{"id":4493,"date":"2023-10-06T14:54:37","date_gmt":"2023-10-06T06:54:37","guid":{"rendered":"https:\/\/regask.com\/?p=4493"},"modified":"2025-01-09T03:32:18","modified_gmt":"2025-01-08T19:32:18","slug":"%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e7%94%b3%e8%ab%8b%e7%b5%8c%e8%b7%af","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/medical-device-submission-pathways\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u7533\u8acb\u30d7\u30ed\u30bb\u30b9\u306b\u95a2\u3059\u308b\u7a76\u6975\u306e\u30ac\u30a4\u30c9"},"content":{"rendered":"<p>\u533b\u7642\u6a5f\u5668\u3092\u53d6\u308a\u5dfb\u304f\u74b0\u5883\u306f\u7d76\u3048\u305a\u5909\u5316\u3057\u3066\u304a\u308a\u3001\u3053\u308c\u3089\u306e\u9769\u65b0\u7684\u306a\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u627f\u8a8d\u3059\u308b\u306b\u306f\u3001\u5805\u7262\u306a\u898f\u5236\u7d4c\u8def\u304c\u5fc5\u8981\u3067\u3059\u3002\u3053\u306e\u4e8b\u5b9f\u306f\u3001\u533b\u7642\u6a5f\u5668\u696d\u754c\u306e\u898f\u5236\u696d\u52d9\u306e\u5c02\u9580\u5bb6\u306b\u3068\u3063\u3066\u7279\u306b\u5f53\u3066\u306f\u307e\u308a\u307e\u3059\u3002\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40 (FDA) \u306e\u898f\u5236\u3092\u9806\u5b88\u3057\u3066\u6a5f\u5668\u306e\u8a8d\u53ef\u307e\u305f\u306f\u627f\u8a8d\u3092\u5f97\u308b\u3053\u3068\u306f\u3001\u8907\u96d1\u3067\u3059\u304c\u91cd\u8981\u306a\u30d7\u30ed\u30bb\u30b9\u3067\u3059\u3002\u3053\u306e\u8a18\u4e8b\u3067\u306f\u3001\u7533\u8acb\u7d4c\u8def\u306e\u5305\u62ec\u7684\u306a\u6982\u8981\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u3001\u3053\u308c\u3089\u306e\u7d4c\u8def\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u304c\u4e0d\u53ef\u6b20\u3067\u3042\u308b\u7406\u7531\u306e\u8aac\u660e\u3001510(k)\u3001De Novo\u3001\u304a\u3088\u3073\u5e02\u8ca9\u524d\u627f\u8a8d (PMA) \u7d4c\u8def\u306e\u6982\u8981\u3001\u304a\u3088\u3073\u7533\u8acb\u30b5\u30dd\u30fc\u30c8\u306e\u30d2\u30f3\u30c8\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n<p><em>\u514d\u8cac\u4e8b\u9805: \u4e00\u90e8\u306e\u30af\u30e9\u30b9 I \u304a\u3088\u3073 II \u30c7\u30d0\u30a4\u30b9\u306f FDA \u306e\u8a8d\u53ef\u3092\u5fc5\u8981\u3068\u305b\u305a\u3001\u9069\u5207\u306a\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u3068\u5805\u7262\u306a\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0 (QMS) \u304c\u3042\u308c\u3070\u5e02\u5834\u306b\u6295\u5165\u3067\u304d\u307e\u3059\u304c\u3001\u30c7\u30d0\u30a4\u30b9 \u30af\u30e9\u30b9\u304c\u30af\u30e9\u30b9 I \u304b\u3089\u30af\u30e9\u30b9 III \u306b\u4e0a\u304c\u308b\u306b\u3064\u308c\u3066\u3001\u898f\u5236\u7ba1\u7406\u304c\u5f37\u5316\u3055\u308c\u308b\u3053\u3068\u3092\u899a\u3048\u3066\u304a\u304f\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u4f8b\u5916\u3092\u7406\u89e3\u3057\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u78ba\u4fdd\u3059\u308b\u306b\u306f\u3001\u5fc5\u305a FDA \u30ac\u30a4\u30c9\u3092\u53c2\u7167\u3057\u3066\u304f\u3060\u3055\u3044\u3002 <\/em><\/p>\n<h2>\u533b\u7642\u6a5f\u5668\u306e\u7533\u8acb\u7d4c\u8def\u3092\u7406\u89e3\u3059\u308b\uff08\u305d\u3057\u3066\u305d\u308c\u304c\u306a\u305c\u91cd\u8981\u306a\u306e\u304b\uff09<\/h2>\n<p>\u7533\u8acb\u7d4c\u8def\u3068\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304c\u5e02\u5834\u306b\u51fa\u308b\u524d\u306b\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b FDA \u304c\u5b9a\u3081\u305f\u898f\u5236\u30d7\u30ed\u30bb\u30b9\u3067\u3059\u3002\u3053\u308c\u3089\u306e\u7d4c\u8def\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u306f\u3001\u958b\u767a\u304b\u3089\u5e02\u5834\u53c2\u5165\u3078\u306e\u30b9\u30e0\u30fc\u30ba\u306a\u79fb\u884c\u3092\u53ef\u80fd\u306b\u3057\u3001\u60a3\u8005\u304c\u3053\u308c\u3089\u306e\u6a5f\u5668\u3092\u3088\u308a\u65e9\u304f\u5229\u7528\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b\u305f\u3081\u3001\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002<\/p>\n<p>\u7533\u8acb\u624b\u7d9a\u304d\u3092\u3046\u307e\u304f\u9032\u3081\u308b\u306b\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u307e\u305a\u81ea\u793e\u306e\u88fd\u54c1\u306b\u6700\u3082\u9069\u3057\u305f\u7533\u8acb\u624b\u7d9a\u304d\u3092\u7279\u5b9a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u6b21\u306b\u3001\u305d\u306e\u7279\u5b9a\u306e\u7533\u8acb\u624b\u7d9a\u304d\u306e\u57fa\u6e96\u3092\u6e80\u305f\u3059\u8a73\u7d30\u306a\u7533\u8acb\u66f8\u985e\u3092\u4f5c\u6210\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002FDA \u306f\u3001\u3053\u306e\u624b\u7d9a\u304d\u3092\u652f\u63f4\u3059\u308b\u305f\u3081\u306b\u3001\u5305\u62ec\u7684\u306a\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3001\u627f\u8a8d\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3001\u30d5\u30ed\u30fc\u30c1\u30e3\u30fc\u30c8\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u5404\u7533\u8acb\u624b\u7d9a\u304d\u306b\u306f\u3001\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u3084\u3001\u5408\u6cd5\u7684\u306b\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u65e2\u5b58\u306e\u6a5f\u5668\u3068\u306e\u985e\u4f3c\u6027\u306e\u6709\u7121\u306a\u3069\u306e\u8981\u56e0\u306b\u3088\u3063\u3066\u6c7a\u307e\u308b\u72ec\u81ea\u306e\u8981\u4ef6\u304c\u3042\u308a\u307e\u3059\u3002\u4ee5\u4e0b\u306b\u3001\u305d\u308c\u305e\u308c\u306e\u8981\u4ef6\u3092\u7c21\u5358\u306b\u307e\u3068\u3081\u307e\u3059\u3002<\/p>\n<h2>1. 510(k)\u30d1\u30b9\u30a6\u30a7\u30a4<\/h2>\n<p>510(k) \u7d4c\u8def\u306f\u3001\u9023\u90a6\u98df\u54c1\u30fb\u533b\u85ac\u54c1\u30fb\u5316\u7ca7\u54c1\u6cd5\u306e\u30bb\u30af\u30b7\u30e7\u30f3 510(k) \u306b\u3061\u306a\u3093\u3067\u540d\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u7d4c\u8def\u3067\u306f\u3001\u88fd\u9020\u696d\u8005\u306b\u5bfe\u3057\u3001\u30c7\u30d0\u30a4\u30b9\u304c\u5408\u6cd5\u7684\u306b\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u30c7\u30d0\u30a4\u30b9 (\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8 \u30c7\u30d0\u30a4\u30b9) \u3068\u5b9f\u8cea\u7684\u306b\u540c\u7b49\u3067\u3042\u308b\u3053\u3068\u3092\u793a\u3059\u5e02\u8ca9\u524d\u901a\u77e5\u3092\u63d0\u51fa\u3059\u308b\u3053\u3068\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u305d\u306e\u76ee\u7684\u306f\u3001\u65b0\u3057\u3044\u30c7\u30d0\u30a4\u30b9\u304c\u540c\u69d8\u306e\u6280\u8853\u7684\u7279\u6027\u3092\u6301\u3061\u3001\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8 \u30c7\u30d0\u30a4\u30b9\u3068\u3057\u3066\u4f7f\u7528\u3059\u308b\u3053\u3068\u3092\u610f\u56f3\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3059\u3053\u3068\u3067\u3059\u3002<\/p>\n<p>\u3053\u306e\u7d4c\u8def\u3067\u627f\u8a8d\u3092\u5f97\u308b\u306b\u306f\u3001\u88fd\u9020\u696d\u8005\u306f\u3001\u65b0\u3057\u3044\u6a5f\u5668\u306e\u7528\u9014\u3001\u8a2d\u8a08\u4e0a\u306e\u7279\u5fb4\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u30c6\u30b9\u30c8\u307e\u305f\u306f\u81e8\u5e8a\u8a66\u9a13\u304b\u3089\u5f97\u305f\u6027\u80fd\u30c7\u30fc\u30bf\u3001\u30e9\u30d9\u30eb\u306e\u8a73\u7d30\u306a\u3069\u306b\u95a2\u3059\u308b\u60c5\u5831\u3092\u542b\u3080\u5305\u62ec\u7684\u306a\u7533\u8acb\u66f8\u3092\u6e96\u5099\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002FDA \u306f\u3053\u306e\u7533\u8acb\u66f8\u3092\u5be9\u67fb\u3057\u3001\u65b0\u3057\u3044\u6a5f\u5668\u3068\u305d\u306e\u5148\u884c\u6a5f\u5668\u306e\u9593\u306b\u5b9f\u8cea\u7684\u306a\u540c\u7b49\u6027\u304c\u5b58\u5728\u3059\u308b\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3057\u307e\u3059\u3002<\/p>\n<h3>510(k) \u30d1\u30b9\u30a6\u30a7\u30a4\u306e\u8cc7\u683c\u304c\u3042\u308b\u306e\u306f\u8ab0\u3067\u3059\u304b?<\/h3>\n<p>510(k) \u7d4c\u8def\u306f\u3001\u9ad8\u30ea\u30b9\u30af\u306b\u5206\u985e\u3055\u308c\u305a\u3001\u5408\u6cd5\u7684\u306b\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8\u3092\u6301\u3064\u533b\u7642\u6a5f\u5668\u3092\u88fd\u9020\u3059\u308b\u30e1\u30fc\u30ab\u30fc\u306b\u9069\u3057\u3066\u3044\u307e\u3059\u3002\u6a5f\u5668\u306f\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8\u3068\u540c\u69d8\u306e\u6280\u8853\u7684\u7279\u6027\u3092\u6301\u3064\u3060\u3051\u3067\u306a\u304f\u3001\u540c\u3058\u4f7f\u7528\u76ee\u7684\u3082\u6301\u305f\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u3053\u306e\u7d4c\u8def\u306f\u30af\u30e9\u30b9 II \u6a5f\u5668\u3067\u6700\u3082\u4e00\u822c\u7684\u3067\u3059\u304c\u3001\u4e00\u90e8\u306e\u30af\u30e9\u30b9 I \u304a\u3088\u3073\u30af\u30e9\u30b9 III \u6a5f\u5668\u3082\u5bfe\u8c61\u3068\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<h2>2. \u30c7\u30fb\u30ce\u30dc\u30fb\u30d1\u30b9\u30a6\u30a7\u30a4\uff08\u7b2c513\u6761(f)(2)\uff09<\/h2>\n<p>De Novo \u7d4c\u8def\u306f\u3001\u5b9f\u8cea\u7684\u540c\u7b49\u6027\u3092\u5b9f\u8a3c\u3067\u304d\u308b\u6cd5\u7684\u306b\u8ca9\u58f2\u3055\u308c\u305f\u6839\u62e0\u304c\u306a\u3044\u65b0\u3057\u3044\u533b\u7642\u6a5f\u5668\u306b\u4ee3\u66ff\u30eb\u30fc\u30c8\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u3053\u306e\u7d4c\u8def\u306b\u3088\u308a\u3001\u88fd\u9020\u696d\u8005\u306f\u30ea\u30b9\u30af \u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u306b\u57fa\u3065\u3044\u3066\u3001\u30c7\u30d0\u30a4\u30b9\u3092\u30af\u30e9\u30b9 I\u3001\u30af\u30e9\u30b9 II\u3001\u307e\u305f\u306f\u30af\u30e9\u30b9 III \u306b\u5206\u985e\u3059\u308b\u3088\u3046\u8981\u6c42\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>\u88fd\u9020\u696d\u8005\u306f\u3001\u6a5f\u5668\u306e\u7528\u9014\u3001\u6280\u8853\u7684\u7279\u5fb4\u3001\u975e\u81e8\u5e8a\u8a66\u9a13\u307e\u305f\u306f\u81e8\u5e8a\u8a66\u9a13\uff08\u8a72\u5f53\u3059\u308b\u5834\u5408\uff09\u304b\u3089\u306e\u5b89\u5168\u6027\u30c7\u30fc\u30bf\u3001\u304a\u3088\u3073\u30e9\u30d9\u30eb\u60c5\u5831\uff08\u4f7f\u7528\u9069\u5fdc\u75c7\u304a\u3088\u3073\u7981\u5fcc\uff08\u3042\u308b\u5834\u5408\uff09\u3092\u542b\u3080\uff09\u306b\u95a2\u3059\u308b\u8a73\u7d30\u60c5\u5831\u3092\u542b\u3080 De Novo \u30ea\u30af\u30a8\u30b9\u30c8\u3092\u63d0\u51fa\u3057\u307e\u3059\u3002\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306e\u5074\u9762\u3092\u8a55\u4fa1\u3059\u308b\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u3084\u533b\u5b66\u306a\u3069\u306e\u95a2\u9023\u5206\u91ce\u306e FDA \u5c02\u9580\u5bb6\u306b\u3088\u308b\u7533\u8acb\u306e\u5be9\u67fb\u5f8c\u3001FDA \u306f\u3001\u6a5f\u5668\u306e\u65b0\u3057\u3044\u898f\u5236\u5206\u985e\u3092\u78ba\u7acb\u3059\u308b De Novo \u5206\u985e\u3092\u4ed8\u4e0e\u3059\u308b\u304b\u3069\u3046\u304b\u3092\u6c7a\u5b9a\u3057\u307e\u3059\u3002<\/p>\n<h3>De Novo Pathway \u306e\u8cc7\u683c\u304c\u3042\u308b\u306e\u306f\u8ab0\u3067\u3059\u304b?<\/h3>\n<p>De Novo \u7d4c\u8def\u306f\u3001\u65b0\u898f\u3067\u3001\u6cd5\u7684\u306b\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8\u304c\u5b58\u5728\u3057\u306a\u3044\u30c7\u30d0\u30a4\u30b9\u5411\u3051\u306b\u8abf\u6574\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306f\u901a\u5e38\u3001\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8\u304c\u306a\u3044\u305f\u3081\u6700\u521d\u306f\u30af\u30e9\u30b9 III (\u9ad8\u30ea\u30b9\u30af) \u306b\u5206\u985e\u3055\u308c\u3066\u3044\u305f\u304c\u3001\u30af\u30e9\u30b9 III \u306e\u5b9a\u7fa9\u306b\u306f\u5f53\u3066\u306f\u307e\u3089\u306a\u3044\u4f4e\u30ea\u30b9\u30af\u304b\u3089\u4e2d\u30ea\u30b9\u30af\u306e\u30c7\u30d0\u30a4\u30b9\u3067\u3059\u3002De Novo \u7d4c\u8def\u3092\u901a\u3058\u3066\u3001\u3053\u308c\u3089\u306e\u30c7\u30d0\u30a4\u30b9\u306f\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306b\u95a2\u3059\u308b\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u8a55\u4fa1\u306e\u5f8c\u3001\u30af\u30e9\u30b9 I \u307e\u305f\u306f\u30af\u30e9\u30b9 II \u306b\u518d\u5206\u985e\u3067\u304d\u307e\u3059\u3002\u958b\u767a\u6bb5\u968e\u3067 FDA \u306b\u30a2\u30d7\u30ed\u30fc\u30c1\u3057\u3001\u5206\u985e\u3001\u5e02\u5834\u3078\u306e\u30eb\u30fc\u30c8\u3001\u81e8\u5e8a\u8a08\u753b\u306b\u3064\u3044\u3066\u5408\u610f\u3092\u5f97\u308b\u305f\u3081\u306b\u3001\u4e8b\u524d\u30b5\u30d6\u4f1a\u8b70\u3092\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3059\u308b\u3053\u3068\u3092\u304a\u52e7\u3081\u3057\u307e\u3059\u3002<\/p>\n<h2>3. PMA \u30d1\u30b9\u30a6\u30a7\u30a4<\/h2>\n<p>\u5e02\u8ca9\u524d\u627f\u8a8d (PMA) \u7d4c\u8def\u306f\u3001\u533b\u7642\u6a5f\u5668\u306b\u5bfe\u3059\u308b\u6700\u3082\u53b3\u683c\u306a\u898f\u5236\u7d4c\u8def\u3067\u3059\u3002\u3053\u306e\u7d4c\u8def\u306f\u3001\u9ad8\u30ea\u30b9\u30af\u306e\u6a5f\u5668\u3001\u307e\u305f\u306f\u6bd4\u8f03\u5bfe\u8c61\u3068\u3057\u3066\u5408\u6cd5\u7684\u306b\u5e02\u8ca9\u3055\u308c\u3066\u3044\u308b\u5148\u884c\u6a5f\u5668\u304c\u306a\u3044\u6a5f\u5668\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u3002<\/p>\n<p>PMA \u627f\u8a8d\u3092\u53d6\u5f97\u3059\u308b\u306b\u306f\u3001\u88fd\u9020\u696d\u8005\u306f\u81e8\u5e8a\u8a66\u9a13\u3001\u975e\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u3001\u54c1\u8cea\u7ba1\u7406\u63aa\u7f6e\u3084\u65bd\u8a2d\u691c\u67fb\u3092\u542b\u3080\u88fd\u9020\u60c5\u5831\u3001\u304a\u3088\u3073\u8a72\u5f53\u3059\u308b\u5834\u5408\u306f\u4f7f\u7528\u9069\u5fdc\u75c7\u3084\u8b66\u544a\u307e\u305f\u306f\u7981\u5fcc\u306a\u3069\u306e\u30e9\u30d9\u30eb\u306e\u8a73\u7d30\u3092\u901a\u3058\u3066\u3001\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u8a3c\u660e\u3059\u308b\u5305\u62ec\u7684\u306a\u79d1\u5b66\u7684\u8a3c\u62e0\u3092\u63d0\u4f9b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002FDA \u306f\u3053\u306e\u5e83\u7bc4\u306a\u7533\u8acb\u3092\u8a73\u7d30\u306b\u5be9\u67fb\u3057\u3001\u88fd\u9020\u696d\u8005\u304c\u63d0\u4f9b\u3057\u305f\u79d1\u5b66\u7684\u8a3c\u62e0\u306e\u8a55\u4fa1\u306b\u57fa\u3065\u3044\u3066\u6c7a\u5b9a\u3057\u307e\u3059\u3002PMA \u7533\u8acb\u306f\u3001\u3053\u306e\u7d4c\u8def\u3067\u627f\u8a8d\u3055\u308c\u305f\u5834\u5408\u3001\u554f\u984c\u306e\u6a5f\u5668\u306e\u8ca9\u58f2\u8a31\u53ef\u3092\u4ed8\u4e0e\u3057\u307e\u3059\u3002<\/p>\n<h3>PMA Pathway \u306e\u8cc7\u683c\u304c\u3042\u308b\u306e\u306f\u8ab0\u3067\u3059\u304b?<\/h3>\n<p>PMA \u7d4c\u8def\u306f\u3001\u30af\u30e9\u30b9 III \u533b\u7642\u6a5f\u5668\u3092\u5bfe\u8c61\u3068\u3057\u3066\u304a\u308a\u3001\u901a\u5e38\u306f\u9ad8\u30ea\u30b9\u30af\u6a5f\u5668\u3001\u307e\u305f\u306f\u4eba\u547d\u3092\u652f\u63f4\u307e\u305f\u306f\u7dad\u6301\u3059\u308b\u6a5f\u5668\u3067\u3059\u3002\u3053\u308c\u3089\u306e\u6a5f\u5668\u306b\u306f 510(k) \u7533\u8acb\u306b\u4f7f\u7528\u3067\u304d\u308b\u9069\u5207\u306a\u6839\u62e0\u304c\u306a\u304f\u3001\u6a5f\u5668\u306b\u95a2\u9023\u3059\u308b\u6f5c\u5728\u7684\u306a\u30ea\u30b9\u30af\u306f\u4e00\u822c\u7ba1\u7406\u307e\u305f\u306f\u7279\u5225\u7ba1\u7406\u3067\u306f\u7ba1\u7406\u3067\u304d\u307e\u305b\u3093\u3002\u4f8b\u3068\u3057\u3066\u306f\u3001\u5fc3\u81d3\u5f01\u3001\u30b7\u30ea\u30b3\u30f3 \u30b8\u30a7\u30eb\u5145\u586b\u4e73\u623f\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u3001\u57cb\u3081\u8fbc\u307f\u578b\u5c0f\u8133\u523a\u6fc0\u88c5\u7f6e\u306a\u3069\u304c\u6319\u3052\u3089\u308c\u307e\u3059\u3002\u3053\u306e\u7d4c\u8def\u3067\u627f\u8a8d\u3092\u6c42\u3081\u308b\u88fd\u9020\u696d\u8005\u306f\u3001\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u8a3c\u660e\u3059\u308b\u5e83\u7bc4\u306a\u81e8\u5e8a\u8a3c\u62e0\u3092\u63d0\u4f9b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p><strong>\u899a\u3048\u3066\u304a\u304f\u3079\u304d\u3053\u3068:<\/strong> 510(k)\u7533\u8acb\u306e\u5834\u5408\u3001\u88fd\u9020\u696d\u8005\u306f\u81ea\u793e\u306e\u6a5f\u5668\u304c\u5148\u884c\u6a5f\u5668\u3068\u5b9f\u8cea\u7684\u306b\u540c\u7b49\u3067\u3042\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u4e00\u65b9\u3001De Novo\u306e\u8981\u6c42\u306b\u306f\u3001\u30ea\u30b9\u30af\u304c\u4f4e\u304b\u3089\u4e2d\u7a0b\u5ea6\u306e\u65b0\u3057\u3044\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306e\u8a3c\u660e\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u5bfe\u7167\u7684\u306b\u3001PMA\u7533\u8acb\u3067\u306f\u3001\u88fd\u9020\u696d\u8005\u306f\u79d1\u5b66\u7684\u30c7\u30fc\u30bf\u3092\u901a\u3058\u3066\u3001\u610f\u56f3\u3055\u308c\u305f\u7528\u9014\u306b\u304a\u3051\u308b\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306e\u5b9f\u8cea\u7684\u306a\u8a3c\u62e0\u3092\u63d0\u4f9b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<table style=\"font-weight: 400;\" data-tablestyle=\"MsoTable15List5DarkAccent1\" data-tablelook=\"1696\">\n<tbody>\n<tr>\n<td data-celllook=\"272\"><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"256\"><b><span data-contrast=\"auto\">510(k) \u30d1\u30b9\u30a6\u30a7\u30a4<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:2,&quot;335551620&quot;:2}\">\u00a0<\/span><\/td>\n<td data-celllook=\"256\"><b><span data-contrast=\"auto\">\u30c7\u30ce\u30dc\u7d4c\u8def<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:2,&quot;335551620&quot;:2}\">\u00a0<\/span><\/td>\n<td data-celllook=\"256\"><b><span data-contrast=\"auto\">PMA \u30d1\u30b9\u30a6\u30a7\u30a4<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:2,&quot;335551620&quot;:2}\">\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td data-celllook=\"16\"><b><span data-contrast=\"auto\">\u76ee\u7684<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u5408\u6cd5\u7684\u306b\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u30c7\u30d0\u30a4\u30b9\u3068\u5b9f\u8cea\u7684\u306b\u540c\u7b49\u306e\u30c7\u30d0\u30a4\u30b9\u306e\u5834\u5408\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u8ff0\u8a9e\u306e\u306a\u3044\u3001\u4f4e\u304b\u3089\u4e2d\u7a0b\u5ea6\u306e\u30ea\u30b9\u30af\u306e\u65b0\u3057\u3044\u30c7\u30d0\u30a4\u30b9\u306e\u5834\u5408\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u4eba\u547d\u3092\u7dad\u6301\u307e\u305f\u306f\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u9ad8\u30ea\u30b9\u30af\u6a5f\u5668\u306e\u5834\u5408\u3001\u4eba\u306e\u5065\u5eb7\u3092\u640d\u306a\u3046\u3053\u3068\u3092\u9632\u3050\u4e0a\u3067\u975e\u5e38\u306b\u91cd\u8981\u3067\u3042\u308a\u3001\u75c5\u6c17\u3084\u602a\u6211\u306e\u4e0d\u5f53\u306a\u30ea\u30b9\u30af\u3092\u3082\u305f\u3089\u3059\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td