{"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":"guide-de-la-fda-sur-les-dispositifs-orthopediques","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/fda-orthopedic-device-guidance\/","title":{"rendered":"Projet de directive propos\u00e9 par la FDA am\u00e9ricaine sur les soumissions pr\u00e9alables \u00e0 la mise sur le march\u00e9\u2026"},"content":{"rendered":"<div>\n<div>\n<div><a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">La Food and Drug Administration (FDA) des \u00c9tats-Unis<\/a> a propos\u00e9 un projet de document d&#039;orientation qui fournit des recommandations aux demandeurs et aux soumissionnaires de soumissions 510(k) pour les plaques osseuses non r\u00e9sorbables, les vis et les dispositifs de rondelle sur les informations \u00e0 inclure.<\/div>\n<div><\/div>\n<div>La port\u00e9e couvre les dispositifs indiqu\u00e9s pour la fixation osseuse orthop\u00e9dique, mais n&#039;inclut pas les dispositifs indiqu\u00e9s pour la fixation des fractures vert\u00e9brales, mandibulaires, maxillo-faciales, cr\u00e2niennes et orbitaires.<\/div>\n<div><\/div>\n<div>Les commentaires \u00e9lectroniques ou \u00e9crits sur le projet d\u2019orientation doivent \u00eatre soumis avant le 30 mai 2023, afin de garantir que l\u2019Agence prenne en compte les commentaires avant de commencer \u00e0 travailler sur la version finale.<\/div>\n<div><\/div>\n<\/div>\n<\/div>\n<div>Besoin d\u2019en savoir plus sur les changements r\u00e9glementaires relatifs aux dispositifs m\u00e9dicaux ? <a href=\"https:\/\/regask.com\/fr\/contact-2\/\" target=\"_blank\" rel=\"noopener\">Contactez les experts de RegASK.<\/a><\/div>\n<div><\/div>\n<a href=\"https:\/\/regask.com\/fr\/contact-2\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contactez RegASK pour plus de d\u00e9tails<\/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>En savoir plus<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-215132704\">\n\n\t<div id=\"col-1806101187\" 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\/fr\/etudes-de-cas\/ressources-etudes-de-cas-dispositifs-medicaux\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lire les \u00e9tudes de cas sur le secteur des dispositifs m\u00e9dicaux<\/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>The U.S. Food and Drug Administration (FDA) proposed a draft guidance document that provides recommendations to applicants, and submitters of 510(k) submissions for non-resorbable bone plates, screws, and washer devices on the information to include. The scope covers devices that are indicated for orthopaedic bone fixation but do not include devices indicated for spinal, mandibular,&#8230;<\/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 v28.3 (Yoast SEO v28.3) - 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\/fr\/guide-de-la-fda-sur-les-dispositifs-orthopediques\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\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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