{"id":7489,"date":"2020-04-30T12:27:13","date_gmt":"2020-04-30T12:27:13","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=7489"},"modified":"2021-09-30T05:09:53","modified_gmt":"2021-09-30T05:09:53","slug":"top-fda-regulatory-pathways-for-medical-devices-based-on-classification","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u306e\u5206\u985e\u306b\u57fa\u3065\u304fFDA\u898f\u5236\u306e\u30c8\u30c3\u30d7\u30d1\u30b9\u30a6\u30a7\u30a4"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">table of contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f2040eb9a27\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f2040eb9a27\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#Regulatory_pathway_for_Class_I_Medical_Devices\" title=\"\u30af\u30e9\u30b9I\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u30d1\u30b9\u30a6\u30a7\u30a4\">\u30af\u30e9\u30b9I\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u30d1\u30b9\u30a6\u30a7\u30a4<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#The_surgical_scalpel\" title=\"\u624b\u8853\u7528\u30e1\u30b9\">\u624b\u8853\u7528\u30e1\u30b9<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#FDA_Regulatory_Pathways_for_Medical_Devices_Risk_Classes\" title=\"\u533b\u7642\u6a5f\u5668\u306e\u305f\u3081\u306eFDA Regulatory Pathways\u3002\u30ea\u30b9\u30af\u30af\u30e9\u30b9\">\u533b\u7642\u6a5f\u5668\u306e\u305f\u3081\u306eFDA Regulatory Pathways\u3002\u30ea\u30b9\u30af\u30af\u30e9\u30b9<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#Has_the_classification_already_been_defined\" title=\"\u5206\u985e\u306f\u3059\u3067\u306b\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u307e\u3059\u304b\uff1f \">\u5206\u985e\u306f\u3059\u3067\u306b\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u307e\u3059\u304b\uff1f <\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#Narrowing_down_the_specific_device_classification\" title=\"\u5177\u4f53\u7684\u306a\u6a5f\u5668\u5206\u985e\u306e\u7d5e\u308a\u8fbc\u307f\">\u5177\u4f53\u7684\u306a\u6a5f\u5668\u5206\u985e\u306e\u7d5e\u308a\u8fbc\u307f<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#Regulatory_Pathway_for_Class_II_Medical_Devices\" title=\"\u30af\u30e9\u30b9II\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u7d4c\u8def\">\u30af\u30e9\u30b9II\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u7d4c\u8def<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#FDA_510K_submission_Pre-market_submission\" title=\"FDA 510(K)\u306e\u63d0\u51fa\u5e02\u8ca9\u524d\u7533\u8acb\">FDA 510(K)\u306e\u63d0\u51fa\u5e02\u8ca9\u524d\u7533\u8acb<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#Q-submission_process\" title=\"Q-submission\u30d7\u30ed\u30bb\u30b9\">Q-submission\u30d7\u30ed\u30bb\u30b9<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#Regulatory_pathway_for_Class_III_medical_devices\" title=\"\u30af\u30e9\u30b9III\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u7d4c\u8def\">\u30af\u30e9\u30b9III\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u7d4c\u8def<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#Pre-market_Approval\" title=\"\u5e02\u8ca9\u524d\u306e\u627f\u8a8d \">\u5e02\u8ca9\u524d\u306e\u627f\u8a8d <\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#Class_III_Medical_Device_Regulatory_Pathway_Example\" title=\"\u30af\u30e9\u30b9III\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u30d1\u30b9\u30a6\u30a7\u30a4\u3002\u4f8b\">\u30af\u30e9\u30b9III\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u30d1\u30b9\u30a6\u30a7\u30a4\u3002\u4f8b<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#Investigational_Device_Exemption_IDE_pathway\" title=\"\u6cbb\u9a13\u85ac\u514d\u9664\uff08IDE\uff09\u306e\u7d4c\u8def\">\u6cbb\u9a13\u85ac\u514d\u9664\uff08IDE\uff09\u306e\u7d4c\u8def<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#De-Novo_request\" title=\"De-Novo\u30ea\u30af\u30a8\u30b9\u30c8\">De-Novo\u30ea\u30af\u30a8\u30b9\u30c8<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#Breakthrough_Devices_Program\" title=\"\u30d6\u30ec\u30a4\u30af\u30b9\u30eb\u30fc\u30c7\u30d0\u30a4\u30b9\u30d7\u30ed\u30b0\u30e9\u30e0\">\u30d6\u30ec\u30a4\u30af\u30b9\u30eb\u30fc\u30c7\u30d0\u30a4\u30b9\u30d7\u30ed\u30b0\u30e9\u30e0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#Emergency_Use_Authorizations\" title=\"\u7dca\u6025\u6642\u306e\u4f7f\u7528\u8a31\u53ef \">\u7dca\u6025\u6642\u306e\u4f7f\u7528\u8a31\u53ef <\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/#Humanitarian_Device_Exemption\" title=\"\u4eba\u9053\u7684\u30c7\u30d0\u30a4\u30b9\u306b\u95a2\u3059\u308b\u514d\u8cac\u4e8b\u9805 \">\u4eba\u9053\u7684\u30c7\u30d0\u30a4\u30b9\u306b\u95a2\u3059\u308b\u514d\u8cac\u4e8b\u9805 <\/a><\/li><\/ul><\/nav><\/div>\n<p><em><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/adam-freeman?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAPathways\">\u30a2\u30c0\u30e0\u30fb\u30d5\u30ea\u30fc\u30de\u30f3<\/a>\u5143FDA\u306e\u533b\u7642\u6a5f\u5668\u62c5\u5f53\u8abf\u67fb\u5b98\u304c\u3001\u533b\u7642\u6a5f\u5668\u306e\u5206\u985e\u3068\u4f7f\u7528\u76ee\u7684\u306b\u57fa\u3065\u3044\u3066\u3001FDA\u306e\u898f\u5236\u7d4c\u8def\u3092\u8aac\u660e\u3057\u3066\u3044\u307e\u3059\u3002\u00a0<\/em><\/p>\n<p><span style=\"font-weight: 400;\">\u306e\u5236\u5fa1\u30d1\u30b9\u30a6\u30a7\u30a4\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAPathways\">\u533b\u7642\u6a5f\u5668<\/a> \u306f\u3001\u305d\u306e\u30e9\u30d9\u30eb\u306b\u5927\u304d\u304f\u4f9d\u5b58\u3057\u3066\u3044\u307e\u3059\u3002  \u79c1\u305f\u3061\u306f\u3001\u3042\u308b\u6a5f\u5668\u304c\u533b\u7642\u6a5f\u5668\u3068\u306a\u308b\u305f\u3081\u306e\u9053\u7b4b\u3092\u660e\u3089\u304b\u306b\u3059\u308b\u305f\u3081\u306b\u3001\u54f2\u5b66\u7684\u306a\u8cea\u554f\u3092\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u00a0 <\/span><\/p>\n<blockquote><p><strong>\u898f\u5236\u3055\u308c\u3066\u3044\u306a\u3044\u30ca\u30a4\u30d5\u3068FDA\u898f\u5236\u306e\u5916\u79d1\u7528\u30e1\u30b9\u3092\u5206\u3051\u308b\u3082\u306e\u306f\uff1f  \u305d\u308c\u306f\u3001\u4f7f\u7528\u306e\u9069\u5fdc\u3067\u3059\u3002\u00a0 <\/strong><b>\u88fd\u54c1\u306e\u8ca9\u58f2\u3092\u4e88\u5b9a\u3057\u3066\u3044\u308b\u9069\u5fdc\u75c7\u306b\u3088\u3063\u3066\u3001\u9069\u7528\u3055\u308c\u308b\u898f\u5236\u306e\u67a0\u7d44\u307f\u304c\u6c7a\u307e\u308a\u307e\u3059\u3002<\/b><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p><\/blockquote>\n<h2><span class=\"ez-toc-section\" id=\"Regulatory_pathway_for_Class_I_Medical_Devices\"><\/span>\u30af\u30e9\u30b9I\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u30d1\u30b9\u30a6\u30a7\u30a4<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h6><span class=\"ez-toc-section\" id=\"The_surgical_scalpel\"><\/span>\u624b\u8853\u7528\u30e1\u30b9<span class=\"ez-toc-section-end\"><\/span><\/h6>\n<p><span style=\"font-weight: 400;\">\u3053\u306e\u601d\u8003\u5b9f\u9a13\u3092\u3069\u306e\u3088\u3046\u306b\u9032\u3081\u308c\u3070\u3001\u898f\u5236\u5bfe\u8c61\u306e\u5916\u79d1\u7528\u30e1\u30b9\u3068\u305d\u308c\u306b\u5bfe\u5fdc\u3059\u308b\u898f\u5236\u8981\u4ef6\u306b\u305f\u3069\u308a\u7740\u3051\u308b\u306e\u304b\u3092\u63a2\u3063\u3066\u307f\u3088\u3046\u3002  \u305d\u3057\u3066\u3001\u4ed6\u306e\u30af\u30e9\u30b9\u306e\u6a5f\u5668\u3084\u753b\u671f\u7684\u306a\u6280\u8853\u306b\u5b58\u5728\u3059\u308b\u5225\u306e\u7d4c\u8def\u3092\u63a2\u3063\u3066\u307f\u3088\u3046\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30ca\u30a4\u30d5\u304c\u5916\u79d1\u7528\u30e1\u30b9\u306b\u9032\u5316\u3057\u305f\u306e\u306f\u3001\u307e\u305a\u4f7f\u7528\u76ee\u7684\u3092\u660e\u78ba\u306b\u3057\u305f\u304b\u3089\u3067\u3059\u3002  \u4f8b\u3048\u3070\u3001\u8cc7\u683c\u3092\u6301\u3063\u305f\u5c02\u9580\u5bb6\u304c\u5916\u79d1\u624b\u8853\u3092\u884c\u3046\u969b\u306b\u4f7f\u7528\u3059\u308b\u30aa\u30fc\u30c8\u30af\u30ec\u30fc\u30d6\u53ef\u80fd\u306a\u5203\u3002  \u9023\u90a6\u98df\u54c1\u533b\u85ac\u54c1\u5316\u7ca7\u54c1\u6cd5\uff08Food, Drug, and Cosmetic Act\uff09\u3067\u306f\u3001201(h)\u9805\u3067\u898f\u5236\u5bfe\u8c61\u3068\u306a\u308b\u6a5f\u5668\u3092\u5b9a\u7fa9\u3057\u3066\u3044\u307e\u3059\u3002  \u3053\u306e\u6761\u9805\u306e\u4e00\u90e8\u3092\u7d39\u4ecb\u3057\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\"\u3068\u3044\u3046\u8a00\u8449\u304c\u3042\u308a\u307e\u3059\u3002<\/span><b><i>\u30c7\u30d0\u30a4\u30b9<\/i><\/b><span style=\"font-weight: 400;\">''***\u3068\u306f <\/span><b>\u697d\u5668<\/b><span style=\"font-weight: 400;\">\u5668\u5177\u3001\u88c5\u7f6e\u3001\u6a5f\u68b0\u3001\u4ed5\u639b\u3051\u3001\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u3001\u4f53\u5916\u8a66\u85ac\u3001\u307e\u305f\u306f\u305d\u306e\u4ed6\u306e\u985e\u4f3c\u307e\u305f\u306f\u95a2\u9023\u3059\u308b\u7269\u54c1\u3092\u542b\u307f\u307e\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">\u3059\u3079\u3066\u306e\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u3001\u90e8\u54c1\u3001\u307e\u305f\u306f\u30a2\u30af\u30bb\u30b5\u30ea\u30fc<\/span><\/i><span style=\"font-weight: 400;\">\u3068\u306a\u308a\u307e\u3059\u3002<\/span><b>\u4f7f\u7528\u76ee\u7684<\/b><span style=\"font-weight: 400;\"> \u75c5\u6c17\u3084\u305d\u306e\u4ed6\u306e\u72b6\u614b\u306e\u8a3a\u65ad\u3001\u307e\u305f\u306f <\/span><b>\u306e\u4e2d\u306b\u3042\u308b\u3002<\/b><b>\u6cbb\u7642<\/b><span style=\"font-weight: 400;\">, <\/span><b>\u30df\u30c6\u30a3\u30b2\u30fc\u30b7\u30e7\u30f3<\/b><span style=\"font-weight: 400;\">, <\/span><b>\u6cbb\u7642<\/b><span style=\"font-weight: 400;\">\u307e\u305f\u306f <\/span><b>\u75be\u75c5\u4e88\u9632<\/b><span style=\"font-weight: 400;\">, <\/span><b>\u4eba\u9593\u3084\u4ed6\u306e\u52d5\u7269\u306e<\/b><span style=\"font-weight: 400;\">\u307e\u305f\u306f***\u3002<\/span><b>\u4eba\u9593\u3084\u4ed6\u306e\u52d5\u7269\u306e\u8eab\u4f53\u306e\u69cb\u9020\u3084\u6a5f\u80fd\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u305f\u3082\u306e<\/b><span style=\"font-weight: 400;\">\u307e\u305f\u3001\u4eba\u9593\u3084\u4ed6\u306e\u52d5\u7269\u306e\u4f53\u5185\u307e\u305f\u306f\u8eab\u4f53\u306b\u5316\u5b66\u7684\u4f5c\u7528\u3092\u53ca\u307c\u3059\u3053\u3068\u306b\u3088\u3063\u3066\u3001\u305d\u306e\u4e3b\u306a\u76ee\u7684\u3092\u9054\u6210\u3059\u308b\u3082\u306e\u3067\u306f\u306a\u304f\u3001\u305d\u306e\u4e3b\u306a\u76ee\u7684\u3092\u9054\u6210\u3059\u308b\u305f\u3081\u306b\u4ee3\u8b1d\u3055\u308c\u308b\u3053\u3068\u306b\u4f9d\u5b58\u3057\u306a\u3044\u3082\u306e\u300d\u3002<\/span><b>[1]<\/b><\/p>\n<p><span