{"id":8556,"date":"2025-08-13T14:18:45","date_gmt":"2025-08-13T06:18:45","guid":{"rendered":"https:\/\/regask.com\/?p=8556"},"modified":"2026-01-05T09:58:11","modified_gmt":"2026-01-05T01:58:11","slug":"la-fda-lance-un-accelerateur-reglementaire-pour-stimuler-linnovation-dans-les-logiciels-de-dispositifs-medicaux","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/fda-launches-regulatory-accelerator-to-boost-medical-device-software-innovation\/","title":{"rendered":"La FDA lance un acc\u00e9l\u00e9rateur r\u00e9glementaire pour stimuler les d\u00e9\u2026"},"content":{"rendered":"<div class=\"row\"  id=\"row-596182846\">\n\n\t<div id=\"col-554874008\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<p><span class=\"TextRun SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163028712 BCX0\">Sur <\/span><\/span><span class=\"TextRun MacChromeBold SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163028712 BCX0\">24 juillet 2025<\/span><\/span><span class=\"TextRun SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163028712 BCX0\">, le <\/span><\/span><a class=\"Hyperlink SCXW163028712 BCX0\" href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"TextRun Underlined MacChromeBold SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW163028712 BCX0\" data-ccp-charstyle=\"Hyperlink\">Administration am\u00e9ricaine des aliments et des m\u00e9dicaments (FDA)<\/span><\/span><\/a><span class=\"TextRun SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163028712 BCX0\"> a pr\u00e9sent\u00e9 son <\/span><\/span><span class=\"TextRun MacChromeBold SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163028712 BCX0\">Acc\u00e9l\u00e9rateur r\u00e9glementaire<\/span><\/span><span class=\"TextRun SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163028712 BCX0\"> Initiative visant \u00e0 soutenir les d\u00e9veloppeurs de dispositifs de sant\u00e9 num\u00e9riques. Cette nouvelle initiative fournit des outils et des conseils cibl\u00e9s pour aider les innovateurs \u00e0 mieux se conformer aux exigences de conformit\u00e9. <\/span><\/span><span class=\"TextRun MacChromeBold SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163028712 BCX0\">logiciel de dispositif m\u00e9dical<\/span><\/span><span class=\"TextRun SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163028712 BCX0\">, <\/span><span class=\"NormalTextRun SCXW163028712 BCX0\">visant en fin de compte<\/span><span class=\"NormalTextRun SCXW163028712 BCX0\"> pour acc\u00e9l\u00e9rer la mise sur le march\u00e9 des <\/span><\/span><span class=\"TextRun MacChromeBold SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163028712 BCX0\">technologies de sant\u00e9 num\u00e9riques s\u00fbres et efficaces<\/span><\/span><span class=\"TextRun SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163028712 BCX0\">.<\/span><\/span><span class=\"EOP SCXW163028712 BCX0\" data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">Ce qui est inclus dans l&#039;initiative :<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Le <\/span><b><span data-contrast=\"auto\">Acc\u00e9l\u00e9rateur r\u00e9glementaire<\/span><\/b><span data-contrast=\"auto\"> pr\u00e9sente plusieurs ressources pour soutenir la conformit\u00e9 tout au long du cycle de d\u00e9veloppement logiciel\u00a0:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"-\" data-font=\"Aptos\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1080,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Aptos&quot;,&quot;469769242&quot;:&#091;8226&#093;,&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;-&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">UN <\/span><b><span data-contrast=\"auto\">Index des ressources pour les innovateurs en mati\u00e8re de dispositifs de sant\u00e9 num\u00e9riques<\/span><\/b><span data-contrast=\"auto\">, qui sert de guide visuel des outils de la FDA, des documents d&#039;orientation pertinents et des opportunit\u00e9s d&#039;engagement avec la FDA.