{"id":8124,"date":"2018-10-17T11:04:42","date_gmt":"2018-10-17T09:04:42","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=8124"},"modified":"2018-10-17T12:26:24","modified_gmt":"2018-10-17T10:26:24","slug":"ee-uu-programa-piloto-de-revision-quik-510k","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2018\/10\/17\/ee-uu-programa-piloto-de-revision-quik-510k\/","title":{"rendered":"EE.UU.: Programa piloto de revisi\u00f3n \u00abQuik\u00bb 510(k)"},"content":{"rendered":"<p><img decoding=\"async\" class=\"size-medium wp-image-8118 alignnone\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/10\/USA-1-300x165.jpg\" alt=\"\" width=\"300\" height=\"165\" \/><\/p>\n<p>Con la intenci\u00f3n de facilitar la comercializaci\u00f3n de dispositivos m\u00e9dicos seguros, efectivos y de alta calidad, en septiembre de 2018, la FDA lanz\u00f3 un nuevo programa piloto titulado <em><strong><a href=\"https:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/HowtoMarketYourDevice\/PremarketSubmissions\/PremarketNotification510k\/ucm618561.htm\" target=\"_blank\" rel=\"noopener\">Quality in 510 (k)<\/a><\/strong><\/em> o \u00abQuik\u00bb. A trav\u00e9s de este programa, la FDA pretende simplificar el procedimiento para revisar las solicitudes 510 (k) previas a la comercializaci\u00f3n de ciertos dispositivos m\u00e9dicos y brindar una decisi\u00f3n final dentro de los 60 d\u00edas posteriores a la recepci\u00f3n de las solicitudes.<\/p>\n<p>Una solicitud 510 (k) debe cumplir con todos los criterios a continuaci\u00f3n para ser admitida en el Programa \u00abQuik\u00bb:<\/p>\n<ul>\n<li>El c\u00f3digo de producto primario del dispositivo debe incluirse en la lista de dispositivos identificados por la FDA;<\/li>\n<li>La presentaci\u00f3n debe construirse utilizando el modelo de eSubmitter <em>\u00abCDRH: Non-In Vitro Diagnostic Device &#8211; 510 (k)\u00bb<\/em>;<\/li>\n<li>El dispositivo no debe ser un producto combinado (es decir, dispositivo-medicamento o dispositivo-producto biol\u00f3gico);<\/li>\n<li>El CDRH (Center for Devices and Radiological Health) debe ser el Centro de referencia para las solicitudes.<\/li>\n<\/ul>\n<p>Solo los tipos de dispositivos m\u00e9dicos conocidos por la FDA se han incluido en la lista oficial de c\u00f3digos de productos primarios elegibles para el programa \u00abQuik\u00bb.<\/p>\n<p>El programa piloto \u00abQuik\u00bb implica:<\/p>\n<ul>\n<li><strong>Preparaci\u00f3n de la 510(k)<\/strong>: la carta de presentaci\u00f3n impresa que acompa\u00f1a la solicitud (en soporte electr\u00f3nico) debe contener una declaraci\u00f3n obligatoria que solicite la inclusi\u00f3n de la solicitud en el Programa \u00abQuik\u00bb;<\/li>\n<li><strong>Procedimiento de env\u00edo<\/strong>: la solicitud debe construirse utilizando un modelo espec\u00edfico de software eSubmitter. El contenido de la solicitud no cambia;<\/li>\n<li><strong>Proceso de revisi\u00f3n<\/strong>: para solicitudes elegibles para el Programa \u00abQuik\u00bb, tanto Traditional como Abbreviated 510 (k), solo se proporciona la revisi\u00f3n interactiva (interactive review). La FDA requiere que los solicitantes respondan r\u00e1pidamente a cualquier solicitud de informaci\u00f3n adicional (dentro de 5 a 7 d\u00edas). Si, en cualquier momento durante la revisi\u00f3n, el env\u00edo ya no es adecuado para \u00abQuik\u00bb, se convertir\u00e1 en una 510 (k) normal que durar\u00e1 90 d\u00edas y estar\u00e1 sujeta a los requisitos de eCopy.<\/li>\n<\/ul>\n<p>El programa piloto \u00abQuik\u00bb estar\u00e1 activo durante un periodo de entre 3 y 6 meses, para permitir que la Agencia recopile datos suficientes para evaluar tanto la eficiencia del Programa como la capacidad del software eSubmitter para estructurar las solicitudes 510 (k) y facilitar el proceso de revisi\u00f3n.<\/p>\n<p>Para m\u00e1s informaci\u00f3n:<\/p>\n<p><a href=\"https:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/HowtoMarketYourDevice\/PremarketSubmissions\/PremarketNotification510k\/ucm618561.htm#quik\" target=\"_blank\" rel=\"noopener\">www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/HowtoMarketYourDevice\/PremarketSubmissions\/PremarketNotification510k\/ucm618561.htm#quik<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Con la intenci\u00f3n de facilitar la comercializaci\u00f3n de dispositivos m\u00e9dicos seguros, efectivos y de alta calidad, en septiembre de 2018, la  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"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":[1,3],"tags":[],"class_list":["post-8124","post","type-post","status-publish","format-standard","hentry","category-news","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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