{"id":18872,"date":"2025-12-25T10:24:55","date_gmt":"2025-12-25T02:24:55","guid":{"rendered":"https:\/\/greenoo.tw\/fda-%e9%a3%9f%e5%93%81%e8%a8%bb%e5%86%8a%e8%a6%81%e5%a4%9a%e4%b9%85%e6%89%8d%e8%83%bd%e5%ae%8c%e6%88%90%ef%bc%9f%e5%8f%b0%e7%81%a3%e5%af%a6%e5%8b%99%e6%99%82%e9%96%93%e8%a7%a3%e6%9e%90\/"},"modified":"2025-12-27T17:45:08","modified_gmt":"2025-12-27T09:45:08","slug":"fda-food-registration-timeline","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/zh\/fda-food-registration-timeline\/","title":{"rendered":"FDA \u98df\u54c1\u8a3b\u518a\u8981\u591a\u4e45\u624d\u80fd\u5b8c\u6210\uff1f\u53f0\u7063\u5be6\u52d9\u6642\u9593\u89e3\u6790"},"content":{"rendered":"<p>&nbsp;<\/p>\n<article class=\"blog-container\"><main id=\"main-content\" class=\"blog-content\"><br \/>\n<img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-full wp-image-18874\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/12\/Gemini_Generated_Image_n8l2hkn8l2hkn8l2.png\" alt=\"\" width=\"2048\" height=\"2048\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/12\/Gemini_Generated_Image_n8l2hkn8l2hkn8l2.png 2048w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/12\/Gemini_Generated_Image_n8l2hkn8l2hkn8l2-768x768.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/12\/Gemini_Generated_Image_n8l2hkn8l2hkn8l2-1536x1536.png 1536w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/12\/Gemini_Generated_Image_n8l2hkn8l2hkn8l2-12x12.png 12w\" sizes=\"(max-width: 2048px) 100vw, 2048px\" \/><\/p>\n<h2><\/h2>\n<p>\u3010\u91cd\u9ede\u7d50\u8ad6\uff5cFDA \u98df\u54c1\u8a3b\u518a\u9700\u8981\u591a\u4e45\uff1f\u3011<\/p>\n<p>FDA \u98df\u54c1\u8a3b\u518a\u672c\u8eab\u4e0d\u9700\u8981\u7b49\u5f85\u4eba\u5de5\u5be9\u6838\uff0c<br \/>\n\u53f0\u7063\u98df\u54c1\u696d\u8005\u5728\u8cc7\u6599\u9f4a\u5168\u7684\u60c5\u6cc1\u4e0b\uff0c<br \/>\n\u901a\u5e38 1\u20132 \u500b\u5de5\u4f5c\u5929\u5373\u53ef\u5b8c\u6210\u7dda\u4e0a\u8a3b\u518a\u4e26\u53d6\u5f97 FDA \u8a3b\u518a\u865f\u78bc\u3002<br \/>\n\u4e0d\u904e\uff0c\u82e5\u5305\u542b\u516c\u53f8\u8cc7\u6599\u6e96\u5099\u3001\u7f8e\u570b\u4ee3\u7406\u4eba\u78ba\u8a8d\uff0c<br \/>\n\u4ee5\u53ca\u4e8b\u524d\u901a\u5831\uff08Prior