{"id":55789,"date":"2022-10-07T08:41:44","date_gmt":"2022-10-07T12:41:44","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-announces-new-medical-device-user-fees-for-fy-2023\/"},"modified":"2022-10-19T11:58:11","modified_gmt":"2022-10-19T15:58:11","slug":"fda-announces-new-medical-device-user-fees-for-fy-2023","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/es\/fda-announces-new-medical-device-user-fees-for-fy-2023\/","title":{"rendered":"La FDA Anuncia las Nuevas Tasas de Usuarios de Dispositivos M\u00e9dicos Para el A\u00f1o Fiscal 2023"},"content":{"rendered":"<p>La Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) ha anunciado las tarifas para el A\u00f1o Fiscal (FY) 2023 bajo las Enmiendas de Tarifas de Usuarios de Dispositivos M\u00e9dicos (MDUFA).<\/p>\n<p>El a\u00f1o fiscal comienza el 1 de octubre de 2022 y termina el 30 de septiembre de 2023. Las instalaciones de dispositivos m\u00e9dicos deben pagar las tasas para mantener su estatus de conformidad con la FDA.<\/p>\n<p><strong>Tasas de Dispositivos M\u00e9dicos<\/strong><\/p>\n<p>La FDA exige tasas a los establecimientos de dispositivos m\u00e9dicos que cubren:<\/p>\n<ul>\n<li>Ciertas aplicaciones de dispositivos m\u00e9dicos<\/li>\n<li>Informes peri\u00f3dicos sobre dispositivos de clase III<\/li>\n<li>Registro anual de establecimientos<\/li>\n<\/ul>\n<p>Las empresas con un total de ventas inferior a 100 millones de d\u00f3lares en el ejercicio fiscal m\u00e1s reciente pueden calificarse como peque\u00f1as empresas para obtener una tasa reducida en las solicitudes. Las empresas con ventas totales inferiores a 30 millones de d\u00f3lares pueden recibir una exenci\u00f3n de las primeras solicitudes o informes previos a la comercializaci\u00f3n. Si usted calific\u00f3 para una tarifa reducida o exenta en el a\u00f1o fiscal 2022, debe volver a presentar su informaci\u00f3n durante la renovaci\u00f3n de la FDA para seguir calificando.<\/p>\n<p>Los registros de establecimientos son consistentes en todos los tama\u00f1os de negocios y deben ser pagados para completar los registros. Para la tasa de registro de establecimientos, no hay exenciones ni reducciones para los peque\u00f1os establecimientos, empresas o grupos. Las empresas deben pagar la tasa de registro de establecimientos por cada ubicaci\u00f3n f\u00edsica que posea la empresa y que maneje ciertas funciones sobre los dispositivos m\u00e9dicos.<\/p>\n<p>Las tasas de dispositivos m\u00e9dicos para el <a href=\"https:\/\/www.fda.gov\/industry\/fda-user-fee-programs\/medical-device-user-fee-amendments-mdufa\">a\u00f1o fiscal 2023<\/a>, aumentaron con respecto al a\u00f1o fiscal 2022. La FDA menciona que esto se debe ya que contempla la inflaci\u00f3n del \u00faltimo a\u00f1o.<\/p>\n<p><strong>Tasas MDUFA del A\u00f1o Fiscal 2023<\/strong><\/p>\n<table class=\"feeTable statistics\" style=\"border: 1px solid grey; border-spacing: 0px !important;\" border=\"1\" width=\"100%\">\n<tbody>\n<tr>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"229\"><strong>Tipo de Tarifa<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" colspan=\"2\" width=\"196\"><strong>2022<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" colspan=\"2\" width=\"213\"><strong>2023<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"229\">Registro Anual de Establecimientos<\/td>\n<td colspan=\"2\" width=\"196\">$5,546<\/td>\n<td colspan=\"2\" width=\"213\">$6,493<\/td>\n<\/tr>\n<tr>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"229\"><strong>Tasas de Solicitud<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"90\"><strong>Est\u00e1ndar<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"106\"><strong>Peque\u00f1a Empresa<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"106\"><strong>Est\u00e1ndar<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"106\"><strong>Peque\u00f1a Empresa<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"229\">510(k)<\/td>\n<td width=\"90\">$12,745<\/td>\n<td width=\"106\">$3,186<\/td>\n<td width=\"106\">$19,870<\/td>\n<td width=\"106\">$4,967<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">513(g)<\/td>\n<td width=\"90\">$5,061<\/td>\n<td width=\"106\">$2,530<\/td>\n<td width=\"106\">$5,961<\/td>\n<td width=\"106\">$2,980<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">Clasificaci\u00f3n Nueva<\/td>\n<td width=\"90\">$112,457<\/td>\n<td width=\"106\">$28,114<\/td>\n<td width=\"106\">$441,547<\/td>\n<td width=\"106\">$110,387<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">PMA, PDP, PMR, BLA<\/td>\n<td width=\"90\">$374,858<\/td>\n<td width=\"106\">$93,714<\/td>\n<td width=\"106\">$132,464<\/td>\n<td width=\"106\">$33,116<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">Suplemento de la pista del panel<\/td>\n<td width=\"90\">$281,143<\/td>\n<td width=\"106\">$70,286<\/td>\n<td width=\"106\">$353,238<\/td>\n<td width=\"106\">$88,309<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">Suplemento de 180 d\u00edas<\/td>\n<td width=\"90\">$56,229<\/td>\n<td width=\"106\">$14,057<\/td>\n<td width=\"106\">$66,232<\/td>\n<td width=\"106\">$16,558<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">Suplemento en Tiempo Real<\/td>\n<td width=\"90\">$26,240<\/td>\n<td width=\"106\">$6,560<\/td>\n<td width=\"106\">$30,908<\/td>\n<td