{"id":40719,"date":"2016-08-01T15:16:36","date_gmt":"2016-08-01T15:16:36","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/"},"modified":"2022-12-26T07:44:29","modified_gmt":"2022-12-26T12:44:29","slug":"fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/es\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/","title":{"rendered":"FDA publica las cuotas de usuario para dispositivos y medicamentos gen\u00e9ricos para el a\u00f1o fiscal 2017."},"content":{"rendered":"<p>La U.S. Food and Drug Administration (FDA) public\u00f3 sus cuotas de usuario anuales para dispositivos m\u00e9dicos y medicamentos gen\u00e9ricos para el a\u00f1o fiscal 2017 (1 de Octubre de 2016 al 30 de Septiembre de 2017).<\/p>\n<p><strong>Cuotas de Usuario para Dispositivos M\u00e9dicos aplicables al a\u00f1o fiscal 2017<\/strong><\/p>\n<ul>\n<li>Cuota de Registro de Establecimiento: $3,382 USD (No hay reducci\u00f3n de costo para Peque\u00f1as Empresas)<\/li>\n<li>Aplicaci\u00f3n Previa a Comercializaci\u00f3n (PMA, BLA, PDP): $234,495 USD \/ $ 58,624 USD para Peque\u00f1as Empresas.<\/li>\n<li>Notificaci\u00f3n Previa a Comercializaci\u00f3n (510(k)): $4,690 USD \/ $2,345 USD para Peque\u00f1as Empresas.<\/li>\n<li>Solicitud 513(g) para clasificaci\u00f3n de informaci\u00f3n: $3,166 USD \/ $1,583 USD para Peque\u00f1as Empresas.<\/li>\n<li>Reporte Anual PMA: $8,207 USD \/ $2,052 USD para Peque\u00f1as Empresas.<\/li>\n<\/ul>\n<p>Las cuotas de usuario para dispositivos m\u00e9dicos aplicables al a\u00f1o fiscal 2017 mostraron una reducci\u00f3n en comparaci\u00f3n con el <a href=\"https:\/\/regstaging.wpengine.com\/2015\/08\/fda-medical-device-drug-user-fees-2016\/\">a\u00f1o fiscal 2016<\/a>.<\/p>\n<p>Registrar Corp puede <a href=\"https:\/\/regstaging.wpengine.com\/fda-medical-device\/registration\/?lang=en\">registrar establecimientos de dispositivos m\u00e9dicos con la FDA<\/a> de EE. UU., as\u00ed como revisar un 510(k) para verificar el cumplimiento de los requisitos de presentaci\u00f3n.<\/p>\n<p><strong>Cuotas de Usuario para Medicamentos Gen\u00e9ricos aplicables al a\u00f1o fiscal 2017<\/strong><\/p>\n<p>Cuotas de Aplicaci\u00f3n:<\/p>\n<ul>\n<li>Aplicaci\u00f3n Abreviada para un Nuevo Medicamento (ANDA): $70,480 USD<\/li>\n<li>Aprobaci\u00f3n Previa Suplemento (PAS) a una ANDA: $35,240 USD<\/li>\n<li>Drug Master File (DMF): $51,140 USD<\/li>\n<\/ul>\n<p>Cuotas para Instalaciones:<\/p>\n<ul>\n<li>Ingrediente Activo Farmac\u00e9utico (API) \u2013 Nacional: $44,234 USD<\/li>\n<li>API \u2013 Extranjera: $59,234 USD<\/li>\n<li>Forma de Dosificaci\u00f3n Final (FDF) \u2013 Nacional: $258,646 USD<\/li>\n<li>FDF \u2013 Extranjera: $273,646 USD<\/li>\n<\/ul>\n<p>Las cuotas de usuario para las aplicaciones ANDA y PAS aplicables para el a\u00f1o fiscal 2017 mostraron una reducci\u00f3n en comparaci\u00f3n con el <a href=\"https:\/\/regstaging.wpengine.com\/2015\/08\/fda-medical-device-drug-user-fees-2016\/\">a\u00f1o fiscal 2016<\/a>. Las cuotas de aplicaci\u00f3n DMF as\u00ed como las cuotas de instalaci\u00f3n API y FDF aplicables al a\u00f1o fiscal 2017 mostraron un incremento en comparaci\u00f3n con el a\u00f1o fiscal 2016.<\/p>\n<p>Registrar Corp puede <a href=\"https:\/\/regstaging.wpengine.com\/fda-drugs\/registration.jsp?lang=en\">registrar un establecimiento de medicamentos<\/a> y <a href=\"https:\/\/regstaging.wpengine.com\/fda-drugs\/master-files\/registration.jsp?lang=en\">presentar DMFs<\/a> ante la U.S. FDA.