{"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>La FDA am\u00e9ricaine a \u00e9tabli des lignes directrices pour la mise sur le march\u00e9 de trois cat\u00e9gories de dispositifs m\u00e9dicaux, dont l&#039;innocuit\u00e9 et l&#039;efficacit\u00e9 sont d\u00e9montr\u00e9es par des crit\u00e8res de performance. Ces trois cat\u00e9gories sont les syst\u00e8mes de plaques spinales, les vis et rondelles m\u00e9talliques orthop\u00e9diques non spinales, et les bobines de r\u00e9ception pour l&#039;imagerie par r\u00e9sonance magn\u00e9tique. &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 v28.5 (Yoast SEO v28.6) - 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\/fr\/directives-de-la-fda-sur-les-dispositifs-medicaux\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\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\/fr\/directives-de-la-fda-sur-les-dispositifs-medicaux\/\" \/>\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 minute\" \/>\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\":\"fr-FR\"},{\"@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. Ensure compliance with RegASK's guidance.\",\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/us-fda-medical-device-guidelines\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/regask.com\\\/us-fda-medical-device-guidelines\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/04\\\/medical-device-diabetes-blood-test.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/04\\\/medical-device-diabetes-blood-test.png\",\"width\":689,\"height\":626,\"caption\":\"Medical Devices Diabetes Blood Test\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/regask.com\\\/#website\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"name\":\"RegASK\",\"description\":\"The Regulatory AI Operating System for High-Performing Teams\",\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/regask.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"fr-FR\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\",\"name\":\"RegASK\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"width\":401,\"height\":401,\"caption\":\"RegASK\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/RegASKRegulatoryAffairs\\\/\",\"https:\\\/\\\/x.com\\\/ASKRegASK\",\"https:\\\/\\\/www.linkedin.com\\\/company\\\/RegASK\\\/\",\"https:\\\/\\\/www.youtube.com\\\/@RegASK\",\"https:\\\/\\\/www.crunchbase.com\\\/organization\\\/regask\",\"https:\\\/\\\/www.bloomberg.com\\\/profile\\\/company\\\/1691237D:SP\",\"https:\\\/\\\/pitchbook.com\\\/profiles\\\/company\\\/265004-02\",\"https:\\\/\\\/www.cbinsights.com\\\/company\\\/RegASK\",\"https:\\\/\\\/vimeo.com\\\/RegASK\"],\"legalName\":\"RegASK PTE. LTD.\",\"foundingDate\":\"2018\",\"slogan\":\"Empowering Smarter Regulatory Decisions\",\"description\":\"Agentic AI regulatory intelligence and workflow orchestration platform for Life Sciences and Consumer Products. RegASK combines vertical LLMs, multi-agent AI architecture, and a global community of 1,800+ subject matter experts to deliver regulatory horizon scanning, impact analysis, compliance workflow automation, and audit-ready outputs across 160+ countries.\",\"areaServed\":\"Worldwide\",\"founder\":{\"@type\":\"Person\",\"name\":\"Caroline Shleifer\",\"jobTitle\":\"Founder & CEO\"},\"address\":{\"@type\":\"PostalAddress\",\"streetAddress\":\"79 Science Park Drive, #06-01, Cintech IV\",\"addressLocality\":\"Singapore\",\"postalCode\":\"118264\",\"addressCountry\":\"SG\"},\"contactPoint\":{\"@type\":\"ContactPoint\",\"telephone\":\"+65 6817 6290\",\"contactType\":\"customer service\",\"availableLanguage\":[\"English\",\"French\",\"Japanese\",\"Spanish\",\"Chinese\",\"German\"]},\"numberOfEmployees\":{\"@type\":\"QuantitativeValue\",\"minValue\":50,\"maxValue\":100},\"knowsAbout\":[\"Regulatory Intelligence\",\"Regulatory Compliance\",\"Regulatory Affairs\",\"Workflow Orchestration\",\"Life Sciences Regulation\",\"Consumer Products Regulation\",\"AI-Driven Compliance\"],\"hasCertification\":[{\"@type\":\"Certification\",\"name\":\"ISO\\\/IEC 42001:2023\"},{\"@type\":\"Certification\",\"name\":\"ISO\\\/IEC 27001:2022\"},{\"@type\":\"Certification\",\"name\":\"ISO\\\/IEC 27701\"},{\"@type\":\"Certification\",\"name\":\"ISO\\\/IEC 27018:2019\"},{\"@type\":\"Certification\",\"name\":\"SOC 2 Type II\"}]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\",\"name\":\"Benoit Trouwaert\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"FDA am\u00e9ricaine : directives sur les dispositifs m\u00e9dicaux | RegASK","description":"La FDA fournit des directives sur les exigences pour 3 cat\u00e9gories de dispositifs m\u00e9dicaux. Assurez-vous de respecter les directives du RegASK.