Notice\uff09\u5e33\u865f\u8a2d\u5b9a\u7b49\u5be6\u52d9\u6d41\u7a0b\uff0c<br \/>\n\u6574\u9ad4\u4f5c\u696d\u6642\u9593\u591a\u534a\u843d\u5728 2\u20134 \u9031\u4e4b\u9593\u3002<\/p>\n<p>\u56e0\u6b64\uff0cFDA \u98df\u54c1\u8a3b\u518a\u300c\u4e0d\u662f\u5be9\u6838\u6162\u300d\uff0c<br \/>\n\u800c\u662f**\u524d\u671f\u6e96\u5099\u662f\u5426\u5b8c\u6574\uff0c\u6c7a\u5b9a\u6574\u9ad4\u6240\u9700\u6642\u9593\u9577\u77ed**\u3002<\/p>\n<h2>\u5f15\u8a00<\/h2>\n<p>\u7814\u7a76\u986f\u793a93%\u7684\u4eba\u60a3\u6709\u300c\u77e5\u8b58\u932f\u89ba\u300d\u2014\u2014\u4ee5\u70ba\u81ea\u5df1\u7406\u89e3\uff0c\u4f46\u5be6\u969b\u4e0a\u4e26\u4e0d\u771f\u6b63\u4e86\u89e3\u3002\u7576\u53f0\u7063\u98df\u54c1\u696d\u8005\u6e96\u5099\u9032\u8ecd\u7f8e\u570b\u5e02\u5834\u6642\uff0c\u5c0d\u65bc<strong>FDA \u98df\u54c1\u8a3b\u518a \u8981\u591a\u4e45 \u53f0\u7063<\/strong>\u4f01\u696d\u80fd\u5b8c\u6210\u9019\u500b\u554f\u984c\uff0c\u8a31\u591a\u4eba\u5b58\u5728\u8457\u985e\u4f3c\u7684\u8a8d\u77e5\u76f2\u9ede\u3002\u6709\u4e9b\u696d\u8005\u4ee5\u70ba\u8a3b\u518a\u9700\u8981\u6578\u500b\u6708\u751a\u81f3\u534a\u5e74\uff0c\u4e5f\u6709\u4eba\u8aa4\u4ee5\u70ba\u53ea\u9700\u5e7e\u5929\u5c31\u80fd\u641e\u5b9a\u3002\u672c\u6587\u5c07\u4ee5\u53f0\u7063\u5be6\u52d9\u7d93\u9a57\u70ba\u57fa\u790e\uff0c\u8a73\u7d30\u89e3\u6790<strong>FDA \u98df\u54c1\u8a3b\u518a<\/strong>\u7684\u5be6\u969b\u6642\u7a0b\uff0c\u5e6b\u52a9\u6240\u6709\u6d88\u8cbb\u8005\u548c\u696d\u8005\u5efa\u7acb\u6b63\u78ba\u7684\u6642\u9593\u9810\u671f\uff0c\u907f\u514d\u56e0\u932f\u8aa4\u4f30\u7b97\u800c\u5f71\u97ff\u51fa\u53e3\u8a08\u756b\u3002<\/p>\n<h2>\u6838\u5fc3\u8981\u9ede\u7e3d\u7d50<\/h2>\n<ul>\n<li><strong>FDA \u98df\u54c1\u8a3b\u518a \u8981\u591a\u4e45 \u53f0\u7063<\/strong>\u696d\u8005\u5e73\u5747\u9700\u89815-7\u500b\u5de5\u4f5c\u5929\u5b8c\u6210\u7dda\u4e0a\u8a3b\u518a\u6d41\u7a0b<\/li>\n<li><strong>\u6a19\u6e96\u8a3b\u518a\u9031\u671f<\/strong>\u7d041\u9031\uff0c\u4f46\u5b8c\u6574\u6e96\u5099\u5230\u901a\u5831\u53ef\u80fd\u9700\u89812-4\u9031<\/li>\n<li><strong>\u8a3b\u518a\u7121\u9700\u5be9\u6838\u7b49\u5f85<\/strong>\uff0c\u7cfb\u7d71\u5373\u6642\u751f\u6210\u8a3b\u518a\u865f\u78bc<\/li>\n<li><strong>FDA\u4e0d\u6838\u767c\u8b49\u66f8<\/strong>\uff0c\u50c5\u63d0\u4f9b\u8a3b\u518a\u865f\u78bc\u8207\u78ba\u8a8d\u56de\u51fd\u4f5c\u70ba\u8b49\u660e<\/li>\n<li><strong>\u63d0\u524d\u6e96\u5099\u6587\u4ef6\u8cc7\u6599<\/strong>\u662f\u7e2e\u77ed\u6574\u9ad4\u6642\u7a0b\u7684\u95dc\u9375\u56e0\u7d20<\/li>\n<\/ul>\n<p><img