{"id":9379,"date":"2025-10-26T01:00:00","date_gmt":"2025-10-26T01:00:00","guid":{"rendered":"https:\/\/aroundthe-world.net\/web\/?p=9379"},"modified":"2025-10-28T15:24:43","modified_gmt":"2025-10-28T15:24:43","slug":"fdapma","status":"publish","type":"post","link":"https:\/\/aroundthe-world.net\/web\/2025\/10\/26\/fdapma\/","title":{"rendered":"FDA\u767b\u9332\u3068PMA\uff08\u533b\u7642\u6a5f\u5668\uff09\u306e\u9055\u3044\u3068\u306f\uff1f"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">\uff5e\u300c\u767b\u9332\u3057\u3066\u308b\uff1d\u58f2\u308c\u308b\u300d\u3067\u306f\u306a\u3044\uff01\uff1f\u533b\u7642\u6a5f\u5668\u30d3\u30b8\u30cd\u30b9\u306e\u843d\u3068\u3057\u7a74\uff5e<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a2\u30e1\u30ea\u30ab\u5e02\u5834\u306b\u533b\u7642\u6a5f\u5668\u3092\u8f38\u51fa\u3057\u3088\u3046\u3068\u3059\u308b\u3068\u3001\u307e\u305a\u8033\u306b\u3059\u308b\u306e\u304c\u300cFDA\u767b\u9332\u300d<strong>\u3068<\/strong>\u300cPMA\uff08Premarket Approval\uff09\u300d\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u300c\u3068\u308a\u3042\u3048\u305aFDA\u767b\u9332\u3059\u308c\u3070\u8ca9\u58f2\u3067\u304d\u308b\u3093\u3067\u3057\u3087\uff1f\u300d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2015\u2015\u5b9f\u306f\u3053\u306e\u8003\u3048\u3001<strong>\u975e\u5e38\u306b\u5371\u967a\u3067\u3059\u3002<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e2\u3064\u306e\u9055\u3044\u3092\u7406\u89e3\u3057\u3066\u3044\u306a\u3044\u3068\u3001\u305b\u3063\u304b\u304f\u306e\u88fd\u54c1\u3082\u30a2\u30e1\u30ea\u30ab\u3067\u201c\u9055\u6cd5\u8ca9\u58f2\u201d\u6271\u3044\u306b\u306a\u3063\u3066\u3057\u307e\u3046\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u8a18\u4e8b\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u696d\u754c\u3067\u3088\u304f\u3042\u308b\u8aa4\u89e3\u3092\u89e3\u304d\u306a\u304c\u3089\u3001<strong>FDA\u767b\u9332\u3068PMA\u306e\u672c\u8cea\u7684\u306a\u9055\u3044\u3068\u3001\u305d\u308c\u305e\u308c\u304c\u5fc5\u8981\u306a\u30b1\u30fc\u30b9<\/strong>\u3092\u308f\u304b\u308a\u3084\u3059\u304f\u89e3\u8aac\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u2705 \u305d\u3082\u305d\u3082FDA\u767b\u9332\u3063\u3066\u4f55\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u300cFDA\u767b\u9332\u300d\u306f\u3001\u30a2\u30e1\u30ea\u30ab\u56fd\u5185\u3067\u533b\u7642\u6a5f\u5668\u306a\u3069\u3092\u8ca9\u58f2\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u201c\u65bd\u8a2d\u60c5\u5831\u306e\u5c4a\u3051\u51fa\u201d\u3067\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u25bc \u30dd\u30a4\u30f3\u30c8\uff1a<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u533b\u7642\u6a5f\u5668\u3092<strong>\u88fd\u9020\u30fb\u52a0\u5de5\u30fb\u5305\u88c5\u30fb\u4fdd\u7ba1\u3059\u308b\u65bd\u8a2d<\/strong>\u306f\u3001FDA\u3078\u306e\u65bd\u8a2d\u767b\u9332\uff08Establishment