style=\"font-weight: 400;\">\u30c7\u30d0\u30a4\u30b9\u306e\u4f7f\u7528\u76ee\u7684\u3092\u7279\u5b9a\u3057\u305f\u3089\u3001\u305d\u306e\u30c7\u30d0\u30a4\u30b9\u306e\u5206\u985e\u3092\u6c7a\u5b9a\u3059\u308b\u305f\u3081\u306e\u691c\u7d22\u3092\u884c\u3044\u307e\u3059\u3002\u30c7\u30d0\u30a4\u30b9\u306e\u5206\u985e\u304c\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u306a\u3044\u5834\u5408\u306f\u3001\u305d\u306e\u7d4c\u8def\u3082\u8abf\u67fb\u3057\u307e\u3059\u3002  \u7c73\u56fd\u9023\u90a6\u898f\u5247\u96c6\u306e\u30bf\u30a4\u30c8\u30eb21\u306e\u4e2d\u306b\u30d1\u30fc\u30c8860\u304c\u3042\u308a\u307e\u3059\u3002  \u3053\u306e\u30d1\u30fc\u30c8\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u5206\u985e\u624b\u9806\u304c\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u5206\u985e\u624b\u9806\u306f\u3001\u6a5f\u5668\u958b\u767a\u8005\u304c\u88fd\u54c1\u304c\u5206\u985e\u3055\u308c\u308b\u30ea\u30b9\u30af\u30af\u30e9\u30b9\u3092\u5b9a\u7fa9\u3059\u308b\u305f\u3081\u306b\u3001FDA\u306b\u3088\u3063\u3066\u898f\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u00a0 <\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"FDA_Regulatory_Pathways_for_Medical_Devices_Risk_Classes\"><\/span>\u533b\u7642\u6a5f\u5668\u306e\u305f\u3081\u306eFDA Regulatory Pathways\u3002\u30ea\u30b9\u30af\u30af\u30e9\u30b9<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u30af\u30e9\u30b9\u306f\u3001FDA\u72ec\u81ea\u306e\u30ea\u30b9\u30af\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u5206\u6790\u306b\u57fa\u3065\u304d\u30013\u3064\u306e\u30ea\u30b9\u30af\u30af\u30e9\u30b9\u306b\u5206\u3051\u3089\u308c\u307e\u3059\u3002  \u3053\u308c\u3089\u306e\u30af\u30e9\u30b9\u306f\u4ee5\u4e0b\u306e\u3088\u3046\u306b\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\"<\/span><b>\u30af\u30e9\u30b9I<\/b><span style=\"font-weight: 400;\"> \u3092\u610f\u5473\u3057\u307e\u3059\u3002 <\/span><b>\u4e00\u822c\u7684\u306a\u5236\u5fa1\u306e\u307f\u304c\u9069\u7528\u3055\u308c\u308b\u30c7\u30d0\u30a4\u30b9\u306e\u30af\u30e9\u30b9<\/b><span style=\"font-weight: 400;\"> \u627f\u8a8d\u3055\u308c\u305f\u3001\u307e\u305f\u306f <\/span><b>\u6cd5\u306e\u7b2c501\u6761\uff08\u7c97\u60aa\u54c1\uff09\u3001\u7b2c502\u6761\uff08\u4e0d\u5f53\u8868\u793a\uff09\u3001\u7b2c510\u6761\uff08\u767b\u9332\uff09\u3001\u7b2c516\u6761\uff08\u7981\u6b62\u3055\u308c\u305f\u88c5\u7f6e\uff09\u3001\u7b2c518\u6761\uff08\u901a\u77e5\u304a\u3088\u3073\u305d\u306e\u4ed6\u306e\u6551\u6e08\u63aa\u7f6e\uff09\u3001\u7b2c519\u6761\uff08\u8a18\u9332\u304a\u3088\u3073\u5831\u544a\uff09\u3001\u7b2c520\u6761\uff08\u4e00\u822c\u898f\u5b9a\uff09\u306b\u57fa\u3065\u304d<\/b><span style=\"font-weight: 400;\">. <\/span><i><span style=\"font-weight: 400;\">(i) \u88c5\u7f6e\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u5408\u7406\u7684\u306b\u4fdd\u8a3c\u3059\u308b\u306e\u306b\u5341\u5206\u306a\u4e00\u822c\u7ba1\u7406\u304c\u884c\u308f\u308c\u3066\u3044\u308b\u5834\u5408\u3001\u305d\u306e\u88c5\u7f6e\u306f\u30af\u30e9\u30b9I\u306b\u5c5e\u3059\u308b\u3002<\/span><\/i><span style=\"font-weight: 400;\">\u307e\u305f\u306f\u3001(ii)\u4e00\u822c\u7684\u306a\u7ba1\u7406\u4f53\u5236\u304c\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u5408\u7406\u7684\u306b\u4fdd\u8a3c\u3059\u308b\u306e\u306b\u5341\u5206\u3067\u3042\u308b\u3068\u5224\u65ad\u3059\u308b\u305f\u3081\u306e\u60c5\u5831\u3084\u3001\u305d\u306e\u3088\u3046\u306a\u4fdd\u8a3c\u3092\u63d0\u4f9b\u3059\u308b\u305f\u3081\u306e\u7279\u5225\u306a\u7ba1\u7406\u4f53\u5236\u3092\u78ba\u7acb\u3059\u308b\u305f\u3081\u306e\u60c5\u5831\u304c\u4e0d\u5341\u5206\u3067\u3042\u308b\u304c\u3001\u305d\u306e\u6a5f\u5668\u304c\u751f\u547d\u7dad\u6301\u88c5\u7f6e\u3084\u4eba\u306e\u5065\u5eb7\u306e\u969c\u5bb3\u3092\u9632\u3050\u4e0a\u3067\u5b9f\u8cea\u7684\u306b\u91cd\u8981\u306a\u7528\u9014\u3067\u306f\u306a\u304f\u3001\u75c5\u6c17\u3084\u602a\u6211\u306e\u6f5c\u5728\u7684\u306a\u4e0d\u5408\u7406\u306a\u30ea\u30b9\u30af\u3092\u3082\u305f\u3089\u3055\u306a\u3044\u3082\u306e\u3067\u3042\u308b\u5834\u5408\u3002***<\/span><\/p>\n<p><b>\u30af\u30e9\u30b9II<\/b><span style=\"font-weight: 400;\"> \u3092\u610f\u5473\u3057\u307e\u3059\u3002 <\/span><b>\u7279\u5225\u306a\u7ba1\u7406\u3092\u53d7\u3051\u3066\u3044\u308b\u3001\u307e\u305f\u306f\u5c06\u6765\u53d7\u3051\u308b\u3053\u3068\u306b\u306a\u308b\u30c7\u30d0\u30a4\u30b9\u306e\u30af\u30e9\u30b9<\/b><span style=\"font-weight: 400;\">. <\/span><i><span style=\"font-weight: 400;\">\u4e00\u822c\u7684\u306a\u7ba1\u7406\u3060\u3051\u3067\u306f\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u5408\u7406\u7684\u306b\u4fdd\u8a3c\u3059\u308b\u306b\u306f\u4e0d\u5341\u5206\u3067\u3042\u308a\u3001\u6027\u80fd\u57fa\u6e96\u306e\u516c\u5e03\u3001\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3001\u60a3\u8005\u767b\u9332\u3001\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306e\u4f5c\u6210\u3068\u914d\u5e03\u306a\u3069\u306e\u7279\u5225\u306a\u7ba1\u7406\u3092\u78ba\u7acb\u3059\u308b\u306e\u306b\u5341\u5206\u306a\u60c5\u5831\u304c\u3042\u308b\u5834\u5408\u3001\u305d\u306e\u6a5f\u5668\u306f\u30af\u30e9\u30b9II\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002 <\/span><\/i><span style=\"font-weight: 400;\">(\u6cd5\u306e\u7b2c510(k)\u6761\u306b\u57fa\u3065\u304f\u5e02\u8ca9\u5f8c\u306e\u5c4a\u51fa\u306b\u304a\u3051\u308b\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u63d0\u51fa\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u542b\u3080\uff09\u3001\u52e7\u544a\u3001\u304a\u3088\u3073\u305d\u306e\u4ed6\u306e\u9069\u5207\u306a\u884c\u52d5\u3092\u3001\u59d4\u54e1\u4f1a\u304c\u305d\u306e\u3088\u3046\u306a\u4fdd\u8a3c\u3092\u63d0\u4f9b\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u3067\u3042\u308b\u3068\u307f\u306a\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">\u4eba\u9593\u306e\u751f\u547d\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u308b\u3068\u79f0\u3055\u308c\u3066\u3044\u308b\u6a5f\u5668\u306e\u5834\u5408<\/span><\/i><span style=\"font-weight: 400;\">, <\/span><i><span style=\"font-weight: 400;\">\u59d4\u54e1\u4f1a\u306f\u3001\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306e\u5341\u5206\u306a\u4fdd\u8a3c\u3092\u63d0\u4f9b\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u7279\u5225\u306a\u7ba1\u7406\u304c\u3042\u308b\u5834\u5408\u306f\u3001\u305d\u308c\u3092\u8abf\u67fb\u3057\u3066\u7279\u5b9a\u3057\u3001\u5f53\u8a72\u7ba1\u7406\u304c\u3069\u306e\u3088\u3046\u306b\u5f53\u8a72\u4fdd\u8a3c\u3092\u63d0\u4f9b\u3057\u3066\u3044\u308b\u304b\u3092\u8aac\u660e\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/span><\/i><span style=\"font-weight: 400;\">. ***<\/span><\/p>\n<p><b>\u30af\u30e9\u30b9III<\/b><span style=\"font-weight: 400;\"> \u3092\u610f\u5473\u3057\u307e\u3059\u3002 <\/span><b>\u6cd5\u306e\u7b2c515\u6761\u306b\u57fa\u3065\u3044\u3066\u5e02\u8ca9\u627f\u8a8d\u304c\u5fc5\u8981\u3068\u3055\u308c\u308b\u3001\u307e\u305f\u306f\u5fc5\u8981\u3068\u306a\u308b\u6a5f\u5668\u306e\u30af\u30e9\u30b9<\/b><span style=\"font-weight: 400;\">. <\/span><i><span style=\"font-weight: 400;\">\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u5408\u7406\u7684\u306b\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306e\u4e00\u822c\u7684\u306a\u7ba1\u7406\u304c\u5341\u5206\u306b\u884c\u308f\u308c\u3066\u3044\u308b\u3068\u5224\u65ad\u3059\u308b\u306b\u306f\u5341\u5206\u306a\u60c5\u5831\u304c\u5b58\u5728\u3057\u306a\u3044\u5834\u5408\u3001\u305d\u306e\u6a5f\u5668\u306f\u30af\u30e9\u30b9III\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002<\/span><\/i><span style=\"font-weight: 400;\"> \u307e\u305f\u306f\u3001\u672c\u9805(c)(2)\u306b\u8a18\u8f09\u3055\u308c\u305f\u7279\u5225\u306a\u7ba1\u7406\u3092\u9069\u7528\u3059\u308b\u3053\u3068\u306b\u3088\u308a\u3001\u305d\u306e\u3088\u3046\u306a\u4fdd\u8a3c\u304c\u5f97\u3089\u308c\u308b\u5834\u5408\u3067\u3001\u3055\u3089\u306b\u3001\u305d\u306e\u6a5f\u5668\u304c\u751f\u547d\u7dad\u6301\u88c5\u7f6e\u307e\u305f\u306f\u751f\u547d\u7d99\u7d9a\u88c5\u7f6e\u3067\u3042\u308b\u5834\u5408\u3001\u307e\u305f\u306f\u3001\u4eba\u9593\u306e\u5065\u5eb7\u969c\u5bb3\u3092\u9632\u6b62\u3059\u308b\u4e0a\u3067\u5b9f\u8cea\u7684\u306b\u91cd\u8981\u306a\u7528\u9014\u3067\u3042\u308b\u5834\u5408\u3001\u307e\u305f\u306f\u3001\u305d\u306e\u6a5f\u5668\u304c\u75c5\u6c17\u3084\u602a\u6211\u306e\u6f5c\u5728\u7684\u306a\u4e0d\u5408\u7406\u306a\u30ea\u30b9\u30af\u3092\u3082\u305f\u3089\u3059\u5834\u5408\u3002\"<\/span><b>[2]<\/b><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Has_the_classification_already_been_defined\"><\/span><span style=\"font-weight: 400;\"><strong>\u5206\u985e\u306f\u3059\u3067\u306b\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u307e\u3059\u304b\uff1f<\/strong> <\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u7c73\u56fd\u9023\u90a6\u898f\u5247\u96c6\u306e\u30bf\u30a4\u30c8\u30eb21\u306e\u30d1\u30fc\u30c8862\u304b\u3089892\u3092\u691c\u7d22\u3059\u308b\u3053\u3068\u3067\u3001\u305d\u306e\u88fd\u54c1\u306b\u5206\u985e\u304c\u3059\u3067\u306b\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<br \/>\n21 CFR\u306e\u30bb\u30af\u30b7\u30e7\u30f3860.1(b)\u306b\u306f\u3001\u6b21\u306e\u3088\u3046\u306b\u66f8\u304b\u308c\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\"<\/span><b>\u3053\u306e\u30d1\u30fc\u30c8\u3067\u306f\u3001\u4f7f\u7528\u3059\u3079\u304d\u57fa\u6e96\u3068\u624b\u9806\u3092\u898f\u5b9a\u3057\u3066\u3044\u307e\u3059\u3002<\/b><span style=\"font-weight: 400;\"> \u5206\u985e\u59d4\u54e1\u4f1a\u304c\u52e7\u544a\u3092\u884c\u3046\u969b\u3001\u304a\u3088\u3073\u30b3\u30df\u30c3\u30b7\u30e7\u30ca\u30fc\u304c <\/span><b>\u4f5c\u308b\u3053\u3068\u3067<\/b><span style=\"font-weight: 400;\"> \u30b3\u30df\u30c3\u30b7\u30e7\u30ca\u30fc\u306e <\/span><b>\u7279\u5b9a\u306e\u6a5f\u5668\u306b\u9069\u3057\u305f\u898f\u5236\u306e\u30af\u30e9\u30b9\uff08\u30af\u30e9\u30b9I\u3001\u30af\u30e9\u30b9II\u3001\u307e\u305f\u306f\u30af\u30e9\u30b9III\uff09\u306b\u95a2\u3059\u308b\u6c7a\u5b9a\u3092\u884c\u3044\u307e\u3059\u3002<\/b><span style=\"font-weight: 400;\"> \u8aee\u554f\u59d4\u54e1\u4f1a\u3092\u7ba1\u7406\u3059\u308b\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\u306e\u4e00\u822c\u7684\u306a\u624b\u7d9a\u304d\u3092\u88dc\u8db3\u3059\u308b\u3082\u306e\uff08\u672c\u7ae0\u7b2c14\u90e8\uff09\u3002 <\/span><b>\u307e\u305f\u3001\u3053\u306e\u30d1\u30fc\u30c8\u3067\u306f\u3001\u88fd\u9020\u8005\u3001\u8f38\u5165\u8005\u3001\u304a\u3088\u3073\u305d\u306e\u4ed6\u306e\u5229\u5bb3\u95a2\u4fc2\u8005\u304c\u6a5f\u5668\u306e\u5206\u985e\u304a\u3088\u3073\u518d\u5206\u985e\u306e\u624b\u7d9a\u304d\u306b\u53c2\u52a0\u3059\u308b\u305f\u3081\u306e\u624b\u9806\u3092\u898f\u5b9a\u3057\u3066\u3044\u307e\u3059\u3002<\/b><span style=\"font-weight: 400;\">. <\/span><i><span style=\"font-weight: 400;\">\u307e\u305f\u3001\u3053\u306e\u30d1\u30fc\u30c8\u3067\u306f\u3001\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u5224\u65ad\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u30c7\u30fc\u30bf\u306e\u7a2e\u985e\u3084\u3001\u5206\u985e\u59d4\u54e1\u4f1a\u3084\u5206\u985e\u5909\u66f4\u624b\u7d9a\u304d\u306b\u95a2\u9023\u3057\u3066\u59d4\u54e1\u4f1a\u306b\u63d0\u51fa\u3055\u308c\u305f\u60c5\u5831\u304c\u4e00\u822c\u306b\u516c\u958b\u3055\u308c\u308b\u72b6\u6cc1\u306b\u3064\u3044\u3066\u3082\u8aac\u660e\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/i><span style=\"font-weight: 400;\">\".