{"id":7342,"date":"2020-04-08T13:49:48","date_gmt":"2020-04-08T13:49:48","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=7342"},"modified":"2021-10-04T08:51:53","modified_gmt":"2021-10-04T08:51:53","slug":"13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/","title":{"rendered":"510K\u63d0\u51fa\u7269\u306e\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u8fc5\u901f\u306aFDA\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u306e\u305f\u3081\u306b\u907f\u3051\u308b\u3079\u304d13\u306e\u9593\u9055\u3044"},"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-69f26fe96506c\" 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-69f26fe96506c\"><\/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\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/#510k_Submissions_Checklist\" title=\"510k\u63d0\u51fa\u7269\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\">510k\u63d0\u51fa\u7269\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/#Acceptance_Review\" title=\"\u53d7\u5165\u5be9\u67fb\">\u53d7\u5165\u5be9\u67fb<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/#Substantive_Review\" title=\"\u5b9f\u8cea\u7684\u306a\u30ec\u30d3\u30e5\u30fc\">\u5b9f\u8cea\u7684\u306a\u30ec\u30d3\u30e5\u30fc<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/#Common_Additional_Information_Requests_of_510k_submission_checklist\" title=\"510k\u63d0\u51fa\u7528\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306e\u5171\u901a\u8ffd\u52a0\u60c5\u5831\u8981\u6c42\">510k\u63d0\u51fa\u7528\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306e\u5171\u901a\u8ffd\u52a0\u60c5\u5831\u8981\u6c42<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/#510k_submission_checklist\" title=\"510k\u63d0\u51fa\u7528\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\">510k\u63d0\u51fa\u7528\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/#1_Refuse_to_Accept_RTA_letter\" title=\"1.RTA\uff08Refuse to Accept\uff09\u30ec\u30bf\u30fc \">1.RTA\uff08Refuse to Accept\uff09\u30ec\u30bf\u30fc <\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/#2_Inadequate_Device_Description\" title=\"2.\u4e0d\u9069\u5207\u306a\u30c7\u30d0\u30a4\u30b9\u306e\u8aac\u660e\">2.\u4e0d\u9069\u5207\u306a\u30c7\u30d0\u30a4\u30b9\u306e\u8aac\u660e<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/#3_Inconsistent_Information_throughout_the_Submission\" title=\"3.\u63d0\u51fa\u7269\u5168\u4f53\u3067\u4e00\u8cab\u6027\u306e\u306a\u3044\u60c5\u5831\">3.\u63d0\u51fa\u7269\u5168\u4f53\u3067\u4e00\u8cab\u6027\u306e\u306a\u3044\u60c5\u5831<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/#4_Different_Intended_Use_than_the_Predicate_Device\" title=\"4.\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8\u30fb\u30c7\u30d0\u30a4\u30b9\u3068\u7570\u306a\u308b\u4f7f\u7528\u76ee\u7684\">4.\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8\u30fb\u30c7\u30d0\u30a4\u30b9\u3068\u7570\u306a\u308b\u4f7f\u7528\u76ee\u7684<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/#5_InadequateMissing_Testing_Information\" title=\"5.\u30c6\u30b9\u30c8\u60c5\u5831\u306e\u4e0d\u5099\u30fb\u6b20\u843d\">5.\u30c6\u30b9\u30c8\u60c5\u5831\u306e\u4e0d\u5099\u30fb\u6b20\u843d<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/#6_Failure_to_Follow_or_Otherwise_Address_Current_Guidance_Documents_or_Recognized_Standards\" title=\"6.\u73fe\u884c\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u307e\u305f\u306f\u627f\u8a8d\u3055\u308c\u305f\u57fa\u6e96\u306b\u5f93\u3063\u3066\u3044\u306a\u3044\u3001\u307e\u305f\u306f\u305d\u306e\u4ed6\u306e\u5bfe\u51e6\u3092\u3057\u3066\u3044\u306a\u3044\u3053\u3068\">6.\u73fe\u884c\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u307e\u305f\u306f\u627f\u8a8d\u3055\u308c\u305f\u57fa\u6e96\u306b\u5f93\u3063\u3066\u3044\u306a\u3044\u3001\u307e\u305f\u306f\u305d\u306e\u4ed6\u306e\u5bfe\u51e6\u3092\u3057\u3066\u3044\u306a\u3044\u3053\u3068<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/#7_NSE_Determination\" title=\"7.NSE\u306e\u6c7a\u5b9a\">7.NSE\u306e\u6c7a\u5b9a<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/#Administrative_Aspects\" title=\"\u7ba1\u7406\u9762\u306b\u3064\u3044\u3066\">\u7ba1\u7406\u9762\u306b\u3064\u3044\u3066<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/#8_Submitting_application_at_the_correct_address\" title=\"8.\u6b63\u3057\u3044\u4f4f\u6240\u3067\u306e\u7533\u8acb\u66f8\u306e\u63d0\u51fa\">8.\u6b63\u3057\u3044\u4f4f\u6240\u3067\u306e\u7533\u8acb\u66f8\u306e\u63d0\u51fa<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/#9_Including_hard_copy_as_well_as_eCopy_as_per_latest_FDA_recommendation\" title=\"9.\u6700\u65b0\u306eFDA\u52e7\u544a\u306b\u57fa\u3065\u304f\u30cf\u30fc\u30c9\u30b3\u30d4\u30fc\u3068e\u30b3\u30d4\u30fc\u3092\u542b\u3080\">9.\u6700\u65b0\u306eFDA\u52e7\u544a\u306b\u57fa\u3065\u304f\u30cf\u30fc\u30c9\u30b3\u30d4\u30fc\u3068e\u30b3\u30d4\u30fc\u3092\u542b\u3080<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/#10_eCopy_related_issues\" title=\"10. eCopy\u306b\u95a2\u3059\u308b\u554f\u984c\">10. eCopy\u306b\u95a2\u3059\u308b\u554f\u984c<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-17\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/#11_Submitting_information_to_reviewer\" title=\"11.\u5be9\u67fb\u54e1\u3078\u306e\u60c5\u5831\u63d0\u4f9b\">11.\u5be9\u67fb\u54e1\u3078\u306e\u60c5\u5831\u63d0\u4f9b<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-18\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/#Technical_Aspects\" title=\"\u6280\u8853\u7684\u5074\u9762\">\u6280\u8853\u7684\u5074\u9762<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-19\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/#12_Traditional_510k_vs_Special_510k\" title=\"12.\u5f93\u6765\u306e510(k)\u3068\u7279\u5225\u306a510(k)\u306e\u6bd4\u8f03\">12.\u5f93\u6765\u306e510(k)\u3068\u7279\u5225\u306a510(k)\u306e\u6bd4\u8f03<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-20\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/#Unique_Challenges\" title=\"\u30e6\u30cb\u30fc\u30af\u306a\u30c1\u30e3\u30ec\u30f3\u30b8\">\u30e6\u30cb\u30fc\u30af\u306a\u30c1\u30e3\u30ec\u30f3\u30b8<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-21\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/#13_Nature_of_the_device\" title=\"13.