decoding=\"async\" class=\"article-image\" src=\"https:\/\/seo-resouce.easyya.ai\/ai-generated\/20251225\/google_ai_20251225_022007_c89e046b.png\" alt=\"\u53f0\u7063\u98df\u54c1\u696d\u8005FDA\u8a3b\u518a\u6e96\u5099\u6587\u4ef6\u8207\u6642\u7a0b\u898f\u5283\u793a\u610f\u5716\" width=\"700\" height=\"500\" \/><\/p>\n<hr \/>\n<h2>FDA \u98df\u54c1\u8a3b\u518a\u57fa\u672c\u8a8d\u8b58<\/h2>\n<h3>\u4ec0\u9ebc\u662f FDA \u98df\u54c1\u8a3b\u518a<\/h3>\n<p><strong><a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener noreferrer\">FDA\uff08\u7f8e\u570b\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40\uff09<\/a><strong>\u662f\u7f8e\u570b\u806f\u90a6\u653f\u5e9c\u8ca0\u8cac\u98df\u54c1\u5b89\u5168\u76e3\u7ba1\u7684\u6b0a\u5a01\u6a5f\u69cb\u3002\u6839\u64da\u300a\u516c\u5171\u5065\u5eb7\u5b89\u5168\u548c\u751f\u7269\u6050\u6016\u4e3b\u7fa9\u6e96\u5099\u548c\u61c9\u5c0d\u6cd5\u6848\u300b\uff08Bioterrorism Act\uff09\uff0c\u6240\u6709\u5411\u7f8e\u570b\u51fa\u53e3\u98df\u54c1\u7684\u5916\u570b\u4f01\u696d\u5fc5\u9808\u5728FDA\u9032\u884c<\/strong>\u98df\u54c1\u8a2d\u65bd\u8a3b\u518a<\/strong>\uff08Food Facility Registration\uff09\u3002<\/p>\n<p>\u5c0d\u65bc<strong>\u53f0\u7063<\/strong>\u98df\u54c1\u696d\u8005\u800c\u8a00\uff0c\u9019\u9805\u8a3b\u518a\u662f\u9032\u5165\u7f8e\u570b\u5e02\u5834\u7684\u6cd5\u5b9a\u9580\u6abb\u3002\u7121\u8ad6\u662f\u8336\u8449\u3001\u7cd5\u9ede\u3001\u8abf\u5473\u6599\u9084\u662f\u7f50\u982d\u98df\u54c1\uff0c\u53ea\u8981\u8a08\u5283\u92b7\u5f80\u7f8e\u570b\uff0c\u5c31\u5fc5\u9808\u5b8c\u6210<strong>FDA \u98df\u54c1\u8a3b\u518a<\/strong>\u7a0b\u5e8f\u3002<\/p>\n<h3>FDA \u8a3b\u518a\u6db5\u84cb\u7684\u98df\u54c1\u985e\u5225<\/h3>\n<p>\u6839\u64da**<a href=\"https:\/\/www.fda.gov\/food\/food-safety-modernization-act-fsma\/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals\" target=\"_blank\" rel=\"noopener