Registration\uff09\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/li>\n\n\n\n<li>\u5e741\u56de\u306e\u66f4\u65b0\u304c\u5fc5\u8981\uff08\u901a\u5e3810\u301c12\u6708\u306b\u884c\u3046\uff09<\/li>\n\n\n\n<li>\u88fd\u54c1\u305d\u306e\u3082\u306e\u306e<strong>\u5b89\u5168\u6027\u3084\u6027\u80fd\u306e\u5be9\u67fb\u306f\u542b\u307e\u308c\u3066\u3044\u306a\u3044<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u25b6 <strong>\u3064\u307e\u308a\uff1a<\/strong><br><strong>\u767b\u9332\uff1d\u300c\u8ca9\u58f2\u8a31\u53ef\u300d\u3067\u306f\u306a\u3044\uff01<\/strong><br>\u767b\u9332\u306f\u3001\u3042\u304f\u307e\u3067\u300c\u79c1\u306f\u3053\u306e\u65bd\u8a2d\u3067\u533b\u7642\u6a5f\u5668\u3092\u6271\u3063\u3066\u3044\u307e\u3059\u300d\u3068<strong>\u540d\u4e57\u308a\u3092\u4e0a\u3052\u308b\u624b\u7d9a\u304d<\/strong>\u306b\u3059\u304e\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u2705 PMA\u3068\u306f\u4f55\u304b\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">PMA\uff08Premarket Approval\uff09\u306f\u3001FDA\u304c\u884c\u3046\u533b\u7642\u6a5f\u5668\u306e\u300c\u4e8b\u524d\u627f\u8a8d\u5236\u5ea6\u300d\u306e\u3053\u3068\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u308c\u306f\u65e5\u672c\u3067\u8a00\u3048\u3070\u300c\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u300d<strong>\u306b\u8fd1\u3044\u3082\u306e\u3067\u3001\u88fd\u54c1\u306e\u5b89\u5168\u6027\u30fb\u6709\u52b9\u6027\u3092<\/strong>\u79d1\u5b66\u7684\u6839\u62e0\u3092\u3082\u3068\u306b\u5be9\u67fb\u3055\u308c\u308b\u975e\u5e38\u306b\u53b3\u3057\u3044\u30d7\u30ed\u30bb\u30b9\u3067\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u25bc \u7279\u5fb4\uff1a<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Class III\uff08\u30ea\u30b9\u30af\u304c\u6700\u3082\u9ad8\u3044\u533b\u7642\u6a5f\u5668\uff09\u306b\u5bfe\u3057\u3066\u9069\u7528\u3055\u308c\u308b<\/li>\n\n\n\n<li>\u81e8\u5e8a\u30c7\u30fc\u30bf\u3001\u6cbb\u9a13\u7d50\u679c\u3001\u88fd\u54c1\u4ed5\u69d8\u306a\u3069<strong>\u81a8\u5927\u306a\u6280\u8853\u6587\u66f8<\/strong>\u304c\u5fc5\u8981<\/li>\n\n\n\n<li>\u627f\u8a8d\u307e\u3067\u306b<strong>1\u301c2\u5e74\u4ee5\u4e0a<\/strong>\u304b\u304b\u308b\u3053\u3068\u3082\u73cd\u3057\u304f\u306a\u3044<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u25b6 <strong>\u3064\u307e\u308a\uff1a<\/strong><br><strong>PMA\uff1d\u300c\u88fd\u54c1\u306e\u6027\u80fd\u30fb\u5b89\u5168\u6027\u3092FDA\u304c\u5be9\u67fb\u30fb\u627f\u8a8d\u3059\u308b\u5236\u5ea6\u300d<\/strong><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u2705 \u767b\u9332\u3060\u3051\u3067OK\u306a\u533b\u7642\u6a5f\u5668\u3082\u3042\u308b\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u306f\u3044\u3002\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u304cPMA\u306e\u5bfe\u8c61\u306b\u306a\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<br>\u533b\u7642\u6a5f\u5668\u306fFDA\u306b\u3088\u3063\u3066\u4ee5\u4e0b\u306e\u3088\u3046\u306b\u5206\u985e\u3055\u308c\u3066\u304a\u308a\u3001<strong>\u30af\u30e9\u30b9\u306b\u3088\u3063\u3066\u5fc5\u8981\u306a\u624b\u7d9a\u304d\u304c\u7570\u306a\u308a\u307e\u3059\u3002<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u25bc \u533b\u7642\u6a5f\u5668\u306e\u5206\u985e\u3068\u5fc5\u8981\u306a\u624b\u7d9a\u304d\uff1a<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u30af\u30e9\u30b9<\/th><th>\u30ea\u30b9\u30af\u30ec\u30d9\u30eb<\/th><th>\u4f8b<\/th><th>\u5fc5\u8981\u306a\u5bfe\u5fdc<\/th><\/tr><\/thead><tbody><tr><td><strong>Class I<\/strong><\/td><td>\u4f4e\u30ea\u30b9\u30af<\/td><td>\u4f53\u6e29\u8a08\u3001\u624b\u8853\u7528\u30ac\u30fc\u30bc\u306a\u3069<\/td><td>\u65bd\u8a2d\u767b\u9332 + \u4e00\u822c\u898f\u5236\u306e\u307f\uff08PMA\u4e0d\u8981\uff09<\/td><\/tr><tr><td><strong>Class II<\/strong><\/td><td>\u4e2d\u30ea\u30b9\u30af<\/td><td>\u8840\u5727\u8a08\u3001\u6b6f\u79d1\u5668\u5177\u306a\u3069<\/td><td>\u65bd\u8a2d\u767b\u9332 + <strong>510(k)\uff08\u4e8b\u524d\u901a\u77e5\uff09<\/strong><\/td><\/tr><tr><td><strong>Class III<\/strong><\/td><td>\u9ad8\u30ea\u30b9\u30af<\/td><td>\u4eba\u5de5\u5fc3\u81d3\u5f01\u3001\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u6a5f\u5668\u306a\u3069<\/td><td>\u65bd\u8a2d\u767b\u9332 + <strong>PMA\uff08\u4e8b\u524d\u627f\u8a8d\uff09<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u2705 \u3088\u304f\u3042\u308b\u8aa4\u89e3\u3068\u73fe\u5834\u306e\u5931\u6557\u4f8b<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">\u274c \u3088\u304f\u3042\u308b\u8aa4\u89e3\uff1a<\/h3>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"wp-block-paragraph\">\u300cFDA\u306b\u767b\u9332\u3057\u305f\u304b\u3089\u3001\u3059\u3050\u8ca9\u58f2\u3067\u304d\u308b\u306f\u305a\u300d<\/p>\n<\/blockquote>\n\n\n\n<p class=\"wp-block-paragraph\">\u2192 \u767b\u9332\u306f<strong>\u65bd\u8a2d\u306e\u767b\u9332<\/strong>\u3002\u88fd\u54c1\u3054\u3068\u306b<strong>510(k)<\/strong> \u3084 <strong>PMA<\/strong> \u306e\u78ba\u8a8d\u304c\u5fc5\u8981\uff01<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u26a0 \u5b9f\u969b\u306b\u3042\u3063\u305f\u5931\u6557\u4f8b\uff1a<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u3042\u308b\u65e5\u672c\u4f01\u696d\u304cClass II\u306e\u533b\u7642\u6a5f\u5668\u3092FDA\u306b\u767b\u9332\u5f8c\u3001\u30a2\u30e1\u30ea\u30ab\u306e\u5c55\u793a\u4f1a\u3067\u8ca9\u58f2\u6d3b\u52d5\u3092\u884c\u3063\u305f\u3068\u3053\u308d\u3001FDA\u304b\u3089\u8b66\u544a\u66f8\uff08Warning Letter\uff09\u3092\u53d7\u3051\u307e\u3057\u305f\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7406\u7531\u306f\u3001\u300c510(k)\u306e\u63d0\u51fa\u30fb\u627f\u8a8d\u304c\u306a\u3055\u308c\u3066\u3044\u306a\u304b\u3063\u305f\u305f\u3081\u300d\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2192 \u88fd\u54c1\u306e\u300c\u8ca9\u58f2\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u300d\u304c\u629c\u3051\u3066\u3044\u305f\u306e\u3067\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u2705 \u9055\u3044\u3092\u3056\u3063\u304f\u308a\u307e\u3068\u3081\u308b\u3068\u2026<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u9805\u76ee<\/th><th>FDA\u767b\u9332<\/th><th>PMA<\/th><\/tr><\/thead><tbody><tr><td>\u5bfe\u8c61<\/td><td>\u65bd\u8a2d\uff08\u5de5\u5834\u3084\u4f01\u696d\uff09<\/td><td>\u88fd\u54c1\uff08\u533b\u7642\u6a5f\u5668\uff09<\/td><\/tr><tr><td>\u5185\u5bb9<\/td><td>\u5c4a\u51fa\u306b\u3088\u308b\u767b\u9332\uff08\u5be9\u67fb\u306a\u3057\uff09<\/td><td>\u88fd\u54c1\u306e\u53b3\u683c\u306a\u4e8b\u524d\u5be9\u67fb<\/td><\/tr><tr><td>\u5fc5\u8981\u306a\u30b1\u30fc\u30b9<\/td><td>\u5168\u3066\u306e\u88fd\u9020\u65bd\u8a2d<\/td><td>\u4e3b\u306bClass III\u88fd\u54c1<\/td><\/tr><tr><td>\u6240\u8981\u6642\u9593<\/td><td>\u6570\u65e5\u301c\u6570\u9031\u9593<\/td><td>\u6570\u304b\u6708\u301c\u6570\u5e74<\/td><\/tr><tr><td>\u624b\u6570\u6599<\/td><td>\u7d046,500\u30c9\u30eb\u524d\u5f8c\uff08\u5e741\u56de\uff09<\/td><td>\u6570\u4e07\u30c9\u30eb\u4ee5\u4e0a\uff0b\u30c7\u30fc\u30bf\u4f5c\u6210\u30b3\u30b9\u30c8<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u2705 \u7d50\u8ad6\uff1a\u300c\u767b\u9332\u300d\u3057\u3066\u3082\u300c\u58f2\u308c\u308b\u300d\u3068\u306f\u9650\u3089\u306a\u3044\uff01<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u6a5f\u5668\u30d3\u30b8\u30cd\u30b9\u3067\u6210\u529f\u3059\u308b\u305f\u3081\u306b\u306f\u3001<strong>FDA\u306e\u767b\u9332\uff08Establishment Registration\uff09\u3068\u3001\u88fd\u54c1\u306e\u627f\u8a8d\uff08PMA\u307e\u305f\u306f510(k)\uff09\u3092\u5206\u3051\u3066\u7406\u89e3\u3059\u308b\u3053\u3068<\/strong>\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7279\u306b\u30a2\u30e1\u30ea\u30ab\u5e02\u5834\u3067\u306f\u3001<strong>\u898f\u5236\u3078\u306e\u5bfe\u5fdc\uff1d\u4fe1\u983c\u306e\u8a3c\u660e<\/strong>\u3002<br>\u6b63\u3057\u3044\u624b\u9806\u3067\u9032\u3081\u308b\u3053\u3068\u3067\u3001\u30d3\u30b8\u30cd\u30b9\u30c1\u30e3\u30f3\u30b9\u3092\u7740\u5b9f\u306b\u3082\u306e\u306b\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<figure class=\"wp-block-embed is-type-wp-embed\"><div class=\"wp-block-embed__wrapper\">\n<div class='avia-iframe-wrap'><blockquote class=\"wp-embedded-content\" data-secret=\"RYjRDmEYOx\"><a href=\"https:\/\/aroundthe-world.net\/web\/2025\/02\/10\/aboutus\/\">\u6d77\u5916\u5c55\u958b\u3068\u500b\u4eba\u30b5\u30dd\u30fc\u30c8\u306e\u4e21\u65b9\u3092\u5b8c\u74a7\u306b\u30ab\u30d0\u30fc\uff01\u696d\u754c\u5c48\u6307\u306e3PL\u30b5\u30fc\u30d3\u30b9<\/a><\/blockquote><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"&#8220;\u6d77\u5916\u5c55\u958b\u3068\u500b\u4eba\u30b5\u30dd\u30fc\u30c8\u306e\u4e21\u65b9\u3092\u5b8c\u74a7\u306b\u30ab\u30d0\u30fc\uff01\u696d\u754c\u5c48\u6307\u306e3PL\u30b5\u30fc\u30d3\u30b9&#8221; &#8212; Around The World Trading\" src=\"https:\/\/aroundthe-world.net\/web\/2025\/02\/10\/aboutus\/embed\/#?secret=kmgQpWDYF7#?secret=RYjRDmEYOx\" data-secret=\"RYjRDmEYOx\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe><\/div>\n<\/div><\/figure>\n\n\n\n\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n<div class=\"yoast-breadcrumbs\"><span><span><a href=\"https:\/\/aroundthe-world.net\/web\/home\/\">Home<\/a><\/span> \u00bb <span class=\"breadcrumb_last\" 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