{"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 v27.3 (Yoast SEO v27.5) - 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. Ensure compliance with RegASK&#039;s guidance.\" \/>\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\/de\/richtlinien-der-us-amerikanischen-fda-fur-medizinprodukte\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"US FDA provided requirement guidelines to allow three categories of medical device into market\" \/>\n<meta property=\"og:description\" content=\"The FDA provides requirement guidelines for 3 categories of medical devices. Ensure compliance with RegASK&#039;s guidance.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/de\/richtlinien-der-us-amerikanischen-fda-fur-medizinprodukte\/\" \/>\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=\"2021-01-06T06:20:21+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-23T17:44:27+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2021\/04\/medical-device-diabetes-blood-test.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\u00a0Minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/us-fda-medical-device-guidelines\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/us-fda-medical-device-guidelines\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"US FDA provided requirement guidelines to allow three c&hellip;\",\"datePublished\":\"2021-01-06T06:20:21+00:00\",\"dateModified\":\"2024-10-23T17:44:27+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/us-fda-medical-device-guidelines\\\/\"},\"wordCount\":90,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/us-fda-medical-device-guidelines\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/04\\\/medical-device-diabetes-blood-test.png\",\"keywords\":[\"Latest Insights\"],\"articleSection\":[\"Medical Devices\"],\"inLanguage\":\"de\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/us-fda-medical-device-guidelines\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/us-fda-medical-device-guidelines\\\/\",\"name\":\"US FDA: Medical Device Guidelines | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/us-fda-medical-device-guidelines\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/us-fda-medical-device-guidelines\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/04\\\/medical-device-diabetes-blood-test.png\",\"datePublished\":\"2021-01-06T06:20:21+00:00\",\"dateModified\":\"2024-10-23T17:44:27+00:00\",\"description\":\"The FDA provides requirement guidelines for 3 categories of medical devices. 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