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/regask.com\/fr\/directives-de-la-fda-sur-les-dispositifs-medicaux\/","og_locale":"fr_FR","og_type":"article","og_title":"US FDA provided requirement guidelines to allow three categories of medical device into market","og_description":"The FDA provides requirement guidelines for 3 categories of medical devices. Ensure compliance with RegASK's guidance.","og_url":"https:\/\/regask.com\/fr\/directives-de-la-fda-sur-les-dispositifs-medicaux\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2021-01-06T06:20:21+00:00","article_modified_time":"2024-10-23T17:44:27+00:00","og_image":[{"width":689,"height":626,"url":"https:\/\/regask.com\/wp-content\/uploads\/2021\/04\/medical-device-diabetes-blood-test.png","type":"image\/png"}],"author":"Benoit Trouwaert","twitter_card":"summary_large_image","twitter_creator":"@ASKRegASK","twitter_site":"@ASKRegASK","twitter_misc":{"Written by":"Benoit Trouwaert","Est. reading time":"1 minute"},"schema":{"@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":"fr-FR"},{"@type":"WebPage","@id":"https:\/\/regask.com\/us-fda-medical-device-guidelines\/","url":"https:\/\/regask.com\/us-fda-medical-device-guidelines\/","name":"FDA am\u00e9ricaine : directives sur les dispositifs m\u00e9dicaux | 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":"La FDA fournit des directives sur les exigences pour 3 cat\u00e9gories de dispositifs m\u00e9dicaux. Assurez-vous de respecter les directives du RegASK.","inLanguage":"fr-FR","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/us-fda-medical-device-guidelines\/"]}]},{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/regask.com\/us-fda-medical-device-guidelines\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2021\/04\/medical-device-diabetes-blood-test.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2021\/04\/medical-device-diabetes-blood-test.png","width":689,"height":626,"caption":"Medical Devices Diabetes Blood Test"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"Le syst\u00e8me d&#039;exploitation d&#039;IA r\u00e9glementaire pour les \u00e9quipes performantes","publisher":{"@id":"https:\/\/regask.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/regask.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"fr-FR"},{"@type":"Organization","@id":"https:\/\/regask.com\/#organization","name":"RegASK","url":"https:\/\/regask.com\/","logo":{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/","url":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","width":401,"height":401,"caption":"RegASK"},"image":{"@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","https:\/\/x.com\/ASKRegASK","https:\/\/www.linkedin.com\/company\/RegASK\/","https:\/\/www.youtube.com\/@RegASK","https:\/\/www.crunchbase.com\/organization\/regask","https:\/\/www.bloomberg.com\/profile\/company\/1691237D:SP","https:\/\/pitchbook.com\/profiles\/company\/265004-02","https:\/\/www.cbinsights.com\/company\/RegASK","https:\/\/vimeo.com\/RegASK"],"legalName":"RegASK PTE. LTD.","foundingDate":"2018","slogan":"Empowering Smarter Regulatory Decisions","description":"Plateforme d&#039;intelligence artificielle multi-agents pour la veille r\u00e9glementaire et l&#039;orchestration des flux de travail dans le secteur des sciences de la vie et des produits de consommation. RegASK combine des LLM verticaux, une architecture d&#039;IA multi-agents et une communaut\u00e9 mondiale de plus de 1\u00a0800 experts pour fournir une veille r\u00e9glementaire, une analyse d&#039;impact, l&#039;automatisation des processus de conformit\u00e9 et des r\u00e9sultats pr\u00eats pour l&#039;audit dans plus de 160 pays.","areaServed":"Worldwide","founder":{"@type":"Person","name":"Caroline Shleifer","jobTitle":"Founder & CEO"},"address":{"@type":"PostalAddress","streetAddress":"79 Science Park Drive, #06-01, Cintech IV","addressLocality":"Singapore","postalCode":"118264","addressCountry":"SG"},"contactPoint":{"@type":"ContactPoint","telephone":"+65 6817 6290","contactType":"customer service","availableLanguage":["English","French","Japanese","Spanish","Chinese","German"]},"numberOfEmployees":{"@type":"QuantitativeValue","minValue":50,"maxValue":100},"knowsAbout":["Regulatory Intelligence","Regulatory Compliance","Regulatory Affairs","Workflow Orchestration","Life Sciences Regulation","Consumer Products Regulation","AI-Driven Compliance"],"hasCertification":[{"@type":"Certification","name":"ISO\/IEC 42001:2023"},{"@type":"Certification","name":"ISO\/IEC 27001:2022"},{"@type":"Certification","name":"ISO\/IEC 27701"},{"@type":"Certification","name":"ISO\/IEC 27018:2019"},{"@type":"Certification","name":"SOC 2 Type II"}]},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/c1d261e8dcf7b1c30b2c4f2c119df42d","name":"Beno\u00eet Trouwaert"}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/posts\/2587","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/users\/39"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/comments?post=2587"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/posts\/2587\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/media\/2486"}],"wp:attachment":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/media?parent=2587"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/categories?post=2587"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/tags?post=2587"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}