noreferrer\">FDA\u5b98\u65b9\u898f\u7bc4<\/a>**\uff0c\u4ee5\u4e0b36\u985e\u98df\u54c1\u9700\u8981\u9032\u884c\u8a3b\u518a\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u98df\u54c1\u985e\u5225<\/th>\n<th>\u7bc4\u4f8b\u7522\u54c1<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u70d8\u7119\u98df\u54c1<\/td>\n<td>\u9eb5\u5305\u3001\u9905\u4e7e\u3001\u86cb\u7cd5<\/td>\n<\/tr>\n<tr>\n<td>\u98f2\u6599\u985e<\/td>\n<td>\u8336\u98f2\u3001\u679c\u6c41\u3001\u5496\u5561<\/td>\n<\/tr>\n<tr>\n<td>\u7cd6\u679c\u985e<\/td>\n<td>\u5de7\u514b\u529b\u3001\u7cd6\u679c\u3001\u53e3\u9999\u7cd6<\/td>\n<\/tr>\n<tr>\n<td>\u7a40\u7269\u88fd\u54c1<\/td>\n<td>\u65e9\u9910\u7a40\u7247\u3001\u71d5\u9ea5<\/td>\n<\/tr>\n<tr>\n<td>\u4e73\u88fd\u54c1<\/td>\n<td>\u5976\u7c89\u3001\u8d77\u53f8\u3001\u512a\u683c<\/td>\n<\/tr>\n<tr>\n<td>\u8abf\u5473\u6599<\/td>\n<td>\u91ac\u6cb9\u3001\u8fa3\u6912\u91ac\u3001\u9999\u6599<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote><p><strong>\u91cd\u8981\u63d0\u793a<\/strong>\uff1a\u5373\u4f7f\u662f\u5c0f\u578b\u7db2\u8def\u8ce3\u5bb6\uff0c\u53ea\u8981\u900f\u904e\u8de8\u5883\u96fb\u5546\u5e73\u53f0\u92b7\u5f80\u7f8e\u570b\uff0c\u90fd\u9700\u8981\u5b8c\u6210FDA\u8a3b\u518a\u3002<\/p><\/blockquote>\n<hr \/>\n<h2>FDA \u98df\u54c1\u8a3b\u518a\u8981\u591a\u4e45\uff1f\u53f0\u7063\u5be6\u52d9\u6642\u7a0b\u89e3\u6790<\/h2>\n<h3>\u6a19\u6e96\u8a3b\u518a\u6d41\u7a0b\u6642\u9593\u8868<\/h3>\n<p>\u5c0d\u65bc<strong>\u53f0\u7063<\/strong>\u98df\u54c1\u4f01\u696d\u4f86\u8aaa\uff0c<strong>FDA \u98df\u54c1\u8a3b\u518a \u8981\u591a\u4e45<\/strong>\u7684\u7b54\u6848\u53d6\u6c7a\u65bc\u6e96\u5099\u7684\u5b8c\u6574\u5ea6\u3002\u4ee5\u4e0b\u662f\u8a73\u7d30\u7684\u6642\u7a0b\u5206\u89e3\uff1a<\/p>\n<p><strong>\u7b2c\u4e00\u968e\u6bb5\uff1a\u8cc7\u6599\u6e96\u5099\u671f\uff083-7\u500b\u5de5\u4f5c\u5929\uff09<\/strong><\/p>\n<ul>\n<li>\u6536\u96c6\u516c\u53f8\u57fa\u672c\u8cc7\u6599\uff08\u7d71\u4e00\u7de8\u865f\u3001\u82f1\u6587\u540d\u7a31\uff09<\/li>\n<li>\u78ba\u8a8d\u7522\u54c1\u985e\u5225\u8207HS\u7de8\u78bc<\/li>\n<li>\u6e96\u5099\u8ca0\u8cac\u4eba\u8eab\u5206\u8b49\u660e\u6587\u4ef6<\/li>\n<li>\u78ba\u8a8d\u7f8e\u570b\u4ee3\u7406\u4eba\u8cc7\u8a0a<\/li>\n<\/ul>\n<p><strong>\u7b2c\u4e8c\u968e\u6bb5\uff1a\u7dda\u4e0a\u8a3b\u518a\u671f\uff081-2\u500b\u5de5\u4f5c\u5929\uff09<\/strong><\/p>\n<ul>\n<li>\u767b\u5165**<a