{"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":"directives-de-la-fda-sur-les-dispositifs-medicaux","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/us-fda-medical-device-guidelines\/","title":{"rendered":"La FDA am\u00e9ricaine a fourni des directives pour autoriser trois c\u2026"},"content":{"rendered":"<p>La FDA am\u00e9ricaine a fourni des lignes directrices pour autoriser la mise sur le march\u00e9 de trois cat\u00e9gories de dispositifs m\u00e9dicaux qui s&#039;appuient sur des crit\u00e8res de performance pour d\u00e9montrer leur s\u00e9curit\u00e9 et leur efficacit\u00e9.<\/p>\n<p>Ces 3 cat\u00e9gories de dispositifs m\u00e9dicaux sont les syst\u00e8mes de plaques vert\u00e9brales, les vis et rondelles osseuses m\u00e9talliques orthop\u00e9diques non vert\u00e9brales et les bobines de r\u00e9ception de r\u00e9sonance magn\u00e9tique uniquement.<\/p>\n<p>&nbsp;<\/p>\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\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>En savoir plus<\/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. 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