancy\" \/>\n<meta property=\"article:published_time\" content=\"2024-09-19T14:24:59+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-09-19T14:28:34+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2024\/09\/3.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"1080\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"ufficiomarketing\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"ufficiomarketing\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 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\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/\"},\"author\":{\"name\":\"ufficiomarketing\",\"@id\":\"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/48e37298d13e3cf7f6d907af6a0d796d\"},\"headline\":\"FDA: se anuncia la fecha de aplicaci\u00f3n de eSTAR para las solicitudes De Novo en una gu\u00eda actualizada\",\"datePublished\":\"2024-09-19T14:24:59+00:00\",\"dateModified\":\"2024-09-19T14:28:34+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/\"},\"wordCount\":569,\"publisher\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2024\/09\/3.jpg\",\"articleSection\":[\"Noticias\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/\",\"url\":\"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/\",\"name\":\"FDA: se anuncia la fecha de aplicaci\u00f3n de eSTAR para las solicitudes De Novo en una gu\u00eda actualizada - Thema - Medical Regulatory Consultancy\",\"isPartOf\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2024\/09\/3.jpg\",\"datePublished\":\"2024-09-19T14:24:59+00:00\",\"dateModified\":\"2024-09-19T14:28:34+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/#breadcrumb\"},\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/#primaryimage\",\"url\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2024\/09\/3.jpg\",\"contentUrl\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2024\/09\/3.jpg\",\"width\":1920,\"height\":1080},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.thema-med.com\/es\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"FDA: se anuncia la fecha de aplicaci\u00f3n de eSTAR para las solicitudes De Novo en una gu\u00eda actualizada\"}]},{\"@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\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/48e37298d13e3cf7f6d907af6a0d796d\",\"name\":\"ufficiomarketing\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/61aa792ee358880e0c04a758e6f9078a28e175950ffc09fbeb595cd0ce2f89e2?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/61aa792ee358880e0c04a758e6f9078a28e175950ffc09fbeb595cd0ce2f89e2?s=96&d=mm&r=g\",\"caption\":\"ufficiomarketing\"},\"url\":\"https:\/\/www.thema-med.com\/es\/author\/ufficiomarketing\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"FDA: se anuncia la fecha de aplicaci\u00f3n de eSTAR para las solicitudes De Novo en una gu\u00eda actualizada - Thema - Medical Regulatory Consultancy","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\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/","og_locale":"es_ES","og_type":"article","og_title":"FDA: se anuncia la fecha de aplicaci\u00f3n de eSTAR para las solicitudes De Novo en una gu\u00eda actualizada - Thema - Medical Regulatory Consultancy","og_description":"La Administraci\u00f3n de Alimentos y Medicamentos de EE.UU. (FDA) anunci\u00f3 recientemente en una gu\u00eda publicada el 23 de agosto de 2024 [...]","og_url":"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/","og_site_name":"Thema - Medical Regulatory Consultancy","article_published_time":"2024-09-19T14:24:59+00:00","article_modified_time":"2024-09-19T14:28:34+00:00","og_image":[{"width":1920,"height":1080,"url":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2024\/09\/3.jpg","type":"image\/jpeg"}],"author":"ufficiomarketing","twitter_card":"summary_large_image","twitter_misc":{"Escrito por":"ufficiomarketing","Tiempo de lectura":"3 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/#article","isPartOf":{"@id":"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/"},"author":{"name":"ufficiomarketing","@id":"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/48e37298d13e3cf7f6d907af6a0d796d"},"headline":"FDA: se anuncia la fecha de aplicaci\u00f3n de eSTAR para las solicitudes De Novo en una gu\u00eda actualizada","datePublished":"2024-09-19T14:24:59+00:00","dateModified":"2024-09-19T14:28:34+00:00","mainEntityOfPage":{"@id":"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/"},"wordCount":569,"publisher":{"@id":"https:\/\/www.thema-med.com\/es\/#organization"},"image":{"@id":"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/#primaryimage"},"thumbnailUrl":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2024\/09\/3.jpg","articleSection":["Noticias"],"inLanguage":"es"},{"@type":"WebPage","@id":"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/","url":"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/","name":"FDA: se anuncia la fecha de aplicaci\u00f3n de eSTAR para las solicitudes De Novo en una gu\u00eda actualizada - Thema - Medical Regulatory Consultancy","isPartOf":{"@id":"https:\/\/www.thema-med.com\/es\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/#primaryimage"},"image":{"@id":"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/#primaryimage"},"thumbnailUrl":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2024\/09\/3.jpg","datePublished":"2024-09-19T14:24:59+00:00","dateModified":"2024-09-19T14:28:34+00:00","breadcrumb":{"@id":"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/#breadcrumb"},"inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/#primaryimage","url":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2024\/09\/3.jpg","contentUrl":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2024\/09\/3.jpg","width":1920,"height":1080},{"@type":"BreadcrumbList","@id":"https:\/\/www.thema-med.com\/es\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.thema-med.com\/es\/"},{"@type":"ListItem","position":2,"name":"FDA: se anuncia la fecha de aplicaci\u00f3n de eSTAR para las solicitudes De Novo en una gu\u00eda actualizada"}]},{"@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\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/"}},{"@type":"Person","@id":"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/48e37298d13e3cf7f6d907af6a0d796d","name":"ufficiomarketing","image":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/61aa792ee358880e0c04a758e6f9078a28e175950ffc09fbeb595cd0ce2f89e2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/61aa792ee358880e0c04a758e6f9078a28e175950ffc09fbeb595cd0ce2f89e2?s=96&d=mm&r=g","caption":"ufficiomarketing"},"url":"https:\/\/www.thema-med.com\/es\/author\/ufficiomarketing\/"}]}},"_links":{"self":[{"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/posts\/33116","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\/115"}],"replies":[{"embeddable":true,"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/comments?post=33116"}],"version-history":[{"count":2,"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/posts\/33116\/revisions"}],"predecessor-version":[{"id":33118,"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/posts\/33116\/revisions\/33118"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/media\/33094"}],"wp:attachment":[{"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/media?parent=33116"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/categories?post=33116"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/tags?post=33116"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}