{"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":"fda-startet-regulatorischen-accelerator-zur-forderung-von-softwareinnovationen-fur-medizinprodukte","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/fda-launches-regulatory-accelerator-to-boost-medical-device-software-innovation\/","title":{"rendered":"FDA startet Regulierungsbeschleuniger zur F\u00f6rderung der medizinischen Entwicklung \u2026"},"content":{"rendered":"<div class=\"row\"  id=\"row-1920484662\">\n\n\t<div id=\"col-2140842565\" 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\">An <\/span><\/span><span class=\"TextRun MacChromeBold SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163028712 BCX0\">24. Juli 2025<\/span><\/span><span class=\"TextRun SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163028712 BCX0\">, Die <\/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\">US-amerikanische Food and Drug Administration (FDA)<\/span><\/span><\/a><span class=\"TextRun SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163028712 BCX0\"> stellte seine <\/span><\/span><span class=\"TextRun MacChromeBold SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163028712 BCX0\">Regulatorischer Beschleuniger<\/span><\/span><span class=\"TextRun SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163028712 BCX0\"> Initiative zur Unterst\u00fctzung von Entwicklern digitaler Gesundheitsger\u00e4te. Diese neue Initiative bietet gezielte Tools und Anleitungen, um Innovatoren dabei zu helfen, die Compliance-Anforderungen effizienter zu erf\u00fcllen. <\/span><\/span><span class=\"TextRun MacChromeBold SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163028712 BCX0\">Software f\u00fcr medizinische Ger\u00e4te<\/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\">letztlich mit dem Ziel<\/span><span class=\"NormalTextRun SCXW163028712 BCX0\"> zur Beschleunigung der Markteinf\u00fchrungszeit f\u00fcr <\/span><\/span><span class=\"TextRun MacChromeBold SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163028712 BCX0\">sichere und wirksame digitale Gesundheitstechnologien<\/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\">Was ist in der Initiative enthalten:<\/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\">Der <\/span><b><span data-contrast=\"auto\">Regulatorischer Beschleuniger<\/span><\/b><span data-contrast=\"auto\"> f\u00fchrt mehrere Ressourcen zur Unterst\u00fctzung der Compliance \u00fcber den gesamten Softwareentwicklungszyklus hinweg ein:<\/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\">A <\/span><b><span data-contrast=\"auto\">Ressourcenindex f\u00fcr Innovatoren digitaler Gesundheitsger\u00e4te<\/span><\/b><span data-contrast=\"auto\">, das als visueller Leitfaden zu FDA-Tools, relevanten Leitf\u00e4den und M\u00f6glichkeiten zur Zusammenarbeit mit der FDA dient.<\/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\">Fr\u00fche Orientierungstreffen<\/span><\/b><span data-contrast=\"auto\"> gelten als bew\u00e4hrte Vorgehensweise f\u00fcr Sponsoren, die bereits in einem fr\u00fchen Stadium des Entwicklungsprozesses mit der FDA zusammenarbeiten m\u00f6chten, insbesondere bei Zulassungsantr\u00e4gen f\u00fcr softwarebasierte Medizinprodukte.<\/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\">A <\/span><b><span data-contrast=\"auto\">Navigator f\u00fcr Software-Leitfaden f\u00fcr Medizinger\u00e4te<\/span><\/b><span data-contrast=\"auto\">, ein Tool, das Innovatoren dabei helfen soll, schnell anwendbare FDA-Richtlinien zu finden. Es entspricht auch den <\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/how-study-and-market-your-device\/estar-program\"><b><span data-contrast=\"none\">Vorlage und Ressource f\u00fcr elektronische Einreichungen (eSTAR)<\/span><\/b><span data-contrast=\"none\"> System<\/span><\/a><span data-contrast=\"auto\">, wodurch eine reibungslosere Einhaltung der Vorschriften w\u00e4hrend der gesamten Produktentwicklung gew\u00e4hrleistet wird.<\/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\">Die Initiative ist speziell darauf ausgerichtet, <\/span><\/span><span class=\"TextRun MacChromeBold SCXW231617538 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW231617538 BCX0\">Erst- und aufstrebende Innovatoren<\/span><\/span><span class=\"TextRun SCXW231617538 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW231617538 BCX0\"> Verstehen Sie die FDA-Prozesse im Zusammenhang mit der beh\u00f6rdlichen \u00dcberpr\u00fcfung und \u00dcberwachung von Medizinger\u00e4tesoftware.<\/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}\">Warum es wichtig ist:<\/span><\/h4>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">Der Regulatory Accelerator verbessert die regulatorische Klarheit und tr\u00e4gt den laufenden Zielen der FDA zur digitalen Transformation Rechnung. Ziel ist es, die Qualit\u00e4t der Einreichungen zu verbessern, die Pr\u00fcfzeit zu verk\u00fcrzen und die Zusammenarbeit zwischen Innovatoren und der FDA zu intensivieren. Diese Initiative unterst\u00fctzt die sicherere und schnellere Einf\u00fchrung digitaler Gesundheitsl\u00f6sungen, ohne den Compliance-Aufwand zu erh\u00f6hen.