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"-\" data-font=\"Aptos\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1080,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Aptos&quot;,&quot;469769242&quot;:&#091;8226&#093;,&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;-&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">R\u00e9unions d&#039;orientation pr\u00e9coces<\/span><\/b><span data-contrast=\"auto\"> sont soulign\u00e9s comme une bonne pratique pour les sponsors qui cherchent \u00e0 s&#039;engager avec la FDA au d\u00e9but du processus de d\u00e9veloppement, en particulier pour les soumissions de commercialisation impliquant des dispositifs m\u00e9dicaux bas\u00e9s sur des logiciels.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"-\" data-font=\"Aptos\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1080,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Aptos&quot;,&quot;469769242&quot;:&#091;8226&#093;,&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;-&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">UN <\/span><b><span data-contrast=\"auto\">Navigateur de conseils sur les logiciels de dispositifs m\u00e9dicaux<\/span><\/b><span data-contrast=\"auto\">, un outil con\u00e7u pour aider les innovateurs \u00e0 trouver rapidement les directives de la FDA applicables. Il est \u00e9galement conforme aux <\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/how-study-and-market-your-device\/estar-program\"><b><span data-contrast=\"none\">Mod\u00e8le et ressource de soumission \u00e9lectronique (eSTAR)<\/span><\/b><span data-contrast=\"none\"> syst\u00e8me<\/span><\/a><span data-contrast=\"auto\">, offrant une conformit\u00e9 plus fluide tout au long du d\u00e9veloppement du produit.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span class=\"TextRun SCXW231617538 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW231617538 BCX0\">L\u2019initiative est con\u00e7ue sp\u00e9cifiquement pour aider <\/span><\/span><span class=\"TextRun MacChromeBold SCXW231617538 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW231617538 BCX0\">innovateurs d\u00e9butants et \u00e9mergents<\/span><\/span><span class=\"TextRun SCXW231617538 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW231617538 BCX0\"> comprendre les processus de la FDA li\u00e9s \u00e0 l\u2019examen r\u00e9glementaire et \u00e0 la surveillance des logiciels de dispositifs m\u00e9dicaux.<\/span><\/span><span class=\"EOP SCXW231617538 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<h4><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">Pourquoi c&#039;est important :<\/span><\/h4>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">L&#039;Acc\u00e9l\u00e9rateur r\u00e9glementaire am\u00e9liore la clart\u00e9 r\u00e9glementaire et s&#039;inscrit dans les objectifs de transformation num\u00e9rique de la FDA. Il vise \u00e0 am\u00e9liorer la qualit\u00e9 des soumissions, \u00e0 r\u00e9duire les d\u00e9lais d&#039;examen et \u00e0 renforcer la collaboration entre les innovateurs et la FDA. Cette initiative favorisera un d\u00e9ploiement plus s\u00fbr et plus rapide des solutions de sant\u00e9 num\u00e9rique sans alourdir les contraintes de conformit\u00e9.\u00a0<\/span><\/p>\n<h4><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\"><span class=\"TextRun MacChromeBold SCXW108145005 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW108145005 BCX0\">\u00c0 qui s&#039;adresse ce message\u00a0:<\/span><\/span><\/span><\/h4>\n<p>Cette mise \u00e0 jour est particuli\u00e8rement pertinente pour les \u00e9quipes des affaires r\u00e9glementaires, les d\u00e9veloppeurs de produits de sant\u00e9 num\u00e9riques, les responsables de la conformit\u00e9 et les \u00e9quipes charg\u00e9es des logiciels de dispositifs m\u00e9dicaux. Elle est \u00e9galement essentielle pour ceux qui pr\u00e9parent des dossiers de mise sur le march\u00e9 impliquant des composants logiciels de dispositifs m\u00e9dicaux.