{"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-lanza-un-acelerador-regulatorio-para-impulsar-la-innovacion-en-software-de-dispositivos-medicos","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/fda-launches-regulatory-accelerator-to-boost-medical-device-software-innovation\/","title":{"rendered":"La FDA lanza un acelerador regulatorio para impulsar el desarrollo m\u00e9dico..."},"content":{"rendered":"<div class=\"row\"  id=\"row-1283671835\">\n\n\t<div id=\"col-1545945681\" 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\">En <\/span><\/span><span class=\"TextRun MacChromeBold SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163028712 BCX0\">24 de julio de 2025<\/span><\/span><span class=\"TextRun SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163028712 BCX0\">, el <\/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\">Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA)<\/span><\/span><\/a><span class=\"TextRun SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163028712 BCX0\"> present\u00f3 su <\/span><\/span><span class=\"TextRun MacChromeBold SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163028712 BCX0\">Acelerador Regulatorio<\/span><\/span><span class=\"TextRun SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163028712 BCX0\"> Iniciativa para apoyar a los desarrolladores de dispositivos de salud digital. Esta nueva iniciativa proporciona herramientas y orientaci\u00f3n espec\u00edficas para ayudar a los innovadores a gestionar los requisitos de cumplimiento de forma m\u00e1s eficiente. <\/span><\/span><span class=\"TextRun MacChromeBold SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163028712 BCX0\">software de dispositivos m\u00e9dicos<\/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\">En \u00faltima instancia, el objetivo<\/span><span class=\"NormalTextRun SCXW163028712 BCX0\"> para acelerar el tiempo de comercializaci\u00f3n de <\/span><\/span><span class=\"TextRun MacChromeBold SCXW163028712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163028712 BCX0\">Tecnolog\u00edas de salud digital seguras y eficaces<\/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\">Qu\u00e9 incluye la iniciativa:<\/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\">El <\/span><b><span data-contrast=\"auto\">Acelerador Regulatorio<\/span><\/b><span data-contrast=\"auto\"> Presenta varios recursos para respaldar el cumplimiento durante todo el ciclo de vida del desarrollo de software:<\/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\">\u00cdndice de recursos para innovadores en dispositivos de salud digital<\/span><\/b><span data-contrast=\"auto\">, que act\u00faa como una gu\u00eda visual de las herramientas de la FDA, los documentos de orientaci\u00f3n relevantes y las oportunidades de interacci\u00f3n con 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\">Reuniones de orientaci\u00f3n temprana<\/span><\/b><span data-contrast=\"auto\"> Se destacan como una buena pr\u00e1ctica para los patrocinadores que buscan colaborar con la FDA en las primeras etapas del proceso de desarrollo, especialmente para presentaciones de marketing que involucran dispositivos m\u00e9dicos basados en software.<\/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\">Navegador de orientaci\u00f3n sobre software de dispositivos m\u00e9dicos<\/span><\/b><span data-contrast=\"auto\">, una herramienta dise\u00f1ada para ayudar a los innovadores a localizar r\u00e1pidamente las directrices aplicables de la FDA. Tambi\u00e9n se alinea con... <\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/how-study-and-market-your-device\/estar-program\"><b><span data-contrast=\"none\">Plantilla y recurso de presentaci\u00f3n electr\u00f3nica (eSTAR)<\/span><\/b><span data-contrast=\"none\"> sistema<\/span><\/a><span data-contrast=\"auto\">, ofreciendo un cumplimiento m\u00e1s fluido durante todo el desarrollo del producto.<\/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\">La iniciativa est\u00e1 dise\u00f1ada espec\u00edficamente para ayudar <\/span><\/span><span class=\"TextRun MacChromeBold SCXW231617538 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW231617538 BCX0\">innovadores primerizos y emergentes<\/span><\/span><span class=\"TextRun SCXW231617538 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW231617538 BCX0\"> Comprender los procesos de la FDA relacionados con la revisi\u00f3n regulatoria y la supervisi\u00f3n del software de dispositivos m\u00e9dicos.<\/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}\">Por qu\u00e9 es importante:<\/span><\/h4>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">El Acelerador Regulatorio mejora la claridad regulatoria y se alinea con los objetivos de transformaci\u00f3n digital de la FDA. Su objetivo es mejorar la calidad de las solicitudes, reducir el tiempo de revisi\u00f3n y fomentar la colaboraci\u00f3n entre los innovadores y la FDA. Esta iniciativa impulsar\u00e1 una implementaci\u00f3n m\u00e1s segura y r\u00e1pida de soluciones de salud digital sin a\u00f1adir cargas de cumplimiento.\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\">\u00bfQui\u00e9n deber\u00eda tomar nota?