width=\"106\">$7,727<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">Suplemento de eficacia BLA<\/td>\n<td width=\"90\">$374,858<\/td>\n<td width=\"106\">$93,714<\/td>\n<td width=\"106\">$441,547<\/td>\n<td width=\"106\">$110,387<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">Reporte Annual PMA<\/td>\n<td width=\"90\">$13,120<\/td>\n<td width=\"106\">$3,280<\/td>\n<td width=\"106\">$15,454<\/td>\n<td width=\"106\">$3,864<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>La FDA no considerar\u00e1 que los registros de dispositivos m\u00e9dicos quedan completos a menos que se hayan remitido todos los pagos requeridos. Si la FDA no ha recibido los pagos antes de la fecha l\u00edmite del 31 de diciembre, su establecimiento puede ser eliminado de la base de datos de la FDA, haciendo que su registro quede inv\u00e1lido. Registrar Corp puede ayudarle a determinar las tasas a las que est\u00e1 sujeta su establecimiento y facilitar el pago a la FDA.<\/p>\n<div class=\"callout-row text-center margin-bottom\">\n<h3>Obtenga Asistencia con el Cumplimiento de la FDA<\/h3>\n<p>Los especialistas en regulaciones de la FDA de Registrar Corp pueden ayudarle a cumplir con las regulaciones de dispositivos m\u00e9dicos de la FDA.<\/p>\n<p>Para tener mayor asistencia con los requisitos regulatorios de la FDA, llame al: +1-757-224-0177, o env\u00ede un correo electr\u00f3nico a: <a href=\"mailto:info@registrarcorp.com\">info@registrarcorp.com<\/a>, o chatee las 24 horas del d\u00eda con un Asesor Regulatorio: <a href=\"https:\/\/regstaging.wpengine.com\/livechat\">regstaging.wpengine.com\/livechat<\/a>.<\/p>\n<p class=\"btn-row\"><a class=\"btn btn-red-white\" href=\"https:\/\/regstaging.wpengine.com\/es\/fda-medical-devices\/?lead_source=blog\">Obtenga Asistencia<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>La Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) ha anunciado las tarifas para el A\u00f1o Fiscal (FY) 2023 bajo las Enmiendas de Tarifas de Usuarios de Dispositivos M\u00e9dicos (MDUFA). El a\u00f1o fiscal comienza el 1 de octubre de 2022 y termina el 30 de septiembre de 2023. Las instalaciones de dispositivos m\u00e9dicos<\/p>\n","protected":false},"author":31,"featured_media":55643,"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],"tags":[],"class_list":{"0":"post-55789","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medical-devices-es","8":"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>La FDA Anuncia las Nuevas Tasas de Usuarios de Dispositivos M\u00e9dicos Para el A\u00f1o Fiscal 2023 - 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=\"La FDA Anuncia las Nuevas Tasas de Usuarios de Dispositivos M\u00e9dicos Para el A\u00f1o Fiscal 2023\" \/>\n<meta property=\"og:description\" content=\"La Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) ha anunciado las tarifas para el A\u00f1o Fiscal (FY) 2023 bajo las Enmiendas de Tarifas de Usuarios de Dispositivos M\u00e9dicos (MDUFA). El a\u00f1o fiscal comienza el 1 de octubre de 2022 y termina el 30 de septiembre de 2023. Las instalaciones de dispositivos m\u00e9dicos\" \/>\n<meta property=\"og:url\" content=\"https:\/\/legacy.registrarcorp.com\/es\/fda-announces-new-medical-device-user-fees-for-fy-2023\/\" \/>\n<meta property=\"og:site_name\" content=\"Registrar\" \/>\n<meta property=\"article:published_time\" content=\"2022-10-07T12:41:44+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-10-19T15:58:11+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2022\/10\/flat-lay-health-still-life-arrangement-with-copy-space-scaled-e1665146316410.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1440\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Ashley Lambert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ashley Lambert\" \/>\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:\/\/legacy.registrarcorp.com\/es\/fda-announces-new-medical-device-user-fees-for-fy-2023\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/es\/fda-announces-new-medical-device-user-fees-for-fy-2023\/\"},\"author\":{\"name\":\"Ashley Lambert\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/es\/#\/schema\/person\/15b1dcde8983ff58d1caac513cd1002e\"},\"headline\":\"La FDA Anuncia las Nuevas Tasas de Usuarios de Dispositivos M\u00e9dicos Para el A\u00f1o Fiscal 2023\",\"datePublished\":\"2022-10-07T12:41:44+00:00\",\"dateModified\":\"2022-10-19T15:58:11+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/es\/fda-announces-new-medical-device-user-fees-for-fy-2023\/\"},\"wordCount\":533,\"publisher\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/es\/#organization\"},\"image\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/es\/fda-announces-new-medical-device-user-fees-for-fy-2023\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2022\/10\/flat-lay-health-still-life-arrangement-with-copy-space-scaled-e1665146316410.jpg\",\"articleSection\":[\"Dispositivos M\u00e9dicos\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/es\/fda-announces-new-medical-device-user-fees-for-fy-2023\/\",\"url\":\"https:\/\/legacy.registrarcorp.com\/es\/fda-announces-new-medical-device-user-fees-for-fy-2023\/\",\"name\":\"La FDA Anuncia las Nuevas Tasas de Usuarios de Dispositivos M\u00e9dicos Para el A\u00f1o Fiscal 2023 - 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