{"id":3038,"date":"2026-08-06T22:01:46","date_gmt":"2026-08-07T05:01:46","guid":{"rendered":"https:\/\/jointechlabs.com\/?p=3038"},"modified":"2026-08-07T08:28:39","modified_gmt":"2026-08-07T15:28:39","slug":"fda-registered-cleared-and-approved-the-difference-and-importance-for-microfat-devices","status":"publish","type":"post","link":"https:\/\/jointechlabs.com\/fr\/fda-registered-cleared-and-approved-the-difference-and-importance-for-microfat-devices\/","title":{"rendered":"Enregistr\u00e9, valid\u00e9 et approuv\u00e9 par la FDA : la diff\u00e9rence et l'importance pour les dispositifs de micrograisse"},"content":{"rendered":"<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"661\" height=\"663\" src=\"https:\/\/jointechlabs.com\/wp-content\/uploads\/2026\/08\/FDATiers.png\" alt=\"Une image montrant trois sommets \u00e9tiquet\u00e9s FDA Registered, FDA Cleared et FDA Approved\" class=\"wp-image-3054\" srcset=\"https:\/\/jointechlabs.com\/wp-content\/uploads\/2026\/08\/FDATiers.png 661w, https:\/\/jointechlabs.com\/wp-content\/uploads\/2026\/08\/FDATiers-300x300.png 300w, https:\/\/jointechlabs.com\/wp-content\/uploads\/2026\/08\/FDATiers-150x150.png 150w, https:\/\/jointechlabs.com\/wp-content\/uploads\/2026\/08\/FDATiers-12x12.png 12w\" sizes=\"auto, (max-width: 661px) 100vw, 661px\" \/><\/figure>\n<\/div>\n\n\n<div style=\"height:39px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 id=\"h-an-easy-guide-to-a-complicated-but-important-area-for-both-practitioners-and-patients-to-understand\" class=\"wp-block-heading\">Un guide simple sur un domaine complexe mais important \u00e0 comprendre tant pour les praticiens que pour les patients<\/h2>\n\n\n\n<div style=\"height:36px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">\u201c Enregistr\u00e9\/List\u00e9 par la FDA \u201d, \u201c autoris\u00e9 par la FDA \u201d et \u201c approuv\u00e9 par la FDA \u201d sont trois termes tr\u00e8s diff\u00e9rents qui peuvent facilement \u00eatre mal compris. Cela peut semer la confusi\u00f3n non seulement chez les praticiens et les patients, mais m\u00eame chez les personnes travaillant dans l'industrie des dispositifs m\u00e9dicaux.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.fda.gov\" data-type=\"link\" data-id=\"https:\/\/www.fda.gov\">La FDA<\/a>\u2019Le r\u00f4le de la FDA sur le march\u00e9 des dispositifs m\u00e9dicaux est de prot\u00e9ger le public. Pour ce faire, elle veille \u00e0 ce que les dispositifs mis en vente soient \u00e0 la fois s\u00fbrs et efficaces. En m\u00eame temps, la FDA ne souhaite pas imposer aux fabricants des d\u00e9marches et des co\u00fbts susceptibles de limiter la concurrence ainsi que la disponibilit\u00e9 de nouveaux dispositifs et traitements innovants. Ce sont les raisons de ces trois \u00e9tiquettes diff\u00e9rentes. En outre, ces \u00e9tiquettes sont li\u00e9es au niveau de risque d'un dispositif donn\u00e9.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Les dispositifs m\u00e9dicaux sont class\u00e9s par la FDA dans l'une des trois cat\u00e9gories suivantes : <\/p>\n\n\n\n<h3 id=\"h-class-i-the-lowest-risk-fda-registration\" class=\"wp-block-heading\">Classe I \u2013 le risque le plus faible (enregistrement aupr\u00e8s de la FDA)<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u201cLes dispositifs de \u201d classe I \u00bb pr\u00e9sentent le risque le plus faible pour le patient, une d\u00e9faillance du produit \u00e9tant peu susceptible de causer des dommages graves. Des exemples de ces dispositifs peuvent \u00eatre des gants d'examen, des bandages, des abaisse-langue, etc. Ces dispositifs exigent g\u00e9n\u00e9ralement que le fabricant soit enregistr\u00e9 aupr\u00e8s de la FDA et que le dispositif soit r\u00e9pertori\u00e9. Souvent, le dispositif et le fabricant doivent se conformer \u00e0 diverses exigences de qualit\u00e9.