<\/p>\n<h4><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\"><span class=\"TextRun MacChromeBold SCXW108145005 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW108145005 BCX0\"><span class=\"TextRun MacChromeBold SCXW82160759 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW82160759 BCX0\">Prochaines \u00e9tapes :<\/span><\/span><span class=\"LineBreakBlob BlobObject DragDrop SCXW82160759 BCX0\"><span class=\"SCXW82160759 BCX0\">\u00a0<\/span><\/span><\/span><\/span><\/span><\/h4>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\"><span class=\"TextRun MacChromeBold SCXW108145005 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW108145005 BCX0\"><span class=\"TextRun SCXW82160759 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW82160759 BCX0\">Il est conseill\u00e9 aux parties prenantes de :<\/span><\/span><span class=\"EOP SCXW82160759 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/span><\/span><\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"-\" data-font=\"Aptos\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1080,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Aptos&quot;,&quot;469769242&quot;:&#091;8226&#093;,&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;-&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Explorez le <\/span><b><span data-contrast=\"auto\">Index des ressources<\/span><\/b><span data-contrast=\"auto\"> et <\/span><b><span data-contrast=\"auto\">Navigateur de guidage<\/span><\/b><span data-contrast=\"auto\"> pour identifier les outils et documents FDA applicables.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"-\" data-font=\"Aptos\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1080,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Aptos&quot;,&quot;469769242&quot;:&#091;8226&#093;,&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;-&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Se familiariser avec <\/span><b><span data-contrast=\"auto\">Alignement eSTAR<\/span><\/b><span data-contrast=\"auto\"> pour des soumissions plus fluides.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"-\" data-font=\"Aptos\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1080,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Aptos&quot;,&quot;469769242&quot;:&#091;8226&#093;,&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;-&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Calendrier <\/span><b><span data-contrast=\"auto\">R\u00e9unions d&#039;orientation pr\u00e9coces<\/span><\/b><span data-contrast=\"auto\"> avec la FDA lors de la pr\u00e9paration des demandes de commercialisation de dispositifs bas\u00e9s sur des logiciels.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">L\u2019utilisation proactive de ces ressources favorisera la r\u00e9ussite des strat\u00e9gies de conformit\u00e9 et r\u00e9duira les retards dans l\u2019examen r\u00e9glementaire.<\/span><\/p>\n<p><span class=\"TextRun SCXW37560054 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW37560054 BCX0\">Alors que les paysages r\u00e9glementaires continuent d\u2019\u00e9voluer avec les avanc\u00e9es technologiques, il est essentiel pour les innovateurs de rester align\u00e9s sur les processus de la FDA.<\/span> <\/span><span class=\"LineBreakBlob BlobObject DragDrop SCXW37560054 BCX0\"><span class=\"SCXW37560054 BCX0\">\u00a0<\/span><br class=\"SCXW37560054 BCX0\" \/><\/span><span class=\"TextRun MacChromeBold SCXW37560054 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW37560054 BCX0\">RegASK<\/span><\/span><span class=\"TextRun SCXW37560054 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW37560054 BCX0\"> est une plateforme bas\u00e9e sur l&#039;IA qui aide les sciences de la vie et <\/span><span class=\"NormalTextRun SCXW37560054 BCX0\">MEDtech<\/span><span class=\"NormalTextRun SCXW37560054 BCX0\"> les entreprises naviguent dans des environnements r\u00e9glementaires complexes avec <\/span><span class=\"NormalTextRun SCXW37560054 BCX0\">opportun<\/span><span class=\"NormalTextRun SCXW37560054 BCX0\"> surveillance, veille r\u00e9glementaire et support de soumission automatis\u00e9.