data-celllook=\"16\"><b><span data-contrast=\"auto\">\u8cc7\u683c<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u30af\u30e9\u30b9 II \u30c7\u30d0\u30a4\u30b9\u3067\u6700\u3082\u4e00\u822c\u7684\u3067\u3059\u304c\u3001\u4e00\u90e8\u306e\u30af\u30e9\u30b9 I \u304a\u3088\u3073\u30af\u30e9\u30b9 III \u30c7\u30d0\u30a4\u30b9\u3082\u5bfe\u8c61\u3068\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u901a\u5e38\u3001\u4f4e\u304b\u3089\u4e2d\u7a0b\u5ea6\u306e\u30ea\u30b9\u30af\u306e\u30c7\u30d0\u30a4\u30b9\u306f\u3001\u8ff0\u8a9e\u304c\u306a\u3044\u305f\u3081\u6700\u521d\u306f\u30af\u30e9\u30b9 III \u306b\u5206\u985e\u3055\u308c\u307e\u3059\u304c\u3001\u30af\u30e9\u30b9 III \u306e\u5b9a\u7fa9\u306b\u9069\u5408\u3057\u307e\u305b\u3093\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u30af\u30e9\u30b9 III \u533b\u7642\u6a5f\u5668\u306f\u3001\u9ad8\u30ea\u30b9\u30af\u6a5f\u5668\u3001\u307e\u305f\u306f\u4eba\u547d\u3092\u30b5\u30dd\u30fc\u30c8\u307e\u305f\u306f\u7dad\u6301\u3059\u308b\u6a5f\u5668\u3067\u3059\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td data-celllook=\"16\"><b><span data-contrast=\"auto\">\u63d0\u51fa\u8981\u4ef6<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u5e02\u8ca9\u524d\u901a\u77e5\u3067\u306f\u3001\u5148\u884c\u30c7\u30d0\u30a4\u30b9\u3068\u306e\u5b9f\u8cea\u7684\u306a\u540c\u7b49\u6027\u304c\u793a\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">De Novo \u30ea\u30af\u30a8\u30b9\u30c8\u3001\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306e\u8a3c\u660e\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u5e02\u8ca9\u524d\u627f\u8a8d\u7533\u8acb\u3001\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u5b9f\u8a3c\u3059\u308b\u81e8\u5e8a\u8a66\u9a13\u304b\u3089\u306e\u5305\u62ec\u7684\u306a\u79d1\u5b66\u7684\u8a3c\u62e0\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td data-celllook=\"16\"><b><span data-contrast=\"auto\">FDA\u306e\u8a55\u4fa1<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">FDA \u306f\u3001\u65b0\u3057\u3044\u30c7\u30d0\u30a4\u30b9\u3068\u305d\u306e\u5148\u884c\u30c7\u30d0\u30a4\u30b9\u3068\u306e\u9593\u306e\u5b9f\u8cea\u7684\u306a\u540c\u7b49\u6027\u3092\u6c7a\u5b9a\u3057\u307e\u3059\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">FDA \u306e\u5c02\u9580\u5bb6\u306f\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306e\u5074\u9762\u3092\u691c\u8a0e\u3057\u3001De Novo \u5206\u985e\u3092\u4ed8\u4e0e\u3059\u308b\u304b\u3069\u3046\u304b\u3092\u6c7a\u5b9a\u3057\u307e\u3059\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">FDA \u306b\u3088\u308b\u5fb9\u5e95\u7684\u306a\u30ec\u30d3\u30e5\u30fc\u3001\u88fd\u9020\u5143\u304c\u63d0\u4f9b\u3059\u308b\u79d1\u5b66\u7684\u8a3c\u62e0\u306e\u8a55\u4fa1\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td data-celllook=\"16\"><b><span data-contrast=\"auto\">\u5e02\u8ca9\u5f8c\u8abf\u67fb<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u88fd\u9020\u696d\u8005\u306f\u3001\u7279\u5b9a\u306e\u7a2e\u985e\u306e\u5e02\u8ca9\u5f8c\u76e3\u8996\u30c7\u30fc\u30bf\u3092\u8ffd\u8de1\u3057\u3001FDA \u306b\u5831\u544a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u88fd\u9020\u696d\u8005\u306f\u3001\u8ffd\u52a0\u306e\u5b89\u5168\u6027\u304a\u3088\u3073\u6709\u52b9\u6027\u30c7\u30fc\u30bf\u3092\u53ce\u96c6\u3059\u308b\u305f\u3081\u306b\u3001\u5e02\u8ca9\u5f8c\u8abf\u67fb\u7814\u7a76\u3092\u5b9f\u65bd\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u308b\u5834\u5408\u3082\u3042\u308a\u307e\u3059\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u88fd\u9020\u696d\u8005\u306f\u901a\u5e38\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u691c\u8a3c\u3059\u308b\u305f\u3081\u306b\u627f\u8a8d\u5f8c\u306e\u7814\u7a76\u3092\u5b9f\u65bd\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td data-celllook=\"16\"><b><span data-contrast=\"auto\">\u6642\u9593\u67a0<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u901a\u5e38\u306f 90 \u65e5\u3067\u3059\u304c\u3001\u7533\u8acb\u66f8\u306e\u5b8c\u5168\u6027\u3068 FDA \u306e\u7167\u4f1a\u5185\u5bb9\u306b\u5fdc\u3058\u3066\u5909\u308f\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u5b8c\u5168\u306a De Novo \u30ea\u30af\u30a8\u30b9\u30c8\u306e\u53d7\u4fe1\u304b\u3089\u7d04 120 \u65e5 (\u7d04 4 \u304b\u6708)\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u30c7\u30d0\u30a4\u30b9\u306e\u8907\u96d1\u3055\u3068\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u306e\u5b8c\u5168\u6027\u306b\u5fdc\u3058\u3066\u30016 \u304b\u6708\u304b\u3089 1 \u5e74\u4ee5\u4e0a\u304b\u304b\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td data-celllook=\"16\"><b><span data-contrast=\"auto\">\u6599\u91d1<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u30e6\u30fc\u30b6\u30fc\u6599\u91d1\u304c\u9069\u7528\u3055\u308c\u307e\u3059\u304c\u3001\u901a\u5e38\u306f PMA \u3088\u308a\u3082\u4f4e\u304f\u306a\u308a\u307e\u3059\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u30e6\u30fc\u30b6\u30fc\u6599\u91d1\u304c\u9069\u7528\u3055\u308c\u307e\u3059\u3002\u901a\u5e38\u306f PMA \u3088\u308a\u4f4e\u304f\u306a\u308a\u307e\u3059\u304c\u3001510(k) \u3088\u308a\u306f\u9ad8\u304f\u306a\u308a\u307e\u3059\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u30ec\u30d3\u30e5\u30fc\u306e\u8907\u96d1\u3055\u3068\u5fb9\u5e95\u6027\u3092\u8003\u616e\u3059\u308b\u3068\u3001\u30e6\u30fc\u30b6\u30fc\u6599\u91d1\u306f\u6700\u3082\u9ad8\u304f\u306a\u308a\u307e\u3059\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2>\u533b\u7642\u6a5f\u5668\u306e\u7533\u8acb\u624b\u7d9a\u304d\u3092\u30ca\u30d3\u30b2\u30fc\u30c8\u3059\u308b\u65b9\u6cd5<\/h2>\n<p>\u3053\u308c\u3089\u306e\u7d4c\u8def\u3092\u9032\u3080\u306b\u306f\u3001\u614e\u91cd\u306a\u8a08\u753b\u3001\u5fb9\u5e95\u3057\u305f\u6587\u66f8\u5316\u3001\u304a\u3088\u3073\u53b3\u683c\u306a\u30c6\u30b9\u30c8\u304c\u5fc5\u8981\u3067\u3059\u3002\u7d4c\u8def\u3054\u3068\u306b\u56fa\u6709\u306e\u8981\u4ef6\u304c\u3042\u308a\u307e\u3059\u3002\u305f\u3068\u3048\u3070\u3001510(k) \u7d4c\u8def\u3067\u306f\u3001\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8 \u30c7\u30d0\u30a4\u30b9\u3068\u306e\u5b9f\u8cea\u7684\u540c\u7b49\u6027\u306e\u8a3c\u62e0\u304c\u5fc5\u8981\u3067\u3059\u3002De Novo \u7d4c\u8def\u3067\u306f\u3001\u65b0\u898f\u30c7\u30d0\u30a4\u30b9\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306e\u8a3c\u660e\u304c\u5fc5\u8981\u3067\u3042\u308a\u3001PMA \u7d4c\u8def\u3067\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306b\u3088\u308b\u5e83\u7bc4\u306a\u79d1\u5b66\u7684\u8a3c\u62e0\u304c\u5fc5\u8981\u3067\u3059\u3002<\/p>\n<p>RegASK \u306f\u4ee5\u4e0b\u306e\u30b5\u30dd\u30fc\u30c8\u3092\u63d0\u4f9b\u3067\u304d\u307e\u3059:<\/p>\n<ol>\n<li><strong>QMS\u306e\u6e96\u5099\u3001\u7dad\u6301\u3001\u76e3\u67fb<\/strong>: \u533b\u7642\u6a5f\u5668\u4f1a\u793e\u306b\u3068\u3063\u3066\u3001\u6a5f\u5668\u306e\u4e00\u8cab\u3057\u305f\u54c1\u8cea\u3001\u5b89\u5168\u6027\u3001\u6709\u52b9\u6027\u3092\u78ba\u4fdd\u3059\u308b\u306b\u306f\u3001\u5805\u7262\u306a\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0 (QMS) \u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002RegASK \u306f\u6226\u7565\u7684\u30d1\u30fc\u30c8\u30ca\u30fc\u3068\u3057\u3066\u3001QMS \u306e\u6e96\u5099\u3068\u7dad\u6301\u306b\u95a2\u3059\u308b\u5c02\u9580\u7684\u306a\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u63d0\u4f9b\u3057\u3001\u3059\u3079\u3066\u306e\u898f\u5236\u30d9\u30f3\u30c1\u30de\u30fc\u30af\u3092\u78ba\u5b9f\u306b\u6e80\u305f\u305b\u308b\u3088\u3046\u306b\u3057\u307e\u3059\u3002\u5f53\u793e\u306e\u30c1\u30fc\u30e0\u306f\u76e3\u67fb\u6e96\u5099\u306e\u91cd\u8981\u6027\u3092\u7406\u89e3\u3057\u3066\u304a\u308a\u3001\u4f01\u696d\u304c\u5e38\u306b\u3042\u3089\u3086\u308b\u898f\u5236\u8abf\u67fb\u306b\u5099\u3048\u3089\u308c\u308b\u3088\u3046\u652f\u63f4\u3057\u307e\u3059\u3002<\/li>\n<li><strong>\u4e8b\u524d\u63d0\u51fa<\/strong>: \u4e8b\u524d\u7533\u8acb\u30d7\u30ed\u30bb\u30b9\u3067\u306f\u3001\u5b9f\u969b\u306e\u898f\u5236\u7533\u8acb\u3092\u884c\u3046\u524d\u306b FDA \u3068\u4ea4\u6e09\u3057\u307e\u3059\u3002\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u3067\u306f\u3001\u30c7\u30d0\u30a4\u30b9\u3001\u81e8\u5e8a\u8a66\u9a13\u3001\u4eca\u5f8c\u306e\u6b63\u5f0f\u306a\u7533\u8acb\u306b\u95a2\u9023\u3059\u308b\u7279\u5b9a\u306e\u8cea\u554f\u3084\u8981\u7d20\u306b\u3064\u3044\u3066\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3092\u5f97\u308b\u6a5f\u4f1a\u304c\u5f97\u3089\u308c\u307e\u3059\u3002\u3053\u306e\u30b9\u30c6\u30c3\u30d7\u306f\u3001510(k)\u3001De