\u30c7\u30d0\u30a4\u30b9\u306e\u6027\u8cea\">13.\u30c7\u30d0\u30a4\u30b9\u306e\u6027\u8cea<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-22\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/#Conclusion\" title=\"\u7d50\u8ad6\">\u7d50\u8ad6<\/a><\/li><\/ul><\/nav><\/div>\n<p><strong><em><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/fda-submissions\">FDA\u63d0\u51fa\u66f8\u985e<\/a> \u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3001\u30ec\u30ae\u30e5\u30ec\u30fc\u30b7\u30e7\u30f3\u30e9\u30a4\u30bf\u30fc<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/samradni-patil\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=510KMistakes\"> Samradni Patil<\/a> \u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/510-k-submissions?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=510KMistakes\">510k\u63d0\u51fa\u7269\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8<\/a> \u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304c\u8fc5\u901f\u304b\u3064\u5bb9\u6613\u306bFDA\u306e\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u3092\u5f97\u3089\u308c\u308b\u3088\u3046\u652f\u63f4\u3057\u307e\u3059\u3002\u00a0<\/em><\/strong><\/p>\n<p>510(k)\u7533\u8acb\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u901a\u5e38\u3001\u30af\u30e9\u30b9II\u306e\u533b\u7642\u6a5f\u5668\u304c\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40(FDA)\u306e\u8a31\u53ef\u3092\u5f97\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002\u5e02\u8ca9\u627f\u8a8d\uff08PMA\uff09\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u901a\u5e38\u3001\u30af\u30e9\u30b9III\u306e\u533b\u7642\u6a5f\u5668\u306b\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002<\/p>\n<p>510(k)\u5be9\u67fb\u3067\u306f\u3001\u985e\u4f3c\u306e\u5408\u6cd5\u7684\u306b\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u30c7\u30d0\u30a4\u30b9\uff08\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8\u30c7\u30d0\u30a4\u30b9\u3068\u3082\u547c\u3070\u308c\u308b\uff09\u3068\u306e\u5b9f\u8cea\u7684\u540c\u7b49\u6027\uff08SE\uff09\u3092\u5224\u5b9a\u3057\u307e\u3059\u3002\u5b9f\u8cea\u7684\u306b\u540c\u7b49\u3067\u3042\u308b\u3068\u4e3b\u5f35\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u305d\u306e\u6a5f\u5668\u304c\u3001\u5408\u6cd5\u7684\u306b\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u6a5f\u5668\u3068\u5c11\u306a\u304f\u3068\u3082\u540c\u7b49\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u6709\u3057\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002510(k)\u5be9\u67fb\u306e\u5bfe\u8c61\u3068\u306a\u308b\u6a5f\u5668\u306f\u3001\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8\u6a5f\u5668\u3068\u306eSE\u3092\u4e3b\u5f35\u3059\u308b\u305f\u3081\u306b\u3001\u4ee5\u4e0b\u306e\u70b9\u3092\u793a\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<ul>\n<li>\u5408\u6cd5\u7684\u306b\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u6a5f\u5668\uff08\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8\u30fb\u30c7\u30d0\u30a4\u30b9\uff09\u3068\u540c\u3058\u4f7f\u7528\u76ee\u7684\u3067\u3042\u308b\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8<\/li>\n<li>\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8\u30fb\u30c7\u30d0\u30a4\u30b9\u3068\u540c\u3058\u6280\u8853\u7684\u7279\u6027\u3092\u6301\u3064 <em>\u307e\u305f\u306f<\/em><\/li>\n<li>\u6280\u8853\u7684\u7279\u5fb4\u3084\u3001\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8\u30fb\u30c7\u30d0\u30a4\u30b9\u3068\u540c\u7b49\u306e\u5b89\u5168\u6027\u30fb\u6709\u52b9\u6027\u3092\u793a\u5506\u3059\u308b\u60c5\u5831\u30fb\u30c6\u30b9\u30c8\u304c\u7570\u306a\u308b\u3053\u3068\u3001\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8\u30fb\u30c7\u30d0\u30a4\u30b9\u3068\u306f\u7570\u306a\u308b\u5b89\u5168\u6027\u30fb\u6709\u52b9\u6027\u306b\u95a2\u3059\u308b\u554f\u984c\u304c\u63d0\u8d77\u3055\u308c\u3066\u3044\u306a\u3044\u3053\u3068\u3002<\/li>\n<\/ul>\n<p>\u4e0a\u8a18\u306e\u57fa\u6e96\u3092\u6e80\u305f\u3055\u306a\u3044\u5834\u5408\u3001Non-Substantial Equivalence\uff08NSE\uff09\u5224\u5b9a\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"510k_Submissions_Checklist\"><\/span><strong>510k\u63d0\u51fa\u7269\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>FDA\u306e510(k)\u5be9\u67fb\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u5927\u304d\u304f\u5206\u3051\u30662\u3064\u306e\u30b9\u30c6\u30c3\u30d7\u3067\u69cb\u6210\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<ul>\n<li>\u53d7\u5165\u5be9\u67fb<\/li>\n<li>\u5b9f\u8cea\u7684\u306a\u30ec\u30d3\u30e5\u30fc<\/li>\n<\/ul>\n<p><strong>\u30ec\u30d3\u30e5\u30fc\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3<\/strong><\/p>\n<table style=\"width: 698px;\">\n<tbody>\n<tr style=\"height: 24px;\">\n<td style=\"height: 24px; width: 149px;\"><strong>\u30ec\u30d3\u30e5\u30fc\u30bf\u30a4\u30d7<\/strong><\/td>\n<td style=\"height: 24px; width: 190px;\"><strong>\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\uff08\u30ab\u30ec\u30f3\u30c0\u30fc\u65e5<\/strong><\/td>\n<td style=\"height: 24px; width: 315px;\"><strong>\u30d7\u30ed\u30bb\u30b9\u30fb\u30a2\u30a6\u30c8\u30ab\u30e0<\/strong><\/td>\n<\/tr>\n<tr style=\"height: 101px;\">\n<td style=\"height: 101px; width: 149px;\">\u53d7\u5165\u5be9\u67fb<\/td>\n<td style=\"height: 101px; width: 190px;\">15\u65e5\u76ee\u307e\u3067<\/td>\n<td style=\"height: 101px; width: 315px;\">\u7533\u8acb\u304c\u53d7\u7406\u3055\u308c\u305f\u304b\u3069\u3046\u304b\u306f\u3001FDA\u304b\u3089\u7533\u8acb\u8005\u306b\u901a\u77e5\u3055\u308c\u307e\u3059\u3002<br \/>\n\u5b9f\u8cea\u7684\u306a\u30ec\u30d3\u30e5\u30fc<br \/>\n<em>\u307e\u305f\u306f<\/em> <span style=\"font-size: 14px;\">RTA\u30db\u30fc\u30eb\u30c9\u306b\u306a\u3063\u305f<\/span><\/td>\n<\/tr>\n<tr style=\"height: 76px;\">\n<td style=\"height: 76px; width: 149px;\">\u5b9f\u8cea\u7684\u306a\u30ec\u30d3\u30e5\u30fc<\/td>\n<td