{"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":"fda-leitfaden-fur-orthopadische-gerate","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/fda-orthopedic-device-guidance\/","title":{"rendered":"Die US-amerikanische FDA hat einen Leitlinienentwurf zu Zulassungsantr\u00e4gen vor der Markteinf\u00fchrung vorgelegt \u2026"},"content":{"rendered":"<div>\n<div>\n<div><a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">Die US-amerikanische Food and Drug Administration (FDA)<\/a> hat den Entwurf eines Leitfadens vorgeschlagen, der Antragstellern und Einreichern von 510(k)-Antr\u00e4gen f\u00fcr nicht resorbierbare Knochenplatten, Schrauben und Unterlegscheiben Empfehlungen zu den aufzunehmenden Informationen gibt.<\/div>\n<div><\/div>\n<div>Der Geltungsbereich umfasst Ger\u00e4te, die f\u00fcr die orthop\u00e4dische Knochenfixierung vorgesehen sind, nicht jedoch Ger\u00e4te, die f\u00fcr die Fixierung von Wirbels\u00e4ulen-, Unterkiefer-, Kiefer- und Gesichtsfrakturen, Sch\u00e4del- und Augenh\u00f6hlenfrakturen vorgesehen sind.<\/div>\n<div><\/div>\n<div>Elektronische oder schriftliche Kommentare zum Leitlinienentwurf sollten bis zum 30. Mai 2023 eingereicht werden, um sicherzustellen, dass die Agentur die Kommentare ber\u00fccksichtigt, bevor sie mit der Arbeit an der endg\u00fcltigen Fassung beginnt.<\/div>\n<div><\/div>\n<\/div>\n<\/div>\n<div>M\u00f6chten Sie mehr \u00fcber \u00c4nderungen der Vorschriften f\u00fcr Medizinprodukte erfahren? <a href=\"https:\/\/regask.com\/de\/kontakt\/\" target=\"_blank\" rel=\"noopener\">Nehmen Sie Kontakt mit den Experten von RegASK auf.<\/a><\/div>\n<div><\/div>\n<a href=\"https:\/\/regask.com\/de\/kontakt\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Kontaktieren Sie RegASK f\u00fcr weitere Details<\/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>Mehr lesen<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-1522314086\">\n\n\t<div id=\"col-1696114629\" 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\/de\/fallstudien\/ressourcen-fallstudien-medizinprodukte\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lesen Sie Fallstudien aus der Medizinger\u00e4tebranche<\/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>Die US-amerikanische Food and Drug Administration (FDA) hat einen Leitfadenentwurf vorgelegt, der Antragstellern und Einreichern von 510(k)-Antr\u00e4gen f\u00fcr nicht resorbierbare Knochenplatten, Schrauben und Unterlegscheiben Empfehlungen zu den einzuschlie\u00dfenden Informationen gibt. Der Geltungsbereich umfasst Produkte zur orthop\u00e4dischen Knochenfixierung, nicht jedoch Produkte zur Wirbels\u00e4ulen-, Unterkiefer-,\u2026<\/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 v28.0 (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. 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