{"id":2587,"date":"2021-01-06T14:20:21","date_gmt":"2021-01-06T06:20:21","guid":{"rendered":"https:\/\/regask.com\/?p=2587"},"modified":"2024-10-24T01:44:27","modified_gmt":"2024-10-23T17:44:27","slug":"%e7%b1%b3%e5%9b%bd-fda-%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%82%ac%e3%82%a4%e3%83%89%e3%83%a9%e3%82%a4%e3%83%b3","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/us-fda-medical-device-guidelines\/","title":{"rendered":"\u7c73\u56fd FDA \u306f\u30013 \u3064\u306e c \u3092\u8a31\u53ef\u3059\u308b\u305f\u3081\u306e\u8981\u4ef6\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u63d0\u4f9b\u3057\u307e\u3057\u305f\u2026"},"content":{"rendered":"<p>\u7c73\u56fd FDA \u306f\u3001\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u8a3c\u660e\u3059\u308b\u305f\u3081\u306e\u6027\u80fd\u57fa\u6e96\u306b\u4f9d\u5b58\u3059\u308b 3 \u3064\u306e\u30ab\u30c6\u30b4\u30ea\u306e\u533b\u7642\u6a5f\u5668\u306e\u5e02\u5834\u6295\u5165\u3092\u8a31\u53ef\u3059\u308b\u305f\u3081\u306e\u8981\u4ef6\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u63d0\u4f9b\u3057\u307e\u3057\u305f\u3002<\/p>\n<p>\u3053\u308c\u3089\u306e 3 \u3064\u306e\u533b\u7642\u6a5f\u5668\u30ab\u30c6\u30b4\u30ea\u306f\u3001\u810a\u690e\u30d7\u30ec\u30fc\u30c8\u30b7\u30b9\u30c6\u30e0\u3001\u6574\u5f62\u5916\u79d1\u7528\u975e\u810a\u690e\u91d1\u5c5e\u9aa8\u30cd\u30b8\u3068\u30ef\u30c3\u30b7\u30e3\u30fc\u3001\u304a\u3088\u3073\u78c1\u6c17\u5171\u9cf4\u53d7\u4fe1\u5c02\u7528\u30b3\u30a4\u30eb\u3067\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<a href=\"https:\/\/regask.com\/ja\/%e6%8e%a5%e8%a7%a6\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>\u8a73\u7d30\u306b\u3064\u3044\u3066\u306fRegASK\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>\u7d9a\u304d\u3092\u8aad\u3080<\/span>\n\t<\/a>","protected":false},"excerpt":{"rendered":"<p>US FDA provided requirement guidelines to allow 3 categories of medical device into market that rely on performance criteria to demonstrate safety and effectiveness. These 3 medical device categories are spinal plating systems, orthopedic non-spinal metallic bone screws and washers, and magnetic resonance receive-only coils. &nbsp;<\/p>","protected":false},"author":39,"featured_media":2486,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[40],"class_list":["post-2587","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-devices-insights","tag-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>US FDA: Medical Device Guidelines | RegASK<\/title>\n<meta name=\"description\" content=\"The FDA provides requirement guidelines for 3 categories of medical devices. 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