style=\"height: 76px; width: 190px;\">60\u65e5\u76ee\u307e\u3067<\/td>\n<td style=\"height: 76px; width: 315px;\">\u30a4\u30f3\u30bf\u30e9\u30af\u30c6\u30a3\u30d6\u30ec\u30d3\u30e5\u30fc<br \/>\n<em>\u307e\u305f\u306f<\/em> \u8ffd\u52a0\u8cc7\u6599\u8acb\u6c42<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><em><strong>\u6ce8\uff09Day1\u3068\u306f\u3001FDA\u304c510(k)\u7533\u8acb\u3092\u53d7\u7406\u3057\u305f\u65e5\u306e\u3053\u3068\u3067\u3059\u3002<\/strong><\/em><\/p>\n<p>\u307e\u305a\u3001\u3053\u308c\u3089\u306e\u5be9\u67fb\u306e\u904e\u7a0b\u3067\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304c\u3069\u306e\u3088\u3046\u306a\u554f\u984c\u306b\u76f4\u9762\u3057\u3066\u3044\u308b\u306e\u304b\u3092\u8aac\u660e\u3057\u307e\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Acceptance_Review\"><\/span><strong>\u53d7\u5165\u5be9\u67fb<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u3053\u306e\u6bb5\u968e\u3067510(k)\u304c\u53d7\u7406\u3055\u308c\u306a\u304b\u3063\u305f\u5834\u5408\u3001510(k)\u306f <strong>RTA(Refuse to Accept)\u30db\u30fc\u30eb\u30c9<\/strong>. <strong>\u306e\u3068\u304a\u308a\u3067\u3059\u3002 <a href=\"https:\/\/www.fda.gov\/media\/115762\/download\">FDA\u30c7\u30fc\u30bf<\/a>, 2018\u5e74\u306b\u306f\u7d0430%\u306e510(k)\u304cRTA\u30db\u30fc\u30eb\u30c9\u3055\u308c\u307e\u3057\u305f\u3002<\/strong><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Substantive_Review\"><\/span><strong>\u5b9f\u8cea\u7684\u306a\u30ec\u30d3\u30e5\u30fc<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u4e0b\u306e\u30b0\u30e9\u30d5\u306f\u3001\u5b9f\u4f53\u5be9\u67fb\u306e\u6bb5\u968e\u3067FDA\u304c\u51fa\u3057\u305f\u8ffd\u52a0\u60c5\u5831\u8981\u6c42\u306e\u5272\u5408\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-7352\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/04\/FDA1.jpg\" alt=\"\" width=\"536\" height=\"304\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/04\/FDA1.jpg 770w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/04\/FDA1-300x170.jpg 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/04\/FDA1-768x436.jpg 768w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/04\/FDA1-300x170@2x.jpg 600w\" sizes=\"(max-width: 536px) 100vw, 536px\" \/><\/p>\n<p><em><strong>\u51fa\u5178\u306f\u3053\u3061\u3089\u3002 <\/strong><a href=\"https:\/\/www.fda.gov\/media\/115762\/download\"><strong>FDA<\/strong><\/a><\/em><\/p>\n<p>\u3068\u3057\u3066\u6c7a\u5b9a\u3057\u305f510ks\u306e\u5272\u5408\u3002 <strong>\u5b9f\u8cea\u7684\u306b\u540c\u7b49\u3067\u306a\u3044\u3082\u306e\uff08NSE <\/strong>\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\u3002<\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-7353\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/04\/FDA2.jpg\" alt=\"\" width=\"556\" height=\"338\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/04\/FDA2.jpg 776w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/04\/FDA2-300x183.jpg 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/04\/FDA2-768x468.jpg 768w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/04\/FDA2-300x183@2x.jpg 600w\" sizes=\"(max-width: 556px) 100vw, 556px\" \/><\/p>\n<p><em><strong>\u51fa\u5178\u306f\u3053\u3061\u3089\u3002 <\/strong><a href=\"https:\/\/www.fda.gov\/media\/115762\/download\"><strong>FDA<\/strong><\/a><\/em><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Common_Additional_Information_Requests_of_510k_submission_checklist\"><\/span><strong>510k\u63d0\u51fa\u7528\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306e\u5171\u901a\u8ffd\u52a0\u60c5\u5831\u8981\u6c42<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>510k\u5be9\u67fb\u306e\u4e00\u74b0\u3068\u3057\u3066\u63d0\u8d77\u3055\u308c\u308b\u4e00\u822c\u7684\u306a\u554f\u984c\u3092\u7406\u89e3\u3057\u305f\u3068\u3053\u308d\u3067\u3001\u3069\u306e\u3088\u3046\u306a\u30bf\u30a4\u30d7\u306e\u8ffd\u52a0\u60c5\u5831\u8981\u6c42\u304c\u591a\u3044\u306e\u304b\u306b\u7126\u70b9\u3092\u5f53\u3066\u3066\u307f\u307e\u3057\u3087\u3046\u3002<\/p>\n<p>\u306e\u3067\u3059\u3002 <a href=\"https:\/\/www.fda.gov\/media\/115762\/download\">FDA\u30c7\u30fc\u30bf <\/a>\u306f\u3001\u4ee5\u4e0b\u306e\u30bf\u30a4\u30d7\u306e\u8ffd\u52a0\u60c5\u5831\u8981\u6c42\u3092\u63cf\u3044\u3066\u3044\u307e\u3059\u3002<\/p>\n<ul>\n<li><em>\u4e0d\u9069\u5207\u306a\u30c7\u30d0\u30a4\u30b9\u306e\u8aac\u660e<\/em><\/li>\n<li><em>\u63d0\u51fa\u7269\u5168\u4f53\u3067\u306e\u4e0d\u4e00\u81f4 - \u3053\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u3067\u306e\u4e0d\u4e00\u81f4\u306e\u591a\u304f\u306f\u3001\u6a5f\u5668\u306e\u8aac\u660e\u3084\u4f7f\u7528\u4e0a\u306e\u9069\u5fdc\u306b\u95a2\u3059\u308b\u3082\u306e\u3067\u3059\u3002<\/em><\/li>\n<li><em>\u52b9\u80fd\u30fb\u52b9\u679c\u306e\u554f\u984c<\/em><\/li>\n<li><em>\u73fe\u884c\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3084\u8a8d\u8b58\u3055\u308c\u3066\u3044\u308b\u57fa\u6e96\u306b\u5f93\u308f\u306a\u3044\u3001\u307e\u305f\u306f\u305d\u306e\u4ed6\u306e\u65b9\u6cd5\u3067\u5bfe\u51e6\u3059\u308b\u3053\u3068<\/em><\/li>\n<li><em>\u7279\u5b9a\u306e\u30c7\u30d0\u30a4\u30b9\u30bf\u30a4\u30d7\u306b\u5fc5\u8981\u306a\u6027\u80fd\u30c6\u30b9\u30c8\u304c\u307e\u3063\u305f\u304f\u884c\u308f\u308c\u3066\u3044\u306a\u3044\uff08\u3064\u307e\u308a\u3001\u6027\u80fd\u30c7\u30fc\u30bf\u304c\u307e\u3063\u305f\u304f\u63d0\u4f9b\u3055\u308c\u3066\u3044\u306a\u3044\uff09\u3002<\/em><\/li>\n<li><em>\u7279\u5b9a\u306e\u30c7\u30d0\u30a4\u30b9\u30bf\u30a4\u30d7\u306b\u5fc5\u8981\u306a\u81e8\u5e8a\u30c7\u30fc\u30bf\u304c\u5168\u304f\u306a\u3044\uff08\u81e8\u5e8a\u30c7\u30fc\u30bf\u304c\u5168\u304f\u63d0\u4f9b\u3055\u308c\u3066\u3044\u306a\u3044\uff09\u3002<\/em><\/li>\n<\/ul>\n<p>\u3053\u3053\u3067\u306f\u3001510k\u7533\u8acb\u66f8\u3092\u4f5c\u6210\u30fb\u63d0\u51fa\u3059\u308b\u969b\u306b\u5f93\u3046\u3079\u304d\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"510k_submission_checklist\"><\/span>510k\u63d0\u51fa\u7528\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"1_Refuse_to_Accept_RTA_letter\"><\/span><strong>1.RTA\uff08Refuse to Accept\uff09\u30ec\u30bf\u30fc <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u521d\u671f\u6bb5\u968e\u3067\u306e\u53d7\u7406\u5be9\u67fb\u306e\u76ee\u7684\u306f\u3001510k\u7533\u8acb\u66f8\u304c\u7ba1\u7406\u4e0a\u5b8c\u5168\u3067\u3042\u308b\u304b\u3069\u3046\u304b\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8 \" \" \u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u53d7\u7406\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3092\u5f37\u304f\u304a\u52e7\u3081\u3057\u307e\u3059\u3002<a href=\"https:\/\/www.fda.gov\/media\/83888\/download\">510ks\u306e\u30dd\u30ea\u30b7\u30fc\u3092\u53d7\u3051\u5165\u308c\u308b\u3053\u3068\u3092\u62d2\u5426\u3059\u308b<\/a>\".