<\/span><b>[2]<\/b><\/p>\n<p><span style=\"font-weight: 400;\">\u00a0<\/span><span style=\"font-weight: 400;\">\u6a5f\u5668\u306e\u30af\u30e9\u30b9\u5206\u3051\u306f\u300121 CFR\u306e\u4e2d\u3067\u4ee5\u4e0b\u306e\u90e8\u5206\u306b\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u30d1\u30fc\u30c8862 - \u81e8\u5e8a\u5316\u5b66\u304a\u3088\u3073\u81e8\u5e8a\u6bd2\u7269\u5b66\u6a5f\u5668<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 864 - \u8840\u6db2\u5b66\u304a\u3088\u3073\u75c5\u7406\u5b66\u95a2\u9023\u6a5f\u5668<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 866 - \u514d\u75ab\u5b66\u304a\u3088\u3073\u5fae\u751f\u7269\u5b66\u95a2\u9023\u6a5f\u5668<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 868 - \u9ebb\u9154\u7528\u6a5f\u5668<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u30d1\u30fc\u30c8870 - \u5fc3\u8840\u7ba1\u30c7\u30d0\u30a4\u30b9<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 872 - \u6b6f\u79d1\u7528\u6a5f\u5668<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u30d1\u30fc\u30c8874 - \u8033\u3001\u9f3b\u3001\u304a\u3088\u3073\u5589\u306e\u30c7\u30d0\u30a4\u30b9<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u30d1\u30fc\u30c8876 - \u6d88\u5316\u5668\u7cfb\u30fb\u6ccc\u5c3f\u5668\u7cfb\u30c7\u30d0\u30a4\u30b9<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u30d1\u30fc\u30c8878 - \u4e00\u822c\u304a\u3088\u3073\u5f62\u6210\u5916\u79d1\u7528\u6a5f\u5668<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u30d1\u30fc\u30c8880 - \u4e00\u822c\u7684\u306a\u75c5\u9662\u3068\u500b\u4eba\u4f7f\u7528\u306e\u30c7\u30d0\u30a4\u30b9<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 882 - \u795e\u7d4c\u5b66\u7684\u30c7\u30d0\u30a4\u30b9<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u30d1\u30fc\u30c8884 - \u7523\u79d1\u30fb\u5a66\u4eba\u79d1\u7528\u6a5f\u5668<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u30d1\u30fc\u30c8886 - \u773c\u79d1\u7528\u6a5f\u5668<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u30d1\u30fc\u30c8888 - \u6574\u5f62\u5916\u79d1\u7528\u6a5f\u5668<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u30d1\u30fc\u30c8890 - \u7269\u7406\u7684\u533b\u7642\u6a5f\u5668<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 892 - \u653e\u5c04\u7dda\u6a5f\u5668<\/span><\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Narrowing_down_the_specific_device_classification\"><\/span><strong>\u5177\u4f53\u7684\u306a\u6a5f\u5668\u5206\u985e\u306e\u7d5e\u308a\u8fbc\u307f<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u4eca\u56de\u306e\u624b\u8853\u7528\u30e1\u30b9\u3092\u5b9a\u7fa9\u3059\u308b\u305f\u3081\u306b\u3001\u30d1\u30fc\u30c8878\u300c\u4e00\u822c\u304a\u3088\u3073\u6574\u5f62\u5916\u79d1\u7528\u6a5f\u5668\u300d\u306b\u6ce8\u76ee\u3057\u307e\u3059\u3002  \u3053\u306e\u30d1\u30fc\u30c8\u3067\u306f\u3001878.4800\u9805\u306b\u624b\u8853\u7528\u30e1\u30b9\u306e\u9069\u5207\u306a\u5206\u985e\u304c\u3042\u308b\u3002  \u3053\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3042\u308b\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\"<\/span><b>\u4e00\u822c\u7528\u306e\u624b\u52d5\u5f0f\u624b\u8853\u5668\u5177\u3002<\/b><\/p>\n<p><span style=\"font-weight: 400;\">(a) \u8b58\u5225\u3002 <\/span><i><span style=\"font-weight: 400;\">\u4e00\u822c\u7684\u306b\u4f7f\u7528\u3055\u308c\u308b\u624b\u52d5\u5f0f\u624b\u8853\u5668\u5177\u3068\u306f\u3001\u52d5\u529b\u3092\u4f7f\u308f\u306a\u3044\u3001\u624b\u3067\u6301\u3063\u305f\u3001\u307e\u305f\u306f\u624b\u3067\u64cd\u4f5c\u3059\u308b\u5668\u5177\u306e\u3053\u3068\u3067\u3059\u3002<\/span><\/i><span style=\"font-weight: 400;\">\u306e\u3044\u305a\u308c\u304b\u306b\u306a\u308a\u307e\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">\u518d\u5229\u7528\u53ef\u80fd<\/span><\/i><span style=\"font-weight: 400;\"> \u3084\u4f7f\u3044\u6368\u3066\u306b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">\u69d8\u3005\u306a\u4e00\u822c\u7684\u306a\u5916\u79d1\u624b\u8853\u306b\u4f7f\u7528\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/i><span style=\"font-weight: 400;\">.\u30c7\u30d0\u30a4\u30b9\u306b\u306f\u3001\u30a2\u30d7\u30ea\u30b1\u30fc\u30bf\u30fc\u3001\u30af\u30ea\u30c3\u30d7\u30a2\u30d7\u30e9\u30a4\u30e4\u30fc\u3001\u30d0\u30a4\u30aa\u30d7\u30b7\u30fc\u30d6\u30e9\u30b7\u3001\u30de\u30cb\u30e5\u30a2\u30eb\u30c0\u30fc\u30de\u30d6\u30ec\u30fc\u30b8\u30e7\u30f3\u30d6\u30e9\u30b7\u3001\u30b9\u30af\u30e9\u30d6\u30d6\u30e9\u30b7\u3001\u30ab\u30cb\u30e5\u30fc\u30ec\u3001\u30ea\u30ac\u30c1\u30e3\u30fc\u30ad\u30e3\u30ea\u30a2\u3001\u30c1\u30bc\u30eb\u3001\u30af\u30e9\u30f3\u30d7\u3001\u30b3\u30f3\u30c8\u30e9\u30af\u30bf\u30fc\u3001\u30ad\u30e5\u30ec\u30c3\u30c8\u306a\u3069\u304c\u3042\u308a\u307e\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">\u30ab\u30c3\u30bf\u30fc<\/span><\/i><span style=\"font-weight: 400;\">, <\/span><i><span style=\"font-weight: 400;\">\u30c7\u30a3\u30bb\u30af\u30bf<\/span><\/i><span style=\"font-weight: 400;\">\u30a8\u30ec\u30d9\u30fc\u30bf\u30fc\u3001\u76ae\u819a\u79fb\u690d\u7528\u30a8\u30ad\u30b9\u30d1\u30f3\u30c0\u30fc\u3001\u30e4\u30b9\u30ea\u3001\u9257\u5b50\u3001\u30ac\u30a6\u30b8\u3001\u30a4\u30f3\u30b9\u30c4\u30eb\u30e1\u30f3\u30c8\u30ac\u30a4\u30c9\u3001\u30cb\u30fc\u30c9\u30eb\u30ac\u30a4\u30c9\u3001\u30cf\u30f3\u30de\u30fc\u3001\u6b62\u8840\u9257\u5b50\u3001\u5207\u65ad\u7528\u30d5\u30c3\u30af\u3001\u7d50\u7d2e\u30d1\u30b9\u3001\u7d50\u675f\u7528\u5668\u5177\u3002 <\/span><b><i>\u30ca\u30a4\u30d5<\/i><\/b><span style=\"font-weight: 400;\">\u8840\u6db2\u30e9\u30f3\u30bb\u30c3\u30c8\u3001\u30de\u30ec\u30c3\u30c8\u3001\u4f7f\u3044\u6368\u3066\u307e\u305f\u306f\u518d\u5229\u7528\u53ef\u80fd\u306a\u5438\u5f15\u30fb\u6ce8\u5c04\u91dd\u3001\u4f7f\u3044\u6368\u3066\u307e\u305f\u306f\u518d\u5229\u7528\u53ef\u80fd\u306a\u7e2b\u5408\u91dd\u3001\u30aa\u30b9\u30c6\u30aa\u30c8\u30fc\u30e0\u3001\u30d7\u30e9\u30a4\u30e4\u30fc\u3001\u30e9\u30b9\u30d7\u3001\u30ea\u30c6\u30fc\u30ca\u30fc\u3001\u30ea\u30c8\u30e9\u30af\u30bf\u30fc\u3001\u30bd\u30fc\u3002 <\/span><b><i>\u30e1\u30b9\u306e\u5203<\/i><\/b><span style=\"font-weight: 400;\">, <\/span><b><i>\u30e1\u30b9\u306e\u67c4<\/i><\/b><span style=\"font-weight: 400;\">, <\/span><b><i>\u30ef\u30f3\u30d4\u30fc\u30b9\u30fb\u30e1\u30b9<\/i><\/b><span style=\"font-weight: 400;\">\u30b9\u30cd\u30a2\u3001\u30b9\u30d1\u30c1\u30e5\u30e9\u3001\u30b9\u30c6\u30fc\u30d7\u30e9\u30fc\u3001\u4f7f\u3044\u6368\u3066\u307e\u305f\u306f\u518d\u4f7f\u7528\u53ef\u80fd\u306a\u30b9\u30c8\u30ea\u30c3\u30d1\u30fc\u3001\u30b9\u30bf\u30a4\u30ec\u30c3\u30c8\u3001\u80c3\u3084\u8178\u306e\u7e2b\u5408\u5668\u5177\u3001\u30e1\u30b8\u30e3\u30fc\u3001\u30ce\u30ae\u30b9\u3002\u7279\u5b9a\u306e\u533b\u7642\u5c02\u9580\u5206\u91ce\u306b\u7279\u5316\u3057\u305f\u7528\u9014\u3092\u6301\u3064\u624b\u8853\u5668\u5177\u306f\u3001\u30d1\u30fc\u30c8868\u304b\u3089892\u306e\u5225\u306e\u898f\u5247\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">(b) <\/span><b>\u5206\u985e<\/b><span style=\"font-weight: 400;\">. <\/span><i><\/i>\u30af\u30e9\u30b9I\uff08\u4e00\u822c\u7684\u306a\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb<span style=\"font-weight: 400;\">.<br \/>\n<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u672c\u88c5\u7f6e\u306f\u3001\u00a7878.9\u306e\u5236\u9650\u306e\u3082\u3068\u3001\u672c\u7ae0\u30d1\u30fc\u30c8807\u306e\u30b5\u30d6\u30d1\u30fc\u30c8E\u306e\u5e02\u8ca9\u524d\u901a\u77e5\u624b\u7d9a\u304d\u304c\u514d\u9664\u3055\u308c\u307e\u3059\u3002\" <\/span><b>[2]<\/b><\/p>\n<blockquote><p><span style=\"font-weight: 400;\">\u3053\u306e\u5b9a\u7fa9\u306e\u4e2d\u3067\u3001\u4e00\u822c\u7684\u306b\u4f7f\u7528\u3055\u308c\u308b\u624b\u52d5\u306e\u624b\u8853\u5668\u5177\u3068\u3057\u3066\u3001\u5f53\u793e\u306e\u5916\u79d1\u7528\u30e1\u30b9\u306f\u30af\u30e9\u30b9I\u306e\u533b\u7642\u6a5f\u5668\u306b\u5206\u985e\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u00a0 <\/span><\/p><\/blockquote>\n<p><span style=\"font-weight: 400;\"><strong>\u3053\u308c\u306f\u3001\u3053\u306e\u6a5f\u5668\u304cFDA\u304c\u898f\u5b9a\u3059\u308b\u4e00\u822c\u7684\u306a\u7ba1\u7406\u8981\u4ef6\u306e\u78ba\u7acb\u3092\u5fc5\u8981\u3068\u3059\u308b\u3053\u3068\u3092\u610f\u5473\u3057\u307e\u3059\u3002\u00a0<\/strong> \u3053\u308c\u3089\u306e\u4e00\u822c\u7684\u306a\u7ba1\u7406\u8981\u4ef6\u306f\u3001\u7c73\u56fd\u9023\u90a6\u98df\u54c1\u533b\u85ac\u54c1\u5316\u7ca7\u54c1\u6cd5\u306e\u4e2d\u3067\u5b9a\u7fa9\u3055\u308c\u3066\u304a\u308a\u3001\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\u3002\u00a0<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u7b2c501\u6761\uff08\u7c97\u60aa\u54c1<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u7b2c502\u6761\uff08\u4e0d\u5f53\u8868\u793a<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u7b2c510\u6761\uff08\u767b\u9332<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u30bb\u30af\u30b7\u30e7\u30f3516\uff08\u7981\u6b62\u3055\u308c\u3066\u3044\u308b\u30c7\u30d0\u30a4\u30b9<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u7b2c518\u6761\uff08\u901a\u77e5\u304a\u3088\u3073\u305d\u306e\u4ed6\u306e\u6551\u6e08\u63aa\u7f6e<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u7b2c519\u6761\uff08\u8a18\u9332\u3068\u5831\u544a<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u7b2c520\u6761\uff08\u4e00\u822c\u898f\u5b9a<\/span><\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Regulatory_Pathway_for_Class_II_Medical_Devices\"><\/span><strong>\u30af\u30e9\u30b9II\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u7d4c\u8def<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u4ed6\u306e\u6a5f\u5668\u3068\u305d\u306e\u898f\u5b9a\u8981\u4ef6\u3092\u5206\u985e\u5225\u306b\u8003\u3048\u3066\u307f\u307e\u3057\u3087\u3046\u3002  \u5203\u7269\u306b\u30d1\u30ef\u30fc\u3092\u52a0\u3048\u3066\u30ea\u30b9\u30af\u30ab\u30c6\u30b4\u30ea\u30fc\u3092\u4e0a\u3052\u308c\u3070\u3001\u30af\u30e9\u30b9II\u306e\u533b\u7642\u6a5f\u5668\u306b\u306a\u308a\u307e\u3059\u300221 CFR Section 878.4400\u306b\u306f\u6b21\u306e\u3088\u3046\u306b\u66f8\u304b\u308c\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\"<\/span><b>\u96fb\u6c17\u5916\u79d1\u7528\u306e\u5207\u65ad\u30fb\u51dd\u56fa\u88c5\u7f6e\u3068\u305d\u306e\u4ed8\u5c5e\u54c1\u3002<\/b><\/p>\n<p><span style=\"font-weight: 400;\">(a) \u8b58\u5225\u3002\u96fb\u6c17\u5916\u79d1\u7528\u5207\u65ad\u30fb\u51dd\u56fa\u88c5\u7f6e\u304a\u3088\u3073\u4ed8\u5c5e\u54c1\u3068\u306f\u3001\u9ad8\u5468\u6ce2\u96fb\u6d41\u3092\u7528\u3044\u3066\u7d44\u7e54\u3092\u9664\u53bb\u3057\u3001\u51fa\u8840\u3092\u6291\u3048\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u305f\u88c5\u7f6e\u3067\u3042\u308b\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">(b) \u5206\u985e <\/span><span style=\"font-weight: 400;\">\u30af\u30e9\u30b9\u2161\u300d\u3067\u3059\u3002<\/span><b>[2]<\/b><\/p>\n<p><span style=\"font-weight: 400;\">\u3055\u3066\u3001\u79c1\u305f\u3061\u306f\u30ea\u30b9\u30af\u30af\u30e9\u30b9\u3092\u30af\u30e9\u30b9II\u306e\u898f\u5236\u5bfe\u8c61\u533b\u7642\u6a5f\u5668\u306b\u683c\u4e0a\u3052\u3057\u305f\u305f\u3081\u3001\u79c1\u305f\u3061\u306e\u88fd\u54c1\u306b\u306fFDA\u306e\u5e02\u8ca9\u524d\u7533\u8acb\u30d7\u30ed\u30bb\u30b9\u306b\u3088\u308b\u8a31\u53ef\u304c\u5fc5\u8981\u3068\u306a\u308a\u307e\u3057\u305f\u3002  \u3053\u306e\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u88fd\u54c1\u304c\u7c73\u56fd\u3067\u306e\u8ca9\u58f2\u8a31\u53ef\u3092\u5f97\u308b\u524d\u306b\u5fc5\u8981\u3067\u3059\u3002 \u00a0 <strong>\u307e\u305f\u3001\u30af\u30e9\u30b9II\u6a5f\u5668\u3068\u3057\u3066\u306e\u8981\u6c42\u4e8b\u9805\u306f\u3001\u4e00\u822c\u7684\u306a\u7ba1\u7406\u304b\u3089\u3001\u533b\u7642\u6a5f\u5668\u306e\u88fd\u9020\u306b\u95a2\u3059\u308b\u73fe\u884c\u306e\u9069\u6b63\u88fd\u9020\u57fa\u6e96\u3067\u5b9a\u3081\u3089\u308c\u305f\u7ba1\u7406\u3078\u3068\u767a\u5c55\u3057\u307e\u3059\u3002\u00a0<\/strong><\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u3053\u308c\u3089\u306e\u8981\u6c42\u4e8b\u9805\u306f\u3001\u8a2d\u8a08\u3001\u88fd\u9020\u5de5\u7a0b\u3001\u5168\u4f53\u7684\u306a\u54c1\u8cea\u3092\u7ba1\u7406\u3059\u308b\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3092\u69cb\u7bc9\u3057\u3001FDA\u304a\u3088\u3073\u8abf\u548c\u3057\u305f\u898f\u683c\u3067\u898f\u5b9a\u3055\u308c\u305f\u8981\u6c42\u4e8b\u9805\u306b\u6e96\u62e0\u3059\u308b\u3053\u3068\u3092\u610f\u5473\u3057\u307e\u3059\u3002  \u79c1\u306f\u3001FDA\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30ac\u30a4\u30c0\u30f3\u30b9\u30d7\u30ed\u30b0\u30e9\u30e0\u30de\u30cb\u30e5\u30a2\u30eb\u306e\u4e2d\u306b\u3001\u3053\u308c\u3089\u306e\u8981\u6c42\u4e8b\u9805\u306e\u6709\u7528\u306a\u30ea\u30b9\u30c8\u3092\u898b\u3064\u3051\u307e\u3057\u305f\u3002  FDA\u306eCPGM 7382.845\u300c\u533b\u7642\u6a5f\u5668\u88fd\u9020\u696d\u8005\u306e\u691c\u67fb\u300d\u3067\u3059\u3002 <\/span><b>[3]<\/b><span style=\"font-weight: 400;\">\u7c73\u56fd\u9023\u90a6\u898f\u5247\u96c6\u306e\u30bf\u30a4\u30c8\u30eb21\u3067\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u308b\u8981\u4ef6\u3092\u8a18\u8f09\u3057\u3066\u3044\u307e\u3059\u3002 <\/span><b>[2]<\/b><span style=\"font-weight: 400;\">.\u305d\u306e\u6761\u4ef6\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\u3002<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 7, Subpart C, \u30ea\u30b3\u30fc\u30eb<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 11, \u96fb\u5b50\u8a18\u9332\u3068\u96fb\u5b50\u7f72\u540d<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u30d1\u30fc\u30c816\u306817\u3001\u30d2\u30a2\u30ea\u30f3\u30b0\u306e\u624b\u9806<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u30d1\u30fc\u30c8800\u3001\u30b5\u30d6\u30d1\u30fc\u30c8C\u3001\u884c\u653f\u62d8\u7981<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 803, \u533b\u7642\u6a5f\u5668\u306e\u5831\u544a<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 806, \u8a02\u6b63\u3068\u524a\u9664\u306e\u30ec\u30dd\u30fc\u30c8<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 807, \u8a2d\u7acb\u767b\u9332\u3068\u30c7\u30d0\u30a4\u30b9\u30ea\u30b9\u30c8<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Part 809.10, \u4f53\u5916\u8a3a\u65ad\u7528\u6a5f\u5668\u306e\u30e9\u30d9\u30ea\u30f3\u30b0<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u30d1\u30fc\u30c8810\u3001\u533b\u7642\u6a5f\u5668\u30ea\u30b3\u30fc\u30eb\u306e\u6a29\u9650<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u30d1\u30fc\u30c8820\u3001\u73fe\u884c\u306e\u9069\u6b63\u88fd\u9020\u57fa\u6e96\/\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u898f\u5236<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u30d1\u30fc\u30c8821\u3001\u30c8\u30e9\u30c3\u30ad\u30f3\u30b0\u8981\u4ef6<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u90e8\u54c11000-1050\u3001\u653e\u5c04\u7dda\u898f\u5236\u3068\u57fa\u6e96<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u3059\u3079\u3066\u306e\u30af\u30e9\u30b9II\u307e\u305f\u306f\u30af\u30e9\u30b9III\u88fd\u54c1\u306f\u3001\u6a5f\u5668\u306b\u95a2\u9023\u3059\u308b\u3053\u308c\u3089\u306e\u8981\u6c42\u4e8b\u9805\u3092\u6e80\u305f\u3055\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\uff08\u30c8\u30e9\u30c3\u30ad\u30f3\u30b0\u8981\u6c42\u4e8b\u9805\u3068\u653e\u5c04\u7dda\u898f\u5236\u306f\u6a5f\u5668\u306b\u56fa\u6709\u3067\u3059\uff09\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30af\u30e9\u30b9II\u88fd\u54c1\u306e\u958b\u767a\u306b\u5f15\u304d\u7d9a\u304d\u3001\u5e02\u8ca9\u524d\u306e\u7533\u8acb\u30d7\u30ed\u30bb\u30b9\u306b\u3064\u3044\u3066\u898b\u3066\u307f\u307e\u3057\u3087\u3046\u3002 <\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"FDA_510K_submission_Pre-market_submission\"><\/span><strong>FDA 510(K)\u306e\u63d0\u51fa\u5e02\u8ca9\u524d\u7533\u8acb<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u306f\u3001FDA\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u304b\u3089\u5f15\u7528\u3057\u305f\u3053\u306e\u8a00\u8449\u306b\u96c6\u7d04\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\"<\/span><span style=\"font-weight: 400;\">A <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/510-k-submissions\">510(k)<\/a> \u306f\u3001\u5e02\u8ca9\u3055\u308c\u308b\u6a5f\u5668\u304c\u5408\u6cd5\u7684\u306b\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u6a5f\u5668\u3068\u540c\u7b49\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3001\u3059\u306a\u308f\u3061\u5b9f\u8cea\u7684\u306b\u540c\u7b49\u3067\u3042\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u305f\u3081\u306bFDA\u306b\u63d0\u51fa\u3059\u308b\u5e02\u8ca9\u524d\u306e\u7533\u8acb\u66f8\u3067\u3059\u3002*** \u7533\u8acb\u8005\u306f\u3001\u81ea\u793e\u306e\u6a5f\u5668\u30921\u3064\u4ee5\u4e0a\u306e\u985e\u4f3c\u3057\u305f\u5408\u6cd5\u7684\u306b\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u6a5f\u5668\u3068\u6bd4\u8f03\u3057\u3001\u5b9f\u8cea\u7684\u306a\u540c\u7b49\u6027\u306e\u4e3b\u5f35\u3092\u884c\u3044\u3001\u305d\u308c\u3092\u88cf\u4ed8\u3051\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\"<\/span><b>[4]<\/b><\/p>\n<p><span style=\"font-weight: 400;\">FDA\u306f\u3001\u305d\u306e\u30d7\u30ed\u30bb\u30b9\u306e\u900f\u660e\u6027\u3092\u9ad8\u3081\u308b\u305f\u3081\u3001510(k)\u306e\u63d0\u51fa\u30d7\u30ed\u30bb\u30b9\u306b\u95a2\u3059\u308b\u591a\u304f\u306e\u6709\u7528\u306a\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u767a\u8868\u3057\u3066\u3044\u307e\u3059\u3002  \u79c1\u304c\u304a\u52e7\u3081\u3059\u308b\u306e\u306f\u3001\u300cThe 510(k) Program\u300d\u3068\u3044\u3046\u30bf\u30a4\u30c8\u30eb\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u3059\u3002The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and Food and Drug Administration Staff\" \u3068\u3044\u3046\u30bf\u30a4\u30c8\u30eb\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u304a\u52e7\u3081\u3057\u307e\u3059\u3002<\/span><b>[5]<\/b><span style=\"font-weight: 400;\">.  \u3053\u306e\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u3067\u306f\u3001FDA\u306b\u5e02\u8ca9\u524d\u7533\u8acb\u3092\u63d0\u51fa\u3059\u308b\u969b\u306b\u3069\u306e\u3088\u3046\u306a\u60c5\u5831\u304c\u6c42\u3081\u3089\u308c\u308b\u304b\u3092\u660e\u3089\u304b\u306b\u3057\u3066\u3044\u307e\u3059\u3002\u63a1\u7528\u3059\u308b <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/510-k-submissions?