{"id":4342,"date":"2023-08-02T10:00:59","date_gmt":"2023-08-02T02:00:59","guid":{"rendered":"https:\/\/regask.com\/?p=4342"},"modified":"2024-10-04T03:26:07","modified_gmt":"2024-10-03T19:26:07","slug":"guia-de-herramientas-para-dispositivos-medicos-de-la-fda","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/fda-medical-device-tools-guidance\/","title":{"rendered":"La FDA de EE. UU. publica una gu\u00eda revisada sobre la calificaci\u00f3n de medicamentos"},"content":{"rendered":"<div>\n<div>Esta gu\u00eda final reemplaza la Calificaci\u00f3n de herramientas de desarrollo de dispositivos m\u00e9dicos: Gu\u00eda para la industria, los desarrolladores de herramientas y el personal de la Administraci\u00f3n de Alimentos y Medicamentos publicada el 10 de agosto de 2017. Describe un programa voluntario para la calificaci\u00f3n de herramientas de desarrollo de dispositivos m\u00e9dicos (MDDT) para su uso en la evaluaci\u00f3n de dispositivos regulados por el CDRH.<\/div>\n<div><\/div>\n<div>Adem\u00e1s de la definici\u00f3n de conceptos clave y una descripci\u00f3n general del programa de calificaci\u00f3n MDDT, la gu\u00eda proporciona informaci\u00f3n sobre el marco de decisi\u00f3n de calificaci\u00f3n CDRH y la comunicaci\u00f3n p\u00fablica de la decisi\u00f3n de calificaci\u00f3n.<\/div>\n<div><\/div>\n<div><span style=\"color: #555555;\">\u00bfNecesita saber m\u00e1s sobre los cambios en la regulaci\u00f3n de dispositivos m\u00e9dicos? <\/span><a href=\"https:\/\/regask.com\/es\/contacto\/\" target=\"_blank\" rel=\"noopener\">Ponte en contacto con los expertos de RegASK.<\/a><\/div>\n<\/div>\n<a href=\"https:\/\/regask.com\/es\/contacto\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contacte con RegASK para m\u00e1s detalles<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/regask.com\/es\/categoria\/ultimos-conocimientos\/medical-devices-latest-insights\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Leer m\u00e1s<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-717289361\">\n\n\t<div id=\"col-1700597034\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/es\/estudios-de-caso\/recursos-casos-de-estudio-dispositivos-medicos\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lea estudios de casos de la industria de dispositivos m\u00e9dicos<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Esta gu\u00eda final reemplaza la Gu\u00eda para la calificaci\u00f3n de herramientas de desarrollo de dispositivos m\u00e9dicos para la industria, los desarrolladores de herramientas y el personal de la Administraci\u00f3n de Alimentos y Medicamentos, publicada el 10 de agosto de 2017. Describe un programa voluntario para la calificaci\u00f3n de herramientas de desarrollo de dispositivos m\u00e9dicos (MDDT, por sus siglas en ingl\u00e9s) para su uso en la evaluaci\u00f3n de dispositivos regulados por el CDRH. Adem\u00e1s de la definici\u00f3n de\u2026<\/p>","protected":false},"author":39,"featured_media":2976,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[40],"class_list":["post-4342","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-devices-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.4 (Yoast SEO v28.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Updates Medical Device Tools Guidance | RegASK<\/title>\n<meta name=\"description\" content=\"The US FDA issues revised guidance on the qualification of medical device development tools. 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Stay informed with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/guia-de-herramientas-para-dispositivos-medicos-de-la-fda\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2023-08-02T02:00:59+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-03T19:26:07+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2021\/09\/Therapeutic-goods-medical-devices.png\" \/>\n\t<meta property=\"og:image:width\" content=\"689\" \/>\n\t<meta property=\"og:image:height\" content=\"626\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minuto\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-medical-device-tools-guidance\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-medical-device-tools-guidance\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"US FDA Issues Revised Guidance on Qualification of Medi&hellip;\",\"datePublished\":\"2023-08-02T02:00:59+00:00\",\"dateModified\":\"2024-10-03T19:26:07+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-medical-device-tools-guidance\\\/\"},\"wordCount\":173,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-medical-device-tools-guidance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/09\\\/Therapeutic-goods-medical-devices.png\",\"keywords\":[\"Latest Insights\"],\"articleSection\":[\"Medical Devices\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-medical-device-tools-guidance\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/fda-medical-device-tools-guidance\\\/\",\"name\":\"FDA Updates Medical Device Tools Guidance | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-medical-device-tools-guidance\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-medical-device-tools-guidance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/09\\\/Therapeutic-goods-medical-devices.png\",\"datePublished\":\"2023-08-02T02:00:59+00:00\",\"dateModified\":\"2024-10-03T19:26:07+00:00\",\"description\":\"The US FDA issues revised guidance on the qualification of medical device development tools. 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