<\/p>\n<p>\u53d7\u3051\u5165\u308c\u5be9\u67fb\u3092\u6210\u529f\u3055\u305b\u308b\u305f\u3081\u306b\u3001\u5404\u4f01\u696d\u306f\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306e\u6b21\u306e\u8868\u306e\u8981\u7d20\u306b\u5f93\u3046\u3053\u3068\u304c\u63a8\u5968\u3055\u308c\u307e\u3059\u3002<\/p>\n<ul>\n<li><strong>\u4e88\u5099\u7684\u306a\u8cea\u554f\u8868<\/strong> \u3053\u306e\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306f\u4e3b\u4efb\u5be9\u67fb\u5b98\u304c\u6700\u521d\u306e\u5224\u65ad\u3092\u3059\u308b\u305f\u3081\u306e\u3082\u306e\u3067\u3059\u304c\u3001FDA\u306b\u7533\u8acb\u3059\u308b\u524d\u306b\u3053\u308c\u3089\u306e\u8cea\u554f\u306b\u975e\u516c\u5f0f\u306b\u7b54\u3048\u308b\u3053\u3068\u3092\u5f37\u304f\u304a\u52e7\u3081\u3057\u307e\u3059\u3002<\/li>\n<li><strong>\u7d44\u7e54\u8981\u7d20\u8868\u3002<\/strong> \u3053\u308c\u3089\u306e\u8981\u7d20\u306f\u3001510(k)\u7533\u8acb\u66f8\u306e\u60c5\u5831\u3092\u5bb9\u6613\u306b\u8b58\u5225\u3067\u304d\u308b\u3088\u3046\u306b510(k)\u3092\u6574\u7406\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002<\/li>\n<li><strong>\u5b8c\u5168\u306a\u63d0\u51fa\u7269\u306e\u8981\u7d20\uff08RTA\u9805\u76ee\uff09 \u8868<\/strong>:\u3053\u306e\u8868\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u8981\u7d20\u306f\u3001RTA\u30ec\u30bf\u30fc\u3092\u53d6\u5f97\u3057\u306a\u3044\u305f\u3081\u306e\u91cd\u8981\u306a\u8981\u7d20\u3067\u3042\u308b\u305f\u3081\u3001\u4f01\u696d\u306f\u3053\u306e\u8868\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u8981\u7d20\u306b\u7d30\u5fc3\u306e\u6ce8\u610f\u3092\u6255\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"2_Inadequate_Device_Description\"><\/span><strong>2.\u4e0d\u9069\u5207\u306a\u30c7\u30d0\u30a4\u30b9\u306e\u8aac\u660e<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>510(k)\u7533\u8acb\u3067\u306f\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u8aac\u660e\u304c\u5fc5\u9808\u3067\u3059\u3002\u3053\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u306b\u306f\u3001\u7c21\u5358\u306a\u8aac\u660e\u3068\u6280\u8853\u4ed5\u69d8\u3092\u8ffd\u52a0\u3059\u308b\u3053\u3068\u3092\u304a\u52e7\u3081\u3057\u307e\u3059\u3002\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u306e\u30e2\u30c7\u30eb\u304a\u3088\u3073\u4ed8\u5c5e\u54c1\u3092\u542b\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u5404\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306e\u5199\u771f\u3001\u56f3\u3001\u5bf8\u6cd5\u3001\u56f3\u9762\u3001\u516c\u5dee\u3092\u542b\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u91cd\u8981\u306a\u30e2\u30c7\u30eb\u3084\u4ed8\u5c5e\u54c1\u304c\u6b20\u3051\u3066\u3044\u308b\u3068\u3001\u6df7\u4e71\u3092\u62db\u304d\u3001\u8ffd\u52a0\u306e\u8cea\u554f\u3092\u53d7\u3051\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u6280\u8853\u4ed5\u69d8\u304c\u4e0d\u9069\u5207\u306a\u5834\u5408\u3001\u8aa4\u89e3\u3092\u62db\u304d\u3001\u8ffd\u52a0\u306e\u30c6\u30b9\u30c8\u3092\u8981\u6c42\u3055\u308c\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"3_Inconsistent_Information_throughout_the_Submission\"><\/span><strong>3.\u63d0\u51fa\u7269\u5168\u4f53\u3067\u4e00\u8cab\u6027\u306e\u306a\u3044\u60c5\u5831<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li><strong>\u30c7\u30d0\u30a4\u30b9\u306e\u8aac\u660e\u306b\u77db\u76fe\u304c\u3042\u308b\u3002 <\/strong>\u30e2\u30c7\u30eb\u3092\u8ffd\u52a0\u3059\u308b\u305f\u3081\u306b510(k)\u7533\u8acb\u3092\u884c\u3046\u3053\u3068\u3092\u6c7a\u5b9a\u3057\u305f\u5834\u5408\u3001\u30ab\u30d0\u30fc\u30ec\u30bf\u30fc\u3001\u6a5f\u5668\u306e\u8aac\u660e\u3001\u30e9\u30d9\u30ea\u30f3\u30b0\u3001\u5b9f\u8cea\u7684\u306a\u540c\u7b49\u6027\u306b\u95a2\u3059\u308b\u8b70\u8ad6\u3001\u6027\u80fd\u95a2\u9023\u30bb\u30af\u30b7\u30e7\u30f3\u306a\u3069\u306e\u8a72\u5f53\u30bb\u30af\u30b7\u30e7\u30f3\u3092\u5b9f\u969b\u306e\u5909\u66f4\u70b9\u3068\u4e00\u81f4\u3055\u305b\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u4e00\u8cab\u6027\u304c\u306a\u3044\u3068\u3001\u7ba1\u7406\u4e0a\u306e\u9045\u5ef6\u3084\u3001\u6700\u60aa\u306e\u5834\u5408\u306f\u8ffd\u52a0\u8a66\u9a13\u306e\u8981\u6c42\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<li><strong>\u52b9\u80fd\u306b\u77db\u76fe\u304c\u3042\u308b\u3002 <\/strong>\u6a5f\u5668\u306e\u8aac\u660e\u3068\u540c\u69d8\u306b\u3001510(k)\u306e\u69d8\u3005\u306a\u30bb\u30af\u30b7\u30e7\u30f3\u3067\u306e\u4f7f\u7528\u76ee\u7684\u306e\u4e0d\u4e00\u81f4\u304c\u554f\u984c\u3068\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u4f7f\u7528\u76ee\u7684\u306e\u8a18\u8ff0\u306f\u3001SE\u306e\u5224\u65ad\u3092\u3059\u308b\u4e0a\u3067\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002<\/li>\n<\/ul>\n<p>\u69d8\u3005\u306a\u30bb\u30af\u30b7\u30e7\u30f3\u3067\u306e\u4e0d\u6574\u5408\u306f\u3001FDA\u306b\u63d0\u51fa\u3059\u308b\u524d\u306b\u63d0\u51fa\u7269\u3092\u614e\u91cd\u306b\u691c\u8a0e\u3059\u308b\u3053\u3068\u3067\u7c21\u5358\u306b\u56de\u907f\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306a\u30df\u30b9\u3092\u907f\u3051\u308b\u305f\u3081\u306b\u3001\u69d8\u3005\u306a\u30bb\u30af\u30b7\u30e7\u30f3\u3092\u898b\u308b\u305f\u3081\u306e\u4f59\u5206\u306a\u76ee\u3092\u6301\u3064\u3053\u3068\u306f\u3001\u5e38\u306b\u826f\u3044\u30a2\u30a4\u30c7\u30a2\u3067\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"4_Different_Intended_Use_than_the_Predicate_Device\"><\/span><strong>4.