{"id":33032,"date":"2024-08-29T09:33:10","date_gmt":"2024-08-29T07:33:10","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/08\/29\/fda-pubblicate-le-tasse-per-lanno-fiscale-2025\/"},"modified":"2024-08-29T11:46:25","modified_gmt":"2024-08-29T09:46:25","slug":"fda-pubblicate-le-tasse-per-lanno-fiscale-2025","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2024\/08\/29\/fda-pubblicate-le-tasse-per-lanno-fiscale-2025\/","title":{"rendered":"FDA: publicadas las tasas para el a\u00f1o fiscal 2025"},"content":{"rendered":"<h2>El 31 de julio de 2024, la U.S. Food and Drug Administration (FDA) anunci\u00f3 oficialmente en el Registro Federal las nuevas tasas de registro de dispositivos m\u00e9dicos y establecimientos anuales para el A\u00f1o Fiscal 2025 (FY 2025), en vigor del 1 de octubre de 2024 al 30 de septiembre de 2025.<\/h2>\n<h2><strong>Aumentos significativos de aqu\u00ed a 2025<\/strong><\/h2>\n<p>Todas las tarifas registran un aumento significativo con respecto a 2024.<br \/>\nEn concreto, la <strong>tasa de registro de<\/strong> <strong>establecimientos<\/strong> <strong>subi\u00f3 a<\/strong> <strong>9.280 d\u00f3lares,<\/strong> frente a los 7.653 d\u00f3lares del a\u00f1o anterior. Por lo que respecta al registro de establecimientos, no existen exenciones ni reducciones para las peque\u00f1as empresas o establecimientos.<\/p>\n<h2><strong>\u00bfQui\u00e9n est\u00e1 obligado al registro del establecimiento? <\/strong><\/h2>\n<p><strong>Los propietarios <\/strong>y <strong>operadores de establecimientos<\/strong> que fabrican y distribuyen productos sanitarios para su comercializaci\u00f3n en Estados Unidos deben registrarse anualmente en la FDA mediante un proceso conocido como <strong>\u00abregistro de establecimientos\u00bb.<\/strong> Los fabricantes y los importadores iniciales, en la mayor\u00eda de los casos, tambi\u00e9n deben enumerar los productos y las actividades llevadas a cabo con dichos productos en sus instalaciones (<strong>\u00ablistado de productos<\/strong>\u00ab), tal y como se indica en <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=807\">21 CFR Parte 807<\/a>.<\/p>\n<h2><strong>Otras tarifas <\/strong><\/h2>\n<p>Adem\u00e1s de la tasa de registro de establecimiento, la FDA comunic\u00f3 las tasas de <strong>otras solicitudes pertinentes<\/strong>, como 510(k), 513(g), PMA, PDP, PMR, BLA y solicitud de clasificaci\u00f3n de novo, que son necesarias para entrar en el mercado estadounidense. Es importante se\u00f1alar que todos los tipos de 510(k) est\u00e1n sujetos a pago, a excepci\u00f3n de los presentados a trav\u00e9s de terceros revisores acreditados.<\/p>\n<p>Para estas solicitudes, <strong>las peque\u00f1as<\/strong> <strong>empresas<\/strong> se benefician de <strong>tasas reducidas<\/strong> a trav\u00e9s del Programa de Determinaci\u00f3n de Peque\u00f1as Empresas del CDRH, sujeto a certificaci\u00f3n.<\/p>\n<p><strong>&gt;&gt;&gt;<\/strong> Thema y <a href=\"https:\/\/www.thema-med.com\/en\/usa\/\">Thema Corp<\/a> (con sede en EE.UU.) ofrecen asesoramiento y asistencia estrat\u00e9gica en materia de reglamentaci\u00f3n en todas las fases del proceso de renovaci\u00f3n del registro y 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\/\">acceso al mercado estadounidense<\/a>, garantizando la eficacia y el cumplimiento de las normas.<\/p>\n<p><strong>FUENTES:<\/strong><br \/>\nPara consultar todas las tarifas: <a href=\"https:\/\/www.fda.gov\/industry\/fda-user-fee-programs\/medical-device-user-fee-amendments-mdufa?utm_medium=email&amp;utm_source=govdelivery\">sitio web<\/a><br \/>\n<a href=\"https:\/\/www.fda.gov\/medical-devices\/device-registration-and-listing\/who-must-register-list-and-pay-fee\">de la<\/a> <a href=\"https:\/\/www.fda.gov\/industry\/fda-user-fee-programs\/medical-device-user-fee-amendments-mdufa?utm_medium=email&amp;utm_source=govdelivery\">FDA<\/a><br \/>\nPara obtener informaci\u00f3n sobre las categor\u00edas de productos obligados a registrarse y c\u00f3mo proceder, puede consultar este art\u00edculo<a href=\"https:\/\/www.fda.gov\/medical-devices\/device-registration-and-listing\/who-must-register-list-and-pay-fee\"> en el sitio web de la FDA.<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>El 31 de julio de 2024, la U.S. Food and Drug Administration (FDA) anunci\u00f3 oficialmente en el Registro Federal las nuevas  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":33004,"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-33032","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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