{"id":7910,"date":"2024-12-18T19:08:58","date_gmt":"2024-12-18T11:08:58","guid":{"rendered":"https:\/\/regask.com\/?p=7910"},"modified":"2024-12-18T19:08:58","modified_gmt":"2024-12-18T11:08:58","slug":"fda-ai%e3%83%87%e3%83%90%e3%82%a4%e3%82%b9%e3%82%ac%e3%82%a4%e3%83%80%e3%83%b3%e3%82%b9-pccp","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/fda-ai-device-guidance-pccp\/","title":{"rendered":"FDA (\u7c73\u56fd) \u304c\u4e8b\u524d\u6c7a\u5b9a\u3055\u308c\u305f\u5909\u66f4\u306b\u95a2\u3059\u308b\u6700\u7d42\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u767a\u884c\u2026"},"content":{"rendered":"<p>2024\u5e7412\u67084\u65e5\u3001\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u306f\u6700\u7d42\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u767a\u884c\u3057\u307e\u3057\u305f\u3002 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\/>\n\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u6539\u8a02\u306f\u3001\u30d1\u30d6\u30ea\u30c3\u30af\u30b3\u30e1\u30f3\u30c8\u304b\u3089\u306e\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3092\u53cd\u6620\u3057\u305f\u3082\u306e\u3067\u3001\u9069\u7528\u7bc4\u56f2\u3001\u30e9\u30d9\u30ea\u30f3\u30b0\u8981\u4ef6\u3001\u8a8d\u53ef\u3055\u308c\u305fPCCP\u306b\u57fa\u3065\u304f\u5b9f\u65bd\u30d7\u30ed\u30bb\u30b9\u3001\u5e02\u8ca9\u5f8c\u8abf\u67fb\u306e\u63a8\u5968\u4e8b\u9805\u306a\u3069\u306b\u3064\u3044\u3066\u660e\u78ba\u5316\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u300c\u4eba\u5de5\u77e5\u80fd\u300d\u3068\u300c\u6a5f\u68b0\u5b66\u7fd2\u300d\u306e\u5b9a\u7fa9\u306f\u3001 <strong>\u5927\u7d71\u9818\u4ee414110\u53f7<\/strong> 2023\u5e7410\u670830\u65e5\u767a\u884c\u3002<\/li>\n<\/ul>\n<p>\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u3068\u516c\u8846\u885b\u751f\u306e\u512a\u5148\u4e8b\u9805\u306e\u30d0\u30e9\u30f3\u30b9\u3092\u53d6\u308a\u306a\u304c\u3089\u3001AI \u5bfe\u5fdc\u30c7\u30d0\u30a4\u30b9\u306e\u898f\u5236\u5b9f\u52d9\u306b\u304a\u3051\u308b\u753b\u671f\u7684\u306a\u51fa\u6765\u4e8b\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n<p>\u8a73\u3057\u3044\u60c5\u5831\u3084\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u6226\u7565\u306b\u3064\u3044\u3066\u3054\u76f8\u8ac7\u3044\u305f\u3060\u304f\u5834\u5408\u306f\u3001\u5f53\u793e\u307e\u3067\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>On December 4, 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance, &#8220;Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions.&#8221; This update represents a key advancement in the FDA&#8217;s regulatory framework, designed to support continuous innovation in AI-enabled medical devices while maintaining their safety and effectiveness. The guidance introduces the concept of a Predetermined Change Control Plan (PCCP), which details planned modifications to AI-enabled devices. The PCCP includes methodologies for development, validation, and implementation of these changes, as well as assessments of their impact on the device&#8217;s safety and effectiveness. Key Highlights: Scope of Application: The guidance applies to AI-enabled&#8230;<\/p>","protected":false},"author":43,"featured_media":7925,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,39],"tags":[165,593,609,610,611],"class_list":["post-7910","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-medical-devices-insights","tag-public-health","tag-innovative-medical-devices","tag-guideline","tag-software-as-a-medical-device-samd","tag-ai-enabled-devices"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Finalizes Guidance on AI-Enabled Device Updates | RegASK<\/title>\n<meta name=\"description\" content=\"FDA issues final guidance on Predetermined Change Control Plans for AI-enabled devices. 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