{"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%e3%80%81%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%82%bd%e3%83%95%e3%83%88%e3%82%a6%e3%82%a7%e3%82%a2%e3%81%ae%e3%82%a4%e3%83%8e%e3%83%99%e3%83%bc%e3%82%b7%e3%83%a7%e3%83%b3%e3%82%92%e4%bf%83","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/fda-launches-regulatory-accelerator-to-boost-medical-device-software-innovation\/","title":{"rendered":"FDA\u3001\u533b\u7642\u958b\u767a\u3092\u4fc3\u9032\u3059\u308b\u898f\u5236\u30a2\u30af\u30bb\u30e9\u30ec\u30fc\u30bf\u30fc\u3092\u7acb\u3061\u4e0a\u3052"},"content":{"rendered":"<div class=\"row\"  id=\"row-1803664308\">\n\n\t<div id=\"col-111676204\" 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\" 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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\">\u30a4\u30cb\u30b7\u30a2\u30c1\u30d6\u306b\u542b\u307e\u308c\u308b\u3082\u306e:<\/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\">\u306e <\/span><b><span data-contrast=\"auto\">\u898f\u5236\u30a2\u30af\u30bb\u30e9\u30ec\u30fc\u30bf\u30fc<\/span><\/b><span data-contrast=\"auto\"> \u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u958b\u767a\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u306b\u308f\u305f\u308b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u305f\u3081\u306e\u3044\u304f\u3064\u304b\u306e\u30ea\u30bd\u30fc\u30b9\u3092\u7d39\u4ecb\u3057\u307e\u3059\u3002<\/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\">\u3042 <\/span><b><span data-contrast=\"auto\">\u30c7\u30b8\u30bf\u30eb\u30d8\u30eb\u30b9\u30c7\u30d0\u30a4\u30b9\u30a4\u30ce\u30d9\u30fc\u30bf\u30fc\u5411\u3051\u30ea\u30bd\u30fc\u30b9\u30a4\u30f3\u30c7\u30c3\u30af\u30b9<\/span><\/b><span data-contrast=\"auto\">\u306f\u3001FDA \u30c4\u30fc\u30eb\u3001\u95a2\u9023\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3001FDA 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\u7279\u306b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30d9\u30fc\u30b9\u306e\u533b\u7642\u6a5f\u5668\u306e\u8ca9\u58f2\u7533\u8acb\u306e\u5834\u5408\u3001\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u306e\u65e9\u3044\u6bb5\u968e\u3067 FDA \u3068\u9023\u643a\u3059\u308b\u3053\u3068\u3092\u691c\u8a0e\u3057\u3066\u3044\u308b\u30b9\u30dd\u30f3\u30b5\u30fc\u306b\u3068\u3063\u3066\u306e\u30d9\u30b9\u30c8 \u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u3068\u3057\u3066\u5f37\u8abf\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/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\">\u3042 <\/span><b><span data-contrast=\"auto\">\u533b\u7642\u6a5f\u5668\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30ac\u30a4\u30c0\u30f3\u30b9\u30ca\u30d3\u30b2\u30fc\u30bf\u30fc<\/span><\/b><span data-contrast=\"auto\">\u306f\u3001\u30a4\u30ce\u30d9\u30fc\u30bf\u30fc\u304cFDA\u306e\u9069\u7528\u53ef\u80fd\u306a\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u8fc5\u901f\u306b\u898b\u3064\u3051\u3089\u308c\u308b\u3088\u3046\u8a2d\u8a08\u3055\u308c\u305f\u30c4\u30fc\u30eb\u3067\u3059\u3002\u307e\u305f\u3001 <\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/how-study-and-market-your-device\/estar-program\"><b><span data-contrast=\"none\">\u96fb\u5b50\u63d0\u51fa\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3068\u30ea\u30bd\u30fc\u30b9\uff08eSTAR\uff09<\/span><\/b><span data-contrast=\"none\"> \u30b7\u30b9\u30c6\u30e0<\/span><\/a><span data-contrast=\"auto\">\u88fd\u54c1\u958b\u767a\u5168\u4f53\u3092\u901a\u3058\u3066\u3088\u308a\u30b9\u30e0\u30fc\u30ba\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u5b9f\u73fe\u3057\u307e\u3059\u3002<\/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\">\u3053\u306e\u53d6\u308a\u7d44\u307f\u306f\u3001\u7279\u306b <\/span><\/span><span class=\"TextRun MacChromeBold SCXW231617538 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW231617538 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data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">Regulatory 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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 includes a Resource Index, a Medical Device Software Guidance Navigator, and promotes Early Orientation Meetings. These are designed to help innovators find relevant guidance and align submissions with FDA expectations.\u00a0<\/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 v27.4) - 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 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