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAPathways\">510(k)\u7533\u8acb\u306e\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/a> \u306f\u3001\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u6cbf\u3063\u3066\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u304c\u4f5c\u6210\u3055\u308c\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u78ba\u8a8d\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><a href=\"https:\/\/www.kolabtree.com\/blog\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAPathways\"><strong>\u3053\u3061\u3089\u3082\u304a\u8aad\u307f\u304f\u3060\u3055\u3044\u3002FDA\u306e\u8fc5\u901f\u306a\u627f\u8a8d\u3092\u5f97\u308b\u305f\u3081\u306b510(k)\u7533\u8acb\u3067\u907f\u3051\u308b\u3079\u304d\u30df\u30b9\u30c8\u30c3\u30d713<\/strong><\/a><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Q-submission_process\"><\/span><strong>Q-submission\u30d7\u30ed\u30bb\u30b9<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u5b9f\u8cea\u7684\u306b\u540c\u7b49\u3067\u3042\u308b\u304b\u3001\u65b0\u3057\u3044\u6a5f\u5668\u3067\u3042\u308b\u304b\u3001\u6280\u8853\u7684\u306b\u65b0\u3057\u3044\u6a5f\u5668\u3067\u3042\u308b\u304b\u3001\u65e2\u5b58\u306e\u6a5f\u5668\u3067\u65b0\u3057\u3044\u9069\u5fdc\u75c7\u306b\u4f7f\u7528\u3055\u308c\u308b\u3053\u3068\u304c\u671b\u307e\u308c\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u304c\u4e0d\u660e\u306a\u5834\u5408\u3001FDA\u306f\u6a5f\u5668\u306e\u5206\u985e\u3068\u30ea\u30b9\u30af\u30af\u30e9\u30b9\u306e\u56fa\u5b9a\u5316\u3092\u691c\u8a0e\u3059\u308b\u305f\u3081\u306e\u30e1\u30ab\u30cb\u30ba\u30e0\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u00a0<strong> \u3053\u308c\u306f\u3001\u958b\u767a\u306e\u9053\u3092\u9032\u3080\u524d\u306e\u30d9\u30b9\u30c8\u30fb\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u3067\u3042\u308b\u3068\u79c1\u306f\u8003\u3048\u3066\u3044\u307e\u3059\u3002  \u305d\u306e\u4ed5\u7d44\u307f\u3092\u300cQ-Submission\u30d7\u30ed\u30bb\u30b9\u300d\u3068\u547c\u3073\u307e\u3059\u3002<\/strong>\u00a0 <\/span><\/p>\n<p><span style=\"font-weight: 400;\">FDA\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001\u4e00\u90e8\u304c\u300c\u533b\u7642\u6a5f\u5668\u63d0\u51fa\u306e\u305f\u3081\u306e\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3068\u30df\u30fc\u30c6\u30a3\u30f3\u30b0\u306e\u8981\u6c42\u300d\u3068\u984c\u3055\u308c\u3066\u3044\u307e\u3059\u3002The Q-Submission Program Guidance for Industry and Food and Drug Administration Staff\u300d\u3068\u984c\u3057\u305f\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u3001FDA\u306f\u4ee5\u4e0b\u306e\u3088\u3046\u306b\u8a18\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cthis guidance is to provide an overview of the mechanisms available to submitters through which they can request feedback from or a meeting with the Food and Drug Administration (FDA) regarding potential or planned medical device Investigational Device Exemption (IDE) applications, Premarket Approval (PMA) applications, Humanitarian Device Exemption (HDE) applications, Evaluation of Automatic Class III Designations (De Novo requests), Premarket Notification (510(k)) Submissions, Clinical Laboratory Improvement Amendments (CLIA) Waiver by Applications (CW), Dual 510(k) and CLIA Waiver by Application Submissions (Duals), Accessory Classification Requests, and certain Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs) submitted to the Center for Biologics Evaluation and <a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">\u30ea\u30b5\u30fc\u30c1<\/a> (CBER)) (specifically, INDs and BLAs for devices that are regulated as biological products\u201d.<\/span><b>[6]<\/b><\/p>\n<p><span style=\"font-weight: 400;\">\u3042\u306a\u305f\u306e\u4f1a\u793e\u304c\u65b0\u3057\u3044\u6a5f\u5668\u3001\u30af\u30e9\u30b9II\u6a5f\u5668\u3001\u30af\u30e9\u30b9III\u6a5f\u5668\u3092\u5e02\u5834\u306b\u51fa\u3059\u3053\u3068\u3092\u610f\u56f3\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u306b\u95a2\u308f\u3089\u305a\u3001\u3042\u306a\u305f\u306e\u4f1a\u793e\u304cFDA\u306e\u6240\u5b9a\u306e\u7d4c\u8def\u306b\u5f93\u3046\u6c7a\u610f\u3068\u5fcd\u8010\u3092\u6301\u3063\u3066\u3044\u308b\u306a\u3089\u3070\u3001FDA\u306f\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u652f\u63f4\u3059\u308b\u3053\u3068\u306b\u524d\u5411\u304d\u3067\u3059\u3002  \u3053\u306e\u3088\u3046\u306a\u300c\u7533\u8acb\u524d\u300d\u306e\u30df\u30fc\u30c6\u30a3\u30f3\u30b0\u306f\u3001\u6a5f\u5668\u306e\u5206\u985e\u3001\u898f\u5236\u306e\u67a0\u7d44\u307f\u3001\u304a\u3088\u3073\u305d\u306e\u5206\u985e\u306b\u57fa\u3065\u3044\u3066\u958b\u767a\u8005\u304c\u5f93\u3046\u3079\u304d\u7d4c\u8def\u306b\u95a2\u3059\u308b\u57fa\u672c\u7684\u306a\u6c7a\u5b9a\u3092\u884c\u3046\u4e0a\u3067\u3001\u975e\u5e38\u306b\u91cd\u8981\u306a\u610f\u5473\u3092\u6301\u3061\u307e\u3059\u3002\u00a0 <\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30af\u30e9\u30b9I\u304a\u3088\u3073\u30af\u30e9\u30b9II\u306e\u88fd\u54c1\u306b\u3064\u3044\u3066\u306f\u3001\u3053\u308c\u3089\u306e\u7d4c\u8def\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u307e\u3057\u305f\u304c\u3001\u30c7\u30d0\u30a4\u30b9\u627f\u8a8d\u306e\u305f\u3081\u306e\u4ed6\u306e\u7d4c\u8def\u306b\u3064\u3044\u3066\u3082\u8a73\u3057\u304f\u8aac\u660e\u3057\u307e\u3059\u3002\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Regulatory_pathway_for_Class_III_medical_devices\"><\/span><span style=\"font-weight: 400;\"><strong>\u30af\u30e9\u30b9III\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u7d4c\u8def<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u30af\u30e9\u30b9III\u306e\u533b\u7642\u6a5f\u5668\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u4e2d\u3067\u3082\u6700\u3082\u30ea\u30b9\u30af\u306e\u9ad8\u3044\u30af\u30e9\u30b9\u306b\u5c5e\u3059\u308b\u3068\u8a8d\u8b58\u3055\u308c\u3066\u3044\u308b\u305f\u3081\u3001\u3053\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u307e\u3068\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002  FDA\u306f\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u3067\u305d\u306e\u4e00\u90e8\u3092\u8a18\u3057\u3066\u3044\u308b\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u300c\u30af\u30e9\u30b9III\u6a5f\u5668\u3068\u306f\u3001\u4eba\u306e\u751f\u547d\u3092\u7dad\u6301\u3059\u308b\u3082\u306e\u3001\u4eba\u306e\u5065\u5eb7\u3092\u640d\u306a\u3046\u3053\u3068\u3092\u9632\u3050\u4e0a\u3067\u5b9f\u8cea\u7684\u306b\u91cd\u8981\u306a\u3082\u306e\u3001\u307e\u305f\u306f\u75c5\u6c17\u3084\u602a\u6211\u306e\u6f5c\u5728\u7684\u306a\u4e0d\u5408\u7406\u306a\u30ea\u30b9\u30af\u3092\u3082\u305f\u3089\u3059\u3082\u306e\u3067\u3042\u308b\u3002\u30af\u30e9\u30b9III\u6a5f\u5668\u306f\u3001\u305d\u306e\u30ea\u30b9\u30af\u306e\u9ad8\u3055\u304b\u3089\u3001\u4e00\u822c\u7684\u306a\u7ba1\u7406\u3068\u7279\u5225\u306a\u7ba1\u7406\u3060\u3051\u3067\u306f\u3001\u30af\u30e9\u30b9III\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u4fdd\u8a3c\u3059\u308b\u306b\u306f\u4e0d\u5341\u5206\u3067\u3042\u308b\u3068FDA\u306f\u5224\u65ad\u3057\u3066\u3044\u308b\u3002\u3057\u305f\u304c\u3063\u3066\u3001\u3053\u308c\u3089\u306e\u6a5f\u5668\u306e\u8ca9\u58f2\u627f\u8a8d\u3092\u5f97\u308b\u305f\u3081\u306b\u306f\u3001FD&amp;C\u6cd5\u7b2c515\u6761\u306b\u57fa\u3065\u304f\u5e02\u8ca9\u524d\u627f\u8a8d\uff08PMA\uff09\u7533\u8acb\u304c\u5fc5\u8981\u3067\u3042\u308b\u3002\" <\/span><b>[7]<\/b><\/p>\n<p><span style=\"font-weight: 400;\">\u591a\u304f\u306eFDA\u30d7\u30ed\u30bb\u30b9\u3068\u540c\u69d8\u306b\u3001FDA\u306f\u30af\u30e9\u30b9III\u533b\u7642\u6a5f\u5668\u3092\u30af\u30ea\u30a2\u3059\u308b\u305f\u3081\u306e\u30d1\u30b9\u30a6\u30a7\u30a4\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u305f\u3081\u306b\u3001\u6570\u591a\u304f\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u767a\u884c\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p>\u30af\u30e9\u30b9III\u6a5f\u5668\u306e\u958b\u767a\u30d1\u30b9\u30a6\u30a7\u30a4\u3092\u305f\u3069\u308b\u4e0a\u3067\u3001\u79c1\u304c\u63a8\u5968\u3059\u308b2\u3064\u306e\u57fa\u790e\u7684\u306a\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> \u00a0 <\/span> <span style=\"font-weight: 400;\">Acceptance and Filing Reviews for \"You remind me of everything that followed.\u3042\u308c\u304b\u3089\u306e\u6bce\u65e5\u304c\u8d08\u308a\u7269\u3067\u3059\u3002\"\u7523\u696d\u754c\u3068\u98df\u54c1\u533b\u85ac\u54c1\u5c40\u30b9\u30bf\u30c3\u30d5\u306e\u305f\u3081\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3002<\/span><b>[8]<\/b><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 <\/span> <span style=\"font-weight: 400;\">Guidance for Industry and FDA Staff Premarket Approval Application Modular Review\u306e\u7565\u3002 <\/span><b>[9]<\/b><\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Pre-market_Approval\"><\/span><strong>\u5e02\u8ca9\u524d\u306e\u627f\u8a8d <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u5e02\u8ca9\u524d\u7533\u8acb\u3068\u540c\u69d8\u306b\u3001\u5e02\u8ca9\u524d\u627f\u8a8d\u7533\u8acb\u3067\u306f\u3001\u88fd\u54c1\u306e\u4f7f\u7528\u304c\u8a31\u53ef\u3055\u308c\u308b\u524d\u306b\u3001\u30c7\u30fc\u30bf\u306e\u30e2\u30b8\u30e5\u30fc\u30eb\u3092FDA\u306b\u63d0\u51fa\u3057\u3001\u5be9\u67fb\u3068\u627f\u8a8d\u3092\u53d7\u3051\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002  FDA\u306f\u3001\u958b\u767a\u306e\u904e\u7a0b\u3067\u958b\u767a\u8005\u3068\u95a2\u308f\u308a\u3092\u6301\u3064\u3053\u3068\u3067\u3001\u30c6\u30b9\u30c8\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u5b9f\u65bd\u524d\u5f8c\u306b\u8a55\u4fa1\u3067\u304d\u308b\u3053\u3068\u3092\u8a55\u4fa1\u3057\u3066\u3044\u307e\u3059\u3002\u9ad8\u30ea\u30b9\u30af\u306e\u6a5f\u5668\u3067\u306f\u3001\u8a2d\u8a08\u691c\u8a3c\u8a66\u9a13\uff08\u30d2\u30c8\u3067\u306e\u8a66\u9a13\uff09\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306b\u3001\u305d\u306e\u6a5f\u5668\u306e\u958b\u767a\u6d3b\u52d5\u306f\u3059\u3067\u306bFDA\u3068\u306e\u95a2\u308f\u308a\u3092\u5fc5\u8981\u3068\u3057\u3066\u3044\u308b\u3053\u3068\u304c\u591a\u3044\u3002  \u3053\u306e\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306e\u4ed5\u7d44\u307f\u306f\u3001IDE\uff08Investigational Device Exemption\uff09\u30d7\u30ed\u30bb\u30b9\u3092\u4ecb\u3057\u3066\u884c\u308f\u308c\u307e\u3059\u3002\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Class_III_Medical_Device_Regulatory_Pathway_Example\"><\/span><strong>\u30af\u30e9\u30b9III\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u30d1\u30b9\u30a6\u30a7\u30a4\u3002\u4f8b<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">IDE\u8a66\u9a13\u3092\u542b\u3080\u30af\u30e9\u30b9III\u306e\u7d4c\u8def\u3067\u958b\u767a\u3055\u308c\u308b\u30c7\u30d0\u30a4\u30b9\u306e\u4f8b\u3068\u3057\u3066\u3001\u4ee5\u4e0b\u306e\u3082\u306e\u3092\u8003\u3048\u3066\u307f\u307e\u3057\u3087\u3046\u3002<strong> \u5fc3\u8840\u7ba1\u30c7\u30d0\u30a4\u30b9<\/strong>.  \u3053\u308c\u3089\u306f\u3001\u901a\u5e38\u3001\u751f\u547d\u7dad\u6301\u3084\u9ad8\u30ea\u30b9\u30af\u306e\u6a5f\u5668\u3067\u3042\u308b\u305f\u3081\u3001\u30af\u30e9\u30b9III\u3067\u3042\u308b\u3053\u3068\u304c\u591a\u3044\u3002  \u3053\u306e\u4f8b\u3067\u306f\u3001\u5fc3\u5ba4\u88dc\u52a9\uff0f\u30d0\u30a4\u30d1\u30b9\u88c5\u7f6e\u3092\u8003\u3048\u3066\u307f\u307e\u3057\u3087\u3046\u3002  \u5fc3\u5ba4\u30d0\u30a4\u30d1\u30b9\uff08\u30a2\u30b7\u30b9\u30c8\uff09\u88c5\u7f6e\u306f\u300121 CFR 870.3545\u9805\u3067\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u307e\u3059\u3002  \u305d\u306e\u5b9a\u7fa9\u306e\u4e00\u90e8\u3092\u7d39\u4ecb\u3057\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u300c\u5fc3\u5ba4\u30d0\u30a4\u30d1\u30b9\uff08\u30a2\u30b7\u30b9\u30c8\uff09\u88c5\u7f6e\u3068\u306f\u3001\u5de6\u5fc3\u5ba4\u307e\u305f\u306f\u53f3\u5fc3\u5ba4\u304c\u5faa\u74b0\u8840\u6d41\u3092\u7dad\u6301\u3059\u308b\u306e\u3092\u88dc\u52a9\u3059\u308b\u88c5\u7f6e\u3067\u3042\u308b\u3002\u3053\u306e\u88c5\u7f6e\u306f\u3001\u5168\u4f53\u307e\u305f\u306f\u90e8\u5206\u7684\u306b\u4f53\u5185\u306b\u57cb\u3081\u8fbc\u307e\u308c\u307e\u3059\u3002***<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u5206\u985e\u3057\u3066\u3044\u307e\u3059\u3002 <\/span><span style=\"font-weight: 400;\">\u30af\u30e9\u30b9III\uff08\u5e02\u8ca9\u524d\u627f\u8a8d\uff09\" <\/span><b>[2]<\/b><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Investigational_Device_Exemption_IDE_pathway\"><\/span><strong>\u6cbb\u9a13\u85ac\u514d\u9664\uff08IDE\uff09\u306e\u7d4c\u8def<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">IDE\uff08Investigational Device Exemption\uff09\u306f\u3001\u8a2d\u8a08\u691c\u8a3c\u306e\u305f\u3081\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u53ce\u96c6\u3092\u76ee\u7684\u3068\u3057\u305f\u5bfe\u7167\u8a66\u9a13\u3078\u306e\u4f7f\u7528\u8a31\u53ef\u3092\u5fc5\u8981\u3068\u3059\u308b\u9ad8\u30ea\u30b9\u30af\u88fd\u54c1\u306e\u305f\u3081\u306e\u7d4c\u8def\u3067\u3059\u3002  FDA\u306f\u3001\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u5b9f\u8a3c\u3059\u308b\u305f\u3081\u306e\u8a55\u4fa1\u306b\u8a66\u4f5c\u54c1\u3092\u4f7f\u7528\u3067\u304d\u308b\u3088\u3046\u3001\u3053\u306e\u7d4c\u8def\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002  IDE\u30d1\u30b9\u30a6\u30a7\u30a4\u3092\u5229\u7528\u3059\u308b\u305f\u3081\u306e\u7279\u5225\u306a\u8981\u4ef6\u304c\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u307e\u3059\u3002  \u3053\u308c\u3089\u306e\u8981\u4ef6\u3092\u4ee5\u4e0b\u306b\u793a\u3057\u307e\u3059\u3002<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">21 CFR 812, \u6cbb\u9a13\u85ac\u306e\u9069\u7528\u9664\u5916<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">21 CFR 50, \u4eba\u4f53\u306e\u4fdd\u8b77<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">21 CFR 56, \u6a5f\u95a2\u5185\u5be9\u67fb\u59d4\u54e1\u4f1a<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">21 CFR 54, \u81e8\u5e8a\u7814\u7a76\u8005\u306b\u3088\u308b\u91d1\u92ad\u7684\u958b\u793a<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">21 CFR 820 Subpart C, \u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u898f\u5236\u306e\u8a2d\u8a08\u7ba1\u7406<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u3053\u306e\u5fc3\u5ba4\u30d0\u30a4\u30d1\u30b9\uff08\u30a2\u30b7\u30b9\u30c8\uff09\u88c5\u7f6e\u306e\u8a2d\u8a08\u691c\u8a3c\u304a\u3088\u3073IE\u81e8\u5e8a\u8a66\u9a13\u306f\u3001FDA\u306e\u30af\u30e9\u30b9III\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u5e02\u8ca9\u524d\u627f\u8a8d\u3092\u5f97\u308b\u305f\u3081\u306e\u30de\u30a4\u30eb\u30b9\u30c8\u30fc\u30f3\u3068\u3057\u3066\u3001\u3053\u306eIDE\u958b\u767a\u7d4c\u8def\u3092\u4f7f\u7528\u3059\u308b\u5019\u88dc\u3068\u306a\u308a\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u958b\u767a\u8005\u304c\u3001\u81ea\u5206\u306e\u30c7\u30d0\u30a4\u30b9\u304c\u5206\u985e\u3055\u308c\u3066\u3044\u306a\u3044\u3001\u65b0\u898f\u6280\u8853\u3067\u3042\u308b\u3001\u307e\u305f\u306f\u65b0\u898f\u306e\u9069\u5fdc\u75c7\u3067\u3042\u308b\u3068\u8003\u3048\u3066\u3044\u308b\u5834\u5408\u3001\u958b\u767a\u306e\u305f\u3081\u306e\u7d4c\u8def\u306f\u3001FDA\u306e\u4ee3\u66ff\u7d4c\u8def\u306e1\u3064\u3092\u901a\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002  \u3053\u308c\u3089\u306e\u4ee3\u66ff\u7d4c\u8def\u306b\u306f\u3001HDE\uff08Humanitarian Device Exemption\uff09\u514d\u9664\u7d4c\u8def\u3001De Novo requests\u7d4c\u8def\u3001FDA\u306eBreakthrough and Emergency\u7d4c\u8def\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u7d4c\u8def\u3092\u500b\u5225\u306b\u5206\u89e3\u3057\u3001\u305d\u306e\u610f\u56f3\u306b\u57fa\u3065\u3044\u3066\u3069\u306e\u3088\u3046\u306b\u6a5f\u80fd\u3059\u308b\u304b\u3092\u8aac\u660e\u3057\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">FDA\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u300cMedical Device Classification Product Codes Guidance for Industry and Food and Drug Administration Staff\u300d\u306e\u811a\u6ce8\u306b\u306f\u3001\u6b21\u306e\u3088\u3046\u306a\u8a18\u8ff0\u304c\u3042\u308b\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u300c\u672a\u5206\u985e\u6a5f\u5668\u3068\u306f\u3001\u6539\u6b63\u524d\u306e\u6a5f\u5668\u3067\u3001\u5206\u985e\u898f\u5247\u304c\u516c\u5e03\u3055\u308c\u3066\u3044\u306a\u3044\u3082\u306e\u3092\u6307\u3057\u307e\u3059\u3002  \u5206\u985e\u3055\u308c\u3066\u3044\u306a\u3044\u6a5f\u5668\u306f\u3001CDRH\u306b510(k)\u5e02\u8ca9\u524d\u901a\u77e5\u3092\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u975e\u5206\u985e\u6a5f\u5668\u3068\u306f\u3001\u6539\u6b63\u5f8c\u306e\u6a5f\u5668\u306e\u3046\u3061\u3001\u7c73\u56fd\u653f\u5e9c\u304c\u8ca9\u58f2\u7533\u8acb\u306e\u5be9\u67fb\u3092\u884c\u3063\u3066\u3044\u306a\u3044\u3082\u306e\u3001\u307e\u305f\u306f\u3001\u305d\u306e\u3088\u3046\u306a\u8ca9\u58f2\u7533\u8acb\u306b\u5bfe\u3057\u3066\u7c73\u56fd\u653f\u5e9c\u304c\u6700\u7d42\u6c7a\u5b9a\u3092\u884c\u3063\u3066\u3044\u306a\u3044\u3082\u306e\u3092\u6307\u3057\u307e\u3059\u3002<\/span><b>[10]<\/b><\/p>\n<h2><span class=\"ez-toc-section\" id=\"De-Novo_request\"><\/span><strong>De-Novo\u30ea\u30af\u30a8\u30b9\u30c8<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">FDA\u306f\u5206\u985e\u3055\u308c\u3066\u3044\u306a\u3044\u6a5f\u5668\u3092510(k)\u30d7\u30ed\u30bb\u30b9\u3067\u63d0\u51fa\u3059\u308b\u3053\u3068\u3092\u63a8\u5968\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u79c1\u306f\u958b\u767a\u8005\u304c\u307e\u305aQ-Submission\u30d1\u30b9\u30a6\u30a7\u30a4\u306b\u5f93\u3063\u3066\u3001\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u30af\u30e9\u30b9\u306b\u95a2\u3057\u3066FDA\u304b\u3089\u540c\u610f\u3092\u5f97\u308b\u3053\u3068\u3092\u304a\u52e7\u3081\u3057\u307e\u3059\u3002\u3053\u306e\u30d1\u30b9\u30a6\u30a7\u30a4\u306e\u4ee3\u308f\u308a\u306b\u3001De Novo\u30ea\u30af\u30a8\u30b9\u30c8\u304c\u3042\u308a\u307e\u3059\u3002  De Novo\u30ea\u30af\u30a8\u30b9\u30c8\u306f\u3001FDA\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u3067\u4ee5\u4e0b\u306e\u3088\u3046\u306b\u4e00\u90e8\u8aac\u660e\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u300c\u65b0\u3057\u3044\u533b\u7642\u6a5f\u5668\u3092\u5206\u985e\u3059\u308b\u305f\u3081\u306e\u9053\u7b4b\u3067\u3042\u308a <\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/regulatory-controls\/general-controls-medical-devices\"><span style=\"font-weight: 400;\">\u4e00\u822c\u7684\u306a\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb<\/span><\/a><span style=\"font-weight: 400;\"> \u5358\u72ec\u3067\u3001\u3042\u308b\u3044\u306f\u4e00\u822c\u7684\u3067 <\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/overview-device-regulation\/regulatory-controls\"><span style=\"font-weight: 400;\">\u30b9\u30da\u30b7\u30e3\u30eb\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb<\/span><\/a><span style=\"font-weight: 400;\">\u610f\u56f3\u3055\u308c\u305f\u7528\u9014\u306b\u5bfe\u3057\u3066\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u304c\u5408\u7406\u7684\u306b\u4fdd\u8a3c\u3055\u308c\u3066\u3044\u308b\u306b\u3082\u304b\u304b\u308f\u3089\u305a\u3001\u5408\u6cd5\u7684\u306b\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u88fd\u54c1\u304c\u5b58\u5728\u3057\u306a\u3044\u5834\u5408\u3002 <\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-notification-510k\/how-find-and-effectively-use-predicate-devices\"><span style=\"font-weight: 400;\">\u8ff0\u8a9e\u30c7\u30d0\u30a4\u30b9<\/span><\/a><span style=\"font-weight: 400;\">.De Novo\u5206\u985e\u306f\u3001\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u5206\u985e\u30d7\u30ed\u30bb\u30b9\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">De Novo\u5206\u985e\u8981\u6c42(De Novo request)\u306b\u3088\u3063\u3066\u30af\u30e9\u30b9I\u307e\u305f\u306f\u30af\u30e9\u30b9II\u306b\u5206\u985e\u3055\u308c\u305f\u6a5f\u5668\u306f\u3001\u5e02\u5834\u3067\u8ca9\u58f2\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u3001\u5c06\u6765\u306e\u5e02\u8ca9\u524d\u901a\u77e5\u306e\u524d\u63d0\u6761\u4ef6\u3068\u3057\u3066\u4f7f\u7528\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/premarket-notification-510k\"><span style=\"font-weight: 400;\">510(k)<\/span><\/a><span style=\"font-weight: 400;\">]\u306e\u6295\u7a3f\u3092\u3057\u3066\u3044\u307e\u3059\u3002<\/span><b>[11]<\/b><\/p>\n<p><span style=\"font-weight: 400;\">De Novo\u30ea\u30af\u30a8\u30b9\u30c8\u306f\u3001Q-Submission\u3068\u4f3c\u3066\u3044\u307e\u3059\u304c\u3001\u3069\u3061\u3089\u3082\u88fd\u54c1\u306e\u30ea\u30b9\u30af\u5206\u985e\u306b\u95a2\u3057\u3066FDA\u306e\u540c\u610f\u3092\u6c42\u3081\u3066\u3044\u307e\u3059\u3002   \u3053\u306e\u30ea\u30b9\u30af\u5206\u985e\u306f\u3001\u95a2\u9023\u3059\u308b\u8981\u4ef6\u3001\u7ba1\u7406\u3001\u304a\u3088\u3073\u7814\u7a76\u3092\u5b9f\u65bd\u3057\u3066\u8a2d\u8a08\u30fb\u958b\u767a\u30d1\u30b9\u30a6\u30a7\u30a4\u3092\u9032\u3081\u308b\u305f\u3081\u306b\u3001\u5b9a\u7fa9\u3059\u308b\u3053\u3068\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002  Covid-19\u306e\u6cbb\u7642\u3092\u76ee\u7684\u3068\u3057\u305f\u65b0\u3057\u3044\u30c7\u30d0\u30a4\u30b9\u306f\u3001\u305d\u306e\u6280\u8853\u304c\u307e\u3060\u65b0\u898f\u6027\u304c\u3042\u308b\u3068\u8003\u3048\u3089\u308c\u308b\u305f\u3081\u3001De Novo\u30ea\u30af\u30a8\u30b9\u30c8\u306e\u7d4c\u8def\u3067\u958b\u767a\u3092\u691c\u8a0e\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u3053\u306e\u3088\u3046\u306a\u6280\u8853\u306f\u5358\u306b\u65b0\u898f\u6027\u304c\u3042\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u7dca\u6025\u6027\u306e\u3042\u308b\u72b6\u6cc1\u4e0b\u3067\u5fc5\u8981\u3068\u3055\u308c\u308b\u3082\u306e\u3067\u3042\u308b\u305f\u3081\u3001\u4ed6\u306e\u7d4c\u8def\u3067\u306e\u8fc5\u901f\u306a\u5c55\u958b\u304c\u53ef\u80fd\u3067\u3059\u3002\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Breakthrough_Devices_Program\"><\/span><strong>\u30d6\u30ec\u30a4\u30af\u30b9\u30eb\u30fc\u30c7\u30d0\u30a4\u30b9\u30d7\u30ed\u30b0\u30e9\u30e0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<blockquote><p><strong>Covid-19\u3068\u533b\u7642\u6a5f\u5668\u306e\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3<br \/>\n<\/strong><span style=\"font-weight: 