<\/p>\n\n\n\n<h3 id=\"h-class-ii-moderate-risk\" class=\"wp-block-heading\">Classe II \u2013 Risque mod\u00e9r\u00e9<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">La plupart des dispositifs m\u00e9dicaux, y compris tous les syst\u00e8mes actuels de traitement de la micro-graisse, sont class\u00e9s comme dispositifs de \u201c classe II \u201d. Les dispositifs de classe II sont plus complexes et pr\u00e9sentent plus de risques que les dispositifs de classe I. La d\u00e9faillance d'un dispositif de classe II pourrait causer des blessures mais g\u00e9n\u00e9ralement pas de dommages mettant la vie en danger.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">La plupart des dispositifs m\u00e9dicaux, de l'\u00e9chographie diagnostique aux pompes \u00e0 perfusion en passant par les lasers chirurgicaux et les arthroscopes, sont des dispositifs de classe II.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Les dispositifs de classe II n\u00e9cessitent g\u00e9n\u00e9ralement une autorisation de la FDA, ce qui signifie que le fabricant du dispositif a d\u00e9montr\u00e9 que celui-ci est sensiblement \u00e9quivalent, du point de vue de la s\u00e9curit\u00e9 et de l'efficacit\u00e9, \u00e0 un autre dispositif commercialis\u00e9 l\u00e9galement. L'autre dispositif est appel\u00e9 le \u201c dispositif de r\u00e9f\u00e9rence \u201d et le processus par lequel le fabricant prouve l'\u00e9quivalence avec le dispositif de r\u00e9f\u00e9rence est appel\u00e9 la proc\u00e9dure ou l'autorisation 510(k). Le fabricant doit non seulement d\u00e9montrer l'\u00e9quivalence, mais il doit \u00e9galement respecter certains contr\u00f4les qui peuvent inclure la validation de la st\u00e9rilit\u00e9, des essais en laboratoire, des normes de performance et d'autres contr\u00f4les.<\/p>\n\n\n\n<h4 id=\"h-efficiency-and-competition-the-reasons-for-class-ii\" class=\"wp-block-heading\">Efficacit\u00e9 et concurrence \u2013 les raisons de la classe II<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Si chaque dispositif approuv\u00e9 par la FDA doit avoir un pr\u00e9dicat, comment le premier dispositif a-t-il \u00e9t\u00e9 approuv\u00e9 ? Dans certaines situations, l'autorisation de la FDA peut \u00eatre accord\u00e9e sans dispositif de pr\u00e9dicat. Cela se fait souvent par le biais d'une voie ou d'une classification appel\u00e9e De Novo, o\u00f9 le fabricant fournit des preuves permettant \u00e0 la FDA de d\u00e9terminer que le dispositif pr\u00e9sente un risque faible ou mod\u00e9r\u00e9 et qu'il existe une assurance raisonnable de s\u00e9curit\u00e9 et d'efficacit\u00e9. \u00c0 partir de ce moment-l\u00e0, le dispositif devient le pr\u00e9dicat pour d'autres dispositifs. Les preuves requises pour une soumission De Novo sont g\u00e9n\u00e9ralement moins vastes que celles requises pour les dispositifs de classe III utilisant une demande d'approbation avant mise sur le march\u00e9 (PMA) (d\u00e9crite ci-dessous) parce qu'il a \u00e9t\u00e9 d\u00e9termin\u00e9 que le dispositif De Novo pr\u00e9sente un risque moindre.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">En permettant aux fabricants de faire r\u00e9f\u00e9rence \u00e0 des dispositifs \u00e9quivalents (predicate devices), la FDA maintient des normes de s\u00e9curit\u00e9 et d'efficacit\u00e9 tout en permettant aux fabricants de proposer de nouveaux produits plus rapidement et \u00e0 moindre co\u00fbt, ce qui permet \u00e0 l'innovation et \u00e0 la concurrence de prosp\u00e9rer.<\/p>\n\n\n\n<h3 id=\"h-class-iii-high-risk\" class=\"wp-block-heading\">Classe III \u2013 Risque \u00e9lev\u00e9<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u201cLes dispositifs de \u201d classe III \u00bb soutiennent ou maintiennent la vie, peuvent \u00eatre implant\u00e9s \u00e0 long terme et pr\u00e9sentent un risque important en cas de d\u00e9faillance.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Les exemples de dispositifs de classe III comprennent les valves cardiaques artificielles, les stimulateurs cardiaques et les d\u00e9fibrillateurs, les neurostimulateurs, les stents cardiaques, entre autres.