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>La U.S. Food and Drug Administration (FDA) public\u00f3 sus cuotas de usuario anuales para dispositivos m\u00e9dicos y medicamentos gen\u00e9ricos para el a\u00f1o fiscal 2017 (1 de Octubre de 2016 al 30 de Septiembre de 2017). Cuotas de Usuario para Dispositivos M\u00e9dicos aplicables al a\u00f1o fiscal 2017 Cuota de Registro de Establecimiento: $3,382 USD (No hay<\/p>\n","protected":false},"author":30,"featured_media":403,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"content-type":"","om_disable_all_campaigns":false,"inline_featured_image":false,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[61,60],"tags":[],"class_list":["post-40719","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medical-devices-es","category-drugs-es","entry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.9 (Yoast SEO v25.5) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA publica las cuotas de usuario para dispositivos y medicamentos gen\u00e9ricos para el a\u00f1o fiscal 2017. - Registrar<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA publica las cuotas de usuario para dispositivos y medicamentos gen\u00e9ricos para el a\u00f1o fiscal 2017.\" \/>\n<meta property=\"og:description\" content=\"La U.S. Food and Drug Administration (FDA) public\u00f3 sus cuotas de usuario anuales para dispositivos m\u00e9dicos y medicamentos gen\u00e9ricos para el a\u00f1o fiscal 2017 (1 de Octubre de 2016 al 30 de Septiembre de 2017). Cuotas de Usuario para Dispositivos M\u00e9dicos aplicables al a\u00f1o fiscal 2017 Cuota de Registro de Establecimiento: $3,382 USD (No hay\" \/>\n<meta property=\"og:url\" content=\"https:\/\/legacy.registrarcorp.com\/es\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/\" \/>\n<meta property=\"og:site_name\" content=\"Registrar\" \/>\n<meta property=\"article:published_time\" content=\"2016-08-01T15:16:36+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-12-26T12:44:29+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2019\/08\/press_release.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1650\" \/>\n\t<meta property=\"og:image:height\" content=\"500\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Mason Grandusky\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Mason Grandusky\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/es\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/es\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/\"},\"author\":{\"name\":\"Mason Grandusky\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/es\/#\/schema\/person\/5460f453ed04f326b4ef5280009675f2\"},\"headline\":\"FDA publica las cuotas de usuario para dispositivos y medicamentos gen\u00e9ricos para el a\u00f1o fiscal 2017.\",\"datePublished\":\"2016-08-01T15:16:36+00:00\",\"dateModified\":\"2022-12-26T12:44:29+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/es\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/\"},\"wordCount\":324,\"publisher\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/es\/#organization\"},\"image\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/es\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2019\/08\/press_release.jpg\",\"articleSection\":[\"Dispositivos M\u00e9dicos\",\"Medicamentos\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/es\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/\",\"url\":\"https:\/\/legacy.registrarcorp.com\/es\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/\",\"name\":\"FDA publica las cuotas de usuario para dispositivos y medicamentos gen\u00e9ricos para el a\u00f1o fiscal 2017. - 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