\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8\u30fb\u30c7\u30d0\u30a4\u30b9\u3068\u7570\u306a\u308b\u4f7f\u7528\u76ee\u7684<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>FDA\u304b\u3089SE\u5224\u5b9a\u3092\u53d7\u3051\u308b\u305f\u3081\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u6761\u4ef6\u3092\u6e80\u305f\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <strong>\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8\u30fb\u30c7\u30d0\u30a4\u30b9\u3068\u540c\u3058\u4f7f\u7528\u76ee\u7684<\/strong>.\u3053\u308c\u306f\u3001\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8\u30c7\u30d0\u30a4\u30b9\u3068\u7570\u306a\u308b\u610f\u56f3\u3055\u308c\u305f\u4f7f\u7528\u304c\u3001\u7570\u306a\u308b\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306e\u554f\u984c\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u305f\u3081\u3001\u91cd\u8981\u3067\u3059\u3002\u3053\u306e\u3088\u3046\u306a\u5834\u5408\u3001510(k)\u306f\u30d7\u30ed\u30c0\u30af\u30c8\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u3092\u5f97\u308b\u305f\u3081\u306e\u9069\u5207\u306a\u7d4c\u8def\u3067\u306f\u306a\u3044\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u306a\u304a\u3001\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8\u30c7\u30d0\u30a4\u30b9\u3068510(k)\u5be9\u67fb\u4e2d\u306e\u30c7\u30d0\u30a4\u30b9\u3068\u306e\u9593\u306e\u4f7f\u7528\u76ee\u7684\u306e\u9055\u3044\u306f\u3001\u5fc5\u305a\u3057\u3082\u4f7f\u7528\u76ee\u7684\u306e\u9055\u3044\u306b\u306f\u306a\u3089\u306a\u3044\u3053\u3068\u306b\u7559\u610f\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u4f01\u696d\u306f\u3001\u9069\u5fdc\u75c7\u306e\u9055\u3044\u304c\u4f7f\u7528\u76ee\u7684\u306e\u9055\u3044\u306b\u3064\u306a\u304c\u3089\u306a\u3044\u3053\u3068\u3092\u660e\u78ba\u306b\u793a\u3059\u305f\u3081\u306b\u3001\u3055\u3089\u306a\u308b\u52aa\u529b\u3092\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>FDA\u306e\u30ac\u30a4\u30c0\u30f3\u30b9 \"<a href=\"https:\/\/www.fda.gov\/media\/82395\/download\">510(k)\u30d7\u30ed\u30b0\u30e9\u30e0\u3002\u5e02\u8ca9\u524d\u306e\u5c4a\u51fa\u306b\u304a\u3051\u308b\u5b9f\u8cea\u7684\u540c\u7b49\u6027\u306e\u8a55\u4fa1\uff3b510(k)<\/a>\u610f\u56f3\u3055\u308c\u305f\u4f7f\u7528\u95a2\u9023\u306e\u8cea\u554f\u3092\u660e\u78ba\u306b\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u300c\u300d\u3092\u53c2\u7167\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"5_InadequateMissing_Testing_Information\"><\/span><strong>5.\u30c6\u30b9\u30c8\u60c5\u5831\u306e\u4e0d\u5099\u30fb\u6b20\u843d<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li><strong>\u4e0d\u5341\u5206\u306a\u30c6\u30b9\u30c8\u60c5\u5831<\/strong><\/li>\n<\/ul>\n<p>\u7279\u5b9a\u306e\u6a5f\u5668\u306b\u9069\u7528\u3055\u308c\u308b\u8a66\u9a13\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u306f\u91cd\u8981\u3067\u3059\u3002\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3084\u6709\u52b9\u6027\u3092\u4e3b\u5f35\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u6a5f\u5668\u306e\u7a2e\u985e\u306b\u5fdc\u3058\u3066\u3001\u96fb\u6c17\u5b89\u5168\u6027\u8a66\u9a13\u3001\u96fb\u78c1\u4e21\u7acb\u6027\uff08EMC\uff09\u8a66\u9a13\u3001\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u8a66\u9a13\u3001\u6ec5\u83cc\u8a66\u9a13\u3001\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u8a66\u9a13\u306a\u3069\u304c\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n<p>\u591a\u304f\u306e\u5834\u5408\u3001\u4f01\u696d\u306f\u5fc5\u8981\u306a\u30c6\u30b9\u30c8\u306e\u91cf\u3092\u904e\u5c0f\u8a55\u4fa1\u3057\u305f\u308a\u3001\u7279\u5b9a\u306e\u30c6\u30b9\u30c8\u3092\u5b9f\u65bd\u3057\u306a\u3044\u305f\u3081\u306e\u7406\u7531\u4ed8\u3051\u3092\u3057\u3088\u3046\u3068\u3057\u307e\u3059\u3002<\/p>\n<p>\u4f8b\u3002\u4f01\u696d\u306f\u3001\u81ea\u793e\u88fd\u54c1\u306e\u751f\u4f53\u9069\u5408\u6027\u3092\u4e3b\u5f35\u3059\u308b\u305f\u3081\u306b\u3001\u985e\u4f3c\u30c7\u30d0\u30a4\u30b9\u306e\u751f\u4f53\u9069\u5408\u6027\u30c7\u30fc\u30bf\u306b\u4f9d\u5b58\u3059\u308b\u3053\u3068\u304c\u3042\u308b\u3002\u3053\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\u306f\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u53d7\u3051\u5165\u308c\u3089\u308c\u308b\u304b\u3082\u3057\u308c\u306a\u3044\u3002\u3057\u304b\u3057\u3001\u591a\u304f\u306e\u5834\u5408\u3001\u3053\u308c\u3089\u306e\u30c7\u30d0\u30a4\u30b9\u9593\u306e\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u3067\u306f\u3001510(k)\u5be9\u67fb\u306e\u4e0b\u3067\u30c7\u30d0\u30a4\u30b9\u306b\u5bfe\u3059\u308b\u500b\u5225\u306e\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\u304c\u5fc5\u8981\u3068\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>\u3053\u306e\u3088\u3046\u306a\u8ffd\u52a0\u8a66\u9a13\u306b\u306f\u6570\u9031\u9593\u304b\u304b\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u3082\u3057FDA\u304c510(k)\u30ec\u30d3\u30e5\u30fc\u4e2d\u306b\u3053\u308c\u3089\u306e\u8ffd\u52a0\u8a66\u9a13\u306e\u5b9f\u65bd\u3092\u8981\u6c42\u3057\u305f\u5834\u5408\u3001\u6700\u7d42\u7684\u306a510(k)\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u306b\u591a\u304f\u306e\u6642\u9593\u3092\u8981\u3059\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n<p>\u9069\u5207\u306a\u30c1\u30fc\u30e0\u306f\u3001\u5fc5\u8981\u306a\u30c6\u30b9\u30c8\u306e\u91cf\u3092\u6c7a\u5b9a\u3059\u308b\u305f\u3081\u306b\u3001\u73fe\u884c\u306eFDA\u30ac\u30a4\u30c0\u30f3\u30b9\u3001\u88fd\u54c1\u8a2d\u8a08\u3001\u30ea\u30b9\u30af\u7ba1\u7406\u30d7\u30ed\u30bb\u30b9\u3092\u5341\u5206\u306b\u8003\u616e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<ul>\n<li><strong>\u30c6\u30b9\u30c8\u60c5\u5831\u306e\u6b20\u843d\u3002<\/strong><\/li>\n<\/ul>\n<p>\u5f93\u6765\u306e510(k)\u3068\u30b9\u30da\u30b7\u30e3\u30eb510(k)\u306e\u9055\u3044\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002 <strong>\u3059\u3079\u3066\u306e\u30c6\u30b9\u30c8\u30c7\u30fc\u30bf\u306f\u3001\u5f93\u6765\u306e510(k)\u63d0\u51fa\u7269\u306b\u542b\u307e\u308c\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002 <\/strong><\/p>\n<h3><span class=\"ez-toc-section\" id=\"6_Failure_to_Follow_or_Otherwise_Address_Current_Guidance_Documents_or_Recognized_Standards\"><\/span><strong>6.