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Les dispositifs de classe III n\u00e9cessitent une approbation de la FDA. L'approbation de la FDA signifie que le fabricant du dispositif doit fournir des preuves substantielles de s\u00e9curit\u00e9 et d'efficacit\u00e9 qui incluent souvent des essais cliniques sur l'homme, des tests de laboratoire et d'ing\u00e9nierie, des \u00e9tudes sur les animaux, des analyses statistiques et un suivi \u00e0 long terme. Il s'agit d'un processus long et co\u00fbteux et le fabricant de chaque dispositif de classe III doit d\u00e9montrer ind\u00e9pendamment la s\u00e9curit\u00e9 et l'efficacit\u00e9 du dispositif au moyen de preuves scientifiques valides. Il n'y a pas de dispositifs \u00e9quivalents de r\u00e9f\u00e9rence.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Le processus pour obtenir l'approbation de la FDA s'appelle PMA ou approbation pr\u00e9alable \u00e0 la mise sur le march\u00e9.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"864\" height=\"576\" src=\"https:\/\/jointechlabs.com\/wp-content\/uploads\/2026\/08\/RegVsClearCsApproved-copy.png\" alt=\"Une infographie montrant les diff\u00e9rences entre enregistr\u00e9 par la FDA, autoris\u00e9 par la FDA et approuv\u00e9 par la FDA concernant les dispositifs de traitement de la micro-graisse.\" class=\"wp-image-3049\" srcset=\"https:\/\/jointechlabs.com\/wp-content\/uploads\/2026\/08\/RegVsClearCsApproved-copy.png 864w, https:\/\/jointechlabs.com\/wp-content\/uploads\/2026\/08\/RegVsClearCsApproved-copy-300x200.png 300w, https:\/\/jointechlabs.com\/wp-content\/uploads\/2026\/08\/RegVsClearCsApproved-copy-768x512.png 768w, https:\/\/jointechlabs.com\/wp-content\/uploads\/2026\/08\/RegVsClearCsApproved-copy-18x12.png 18w\" sizes=\"auto, (max-width: 864px) 100vw, 864px\" \/><\/figure>\n\n\n\n<h3 id=\"h-microfat-devices\" class=\"wp-block-heading\">Dispositifs de micrograisse<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Vous verrez peut-\u00eatre des dispositifs de micrograisse \u00e9tiquet\u00e9s \u201c Enregistr\u00e9s aupr\u00e8s de la FDA \u201d ou \u201c Inscrits aupr\u00e8s de la FDA \u201d. Un dispositif de traitement de la micrograisse commercialis\u00e9 uniquement comme \u201c Enregistr\u00e9 aupr\u00e8s de la FDA \u201d ou \u201c Inscrit aupr\u00e8s de la FDA \u201d devrait susciter des questions suppl\u00e9mentaires. Un syst\u00e8me de traitement de la micrograisse de classe II en vente aux \u00c9tats-Unis doit disposer d'une autorisation de la FDA pour cette utilisation pr\u00e9vue. Les dispositifs qui sont simplement enregistr\u00e9s aupr\u00e8s de la FDA peuvent l'\u00eatre pour une autre utilisation que le traitement de la micrograisse, mais le dispositif n'est pas l\u00e9galement autoris\u00e9 \u00e0 \u00eatre utilis\u00e9 pour le traitement de la micrograisse. L'enregistrement ou l'inscription \u00e0 elle seule ne signifie pas que la FDA a examin\u00e9 le dispositif pour \u00e9valuer son innocuit\u00e9 et son efficacit\u00e9 en mati\u00e8re de traitement de la micrograisse.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">De m\u00eame, un syst\u00e8me de traitement de micrograisse de classe II annonc\u00e9 comme \u201c approuv\u00e9 par la FDA \u201d doit \u00eatre examin\u00e9 avec attention. La FDA utilise g\u00e9n\u00e9ralement le terme \u201c approuv\u00e9 \u201d pour les dispositifs qui ont fait l'objet du processus d'approbation pr\u00e9alable \u00e0 la mise sur le march\u00e9 (PMA) pour les dispositifs de classe III. Les syst\u00e8mes de traitement de la micrograisse sont g\u00e9n\u00e9ralement des dispositifs de classe II autoris\u00e9s par le processus 510(k), la terminologie appropri\u00e9e est donc \u201c autoris\u00e9 par la FDA \u201d.