{"id":30195,"date":"2023-09-19T08:30:06","date_gmt":"2023-09-19T06:30:06","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=30195"},"modified":"2023-09-19T08:34:59","modified_gmt":"2023-09-19T06:34:59","slug":"ee-uu-presentacion-de-contenidos-para-los-software-ots","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2023\/09\/19\/ee-uu-presentacion-de-contenidos-para-los-software-ots\/","title":{"rendered":"EE.UU.: presentaci\u00f3n de contenidos para los software OTS"},"content":{"rendered":"<h2>El 11 de agosto de 2023, la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) actualiz\u00f3 la directriz Off-The-Shelf Software Use in Medical Devices utilizados en los productos sanitarios para identificar la informaci\u00f3n m\u00ednima que debe introducirse en la documentaci\u00f3n sujeta a revisi\u00f3n previa a la comercializaci\u00f3n por parte de la agencia.<\/h2>\n<p>De hecho, la directriz proporciona los elementos y contenidos necesarios que deben incluirse en la <strong>documentaci\u00f3n<\/strong> para presentar una solicitud previa a la comercializaci\u00f3n, como la Notificaci\u00f3n Previa a la Comercializaci\u00f3n (510(k)), la Aprobaci\u00f3n De Novo o la Aprobaci\u00f3n Previa a la Comercializaci\u00f3n (PMA), para un producto sanitario que integre y utilice software OTS para el que el fabricante del producto no pueda reclamar el control completo del ciclo de vida (por ejemplo, el sistema operativo y las librer\u00edas).<\/p>\n<p>La informaci\u00f3n que debe incluirse en la documentaci\u00f3n depende del riesgo del producto para el paciente, el usuario u otras personas en el entorno de uso. Para determinar el <strong>nivel m\u00ednimo de documentaci\u00f3n<\/strong>, la FDA adopta un enfoque <strong>basado en el<\/strong><strong> riesgo<\/strong>. En concreto, la \u00faltima actualizaci\u00f3n de las directrices no se basa en <strong>\u00e1rboles de decisi\u00f3n<\/strong>, sino que permite al fabricante realizar una evaluaci\u00f3n de riesgos y proporcionar una evaluaci\u00f3n en la que se describan las caracter\u00edsticas, funciones y riesgos potenciales del programa inform\u00e1tico OTS. Para facilitar el proceso, la FDA ha incluido en la directriz preguntas y cuadros resumen que ofrecen un esquema general de apoyo.<\/p>\n<p>Desde un punto de vista pr\u00e1ctico, se debe incluir un<strong> plan de gesti\u00f3n de riesgos<\/strong> y un <strong>archivo de gesti\u00f3n de riesgos<\/strong> en la documentaci\u00f3n de presentaci\u00f3n previa a la comercializaci\u00f3n, ya sea para 510K, De Novo o PMA. Los solicitantes aclaran espec\u00edficamente en el plan de gesti\u00f3n de riesgos c\u00f3mo pretenden evaluar el riesgo residual global e incluyen en el archivo de gesti\u00f3n de riesgos una <strong>evaluaci\u00f3n de<\/strong> <strong>riesgos<\/strong> que demuestre la reducci\u00f3n del riesgo.<\/p>\n<p>La documentaci\u00f3n tambi\u00e9n debe incluir el <strong>plan de<\/strong> <strong>pruebas <\/strong>y sus resultados. Las actividades de prueba incluyen no s\u00f3lo las realizadas por el desarrollador del software OTS, sino tambi\u00e9n las realizadas durante la validaci\u00f3n del software OTS para su uso en el dispositivo espec\u00edfico.<\/p>\n<p>Por \u00faltimo, la directriz define los requisitos necesarios para garantizar el funcionamiento seguro y eficaz del software OTS durante todo el ciclo de vida del producto sanitario, identificando algunos aspectos esenciales como la seguridad general, la eficacia, el dise\u00f1o, las pruebas del software, la verificaci\u00f3n\/validaci\u00f3n, las modificaciones y la instalaci\u00f3n.<\/p>\n<p>&gt;&gt;&gt; A trav\u00e9s de los servicios de\u00a0<a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/consulenza-strategico-regolatoria-dispositivi-medici-medical-devices\/\"><strong>consultor\u00eda estrat\u00e9gica-normativa<\/strong><\/a> y redacci\u00f3n 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\/\"><strong>notificaciones previas a la comercializaci\u00f3n 510(k), De Novo y aprobaci\u00f3n previa a la comercializaci\u00f3n (PMA)<\/strong><\/a> tambi\u00e9n con software, Thema puede ayudar a comercializar productos sanitarios en los EE.UU. de conformidad con los requisitos de la Administraci\u00f3n de Alimentos y Medicamentos (FDA).<\/p>\n<p><strong>Fuente<\/strong>:<\/p>\n<p><em><a href=\"https:\/\/www.fda.gov\/media\/71794\/download\">Off-The-Shelf Software Use in Medical Devices<\/a><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>El 11 de agosto de 2023, la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) actualiz\u00f3 la directriz Off-The-Shelf  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":30175,"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-30195","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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