\u30d5\u30a9\u30ed\u30fc\u4e0d\u8db3\u3084\u305d\u306e\u4ed6\u306e\u5bfe\u5fdc <u>\u73fe\u5728 <\/u>\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u307e\u305f\u306f\u516c\u8a8d\u898f\u683c<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u4e0a\u8ff0\u3057\u305f\u3088\u3046\u306b\u3001\u6700\u65b0\u306e\u8a8d\u8b58\u3055\u308c\u305f\u898f\u683c\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3059\u305f\u3081\u306e\u30c6\u30b9\u30c8\u3092\u78ba\u5b9f\u306b\u5b9f\u65bd\u3059\u308b\u3053\u3068\u3002\u6700\u65b0\u7248\u306e\u898f\u683c\u306f\u3001\u65e7\u7248\u3068\u6bd4\u8f03\u3057\u3066\u5927\u5e45\u306b\u5909\u66f4\u3055\u308c\u3066\u3044\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u6700\u65b0\u7248\u306e\u898f\u683c\u3067\u30c6\u30b9\u30c8\u3055\u308c\u3066\u3044\u306a\u3044\u5834\u5408\u306f\u3001\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306b\u3064\u3044\u3066\u65b0\u305f\u306a\u7591\u554f\u304c\u751f\u3058\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>\u6700\u65b0\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3092\u53c2\u7167\u3059\u308b\u3053\u3068\u3067\u3001FDA\u306e\u671f\u5f85\u5024\u3084\u63a8\u5968\u4e8b\u9805\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u307e\u305f\u3001\u63d0\u51fa\u7269\u304c\u67fb\u8aad\u8005\u306e\u7406\u89e3\u3057\u3084\u3059\u3044\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\u3067\u66f8\u304b\u308c\u3066\u3044\u308b\u305f\u3081\u3001FDA\u306e\u67fb\u8aad\u30d7\u30ed\u30bb\u30b9\u304c\u5bb9\u6613\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"7_NSE_Determination\"><\/span><strong>7.NSE\u306e\u6c7a\u5b9a<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>510(k)\u30d7\u30ed\u30bb\u30b9\u306e\u6700\u7d42\u76ee\u6a19\u306f\u3001\u5148\u884c\u30c7\u30d0\u30a4\u30b9\u3068\u306e\u5b9f\u8cea\u7684\u540c\u7b49\u6027(SE)\u3092\u6c7a\u5b9a\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u5b9f\u4f53\u5be9\u67fb\u306e\u6bb5\u968e\u3067FDA\u304b\u3089\u8ffd\u52a0\u60c5\u5831\u3092\u8981\u6c42\u3055\u308c\u305f\u5834\u5408\u3001\u4f01\u696d\u306f\u5404\u8981\u6c42\u3092\u614e\u91cd\u306b\u691c\u8a0e\u3057\u3001\u79d1\u5b66\u7684\u306b\u6b63\u3057\u3044\u56de\u7b54\u3092\u63d0\u4f9b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u8981\u6c42\u3055\u308c\u305f\u30c7\u30fc\u30bf\u3084\u56de\u7b54\u3092\u63d0\u4f9b\u3057\u306a\u304b\u3063\u305f\u5834\u5408\u3001NSE\u5224\u5b9a\u3068\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002 <strong>\u591a\u304f\u306eNSE\u5224\u5b9a\u306f\u3001\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u30c7\u30fc\u30bf\u3092\u63d0\u4f9b\u3057\u3066\u3044\u306a\u3044\u3053\u3068\u304c\u539f\u56e0\u3067\u3059\u3002<\/strong><strong>\u00a0<\/strong><\/p>\n<p>\u3053\u306e\u6bb5\u968e\u3067\u671f\u5f85\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u7406\u89e3\u3059\u308b\u305f\u3081\u306b\u3001FDA\u3068\u76f8\u8ac7\u3057\u3001\u5354\u529b\u3059\u308b\u3053\u3068\u3092\u5f37\u304f\u304a\u52e7\u3081\u3057\u307e\u3059\u3002\u305d\u306e\u4ed6\u3001\u79c1\u306e\u7d4c\u9a13\u304b\u3089\u6c17\u3065\u3044\u305f\u3088\u304f\u3042\u308b\u9593\u9055\u3044\u3092\u3054\u7d39\u4ecb\u3057\u307e\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Administrative_Aspects\"><\/span><em><strong>\u7ba1\u7406\u9762\u306b\u3064\u3044\u3066<\/strong><\/em><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<h3><span class=\"ez-toc-section\" id=\"8_Submitting_application_at_the_correct_address\"><\/span><strong>8.\u6b63\u3057\u3044\u4f4f\u6240\u3067\u306e\u7533\u8acb\u66f8\u306e\u63d0\u51fa<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u3053\u308c\u306f\u7c21\u5358\u306b\u56de\u907f\u3067\u304d\u308b\u30d2\u30e5\u30fc\u30de\u30f3\u30a8\u30e9\u30fc\u3067\u3059\u3002\u5fc5\u305aFDA\u306e\u30b5\u30a4\u30c8\u3092\u53c2\u7167\u3057\u3066 <a href=\"https:\/\/www.fda.gov\/medical-devices\/how-study-and-market-your-device\/ecopy-program-medical-device-submissions\">\u6b63\u3057\u3044\u30a2\u30c9\u30ec\u30b9<\/a> \u3092\u30af\u30ea\u30c3\u30af\u3057\u3066\u3054\u5fdc\u52df\u304f\u3060\u3055\u3044\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"9_Including_hard_copy_as_well_as_eCopy_as_per_latest_FDA_recommendation\"><\/span><strong>9.\u6700\u65b0\u306eFDA\u52e7\u544a\u306b\u57fa\u3065\u304f\u30cf\u30fc\u30c9\u30b3\u30d4\u30fc\u3068e\u30b3\u30d4\u30fc\u3092\u542b\u3080<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>FDA\u306f\u3001510(k)\u7533\u8acb\u306b\u5fc5\u8981\u306a\u30cf\u30fc\u30c9\u30b3\u30d4\u30fc\u3068e\u30b3\u30d4\u30fc\u306e\u679a\u6570\u3092\u898f\u5b9a\u3057\u3066\u3044\u307e\u3059\u3002\u73fe\u5728\u306e\u3068\u3053\u308d\u3001\u30cf\u30fc\u30c9\u30b3\u30d4\u30fc1\u90e8\u3068e\u30b3\u30d4\u30fc1\u90e8\u304c\u5fc5\u8981\u3068\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u4eee\u5b9a\u306e\u8a71\u3092\u3057\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002\u7d50\u8ad6\u3092\u51fa\u3059\u524d\u306b\u3001FDA\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u3092\u53c2\u7167\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"10_eCopy_related_issues\"><\/span><strong>10. eCopy\u306b\u95a2\u3059\u308b\u554f\u984c<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>eCopy\u306e\u6280\u8853\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002  \u3092\u53c2\u7167\u3057\u3066\u304f\u3060\u3055\u3044\u3002 <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/ecopy-program-medical-device-submissions\">e\u30b3\u30d4\u30fc\u30ac\u30a4\u30c0\u30f3\u30b9<\/a> \u3092\u30af\u30ea\u30c3\u30af\u3059\u308b\u3068\u3001\u7533\u8acb\u66f8\u306eeCopy\u304c\u4f5c\u6210\u3055\u308c\u307e\u3059\u3002<\/p>\n<blockquote><p>eCopy hold letter\u3092\u907f\u3051\u308b\u305f\u3081\u306b\u306f\u3001PDF\u306e\u547d\u540d\u898f\u5247\u3068\u30d5\u30a1\u30a4\u30eb\u30b5\u30a4\u30ba\u306e\u63a8\u5968\u306b\u5f93\u308f\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u306e\u4f7f\u7528\u306f\u3067\u304d\u307e\u305b\u3093\u304c\u00a0<a href=\"https:\/\/www.fda.gov\/industry\/fda-esubmitter\/esubmitter-ecopies-tool\">eSubmitter-eCopies\u30c4\u30fc\u30eb<\/a>\u00a0\u306f\u4efb\u610f\u3067\u3059\u304c\u3001\u3053\u306e\u30c4\u30fc\u30eb\u306fFDA\u306e\u52e7\u544a\u306b\u6cbf\u3063\u3066eCopy\u3092\u691c\u8a3c\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002<\/p><\/blockquote>\n<h3><span class=\"ez-toc-section\" id=\"11_Submitting_information_to_reviewer\"><\/span><strong>11.