Novo\u3001PMA \u306e\u3044\u305a\u308c\u3067\u3042\u3063\u3066\u3082\u3001\u30c7\u30d0\u30a4\u30b9\u306b\u6700\u3082\u9069\u3057\u305f\u898f\u5236\u7d4c\u8def\u3092\u6c7a\u5b9a\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002RegASK \u306f\u3053\u306e\u30b9\u30c6\u30c3\u30d7\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u3001\u4eca\u5f8c\u306e\u6b63\u5f0f\u306a\u7533\u8acb\u306b\u95a2\u3059\u308b\u4e0d\u660e\u70b9\u3092\u660e\u78ba\u306b\u3057\u305f\u308a\u3001\u6f5c\u5728\u7684\u306a\u61f8\u5ff5\u4e8b\u9805\u306b\u5bfe\u51e6\u3057\u305f\u308a\u3057\u307e\u3059\u3002<\/li>\n<li><strong>\u30d7\u30ed\u30bb\u30b9\u30d5\u30ed\u30fc\u30c1\u30e3\u30fc\u30c8:<\/strong> RegASK \u304c\u63d0\u4f9b\u3059\u308b\u30d7\u30ed\u30bb\u30b9 \u30d5\u30ed\u30fc\u30c1\u30e3\u30fc\u30c8\u3092\u4f7f\u7528\u3059\u308b\u3068\u3001\u63d0\u51fa\u30d7\u30ed\u30bb\u30b9\u5168\u4f53\u3092\u8996\u899a\u7684\u306b\u8868\u73fe\u3067\u304d\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u30c1\u30fc\u30e0\u306f\u3001\u5b9f\u884c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u624b\u9806\u3001\u9806\u5e8f\u3001\u6f5c\u5728\u7684\u306a\u969c\u5bb3\u306e\u767a\u751f\u53ef\u80fd\u6027\u3092\u628a\u63e1\u3067\u304d\u307e\u3059\u3002\u63d0\u51fa\u30d7\u30ed\u30bb\u30b9\u306e\u660e\u78ba\u306a\u30ed\u30fc\u30c9\u30de\u30c3\u30d7\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u3067\u3001\u6f5c\u5728\u7684\u306a\u843d\u3068\u3057\u7a74\u3092\u4e88\u6e2c\u3057\u3066\u8a08\u753b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u3001\u521d\u56de\u306e\u63d0\u51fa\u304c\u6210\u529f\u3059\u308b\u53ef\u80fd\u6027\u304c\u9ad8\u307e\u308a\u307e\u3059\u3002<\/li>\n<li><strong>\u30c7\u30d0\u30a4\u30b9\u306e\u5206\u985e\u3068\u6b63\u5f53\u5316:<\/strong> \u30c7\u30d0\u30a4\u30b9\u306e\u6b63\u3057\u3044\u5206\u985e\u3092\u9078\u629e\u3059\u308b\u3068\u3001\u898f\u5236\u306e\u7d4c\u8def\u3001\u5fc5\u8981\u306a\u8a3c\u62e0\u306e\u6df1\u3055\u3001\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6642\u9593\u3068\u30b3\u30b9\u30c8\u306b\u5927\u304d\u306a\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002RegASK \u306e\u30c7\u30d0\u30a4\u30b9\u5206\u985e\u306b\u95a2\u3059\u308b\u5c02\u9580\u77e5\u8b58\u3068\u3001\u3053\u308c\u3089\u306e\u5206\u985e\u306e\u5f37\u529b\u306a\u6839\u62e0\u3092\u63d0\u4f9b\u3059\u308b\u80fd\u529b\u306b\u3088\u308a\u3001\u4e0d\u8981\u306a\u898f\u5236\u8abf\u67fb\u3092\u56de\u907f\u3057\u3001\u7d44\u7e54\u306e\u6642\u9593\u3068\u30ea\u30bd\u30fc\u30b9\u3092\u7bc0\u7d04\u3067\u304d\u307e\u3059\u3002<\/li>\n<li><strong>\u63d0\u51fa\u306b\u5fc5\u8981\u306a\u66f8\u985e\u306e\u5305\u62ec\u7684\u306a\u30ea\u30b9\u30c8:<\/strong> 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\u660e\u78ba\u3067\u5305\u62ec\u7684\u306a\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3092\u7528\u610f\u3059\u308b\u3053\u3068\u306f\u3001\u7533\u8acb\u306b\u5fc5\u8981\u306a\u60c5\u5831\u3068\u6587\u66f8\u304c\u3059\u3079\u3066\u542b\u307e\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306e\u9375\u3068\u306a\u308a\u307e\u3059\u3002\u60c5\u5831\u304c\u4e0d\u8db3\u3057\u3066\u3044\u305f\u308a\u4e0d\u5b8c\u5168\u3060\u3063\u305f\u308a\u3059\u308b\u3068\u3001\u7533\u8acb\u304c\u9045\u308c\u305f\u308a\u3001\u8ffd\u52a0\u60c5\u5831\u306e\u8981\u6c42\u304c\u3042\u3063\u305f\u308a\u3001\u7533\u8acb\u304c\u62d2\u5426\u3055\u308c\u305f\u308a\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002RegASK \u306e\u627f\u8a8d\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306f\u3001\u30c1\u30fc\u30e0\u306e\u6574\u7406\u6574\u9813\u306b\u5f79\u7acb\u3061\u3001FDA \u306e\u3059\u3079\u3066\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u3066\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6642\u9593\u3092\u77ed\u7e2e\u3057\u307e\u3059\u3002<\/li>\n<li><strong>\u30ea\u30b9\u30af\u3068\u5229\u76ca\u306e\u8a55\u4fa1:<\/strong> \u5fb9\u5e95\u3057\u305f\u30ea\u30b9\u30af\u3068\u5229\u70b9\u306e\u8a55\u4fa1\u306f\u3001\u7533\u8acb\u30d7\u30ed\u30bb\u30b9\u306e\u91cd\u8981\u306a\u90e8\u5206\u3067\u3059\u3002RegASK \u306f\u3001\u30c1\u30fc\u30e0\u304c\u30c7\u30d0\u30a4\u30b9\u306b\u95a2\u9023\u3059\u308b\u6f5c\u5728\u7684\u306a\u30ea\u30b9\u30af\u3092\u7279\u5b9a\u3057\u3066\u8a55\u4fa1\u3057\u3001\u305d\u308c\u3089\u306e\u30ea\u30b9\u30af\u304c\u30c7\u30d0\u30a4\u30b9\u306e\u5229\u70b9\u3068\u3069\u306e\u3088\u3046\u306b\u6bd4\u8f03\u3055\u308c\u308b\u304b\u3092\u5224\u65ad\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002\u3053\u306e\u91cd\u8981\u306a\u5206\u6790\u306b\u3088\u308a\u3001FDA \u306b\u30c7\u30d0\u30a4\u30b9\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u4fdd\u8a3c\u3057\u3001\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u3092\u3088\u308a\u30b9\u30e0\u30fc\u30ba\u306b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/li>\n<li><strong>\u63d0\u51fa\u30b5\u30dd\u30fc\u30c8:<\/strong> \u7533\u8acb\u30d7\u30ed\u30bb\u30b9\u3092\u9032\u3081\u308b\u306e\u306f\u8907\u96d1\u3067\u5927\u5909\u306a\u4f5c\u696d\u3067\u3059\u3002RegASK \u306e\u7533\u8acb\u30b5\u30dd\u30fc\u30c8\u306f\u3001\u7533\u8acb\u30d7\u30ed\u30bb\u30b9\u3092\u7ba1\u7406\u3059\u308b\u3053\u3068\u3067\u793e\u5185\u30c1\u30fc\u30e0\u306e\u8ca0\u62c5\u3092\u8efd\u6e1b\u3057\u307e\u3059\u3002FDA \u306e\u8981\u4ef6\u3068\u7533\u8acb\u30d7\u30ed\u30bb\u30b9\u306b\u95a2\u3059\u308b\u6df1\u3044\u5c02\u9580\u77e5\u8b58\u3092\u6301\u3064 RegASK \u306f\u3001\u3088\u304f\u3042\u308b\u843d\u3068\u3057\u7a74\u3092\u56de\u907f\u3057\u3001\u793e\u5185\u30ea\u30bd\u30fc\u30b9\u306e\u8ca0\u62c5\u3092\u8efd\u6e1b\u3057\u306a\u304c\u3089\u3001\u7533\u8acb\u3092\u6210\u529f\u306b\u5c0e\u304d\u307e\u3059\u3002<\/li>\n<li><strong>\u63d0\u51fa\uff1a<\/strong> \u63d0\u51fa\u30d5\u30a7\u30fc\u30ba\u3067\u306f\u3001\u5b9f\u969b\u306e\u898f\u5236\u63d0\u51fa\u30d1\u30c3\u30b1\u30fc\u30b8\u304c FDA \u306b\u6b63\u5f0f\u306b\u63d0\u51fa\u3055\u308c\u3001\u5be9\u67fb\u3092\u53d7\u3051\u307e\u3059\u3002\u3053\u306e\u63d0\u51fa\u306b\u306f\u3001FDA \u304c\u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3001\u6709\u52b9\u6027\u3001\u54c1\u8cea\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u3059\u3079\u3066\u306e\u30c7\u30fc\u30bf\u3068\u60c5\u5831\u304c\u542b\u307e\u308c\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002RegASK \u306f\u3053\u306e\u30b9\u30c6\u30c3\u30d7\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u3001\u88fd\u54c1\u306e\u72ec\u81ea\u306e\u7279\u6027\u3068\u6226\u7565\u76ee\u6a19\u3092\u63d0\u793a\u3059\u308b\u304a\u624b\u4f1d\u3044\u3092\u3057\u307e\u3059\u3002<\/li>\n<li><strong>\u63d0\u51fa\u5f8c:<\/strong> FDA \u3068\u306e\u95a2\u308f\u308a\u306f\u63d0\u51fa\u3067\u7d42\u308f\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002RegASK \u306f\u63d0\u51fa\u5f8c\u306e\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3092\u4fc3\u9032\u3057\u3001FDA \u304b\u3089\u306e\u8cea\u554f\u3084\u8aac\u660e\u306b\u5bfe\u5fdc\u3057\u3066\u3001\u3088\u308a\u30b9\u30e0\u30fc\u30ba\u306a\u5be9\u67fb\u30d7\u30ed\u30bb\u30b9\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002<\/li>\n<\/ol>\n<h2>\u533b\u7642\u6a5f\u5668\u7533\u8acb\u3092\u30b9\u30e0\u30fc\u30ba\u306b\u884c\u3046\u305f\u3081\u306e\u30d2\u30f3\u30c8\u3068\u30b3\u30c4<\/h2>\n<ul>\n<li>\u65e9\u3081\u306b\u59cb\u3081\u307e\u3057\u3087\u3046: \u63d0\u51fa\u306e\u6e96\u5099\u306b\u306f\u6642\u9593\u304c\u304b\u304b\u308a\u307e\u3059\u3002\u571f\u58c7\u5834\u3067\u614c\u3066\u306a\u3044\u3088\u3046\u306b\u3001\u65e9\u3081\u306b\u6e96\u5099\u3092\u59cb\u3081\u3066\u304f\u3060\u3055\u3044\u3002<\/li>\n<li>\u5fb9\u5e95\u3057\u3066\u304f\u3060\u3055\u3044: \u5fc5\u8981\u306a\u60c5\u5831\u3092\u3059\u3079\u3066\u63d0\u4f9b\u3057\u3001\u30c7\u30fc\u30bf\u304c\u6b63\u78ba\u304b\u3064\u5b8c\u5168\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/li>\n<li>\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u652f\u63f4\u3092\u6c42\u3081\u3066\u304f\u3060\u3055\u3044: RegASK \u306e\u3088\u3046\u306a\u7d44\u7e54\u306f\u3001\u627f\u8a8d\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u304b\u3089\u63d0\u51fa\u30b5\u30dd\u30fc\u30c8\u307e\u3067\u3001\u63d0\u51fa\u30d7\u30ed\u30bb\u30b9\u306e\u3055\u307e\u3056\u307e\u306a\u5074\u9762\u3067\u8cb4\u91cd\u306a\u652f\u63f4\u3092\u63d0\u4f9b\u3067\u304d\u307e\u3059\u3002<\/li>\n<\/ul>\n<h2>\u533b\u7642\u6a5f\u5668\u7533\u8acb\u624b\u7d9a\u304d\u306e\u7c21\u7d20\u5316<\/h2>\n<p>FDA \u306e 510(k)\u3001De Novo\u3001\u304a\u3088\u3073 PMA \u7d4c\u8def\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306b\u5bfe\u3057\u3066\u3001\u305d\u306e\u6a5f\u5668\u306e\u30ea\u30b9\u30af 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