{"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-684844167\">\n\n\t<div id=\"col-97792947\" 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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\u30ea\u30bd\u30fc\u30b9\u30a4\u30f3\u30c7\u30c3\u30af\u30b9\u3001\u533b\u7642\u6a5f\u5668\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30ac\u30a4\u30c0\u30f3\u30b9\u30ca\u30d3\u30b2\u30fc\u30bf\u30fc\u3001\u65e9\u671f\u30aa\u30ea\u30a8\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3\u30df\u30fc\u30c6\u30a3\u30f3\u30b0\u306e\u63a8\u9032\u306a\u3069\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u3053\u308c\u3089\u306f\u3001\u30a4\u30ce\u30d9\u30fc\u30bf\u30fc\u304c\u95a2\u9023\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u898b\u3064\u3051\u3001\u63d0\u51fa\u7269\u3092FDA\u306e\u671f\u5f85\u306b\u6cbf\u308f\u305b\u308b\u306e\u306b\u5f79\u7acb\u3064\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u3066\u3044\u307e\u3059\u3002.\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 v28.0 (Yoast SEO v28.0) - 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, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/ja\/fda\u3001\u533b\u7642\u6a5f\u5668\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u3092\u4fc3\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Launches Regulatory Accelerator to Boost Medical Device Software Innovation\" \/>\n<meta property=\"og: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 property=\"og:url\" content=\"https:\/\/regask.com\/ja\/fda\u3001\u533b\u7642\u6a5f\u5668\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u3092\u4fc3\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2025-08-13T06:18:45+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-01-05T01:58:11+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2025\/08\/fda-launches-regulatory-accelerator-boost-medical-device-software-innovation-2.png\" \/>\n\t<meta property=\"og:image:width\" 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