\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\">Wer sollte Folgendes beachten:<\/span><\/span><\/span><\/h4>\n<p>Dieses Update ist insbesondere f\u00fcr Regulatory Affairs-Teams, Entwickler digitaler Gesundheitsprodukte, Compliance-Beauftragte und Softwareteams f\u00fcr Medizinprodukte relevant. Es ist auch f\u00fcr diejenigen unerl\u00e4sslich, die Zulassungsantr\u00e4ge f\u00fcr Softwarekomponenten in Medizinprodukten vorbereiten.<\/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\">N\u00e4chste Schritte:<\/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\">Den Beteiligten wird Folgendes empfohlen:<\/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\">Entdecken Sie die <\/span><b><span data-contrast=\"auto\">Ressourcenindex<\/span><\/b><span data-contrast=\"auto\"> Und <\/span><b><span data-contrast=\"auto\">Orientierungsnavigator<\/span><\/b><span data-contrast=\"auto\"> um anwendbare FDA-Tools und -Dokumente zu identifizieren.<\/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\">Machen Sie sich vertraut mit <\/span><b><span data-contrast=\"auto\">eSTAR-Ausrichtung<\/span><\/b><span data-contrast=\"auto\"> f\u00fcr reibungslosere Einreichungen.<\/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\">Zeitplan <\/span><b><span data-contrast=\"auto\">Fr\u00fche Orientierungstreffen<\/span><\/b><span data-contrast=\"auto\"> mit der FDA bei der Vorbereitung von Markteinf\u00fchrungsantr\u00e4gen f\u00fcr softwarebasierte Ger\u00e4te.<\/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\">Durch die proaktive Nutzung dieser Ressourcen werden erfolgreiche Compliance-Strategien unterst\u00fctzt und Verz\u00f6gerungen bei der beh\u00f6rdlichen \u00dcberpr\u00fcfung reduziert.<\/span><\/p>\n<p><span class=\"TextRun SCXW37560054 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW37560054 BCX0\">Da sich die regulatorischen Rahmenbedingungen mit fortschreitenden Technologien weiterentwickeln, ist es f\u00fcr Innovatoren von entscheidender Bedeutung, mit den FDA-Prozessen Schritt zu halten.<\/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\"> ist eine KI-gesteuerte Plattform, die Biowissenschaften und <\/span><span class=\"NormalTextRun SCXW37560054 BCX0\">MEDtech<\/span><span class=\"NormalTextRun SCXW37560054 BCX0\"> Unternehmen navigieren durch komplexe regulatorische Umgebungen mit <\/span><span class=\"NormalTextRun SCXW37560054 BCX0\">rechtzeitig<\/span><span class=\"NormalTextRun SCXW37560054 BCX0\"> \u00dcberwachung, regulatorische Informationen und automatisierte Einreichungsunterst\u00fctzung.<\/span><\/span><\/p>\n<p><a class=\"Hyperlink SCXW37560054 BCX0\" href=\"https:\/\/regask.com\/de\/\" 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\">Mehr erfahren<\/span><\/span><\/a><span class=\"TextRun SCXW37560054 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW37560054 BCX0\"> \u00fcber RegASK!<\/span><\/span><\/p>\n<a href=\"https:\/\/regask.com\/de\/demo-buchen\/\" target=\"_blank\" class=\"button secondary\" rel=\"noopener\" style=\"border-radius:99px;\">\n\t\t<span>Demo buchen<\/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-1177637666\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1177637666 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<h3 aria-level=\"3\"><b><span data-contrast=\"none\">FAQs<\/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-349435829\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-349435829 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h5><b><span data-contrast=\"auto\">Was ist der Regulatory Accelerator der FDA?<\/span><\/b><\/h5>\n<p><span data-contrast=\"auto\">Der <\/span><b><span data-contrast=\"auto\">Regulatorischer Beschleuniger<\/span><\/b><span data-contrast=\"auto\"> ist eine Initiative der FDA vom 24. Juli 2025, die Innovatoren im Bereich der digitalen Gesundheit bei der Bew\u00e4ltigung der Softwarevorschriften f\u00fcr Medizinprodukte unterst\u00fctzt. Sie bietet Tools und Anleitungen zur Verbesserung der Einreichungsqualit\u00e4t und zur Beschleunigung des Marktzugangs.<\/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\">Welche Tools sind im Regulatory Accelerator enthalten?<\/span><\/b><\/h5>\n<p><span data-contrast=\"auto\"> Es umfasst eine <\/span><b><span data-contrast=\"auto\">Ressourcenindex<\/span><\/b><span data-contrast=\"auto\">, A <\/span><b><span data-contrast=\"auto\">Navigator f\u00fcr Software-Leitfaden f\u00fcr Medizinger\u00e4te<\/span><\/b><span data-contrast=\"auto\">und f\u00f6rdert <\/span><b><span data-contrast=\"auto\">Fr\u00fche Orientierungstreffen<\/span><\/b><span data-contrast=\"auto\">. Diese sollen Innovatoren dabei helfen, relevante Leitlinien zu finden und Einreichungen an die Erwartungen der FDA anzupassen.<\/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>FAQs Was ist der Regulatory Accelerator der FDA? Der Regulatory Accelerator ist eine Initiative der FDA vom 24. Juli 2025, die Innovatoren im Bereich der digitalen Gesundheit bei der Bew\u00e4ltigung der Softwarevorschriften f\u00fcr Medizinprodukte unterst\u00fctzt. Er bietet Tools und Anleitungen zur Verbesserung der Einreichungsqualit\u00e4t und zur Beschleunigung des Marktzugangs. Welche Tools sind im Regulatory Accelerator enthalten? Er\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 v27.3 (Yoast SEO v27.5) - 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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