{"id":7910,"date":"2024-12-18T19:08:58","date_gmt":"2024-12-18T11:08:58","guid":{"rendered":"https:\/\/regask.com\/?p=7910"},"modified":"2024-12-18T19:08:58","modified_gmt":"2024-12-18T11:08:58","slug":"guia-de-dispositivos-de-inteligencia-artificial-de-la-fda-pccp","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/fda-ai-device-guidance-pccp\/","title":{"rendered":"La FDA (EE. UU.) publica una gu\u00eda final sobre el cambio predeterminado\u2026"},"content":{"rendered":"<p>El 4 de diciembre de 2024, la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) emiti\u00f3 su gu\u00eda final, <strong>\u201cRecomendaciones de presentaci\u00f3n de marketing para un plan de control de cambios predeterminado para funciones de software de dispositivos habilitados para inteligencia artificial\u201d.<\/strong> Esta actualizaci\u00f3n representa un avance clave en el <a href=\"https:\/\/regask.com\/es\/guia-de-la-fda-sobre-dispositivos-medicos-contra-el-covid-19\/\">Marco regulatorio de la FDA<\/a>, dise\u00f1ado para respaldar la innovaci\u00f3n continua en dispositivos m\u00e9dicos habilitados con IA, manteniendo al mismo tiempo su seguridad y eficacia.<\/p>\n<p>La gu\u00eda introduce el concepto de <strong>Plan de control de cambios predeterminado (PCCP)<\/strong>, que detalla las modificaciones planificadas para los dispositivos habilitados con IA. El PCCP incluye metodolog\u00edas para el desarrollo, la validaci\u00f3n y la implementaci\u00f3n de estos cambios, as\u00ed como evaluaciones de su impacto en la seguridad y la eficacia del dispositivo.<\/p>\n<p><strong>Puntos destacados:<\/strong><\/p>\n<ul>\n<li><strong>\u00c1mbito de aplicaci\u00f3n:<\/strong><br \/>\nLa gu\u00eda se aplica a dispositivos habilitados para IA en varias categor\u00edas de productos, incluidos aquellos revisados bajo las v\u00edas de notificaci\u00f3n previa a la comercializaci\u00f3n 510(k), solicitud de clasificaci\u00f3n De Novo y aprobaci\u00f3n previa a la comercializaci\u00f3n (PMA). Tambi\u00e9n abarca componentes de dispositivos de productos combinados dirigidos por dispositivos.<\/li>\n<li><strong>Proceso de revisi\u00f3n:<\/strong><br \/>\nLa FDA evaluar\u00e1 el PCCP como parte de la presentaci\u00f3n de la solicitud de comercializaci\u00f3n del dispositivo, asegur\u00e1ndose de que las modificaciones planificadas cumplan con los est\u00e1ndares de seguridad y eficacia. Esto elimina la necesidad de nuevas solicitudes de comercializaci\u00f3n para cada modificaci\u00f3n incluida en el PCCP.<\/li>\n<li><strong>Comentarios p\u00fablicos y actualizaciones:<\/strong><br \/>\nLas revisiones de la gu\u00eda reflejan los comentarios del p\u00fablico, incluidas las aclaraciones sobre el alcance, los requisitos de etiquetado, los procesos de implementaci\u00f3n bajo un PCCP autorizado y las recomendaciones de vigilancia posterior a la comercializaci\u00f3n. Se actualizaron las definiciones de &quot;inteligencia artificial&quot; y &quot;aprendizaje autom\u00e1tico&quot; para alinearse con <strong>Orden ejecutiva 14110<\/strong> emitida el 30 de octubre de 2023.<\/li>\n<\/ul>\n<p>Esta gu\u00eda marca un hito en las pr\u00e1cticas regulatorias para dispositivos habilitados para IA, equilibrando la innovaci\u00f3n con las prioridades de salud p\u00fablica.<\/p>\n<p>Para obtener m\u00e1s informaci\u00f3n o discutir estrategias de cumplimiento, comun\u00edquese con nosotros.<\/p>","protected":false},"excerpt":{"rendered":"<p>El 4 de diciembre de 2024, la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) public\u00f3 su gu\u00eda final, \u201cRecomendaciones para la presentaci\u00f3n de solicitudes de comercializaci\u00f3n de un plan de control de cambios predeterminado para las funciones de software de dispositivos con inteligencia artificial\u201d. Esta actualizaci\u00f3n representa un avance clave en el marco regulatorio de la FDA, dise\u00f1ado para respaldar la innovaci\u00f3n continua en dispositivos m\u00e9dicos con IA, manteniendo al mismo tiempo su seguridad y...<\/p>","protected":false},"author":43,"featured_media":7925,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,39],"tags":[165,593,609,610,611],"class_list":["post-7910","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-medical-devices-insights","tag-public-health","tag-innovative-medical-devices","tag-guideline","tag-software-as-a-medical-device-samd","tag-ai-enabled-devices"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.8 (Yoast SEO v28.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Finalizes Guidance on AI-Enabled Device Updates | RegASK<\/title>\n<meta name=\"description\" content=\"FDA issues final guidance on Predetermined Change Control Plans for AI-enabled devices. 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