400;\">Covid-19\u306b\u3088\u308b\u56f0\u96e3\u306a\u72b6\u6cc1\u306e\u4e2d\u3067\u3001\u30d6\u30ec\u30a4\u30af\u30b9\u30eb\u30fc\u30d1\u30b9\u30a6\u30a7\u30a4\u3068\u7dca\u6025\u4f7f\u7528\u8a31\u53ef\u30d1\u30b9\u30a6\u30a7\u30a4\u306f\u3001\u611f\u67d3\u75c7\u5bfe\u7b56\u3092\u76ee\u7684\u3068\u3057\u305f\u65b0\u6280\u8853\u306e\u30db\u30c3\u30c8\u306a\u8a71\u984c\u3068\u306a\u308a\u307e\u3057\u305f\u3002  \u3053\u308c\u3089\u306e\u30d1\u30b9\u30a6\u30a7\u30a4\u306f\u4ee5\u524d\u304b\u3089\u5b58\u5728\u3057\u3066\u3044\u307e\u3057\u305f\u304c\u3001\u65b0\u6280\u8853\u3092\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u305f\u3081\u306e\u30d1\u30b9\u30a6\u30a7\u30a4\u3068\u3057\u3066\u306e\u4eba\u6c17\u306f\u3001\u4eca\u56de\u306e\u5371\u6a5f\u3067\u9855\u8457\u306b\u9ad8\u307e\u308a\u307e\u3057\u305f\u3002\u00a0 <\/span><\/p><\/blockquote>\n<p><span style=\"font-weight: 400;\">\u305d\u306e\u4ed5\u7d44\u307f\u3092\u7406\u89e3\u3059\u308b\u305f\u3081\u306b\u3001\u305d\u308c\u305e\u308c\u306e\u7d4c\u8def\u3092\u5206\u89e3\u3057\u3066\u307f\u307e\u3057\u3087\u3046\u3002\u00a0\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">FDA\u306f\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u3067\u5831\u544a\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u300cBreakthrough Devices Program\u306e\u76ee\u7684\u306f\u3001\u516c\u8846\u885b\u751f\u3092\u4fdd\u8b77\u30fb\u4fc3\u9032\u3059\u308b\u3068\u3044\u3046\u7c73\u56fd\u653f\u5e9c\u306e\u4f7f\u547d\u306b\u6cbf\u3063\u3066\u3001\u5e02\u8ca9\u524d\u627f\u8a8d\u3001510(k)\u8a8d\u53ef\u3001De Novo\u8ca9\u58f2\u627f\u8a8d\u306e\u6cd5\u5b9a\u57fa\u6e96\u3092\u7dad\u6301\u3057\u3064\u3064\u3001\u958b\u767a\u3001\u8a55\u4fa1\u3001\u5be9\u67fb\u3092\u8fc5\u901f\u5316\u3059\u308b\u3053\u3068\u3067\u3001\u60a3\u8005\u3084\u533b\u7642\u5f93\u4e8b\u8005\u306b\u3053\u308c\u3089\u306e\u533b\u7642\u6a5f\u5668\u3092\u30bf\u30a4\u30e0\u30ea\u30fc\u306b\u63d0\u4f9b\u3059\u308b\u3053\u3068\u3067\u3059\u300d\u3068\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002<\/span><b>[12]<\/b><\/p>\n<p><span style=\"font-weight: 400;\">\u753b\u671f\u7684\u30c7\u30d0\u30a4\u30b9\u30d7\u30ed\u30b0\u30e9\u30e0\u306e\u5bfe\u8c61\u88fd\u54c1\u3068\u306a\u308b\u305f\u3081\u306b\u306f\u3001\u751f\u547d\u3092\u8105\u304b\u3059\u3001\u3042\u308b\u3044\u306f\u4e0d\u53ef\u9006\u7684\u306b\u8870\u5f31\u3055\u305b\u308b\u30d2\u30c8\u306e\u75be\u60a3\u3084\u72b6\u614b\u306e\u6cbb\u7642\u306b\u304a\u3044\u3066\u3001\u73fe\u5728\u5229\u7528\u53ef\u80fd\u306a\u6cbb\u7642\u6cd5\u3084\u8a3a\u65ad\u6cd5\u3088\u308a\u3082\u9ad8\u3044\u6709\u52b9\u6027\u3092\u793a\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002  \u3055\u3089\u306b\u3001\u305d\u306e\u88fd\u54c1\u306f\u4ee5\u4e0b\u306e\u8981\u4ef6\u306e\u3046\u3061\u5c11\u306a\u304f\u3068\u30821\u3064\u3092\u6e80\u305f\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u753b\u671f\u7684\u306a\u6280\u8853\u3092\u8868\u3059<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\"FDA\u306f\u3001\u305d\u306e\u6a5f\u5668\u304c\u3001\u751f\u547d\u3092\u8105\u304b\u3059\u3001\u307e\u305f\u306f\u4e0d\u53ef\u9006\u7684\u306b\u8870\u5f31\u3055\u305b\u308b\u75c5\u6c17\u3084\u72b6\u614b\u306e\u8a3a\u65ad\u3001\u6cbb\u7642\uff08\u6cbb\u7642\u306e\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3092\u542b\u3080\uff09\u3001\u6cbb\u7652\u3001\u7de9\u548c\u3001\u307e\u305f\u306f\u4e88\u9632\u306e\u81e8\u5e8a\u7684\u6539\u5584\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u3001\u65b0\u898f\u6280\u8853\u307e\u305f\u306f\u65e2\u5b58\u6280\u8853\u306e\u65b0\u898f\u5fdc\u7528\u3092\u8868\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u691c\u8a0e\u3057\u307e\u3059\" \u3068\u3057\u3066\u3044\u307e\u3059\u3002 <\/span><b>[13]<\/b><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u627f\u8a8d\u307e\u305f\u306f\u30af\u30ea\u30a2\u3055\u308c\u305f\u4ee3\u66ff\u54c1\u304c\u5b58\u5728\u3057\u306a\u3044<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\"FDA\u306f\u3001\u691c\u8a0e\u3055\u308c\u3066\u3044\u308b\u306e\u3068\u540c\u3058\u9069\u5fdc\u75c7\u306b\u5bfe\u3057\u3066\u3001\u5e02\u8ca9\u524d\u5be9\u67fb\u5f8c\u306bFDA\u306e\u8ca9\u58f2\u627f\u8a8d\u3092\u53d7\u3051\u305f\u533b\u85ac\u54c1\u3001\u751f\u7269\u5b66\u7684\u88fd\u54c1\u3001\u6a5f\u5668\u3001\u307e\u305f\u306f\u7d44\u307f\u5408\u308f\u305b\u88fd\u54c1\u304c\u3042\u308b\u304b\u3069\u3046\u304b\u3092\u691c\u8a0e\u3057\u307e\u3059\uff08\u3059\u306a\u308f\u3061\u3001FDA\u304c\u627f\u8a8d\u3001\u8a8d\u53ef\u3001\u307e\u305f\u306f\u30e9\u30a4\u30bb\u30f3\u30b9\u3092\u53d6\u5f97\u3057\u305f\u4ee3\u66ff\u88fd\u54c1\u304c\u3042\u308b\u304b\u3069\u3046\u304b\u3001\u307e\u305f\u306fFDA\u304cDe Novo\u30ea\u30af\u30a8\u30b9\u30c8\u3092\u8a31\u53ef\u3057\u305f\u88fd\u54c1\u304c\u3042\u308b\u304b\u3069\u3046\u304b\uff09\"\u3002<\/span><b>[13]<\/b><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u65e2\u5b58\u306e\u627f\u8a8d\u30fb\u8a8d\u53ef\u3055\u308c\u305f\u4ee3\u66ff\u54c1\u3068\u6bd4\u8f03\u3057\u3066\u3001\u5927\u304d\u306a\u5229\u70b9\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u300cFDA\u306f\u3001\u65e2\u5b58\u306e\u627f\u8a8d\u6e08\u307f\u307e\u305f\u306f\u30af\u30ea\u30a2\u6e08\u307f\u306e\u4ee3\u66ff\u54c1\u3068\u6bd4\u8f03\u3057\u3066\u3001\u300c\u5165\u9662\u306e\u5fc5\u8981\u6027\u3092\u4f4e\u6e1b\u307e\u305f\u306f\u6392\u9664\u3057\u3001\u60a3\u8005\u306e\u751f\u6d3b\u306e\u8cea\u3092\u5411\u4e0a\u3055\u305b\u3001\u60a3\u8005\u304c\u81ea\u5206\u306e\u30b1\u30a2\u3092\u7ba1\u7406\u3059\u308b\u80fd\u529b\uff08\u81ea\u5df1\u7ba1\u7406\u578b\u30d1\u30fc\u30bd\u30ca\u30eb\u30a2\u30b7\u30b9\u30bf\u30f3\u30b9\u306a\u3069\uff09\u3092\u4fc3\u9032\u3057\u3001\u307e\u305f\u306f\u9577\u671f\u7684\u306a\u81e8\u5e8a\u52b9\u7387\u3092\u78ba\u7acb\u3059\u308b\u53ef\u80fd\u6027\u300d\u3092\u8003\u616e\u3057\u307e\u3059\u3002\"<\/span><b>[13]<\/b><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u30c7\u30d0\u30a4\u30b9\u306e\u63d0\u4f9b\u306f\u60a3\u8005\u3055\u3093\u306e\u305f\u3081\u306b\u306a\u308b<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\"FDA\u306f\u3001\u63d0\u6848\u3055\u308c\u305f\u6a5f\u5668\u3068\u9069\u5fdc\u75c7\u304c\u3001\u5225\u306e\u30bf\u30a4\u30d7\u306e\u7279\u5b9a\u306e\u516c\u8846\u885b\u751f\u4e0a\u306e\u5229\u76ca\u3092\u63d0\u4f9b\u3059\u308b\u304b\u3069\u3046\u304b\u3092\u691c\u8a0e\u3059\u308b\"\u3002<\/span><b>[13]<\/b><\/p>\n<p><span style=\"font-weight: 400;\">\u524d\u8ff0\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u52a0\u3048\u3066\u3001FDA\u306f\u3001\u4f01\u696d\u304c\u5fc5\u8981\u306a\u30c7\u30fc\u30bf\u3092\u8fc5\u901f\u306bFDA\u306b\u63d0\u4f9b\u3067\u304d\u308b\u3088\u3046\u306b\u652f\u63f4\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u305f\u3001\u69d8\u3005\u306a\u958b\u767a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3084\u30c4\u30fc\u30eb\u3092\u767a\u8868\u3057\u3066\u3044\u307e\u3059\u3002  \u3053\u308c\u306f\u3001\u7dca\u6025\u4f7f\u7528\u8a31\u53ef\u3092\u5f97\u305f\u6280\u8853\u306b\u3064\u3044\u3066\u3082\u540c\u69d8\u3067\u3059\u3002\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Emergency_Use_Authorizations\"><\/span><span style=\"font-weight: 400;\"><strong>\u7dca\u6025\u6642\u306e\u4f7f\u7528\u8a31\u53ef<\/strong> <\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u7dca\u6025\u4f7f\u7528\u8a31\u53ef(EAU)\u306f\u3001FDA\u304c\u6e80\u305f\u3055\u308c\u3066\u3044\u306a\u3044\u7dca\u6025\u306e\u5fc5\u8981\u6027\u304c\u3042\u308b\u3068\u5224\u65ad\u3057\u305f\u5834\u5408\u306b\u958b\u59cb\u3055\u308c\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002  EUA\u3092\u53d6\u5f97\u3059\u308b\u305f\u3081\u306b\u306f\u3001FDA\u306f\u4e8b\u524d\u306bEUA\u30df\u30fc\u30c6\u30a3\u30f3\u30b0\u3092\u958b\u50ac\u3059\u308b\u3053\u3068\u3092\u6c42\u3081\u3066\u3044\u307e\u3059\u3002  FDA\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u306b\u306f\u3001EUA\u3092\u53d6\u5f97\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u60c5\u5831\u306e\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u304c\u7528\u610f\u3055\u308c\u3066\u3044\u307e\u3059\u3002  \u30d7\u30ecEUA\u30df\u30fc\u30c6\u30a3\u30f3\u30b0\u304c\u958b\u59cb\u3055\u308c\u308b\u3068\u3001FDA\u306f\u88fd\u54c1\u306e\u958b\u767a\u3068\u30ea\u30ea\u30fc\u30b9\u3092\u9032\u3081\u308b\u305f\u3081\u306b\u8cb4\u793e\u3068\u3069\u306e\u3088\u3046\u306b\u5354\u529b\u3057\u3066\u3044\u304d\u305f\u3044\u304b\u306b\u3064\u3044\u3066\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Humanitarian_Device_Exemption\"><\/span><span style=\"font-weight: 400;\"><strong>\u4eba\u9053\u7684\u30c7\u30d0\u30a4\u30b9\u306b\u95a2\u3059\u308b\u514d\u8cac\u4e8b\u9805<\/strong> <\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Humanitarian Device Exemption\u3068Humanitarian Use Devices\u306f\u3001\u5c11\u6570\u306e\u60a3\u8005\u306b\u4f7f\u7528\u3055\u308c\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u305f\u6a5f\u5668\u3092\u691c\u8a0e\u3059\u308b\u305f\u3081\u306e\u9053\u7b4b\u3067\u3059\u3002  FDA\u306f\u3001\u4eba\u9053\u7684\u4f7f\u7528\u6a5f\u5668\uff08HUD\uff09\u3092\u4ee5\u4e0b\u306e\u3088\u3046\u306b\u5b9a\u7fa9\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u300c\u7c73\u56fd\u5185\u3067\u5e74\u95938,000\u4eba\u4ee5\u4e0b\u306e\u60a3\u8005\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u305f\u308a\u3001\u75c7\u72b6\u304c\u73fe\u308c\u305f\u308a\u3059\u308b\u75be\u60a3\u3084\u72b6\u614b\u306e\u6cbb\u7642\u3084\u8a3a\u65ad\u306b\u304a\u3044\u3066\u3001\u60a3\u8005\u306b\u5229\u76ca\u3092\u3082\u305f\u3089\u3059\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u305f\u533b\u7642\u6a5f\u5668\u300d\u3068\u3057\u3066\u3044\u307e\u3059\u3002 <\/span><b>[14]<\/b><\/p>\n<p><span style=\"font-weight: 