{"id":2587,"date":"2021-01-06T14:20:21","date_gmt":"2021-01-06T06:20:21","guid":{"rendered":"https:\/\/regask.com\/?p=2587"},"modified":"2024-10-24T01:44:27","modified_gmt":"2024-10-23T17:44:27","slug":"richtlinien-der-us-amerikanischen-fda-fur-medizinprodukte","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/us-fda-medical-device-guidelines\/","title":{"rendered":"Die US-amerikanische FDA hat Richtlinien zur Zulassung von drei C\u2026 herausgegeben."},"content":{"rendered":"<p>Die US-amerikanische FDA hat Richtlinien f\u00fcr die Marktzulassung von drei Kategorien medizinischer Ger\u00e4te herausgegeben, deren Sicherheit und Wirksamkeit auf Leistungskriterien beruhen.<\/p>\n<p>Diese drei Kategorien medizinischer Ger\u00e4te sind Wirbels\u00e4ulenplattensysteme, orthop\u00e4dische nicht-spinale metallische Knochenschrauben und -scheiben sowie reine Magnetresonanz-Empfangsspulen.<\/p>\n<p>&nbsp;<\/p>\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\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Mehr lesen<\/span>\n\t<\/a>","protected":false},"excerpt":{"rendered":"<p>US FDA provided requirement guidelines to allow 3 categories of medical device into market that rely on performance criteria to demonstrate safety and effectiveness. These 3 medical device categories are spinal plating systems, orthopedic non-spinal metallic bone screws and washers, and magnetic resonance receive-only coils. &nbsp;<\/p>","protected":false},"author":39,"featured_media":2486,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[40],"class_list":["post-2587","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>US FDA: Medical Device Guidelines | RegASK<\/title>\n<meta name=\"description\" content=\"The FDA provides requirement guidelines for 3 categories of medical devices. 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