<\/span><\/span><\/p>\n<p><a class=\"Hyperlink SCXW37560054 BCX0\" href=\"https:\/\/regask.com\/fr\/\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"TextRun Underlined SCXW37560054 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW37560054 BCX0\" data-ccp-charstyle=\"Hyperlink\">En savoir plus<\/span><\/span><\/a><span class=\"TextRun SCXW37560054 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW37560054 BCX0\"> \u00e0 propos de RegASK !<\/span><\/span><\/p>\n<a href=\"https:\/\/regask.com\/fr\/reserver-une-demo\/\" target=\"_blank\" class=\"button secondary\" rel=\"noopener\" style=\"border-radius:99px;\">\n\t\t<span>R\u00e9server une d\u00e9mo<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n<div class=\"is-divider divider clearfix\" style=\"height:2px;background-color:#7b81a3;\"><\/div>\n\t<div id=\"gap-1478920925\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1478920925 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<h3 aria-level=\"3\"><b><span data-contrast=\"none\">FAQ<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/h3>\n\t<div id=\"gap-1257413029\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1257413029 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h5><b><span data-contrast=\"auto\">Qu&#039;est-ce que l&#039;acc\u00e9l\u00e9rateur r\u00e9glementaire de la FDA ?<\/span><\/b><\/h5>\n<p><span data-contrast=\"auto\">Le <\/span><b><span data-contrast=\"auto\">Acc\u00e9l\u00e9rateur r\u00e9glementaire<\/span><\/b><span data-contrast=\"auto\"> est une initiative lanc\u00e9e par la FDA le 24 juillet 2025 pour aider les innovateurs du secteur de la sant\u00e9 num\u00e9rique \u00e0 s&#039;y retrouver dans la r\u00e9glementation relative aux logiciels de dispositifs m\u00e9dicaux. Elle fournit des outils et des conseils pour am\u00e9liorer la qualit\u00e9 des soumissions et acc\u00e9l\u00e9rer l&#039;acc\u00e8s au march\u00e9.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<h5><b><span data-contrast=\"auto\">Quels outils sont inclus dans l\u2019Acc\u00e9l\u00e9rateur R\u00e9glementaire ?<\/span><\/b><\/h5>\n<p><span data-contrast=\"auto\"> Il comprend un <\/span><b><span data-contrast=\"auto\">Index des ressources<\/span><\/b><span data-contrast=\"auto\">, un <\/span><b><span data-contrast=\"auto\">Navigateur de conseils sur les logiciels de dispositifs m\u00e9dicaux<\/span><\/b><span data-contrast=\"auto\">, et favorise <\/span><b><span data-contrast=\"auto\">R\u00e9unions d&#039;orientation pr\u00e9coces<\/span><\/b><span data-contrast=\"auto\">. Ces outils sont con\u00e7us pour aider les innovateurs \u00e0 trouver des conseils pertinents et \u00e0 aligner les soumissions sur les attentes de la FDA.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>FAQ\u00a0: Qu\u2019est-ce que l\u2019Acc\u00e9l\u00e9rateur r\u00e9glementaire de la FDA\u00a0? L\u2019Acc\u00e9l\u00e9rateur r\u00e9glementaire est une initiative lanc\u00e9e par la FDA le 24\u00a0juillet\u00a02025 pour aider les innovateurs en sant\u00e9 num\u00e9rique \u00e0 s\u2019y retrouver dans la r\u00e9glementation relative aux logiciels de dispositifs m\u00e9dicaux. Il fournit des outils et des conseils pour am\u00e9liorer la qualit\u00e9 des soumissions et acc\u00e9l\u00e9rer l\u2019acc\u00e8s au march\u00e9. Quels outils sont inclus dans l\u2019Acc\u00e9l\u00e9rateur r\u00e9glementaire\u00a0? Il\u2026<\/p>","protected":false},"author":32,"featured_media":8559,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,39,35],"tags":[],"class_list":["post-8556","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-medical-devices-insights","category-pharma-biotech-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.8 (Yoast SEO v27.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Launches Regulatory Accelerator to Boost Medical Device Software Innovation | RegASK<\/title>\n<meta name=\"description\" content=\"RegASK | The FDA\u2019s new Regulatory Accelerator helps digital health innovators navigate medical device software regulations with tools, guidance, and faster review pathways.\" \/>\n<meta name=\"robots\" content=\"index, follow, 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