\u5be9\u67fb\u54e1\u3078\u306e\u60c5\u5831\u63d0\u4f9b<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>FDA\u304b\u3089\u6700\u521d\u306e\u30db\u30fc\u30eb\u30c9\u30ec\u30bf\u30fc\uff08RTA\u30db\u30fc\u30eb\u30c9\u3001eCopy\u30db\u30fc\u30eb\u30c9\uff09\u3092\u53d7\u3051\u53d6\u3063\u305f\u5f8c\u3001\u4f01\u696d\u306f\u30ec\u30d3\u30e5\u30fc\u30a2\u306b\u60c5\u5831\u3092\u63d0\u51fa\u3059\u308b\u969b\u306b\u9593\u9055\u3044\u3092\u72af\u3059\u3053\u3068\u304c\u3088\u304f\u3042\u308a\u307e\u3059\u3002  FDA\u304b\u3089\u5c4a\u3044\u305f\u30e1\u30fc\u30eb\u3084FDA\u306e\u9069\u5207\u306a\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u78ba\u8a8d\u3057\u3066\u3001\u30db\u30fc\u30eb\u30c9\u30ec\u30bf\u30fc\u306b\u5bfe\u3059\u308b\u56de\u7b54\u3092\u3069\u3053\u306b\u9001\u308c\u3070\u3088\u3044\u304b\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Technical_Aspects\"><\/span><em><strong>\u6280\u8853\u7684\u5074\u9762<\/strong><\/em><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<h3><span class=\"ez-toc-section\" id=\"12_Traditional_510k_vs_Special_510k\"><\/span><strong>12.\u5f93\u6765\u306e510(k)\u3068\u7279\u5225\u306a510(k)\u306e\u6bd4\u8f03<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u4f01\u696d\u306f\u3001\u7533\u8acb\u66f8\u3092\u5f93\u6765\u306e510(k)\u307e\u305f\u306f\u7279\u5225\u306a510(k)\u306b\u5206\u985e\u3059\u308b\u3068\u3044\u3046\u9593\u9055\u3044\u3092\u72af\u3059\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002 <strong>\u5f93\u6765\u306e510(k)\u3068\u30b9\u30da\u30b7\u30e3\u30eb510(k)\u306e\u5927\u304d\u306a\u9055\u3044\u306f\u3001FDA\u306b\u3088\u308b\u7533\u8acb\u306e\u5be9\u67fb\u306b\u8981\u3059\u308b\u6642\u9593\u3067\u3059\u3002\u30b9\u30da\u30b7\u30e3\u30eb510(k)\u306f30\u65e5\u3001\u5f93\u6765\u578b510(k)\u306f90\u65e5\u304b\u304b\u308a\u307e\u3059\u3002<\/strong> \u79c1\u306f\u3001FDA\u304c\u30b9\u30da\u30b7\u30e3\u30eb510(k)\u3092\u5f93\u6765\u306e510(k)\u306b\u5909\u63db\u3059\u308b\u3088\u3046\u4f01\u696d\u306b\u8981\u6c42\u3057\u3066\u3044\u308b\u306e\u3092\u4f55\u5ea6\u304b\u898b\u305f\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u5834\u5408\u3001\u4f01\u696d\u306f\u5909\u63db\u30d7\u30ed\u30bb\u30b9\u3067\u975e\u5e38\u306b\u591a\u304f\u306e\u6642\u9593\u3092\u8cbb\u3084\u3059\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n<p>FDA\u3067\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u5834\u5408\u306b\u30b9\u30da\u30b7\u30e3\u30eb510(k)\u304c\u9069\u5207\u3067\u3042\u308b\u3068\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<ul>\n<li><em>\u63d0\u6848\u3055\u308c\u305f\u5909\u66f4\u306f\u3001\u65e2\u5b58\u306e\u6a5f\u5668\u3092\u8ca9\u58f2\u3059\u308b\u3053\u3068\u304c\u6cd5\u7684\u306b\u8a8d\u3081\u3089\u308c\u3066\u3044\u308b\u30e1\u30fc\u30ab\u30fc\u306b\u3088\u3063\u3066\u63d0\u51fa\u3055\u308c\u307e\u3059\u3002<\/em><\/li>\n<li><em>\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u30c7\u30fc\u30bf\u304c\u4e0d\u8981\u3067\u3042\u308b\u304b\u3001\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u30c7\u30fc\u30bf\u304c\u5fc5\u8981\u306a\u5834\u5408\u306f\u3001\u5909\u5316\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306e\u78ba\u7acb\u3055\u308c\u305f\u65b9\u6cd5\u304c\u5229\u7528\u53ef\u80fd\u3067\u3042\u308b\u3053\u3068\u3002<\/em><\/li>\n<li><em>\u5b9f\u8cea\u7684\u306a\u540c\u7b49\u6027\u3092\u88cf\u4ed8\u3051\u308b\u306e\u306b\u5fc5\u8981\u306a\u3059\u3079\u3066\u306e\u6027\u80fd\u30c7\u30fc\u30bf\u306f\u3001\u8981\u7d04\u307e\u305f\u306f\u30ea\u30b9\u30af\u5206\u6790\u306e\u5f62\u5f0f\u3067\u30ec\u30d3\u30e5\u30fc\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/em><\/li>\n<\/ul>\n<p>To avoid such mistake, do thorough <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> on the FDA database to identify if similar change was submitted as Special 510(k) or Traditional 510(k). Refer to the <a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-notification-510k\/510k-submission-programs\">\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8<\/a> FDA\u304b\u3089\u3002\u305d\u308c\u3067\u3082\u7591\u554f\u304c\u3042\u308b\u5834\u5408\u306f\u3001\u898f\u5236\u5f53\u5c40\u306e\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u306e\u52a9\u3051\u3092\u501f\u308a\u3066\u304f\u3060\u3055\u3044\u3002\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u884c\u3046\u3002\u305d\u308c\u3067\u3082\u7591\u554f\u304c\u3042\u308b\u5834\u5408\u306f\u3001\u4fdd\u5b88\u7684\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u3068\u308a\u3001\u5f93\u6765\u306e510(k)\u3092\u63d0\u51fa\u3059\u308b\u3053\u3068\u3092\u304a\u52e7\u3081\u3057\u307e\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Unique_Challenges\"><\/span><em><strong>\u30e6\u30cb\u30fc\u30af\u306a\u30c1\u30e3\u30ec\u30f3\u30b8<\/strong><\/em><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<h3><span class=\"ez-toc-section\" id=\"13_Nature_of_the_device\"><\/span>13.