{"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>On December 4, 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance, &#8220;Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions.&#8221; This update represents a key advancement in the FDA&#8217;s regulatory framework, designed to support continuous innovation in AI-enabled medical devices while maintaining their safety and&#8230;<\/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 v28.0 (Yoast SEO v28.1) - 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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