\u201d<\/p>\n\n\n\n<h3 id=\"h-bottom-line\" class=\"wp-block-heading\">En fin de compte<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Tout syst\u00e8me de micrograisse que vous choisissez doit avoir l'autorisation de la FDA pour \u00eatre vendu l\u00e9galement et vous devez v\u00e9rifier qu'il est \u00e9tiquet\u00e9 comme tel. Les termes \u201c enregistr\u00e9 aupr\u00e8s de la FDA \u201d ou \u201c inscrit sur la liste de la FDA \u201d sont insuffisants, tandis que \u201c approuv\u00e9 par la FDA \u201d peut \u00eatre inexact.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Soyez assur\u00e9 que <a href=\"https:\/\/jointechlabs.com\/fr\/minitc\/\">M<\/a><a href=\"https:\/\/jointechlabs.com\/fr\/minitc\/\" target=\"_blank\" rel=\"noreferrer noopener\">iniTC\u00ae<\/a> le syst\u00e8me de Jointechlabs est un dispositif m\u00e9dical de classe II qui a re\u00e7u l'autorisation de la FDA.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>Ce billet passe en revue les termes \u201c enregistr\u00e9\/inscrit aupr\u00e8s de la FDA \u201d, \u201c autoris\u00e9 par la FDA \u201d et \u201c approuv\u00e9 par la FDA \u201d tels qu'ils s'appliquent aux dispositifs m\u00e9dicaux en g\u00e9n\u00e9ral et aux dispositifs de traitement de la micro-graisse en particulier. Un incontournable pour les praticiens et les patients.<\/p>","protected":false},"author":4,"featured_media":3055,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"om_disable_all_campaigns":false,"footnotes":""},"categories":[19,123],"tags":[126,127,128,101,125,53,124],"class_list":["post-3038","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-microfat","category-regulatory","tag-class-i-medical-device","tag-class-ii-medical-device","tag-class-iii-medical-device","tag-fda","tag-fda-approved","tag-fda-cleared","tag-fda-registered"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.2 (Yoast SEO v28.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Registered, Cleared, and Approved - The Difference and Importance for Microfat Devices - Jointechlabs, Inc<\/title>\n<meta name=\"description\" content=\"This post reviews the terms \u201cFDA Registered\/Listed,\u201d \u201cFDA Cleared,\u201d and \u201cFDA Approved\u201d as they relate to microfat processing devices.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/jointechlabs.com\/fr\/fda-registered-cleared-and-approved-the-difference-and-importance-for-microfat-devices\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Registered, Cleared, and Approved - The Difference and Importance for Microfat Devices\" \/>\n<meta property=\"og:description\" content=\"This post reviews the terms \u201cFDA Registered\/Listed,\u201d \u201cFDA Cleared,\u201d and \u201cFDA Approved\u201d as they relate to microfat processing devices.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/jointechlabs.com\/fr\/fda-registered-cleared-and-approved-the-difference-and-importance-for-microfat-devices\/\" \/>\n<meta property=\"og:site_name\" content=\"Jointechlabs, Inc\" \/>\n<meta property=\"article:published_time\" content=\"2026-08-07T05:01:46+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-08-07T15:28:39+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/jointechlabs.com\/wp-content\/uploads\/2026\/08\/FDATiers-copy.png\" \/>\n\t<meta property=\"og:image:width\" content=\"300\" \/>\n\t<meta property=\"og:image:height\" content=\"301\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Jointechlabs, Inc.\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Jointechlabs, Inc.\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/jointechlabs.com\\\/fda-registered-cleared-and-approved-the-difference-and-importance-for-microfat-devices\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/jointechlabs.com\\\/fda-registered-cleared-and-approved-the-difference-and-importance-for-microfat-devices\\\/\"},\"author\":{\"name\":\"Jointechlabs, Inc.\",\"@id\":\"https:\\\/\\\/jointechlabs.com\\\/#\\\/schema\\\/person\\\/35439e111f8cac62a4e01c1313818de9\"},\"headline\":\"FDA Registered, Cleared, and Approved &#8211; 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