\u30c7\u30d0\u30a4\u30b9\u306e\u6027\u8cea<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u30c7\u30d0\u30a4\u30b9\u306b\u3088\u3063\u3066\u306f\u3001\u305d\u306e\u30e6\u30cb\u30fc\u30af\u306a\u6027\u8cea\u306e\u305f\u3081\u306b\u30e6\u30cb\u30fc\u30af\u306a\u554f\u984c\u304c\u767a\u751f\u3059\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u7279\u5b9a\u306e\u6280\u8853\u5206\u91ce <a href=\"https:\/\/www.fda.gov\/files\/medical%20devices\/published\/US-FDA-Artificial-Intelligence-and-Machine-Learning-Discussion-Paper.pdf\">\u4eba\u5de5\u77e5\u80fd\uff08AI\uff09\u306b\u3064\u3044\u3066<\/a> \u305d\u3057\u3066 <a href=\"https:\/\/www.fda.gov\/medical-devices\/digital-health\/cybersecurity#guidance\">\u30b5\u30a4\u30d0\u30fc\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3<\/a> \u306f\u6bd4\u8f03\u7684\u65b0\u3057\u3044\u5206\u91ce\u3067\u3059\u3002FDA\u306f\u696d\u754c\u3068\u5354\u529b\u3057\u3066\u3053\u308c\u3089\u306e\u5206\u91ce\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3092\u4f5c\u6210\u3057\u305f\u3002<\/p>\n<blockquote><p>\u3053\u306e\u3088\u3046\u306a\u5834\u5408\u306b\u306f\u3001510(k)\u7533\u8acb\u524d\u306bFDA\u3068\u306e\u4e8b\u524d\u6253\u3061\u5408\u308f\u305b\u3092\u884c\u3046\u3053\u3068\u3092\u5f37\u304f\u304a\u52e7\u3081\u3057\u307e\u3059\u3002\u8a73\u7d30\u306f <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/requests-feedback-and-meetings-medical-device-submissions-q-submission-program\">FDA\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8<\/a> 510(k)\u7533\u8acb\u524d\u306bFDA\u3078\u306e\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3084\u30df\u30fc\u30c6\u30a3\u30f3\u30b0\u304c\u5fc5\u8981\u306a\u5834\u5408\u3002<\/p><\/blockquote>\n<h2><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span><strong>\u7d50\u8ad6<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u3053\u308c\u3089\u306f\u3001510(k)\u63d0\u51fa\u7269\u306e\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306b\u304a\u3051\u308b\u91cd\u8981\u306a\u30dd\u30a4\u30f3\u30c8\u3067\u3057\u305f\u3002FDA\u304b\u3089\u306eRTA\uff08Refuse to Accept\uff09\u30ec\u30bf\u30fc\u306f\u3001\u63d0\u51fa\u66f8\u985e\u3092\u614e\u91cd\u306b\u691c\u8a0e\u3057\u3001FDA\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306b\u5f93\u3046\u3053\u3068\u3067\u3001\u5bb9\u6613\u306b\u56de\u907f\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u305f\u3002<\/p>\n<p>\u660e\u77ad\u3067\u7c21\u6f54\u306a510(k)\u3092\u66f8\u304f\u3053\u3068\u3067\u3001\u5b9f\u8cea\u7684\u306a\u5be9\u67fb\u30d7\u30ed\u30bb\u30b9\u306e\u4e00\u74b0\u3068\u3057\u3066\u8981\u6c42\u3055\u308c\u308b\u8ffd\u52a0\u60c5\u5831\u3092\u6e1b\u3089\u3059\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u79d1\u5b66\u3001\u82b8\u8853\u3001\u7d4c\u9a13\u306e\u7d44\u307f\u5408\u308f\u305b\u3067\u3042\u308b\u3053\u3068\u304c\u591a\u3044\u3067\u3059\u3002\u7d4c\u9a13\u8c4a\u5bcc\u306a\u5c02\u9580\u5bb6\u306e\u52a9\u3051\u3092\u501f\u308a\u308b\u3053\u3068\u3092\u5f37\u304f\u304a\u52e7\u3081\u3057\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=510KMistakes\">\u85ac\u4e8b\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> 510(k)\u7533\u8acb\u6642\u306e\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306b\u5f93\u3046\u3053\u3068\u3067\u3001\u30b3\u30b9\u30c8\u306e\u304b\u304b\u308b\u30df\u30b9\u3092\u907f\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u7533\u8acb\u3092\u6210\u529f\u3055\u305b\u308b\u53ef\u80fd\u6027\u3092\u9ad8\u3081\u308b\u305f\u3081\u306b\u3001\u9069\u7528\u3055\u308c\u308b\u898f\u5236\u3001\u57fa\u6e96\u3001\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306b\u3064\u3044\u3066\u5e38\u306b\u6700\u65b0\u306e\u60c5\u5831\u3092\u5f97\u308b\u3088\u3046\u306b\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n<p><strong>\u306b\u76f8\u8ac7\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/fda-submissions?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=510KMistakes\">FDA\u7533\u8acb\u306e\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/a>?\u7d4c\u9a13\u8c4a\u5bcc\u306a\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30e9\u30a4\u30bf\u30fc\u3001\u533b\u7642\u6a5f\u5668\u696d\u754c\u306e\u5c02\u9580\u5bb6\u3068\u5354\u529b\u3057\u3066 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/510-k-submissions\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=510KMistakes\">510k\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> \u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304cFDA\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u3092\u6210\u529f\u3055\u305b\u308b\u305f\u3081\u306e\u898f\u5236\u6587\u66f8\u4f5c\u6210\u3092\u652f\u63f4\u3057\u3066\u304d\u307e\u3057\u305f\u3002\u00a0<\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>FDA\u7533\u8acb\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3067\u3042\u308a\u3001\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30e9\u30a4\u30bf\u30fc\u3067\u3042\u308bSamradni Patil\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304c\u8fc5\u901f\u304b\u3064\u5bb9\u6613\u306bFDA\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u3092\u53d6\u5f97\u3059\u308b\u305f\u3081\u306e510k\u7533\u8acb\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002  510(k)\u7533\u8acb\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u901a\u5e38\u3001\u30af\u30e9\u30b9II\u306e\u533b\u7642\u6a5f\u5668\u304c\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40(FDA)\u306e\u8a31\u53ef\u3092\u5f97\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002\u30af\u30e9\u30b9III\u306e\u533b\u7642\u6a5f\u5668\u3067\u306f\u3001\u901a\u5e38\u3001\u5e02\u8ca9\u524d\u627f\u8a8d\uff08PMA\uff09\u30d7\u30ed\u30bb\u30b9\u304c\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002510(k)\u5be9\u67fb\u3067\u306f\u3001\u5408\u6cd5\u7684\u306b\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u985e\u4f3c\u306e\u30c7\u30d0\u30a4\u30b9\uff08\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8\u30c7\u30d0\u30a4\u30b9\u3068\u3082\u547c\u3070\u308c\u308b\uff09\u3068\u306e\u5b9f\u8cea\u7684\u540c\u7b49\u6027\uff08SE\uff09\u3092\u5224\u5b9a\u3057\u307e\u3059\u3002\u5b9f\u8cea\u7684\u306b\u540c\u7b49\u3067\u3042\u308b\u3068\u4e3b\u5f35\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u305d\u306e\u6a5f\u5668\u304c\u5408\u6cd5\u7684\u306b\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u6a5f\u5668\u3068\u5c11\u306a\u304f\u3068\u3082\u540c\u7b49\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u6709\u3057\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002510(k)\u5be9\u67fb\u306e\u5bfe\u8c61\u3068\u306a\u308b\u6a5f\u5668\u306f\u3001\u4ee5\u4e0b\u306e\u70b9\u3092\u793a\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<div 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