{"id":4215,"date":"2023-04-24T07:30:21","date_gmt":"2023-04-23T23:30:21","guid":{"rendered":"https:\/\/regask.com\/?p=4215"},"modified":"2024-11-22T04:50:53","modified_gmt":"2024-11-21T20:50:53","slug":"guia-de-la-fda-sobre-dispositivos-ortopedicos","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/fda-orthopedic-device-guidance\/","title":{"rendered":"Propuesta preliminar de la FDA de EE. UU. de orientaci\u00f3n sobre presentaciones previas a la comercializaci\u00f3n\u2026"},"content":{"rendered":"<div>\n<div>\n<div><a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">La Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA)<\/a> propuso un borrador de documento de orientaci\u00f3n que proporciona recomendaciones a los solicitantes y a quienes presentan solicitudes 510(k) para placas \u00f3seas no reabsorbibles, tornillos y dispositivos de arandela sobre la informaci\u00f3n que se debe incluir.<\/div>\n<div><\/div>\n<div>El alcance cubre los dispositivos que est\u00e1n indicados para la fijaci\u00f3n \u00f3sea ortop\u00e9dica, pero no incluye los dispositivos indicados para la fijaci\u00f3n de fracturas espinales, mandibulares, maxilofaciales, craneales y orbitarias.<\/div>\n<div><\/div>\n<div>Los comentarios electr\u00f3nicos o escritos sobre el proyecto de orientaci\u00f3n deben enviarse antes del 30 de mayo de 2023, para garantizar que la Agencia los considere antes de comenzar a trabajar en la versi\u00f3n final.<\/div>\n<div><\/div>\n<\/div>\n<\/div>\n<div>\u00bfNecesita saber m\u00e1s sobre los cambios en la regulaci\u00f3n de dispositivos m\u00e9dicos? <a href=\"https:\/\/regask.com\/es\/contacto\/\" target=\"_blank\" rel=\"noopener\">Ponte en contacto con los expertos de RegASK.<\/a><\/div>\n<div><\/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:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/orthopedic-non-spinal-bone-plates-screws-and-washers-premarket-notification-510k-submissions\" 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-1641320628\">\n\n\t<div id=\"col-1614669754\" 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>La Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) propuso un borrador de gu\u00eda que ofrece recomendaciones a los solicitantes y a quienes presentan solicitudes 510(k) para placas, tornillos y arandelas \u00f3seas no reabsorbibles sobre la informaci\u00f3n que debe incluirse. El alcance abarca los dispositivos indicados para la fijaci\u00f3n \u00f3sea ortop\u00e9dica, pero no incluye los dispositivos indicados para la columna vertebral, la mand\u00edbula, etc.<\/p>","protected":false},"author":39,"featured_media":3080,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[40],"class_list":["post-4215","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 v27.2 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Draft Guidance on Orthopedic Device Submissions | RegASK<\/title>\n<meta name=\"description\" content=\"The FDA proposes new draft guidance for premarket submissions of orthopedic non-spinal bone plates, screws, and washers. Learn more.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/es\/guia-de-la-fda-sobre-dispositivos-ortopedicos\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"US FDA Proposed Draft Guidance on Premarket Submissions for Orthopedic Non-Spinal Bone Plates, Screws, and Washers\" \/>\n<meta property=\"og:description\" content=\"The FDA proposes new draft guidance for premarket submissions of orthopedic non-spinal bone plates, screws, and washers. 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