400;\">HDE\u306f\u3001\u98df\u54c1\u533b\u85ac\u54c1\u5316\u7ca7\u54c1\u6cd5\u7b2c514\u6761\u304a\u3088\u3073\u7b2c515\u6761\u306b\u898f\u5b9a\u3055\u308c\u3066\u3044\u308b\u8981\u4ef6\u306b\u5f93\u3063\u3066\u3001\u6a5f\u5668\u306e\u6709\u52b9\u6027\u3092\u5b9f\u8a3c\u3059\u308b\u8981\u4ef6\u3092\u514d\u9664\u3059\u308b\u3082\u306e\u3067\u3042\u308b\u3002\u5fc3\u81d3\u8840\u7ba1\u306e\u4f8b\u3067\u8a00\u3048\u3070\u3001\u5c0f\u5150\u7528\u88dc\u52a9\u4eba\u5de5\u5fc3\u81d3\u306b\u3064\u3044\u3066FDA\u304b\u3089HDE\u304c\u767a\u884c\u3055\u308c\u3066\u3044\u308b\u304c\u3001\u3053\u308c\u306f\u3001\u3053\u308c\u3089\u306e\u60a3\u8005\u96c6\u56e3\u304cFDA\u306eHDE\u7d4c\u8def\u3067\u9069\u683c\u306a\u72b6\u614b\u3092\u69cb\u6210\u3059\u308b\u305f\u3081\u306e\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u305f\u3081\u3067\u3042\u308b\uff08\u3059\u306a\u308f\u3061\u3001\u7c73\u56fd\u3067\u5e74\u95938,000\u4eba\u4ee5\u4e0b\u306e\u4eba\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u3001\u307e\u305f\u306f\u75c7\u72b6\u304c\u73fe\u308c\u3066\u3044\u308b\u75be\u60a3\u307e\u305f\u306f\u72b6\u614b\uff09\u3002<\/span><\/p>\n<blockquote><p>FDA\u306f\u3001\u4e00\u822c\u5e02\u6c11\u306b\u63d0\u4f9b\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3044\u3066\u900f\u660e\u6027\u3092\u4fdd\u3064\u3053\u3068\u3092\u610f\u56f3\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u305d\u306e\u30d7\u30ed\u30bb\u30b9\u306f\u6642\u306b\u4e0d\u53ef\u89e3\u3067\u56f0\u96e3\u306a\u3082\u306e\u3067\u3059\u3002  \u79c1\u306f\u3001\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u306e\u4e16\u754c\u306b\u98db\u3073\u8fbc\u3080\u524d\u306e7\u5e74\u534a\u3001\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08Food and Drug Administration\uff09\u306e\u8abf\u67fb\u5b98\u3092\u52d9\u3081\u3066\u3044\u307e\u3057\u305f\u3002  \u8abf\u67fb\u5b98\u3068\u3057\u3066\u306e\u671f\u9593\u306f <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAPathways\">\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a>t \u79c1\u306f\u533b\u7642\u6a5f\u5668\u306eFDA\u898f\u5236\u306e\u30d1\u30b9\u30a6\u30a7\u30a4\u3092\u652f\u63f4\u3057\u3066\u304d\u307e\u3057\u305f\u3002\u898f\u5236\u3092\u53d7\u3051\u308b\u7acb\u5834\u304b\u3089\u3001\u8a2d\u8a08\u3001\u88fd\u9020\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u95a2\u3059\u308b\u6307\u5c0e\u3092\u53d7\u3051\u308b\u7acb\u5834\u306b\u306a\u3063\u305f\u3053\u3068\u306f\u3001\u3068\u3066\u3082\u65b0\u9bae\u3067\u3057\u305f\u3002  \u307e\u305f\u3001\u79c1\u304c\u60c5\u71b1\u3092\u6301\u3063\u3066\u53d6\u308a\u7d44\u3093\u3067\u3044\u308b\u9769\u65b0\u7684\u3067\u8d77\u696d\u5bb6\u7684\u306a\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306b\u53c2\u52a0\u3059\u308b\u6a5f\u4f1a\u3082\u5f97\u3089\u308c\u307e\u3057\u305f\u3002<\/p><\/blockquote>\n<p><strong>\u81ea\u793e\u306e\u533b\u7642\u6a5f\u5668\u306b\u6700\u9069\u306aFDA\u30d1\u30b9\u30a6\u30a7\u30a4\u3092\u628a\u63e1\u3059\u308b\u305f\u3081\u306e\u30b5\u30dd\u30fc\u30c8\u304c\u5fc5\u8981\u3067\u3059\u304b\uff1f <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/adam-freeman?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAPathways\">\u898f\u5236\u306b\u95a2\u3059\u308b\u30b5\u30dd\u30fc\u30c8\u306f\u30a2\u30c0\u30e0\u30fb\u30d5\u30ea\u30fc\u30de\u30f3\u306b\u3054\u76f8\u8ac7\u304f\u3060\u3055\u3044\u3002 <\/a><\/strong><\/p>\n<p><strong>OR \u305d\u306e\u4ed6\u3092\u898b\u308b <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/fda-submissions\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAPathways\">FDA\u7533\u8acb\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/a> \u3092Kolabtree\u306b\u63b2\u8f09\u3057\u307e\u3057\u305f\u3002<br \/>\n<\/strong><\/p>\n<hr \/>\n<p><b>\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9<\/b><span style=\"font-weight: 400;\">:<\/span><\/p>\n<ol>\n<li><span style=\"font-weight: 400;\">Federal Food, Drug, and Cosmetic Act\uff08\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5316\u7ca7\u54c1\u6cd5\uff09\u3002<\/span><a href=\"https:\/\/www.govinfo.gov\/content\/pkg\/USCODE-2014-title21\/pdf\/USCODE-2014-title21.pdf\"> <span style=\"font-weight: 400;\">https:\/\/www.govinfo.gov\/content\/pkg\/USCODE-2014-title21\/pdf\/USCODE-2014-title21.pdf<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">United States Code of Federal Regulations\uff08\u7c73\u56fd\u9023\u90a6\u898f\u5247\uff09\u306e\u30bf\u30a4\u30c8\u30eb21\u3002<\/span><a href=\"https:\/\/www.govinfo.gov\/content\/pkg\/CFR-2011-title21-vol8\/pdf\/CFR-2011-title21-vol8-chapI-subchapH.pdf\"> <span style=\"font-weight: 400;\">https:\/\/www.govinfo.gov\/content\/pkg\/CFR-2011-title21-vol8\/pdf\/CFR-2011-title21-vol8-chapI-subchapH.pdf<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">FDA\u306eCPGM 7382.845\u300c\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306e\u691c\u67fb\u300d\u3002<\/span><a href=\"https:\/\/www.fda.gov\/media\/80195\/download\"> <span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/media\/80195\/download<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">FDA\u306ePremarket Notification Website\u3067\u3059\u3002<\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/premarket-notification-510k\"> <span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/premarket-notification-510k<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">The 510(k) Program:\u5e02\u8ca9\u627f\u8a8d\u7533\u8acb\u306b\u304a\u3051\u308b\u5b9f\u8cea\u7684\u540c\u7b49\u6027\u306e\u8a55\u4fa1 [510(k)] \u7523\u696d\u754c\u3068\u98df\u54c1\u533b\u85ac\u54c1\u5c40\u30b9\u30bf\u30c3\u30d5\u306e\u305f\u3081\u306e\u30ac\u30a4\u30c0\u30f3\u30b9<\/span><a href=\"https:\/\/www.fda.gov\/media\/82395\/download\"> <span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/media\/82395\/download<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306e\u63d0\u51fa\u7269\u306b\u5bfe\u3059\u308b\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3068\u30df\u30fc\u30c6\u30a3\u30f3\u30b0\u306e\u304a\u9858\u3044\u3002Q-Submission Program Guidance for Industry and Food and Drug Administration Staff:<\/span><a href=\"https:\/\/www.fda.gov\/media\/114034\/download\"> <span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/media\/114034\/download<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">FDA\u306e\u5e02\u8ca9\u524d\u627f\u8a8d\uff08PMA\uff09\u30b5\u30a4\u30c8\u3002<\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/premarket-approval-pma\"> <span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/premarket-approval-pma<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">\u5e02\u8ca9\u627f\u8a8d\u7533\u8acb(PMA)\u306e\u53d7\u7406\u304a\u3088\u3073\u63d0\u51fa\u5be9\u67fb \u7523\u696d\u754c\u304a\u3088\u3073\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\u30b9\u30bf\u30c3\u30d5\u5411\u3051\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3002<\/span><a href=\"https:\/\/www.fda.gov\/media\/83408\/download\"> <span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/media\/83408\/download<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">Guidance for Industry and FDA Staff Premarket Approval Application Modular Review\u306e\u7565\u3002<\/span><a href=\"https:\/\/www.fda.gov\/media\/73513\/download\"> <span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/media\/73513\/download<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u5206\u985e\u88fd\u54c1\u30b3\u30fc\u30c9 \u7523\u696d\u754c\u304a\u3088\u3073\u98df\u54c1\u533b\u85ac\u54c1\u5c40\u30b9\u30bf\u30c3\u30d5\u5411\u3051\u30ac\u30a4\u30c0\u30f3\u30b9<\/span><span style=\"font-weight: 400;\">:<\/span><a href=\"https:\/\/www.fda.gov\/media\/82781\/download\"> <span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/media\/82781\/download<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">FDA\u306eDe Novo\u5206\u985e\u8981\u6c42\u30b5\u30a4\u30c8\u3002<\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/de-novo-classification-request\"> <span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/de-novo-classification-request<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">FDA\u306e\u30d6\u30ec\u30a4\u30af\u30b9\u30eb\u30fc\u30c7\u30d0\u30a4\u30b9\u30d7\u30ed\u30b0\u30e9\u30e0\u3002<\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/how-study-and-market-your-device\/breakthrough-devices-program\"> <span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/medical-devices\/how-study-and-market-your-device\/breakthrough-devices-program<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">FDA\u306e\u30ac\u30a4\u30c0\u30f3\u30b9 Breakthrough Devices Program Guidance for Industry and Food and Drug Administration Staff (\u82f1\u8a9e)<\/span><span style=\"font-weight: 400;\">:<\/span><a href=\"https:\/\/www.fda.gov\/media\/108135\/download\"> <span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/media\/108135\/download<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">FDA\u306e\u4eba\u9053\u7684\u4f7f\u7528\u6a5f\u5668\uff08HUD\uff09\u6307\u5b9a\u30d7\u30ed\u30b0\u30e9\u30e0\u3002<\/span><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.fda.gov\/industry\/developing-products-rare-diseases-conditions\/humanitarian-use-device-hud-designation-program\">https:\/\/www.fda.gov\/industry\/developing-products-rare-diseases-conditions\/humanitarian-use-device-hud-designation-program<\/a><\/span><\/li>\n<\/ol>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>Adam Freeman, ex-FDA investigator for medical devices, describes the FDA regulatory pathways for medical devices, based on classification and intended use.\u00a0 The regulatory pathway of a medical device depends mostly on its labeling.\u00a0 We can ask a philosophical question in an effort to tease out that pathway for which a device takes in becoming a medical device.\u00a0 What separates an unregulated knife from an FDA regulated surgical scalpel?\u00a0 The indications for use.\u00a0 The indications you intend to market your product under will establish the framework of applicable regulations.\u00a0 Regulatory pathway for Class I Medical Devices The surgical scalpel Let\u2019s explore how we progress through this thought experiment to arrive at<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":7505,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[540],"tags":[528,559,524],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Top FDA Regulatory Pathways for Medical Devices Based on Classification<\/title>\n<meta name=\"description\" content=\"Ex-FDA investigator Adam Freeman recommends top FDA regulatory pathways for medical devices including 510(k), De Novo, IDE, Breakthrough Devices, and more.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Top FDA Regulatory Pathways for Medical Devices Based on Classification\" \/>\n<meta property=\"og:description\" content=\"Ex-FDA investigator Adam Freeman recommends top FDA regulatory pathways for medical devices including 510(k), De Novo, IDE, Breakthrough Devices, and more.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" 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