{"id":8703,"date":"2019-01-18T13:56:15","date_gmt":"2019-01-18T12:56:15","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=8703"},"modified":"2023-01-26T12:21:51","modified_gmt":"2023-01-26T11:21:51","slug":"ee-uu-cierre-de-la-fda-en-2019-que-consecuencias-tiene-para-los-dispositivos-medicos","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2019\/01\/18\/ee-uu-cierre-de-la-fda-en-2019-que-consecuencias-tiene-para-los-dispositivos-medicos\/","title":{"rendered":"EE. UU.: Cierre de la FDA en 2019, \u00bfqu\u00e9 consecuencias tiene para los dispositivos m\u00e9dicos?"},"content":{"rendered":"<p><img decoding=\"async\" class=\"aligncenter wp-image-8641 size-full\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2019\/01\/FDA-shutdown-2019.jpg\" alt=\"\" width=\"912\" height=\"513\" \/><\/p>\n<p><em>Actualizaci\u00f3n: La FDA reanud\u00f3 sus operaciones el s\u00e1bado 26 de enero de 2019.<\/em><\/p>\n<p>Los conflictos sobre temas de seguridad entre Donald Trump y el Congreso provocados luego de la solicitud del presidente para financiar el muro fronterizo entre M\u00e9xico y Estados Unidos han provocado que el <a href=\"https:\/\/www.fda.gov\/AboutFDA\/WorkingatFDA\/ucm629100.htm\">cierre parcial del Gobierno<\/a> desde el 22 de diciembre de 2018, a\u00fan en curso.<\/p>\n<p>Debido al cierre parcial, la FDA no puede cobrar tarifas de usuario para el a\u00f1o fiscal 2019. \u00a0Como resultado, no puede aceptar ni evaluar nuevas solicitudes de pre-comercializaci\u00f3n relacionadas con dispositivos m\u00e9dicos sujetos al pago de dichas tarifas de usuario.<\/p>\n<p>Con aproximadamente el 41% del personal despedido debido a la <strong>financiaci\u00f3n bloqueada<\/strong>, la FDA est\u00e1 obligada a operar a capacidad reducida. A la espera de nuevos desarrollos, el 23 \u00b0 Comisionado de la FDA, <a href=\"https:\/\/twitter.com\/SGottliebFDA\/status\/1081625342509543425\">Scott Gottlieb<\/a>, ha asegurado a los fabricantes de dispositivos m\u00e9dicos que la FDA continuar\u00e1, aunque a un ritmo m\u00e1s lento, para evaluar las solicitudes actuales 510 (k) previas a la comercializaci\u00f3n cuyas tarifas de usuario han sido Pagado antes del 22 de diciembre de 2018.<\/p>\n<p>Si, en cambio, las tarifas de los usuarios no se han pagado en su totalidad o si el pago no se ha procesado por completo antes del 22 de diciembre de 2018, las solicitudes relativas permanecen \u00aben espera\u00bb hasta que el Gobierno vuelva ser cien por ciento operativo, cuando se pueda completar el pago.<\/p>\n<p>Gracias a las tarifas de los usuarios pagadas por las compa\u00f1\u00edas farmac\u00e9uticas y los dispositivos m\u00e9dicos, por el momento, la FDA puede pagar al personal considerado \u00abesencial\u00bb, que continuar\u00e1 realizando <strong>actividades \u00abcr\u00edticas\u00bb<\/strong>, como el retiro de dispositivos m\u00e9dicos, la detecci\u00f3n de dispositivos m\u00e9dicos importados, y actividades esenciales de vigilancia del mercado para garantizar la salvaguardia de la salud p\u00fablica.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Actualizaci\u00f3n: La FDA reanud\u00f3 sus operaciones el s\u00e1bado 26 de enero de 2019. Los conflictos sobre temas de seguridad entre Donald  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":23480,"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-8703","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>EE. 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