<\/span><\/span><\/span><\/h4>\n<p>Esta actualizaci\u00f3n es especialmente relevante para los equipos de Asuntos Regulatorios, desarrolladores de productos de salud digital, responsables de cumplimiento normativo y equipos de software de dispositivos m\u00e9dicos. Tambi\u00e9n es esencial para quienes preparan presentaciones de marketing relacionadas con componentes de software en dispositivos m\u00e9dicos.<\/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\">Pr\u00f3ximos pasos:<\/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\">Se recomienda a las partes interesadas:<\/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\">Explora el <\/span><b><span data-contrast=\"auto\">\u00cdndice de recursos<\/span><\/b><span data-contrast=\"auto\"> y <\/span><b><span data-contrast=\"auto\">Navegador de orientaci\u00f3n<\/span><\/b><span data-contrast=\"auto\"> Identificar herramientas y documentos aplicables 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><\/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\">Familiarizarse con <\/span><b><span data-contrast=\"auto\">Alineaci\u00f3n eSTAR<\/span><\/b><span data-contrast=\"auto\"> para env\u00edos m\u00e1s fluidos.<\/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\">Cronograma <\/span><b><span data-contrast=\"auto\">Reuniones de orientaci\u00f3n temprana<\/span><\/b><span data-contrast=\"auto\"> con la FDA al prepararse para presentaciones de comercializaci\u00f3n de dispositivos basados en software.<\/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\">La interacci\u00f3n proactiva con estos recursos respaldar\u00e1 estrategias de cumplimiento exitosas y reducir\u00e1 demoras en la revisi\u00f3n regulatoria.<\/span><\/p>\n<p><span class=\"TextRun SCXW37560054 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW37560054 BCX0\">A medida que los panoramas regulatorios contin\u00faan evolucionando con el avance de las tecnolog\u00edas, es fundamental que los innovadores se mantengan alineados con los procesos 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\"> es una plataforma impulsada por IA que ayuda a las ciencias de la vida y <\/span><span class=\"NormalTextRun SCXW37560054 BCX0\">Tecnolog\u00eda m\u00e9dica<\/span><span class=\"NormalTextRun SCXW37560054 BCX0\"> Las empresas navegan por entornos regulatorios complejos con <\/span><span class=\"NormalTextRun SCXW37560054 BCX0\">oportuno<\/span><span class=\"NormalTextRun SCXW37560054 BCX0\"> Monitoreo, inteligencia regulatoria y soporte de presentaci\u00f3n automatizada.<\/span><\/span><\/p>\n<p><a class=\"Hyperlink SCXW37560054 BCX0\" href=\"https:\/\/regask.com\/es\/\" 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\">M\u00e1s informaci\u00f3n<\/span><\/span><\/a><span class=\"TextRun SCXW37560054 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW37560054 BCX0\"> \u00a1Acerca de RegASK!<\/span><\/span><\/p>\n<a href=\"https:\/\/regask.com\/es\/reservar-una-demostracion\/\" target=\"_blank\" class=\"button secondary\" rel=\"noopener\" style=\"border-radius:99px;\">\n\t\t<span>Reservar una demostraci\u00f3n<\/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-1435518438\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1435518438 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<h3 aria-level=\"3\"><b><span data-contrast=\"none\">Preguntas frecuentes<\/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-2934596\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2934596 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h5><b><span data-contrast=\"auto\">\u00bfQu\u00e9 es el Acelerador Regulatorio de la FDA?<\/span><\/b><\/h5>\n<p><span data-contrast=\"auto\">El <\/span><b><span data-contrast=\"auto\">Acelerador Regulatorio<\/span><\/b><span data-contrast=\"auto\"> Es una iniciativa lanzada por la FDA el 24 de julio de 2025 para apoyar a los innovadores en salud digital en la gesti\u00f3n de las regulaciones de software para dispositivos m\u00e9dicos. Proporciona herramientas y orientaci\u00f3n para mejorar la calidad de las solicitudes y agilizar el acceso al mercado.<\/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\">\u00bfQu\u00e9 herramientas incluye el Acelerador Regulatorio?<\/span><\/b><\/h5>\n<p><span data-contrast=\"auto\"> Incluye un <\/span><b><span data-contrast=\"auto\">\u00cdndice de recursos<\/span><\/b><span data-contrast=\"auto\">, a <\/span><b><span data-contrast=\"auto\">Navegador de orientaci\u00f3n sobre software de dispositivos m\u00e9dicos<\/span><\/b><span data-contrast=\"auto\">, y promueve <\/span><b><span data-contrast=\"auto\">Reuniones de orientaci\u00f3n temprana<\/span><\/b><span data-contrast=\"auto\">Estos est\u00e1n dise\u00f1ados para ayudar a los innovadores a encontrar orientaci\u00f3n relevante y alinear las presentaciones con las expectativas 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>FAQs\u00a0 What is the FDA\u2019s Regulatory Accelerator? The Regulatory Accelerator is an initiative launched by the FDA on 24 July 2025 to support digital health innovators in navigating medical device software regulations. It provides tools and guidance to improve submission quality and speed up market access.\u00a0 What tools are included in the Regulatory Accelerator? It&#8230;<\/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 v27.3) - 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, 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