href=\"https:\/\/www.fda.gov\/food\/food-facility-registration\/how-register-food-facility\" target=\"_blank\" rel=\"noopener noreferrer\">FDA\u98df\u54c1\u8a2d\u65bd\u8a3b\u518a\u7cfb\u7d71<\/a>**<\/li>\n<li>\u586b\u5beb\u8a2d\u65bd\u8cc7\u8a0a\u8207\u7522\u54c1\u985e\u5225<\/li>\n<li>\u6307\u5b9a\u7f8e\u570b\u4ee3\u7406\u4eba<\/li>\n<li>\u63d0\u4ea4\u8a3b\u518a\u7533\u8acb<\/li>\n<\/ul>\n<p><strong>\u7b2c\u4e09\u968e\u6bb5\uff1a\u53d6\u5f97\u8a3b\u518a\u865f\uff08\u5373\u6642\uff09<\/strong><\/p>\n<ul>\n<li>\u7cfb\u7d71\u81ea\u52d5\u5be9\u6838\u57fa\u672c\u8cc7\u6599<\/li>\n<li>\u5373\u6642\u751f\u621011\u4f4d\u6578\u8a3b\u518a\u865f\u78bc\uff08Registration Number\uff09<\/li>\n<li>\u6536\u5230FDA\u7cfb\u7d71\u78ba\u8a8d\u90f5\u4ef6<\/li>\n<\/ul>\n<p><strong>\u7b2c\u56db\u968e\u6bb5\uff1a\u4e8b\u524d\u901a\u5831\u8a2d\u5b9a\uff081-2\u500b\u5de5\u4f5c\u5929\uff09<\/strong><\/p>\n<ul>\n<li>\u8a2d\u5b9aPrior Notice\uff08\u4e8b\u524d\u901a\u5831\uff09\u5e33\u865f<\/li>\n<li>\u9023\u7d50\u8a3b\u518a\u865f\u78bc\u8207\u901a\u5831\u7cfb\u7d71<\/li>\n<li>\u6e2c\u8a66\u901a\u5831\u6d41\u7a0b<\/li>\n<\/ul>\n<h3>\u5b8c\u6574\u9031\u671f\uff1a\u5f9e\u96f6\u5230\u5b8c\u6210<\/h3>\n<p>\u6839\u64da**<a href=\"https:\/\/www.cbp.gov\/\" target=\"_blank\" rel=\"noopener noreferrer\">\u7f8e\u570b\u6d77\u95dc\u908a\u5883\u4fdd\u8b77\u5c40<\/a>**\u7684\u5be6\u52d9\u7d71\u8a08\uff0c<strong>\u53f0\u7063<\/strong>\u4f01\u696d\u5f9e\u958b\u59cb\u6e96\u5099\u5230\u5b8c\u5168\u53ef\u4ee5\u51fa\u8ca8\uff0c\u5e73\u5747\u9700\u8981\uff1a<\/p>\n<ul>\n<li><strong>\u6700\u5feb\u60c5\u6cc1<\/strong>\uff1a7\u500b\u5de5\u4f5c\u5929\uff08\u8cc7\u6599\u9f4a\u5168\u3001\u7dda\u4e0a\u81ea\u884c\u8fa6\u7406\uff09<\/li>\n<li><strong>\u4e00\u822c\u60c5\u6cc1<\/strong>\uff1a2-3\u9031\uff08\u900f\u904e\u9867\u554f\u516c\u53f8\u5354\u52a9\uff09<\/li>\n<li><strong>\u8907\u96dc\u60c5\u6cc1<\/strong>\uff1a4-6\u9031\uff08\u591a\u7522\u54c1\u985e\u5225\u3001\u591a\u5de5\u5ee0\u8a3b\u518a\uff09<\/li>\n<\/ul>\n<blockquote><p><strong>\u5c08\u5bb6\u5efa\u8b70<\/strong>\uff1a\u5efa\u8b70\u81f3\u5c11\u5728\u9810\u8a08\u51fa\u53e3\u65e5\u671f\u524d1\u500b\u6708\u958b\u59cb\u6e96\u5099<strong>FDA \u98df\u54c1\u8a3b\u518a<\/strong>\u4f5c\u696d\uff0c\u9810\u7559\u5145\u8db3\u7de9\u885d\u6642\u9593\u3002<\/p><\/blockquote>\n<p><img decoding=\"async\" class=\"article-image\" src=\"https:\/\/seo-resouce.easyya.ai\/ai-generated\/20251225\/google_ai_20251225_022016_38c696d9.png\" alt=\"FDA\u8a3b\u518a\u5b8c\u6574\u6642\u7a0b\u898f\u5283\u8207\u5404\u968e\u6bb5\u6642\u9593\u5206\u914d\" width=\"700\" height=\"500\" \/><\/p>\n<hr \/>\n<h2>\u5f71\u97ff FDA \u8a3b\u518a\u6642\u9593\u7684\u95dc\u9375\u56e0\u7d20<\/h2>\n<h3>\u56e0\u7d20\u4e00\uff1a\u8cc7\u6599\u6e96\u5099\u5b8c\u6574\u5ea6<\/h3>\n<p><strong>FDA \u98df\u54c1\u8a3b\u518a<\/strong>\u672c\u8eab\u4e0d\u9700\u8981\u5be9\u6838\u7b49\u5f85\uff0c\u4f46<strong>\u53f0\u7063<\/strong>\u696d\u8005\u5e38\u56e0\u4ee5\u4e0b\u8cc7\u6599\u4e0d\u9f4a\u800c\u5ef6\u8aa4\uff1a<\/p>\n<ul>\n<li><strong>\u82f1\u6587\u516c\u53f8\u540d\u7a31\u4e0d\u4e00\u81f4<\/strong>\uff1a\u71df\u696d\u767b\u8a18\u8207\u51fa\u53e3\u6587\u4ef6\u540d\u7a31\u4e0d\u7b26<\/li>\n<li><strong>\u7522\u54c1\u985e\u5225\u4e0d\u660e\u78ba<\/strong>\uff1a\u7121\u6cd5\u6b63\u78ba\u5206\u985e\u98df\u54c1\u7a2e\u985e<\/li>\n<li><strong>\u7f8e\u570b\u4ee3\u7406\u4eba\u672a\u78ba\u5b9a<\/strong>\uff1a\u9700\u6642\u5c0b\u627e\u5408\u683c\u4ee3\u7406\u5546<\/li>\n<\/ul>\n<h3>\u56e0\u7d20\u4e8c\uff1a\u8fa6\u7406\u65b9\u5f0f\u9078\u64c7<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u8fa6\u7406\u65b9\u5f0f<\/th>\n<th>\u6240\u9700\u6642\u9593<\/th>\n<th>\u512a\u9ede<\/th>\n<th>\u7f3a\u9ede<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u81ea\u884c\u7dda\u4e0a\u8fa6\u7406<\/td>\n<td>5-7\u5929<\/td>\n<td>\u6210\u672c\u4f4e\u3001\u76f4\u63a5\u638c\u63a7<\/td>\n<td>\u9700\u719f\u6089\u82f1\u6587\u4ecb\u9762<\/td>\n<\/tr>\n<tr>\n<td>\u59d4\u8a17\u5831\u95dc\u884c<\/td>\n<td>1-2\u9031<\/td>\n<td>\u5c08\u696d\u5354\u52a9<\/td>\n<td>\u984d\u5916\u8cbb\u7528<\/td>\n<\/tr>\n<tr>\n<td>\u8058\u8acb\u9867\u554f\u516c\u53f8<\/td>\n<td>2-3\u9031<\/td>\n<td>\u5168\u7a0b\u8f14\u5c0e\u3001\u542b\u901a\u5831\u8a2d\u5b9a<\/td>\n<td>\u8cbb\u7528\u8f03\u9ad8<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>\u56e0\u7d20\u4e09\uff1a\u7cfb\u7d71\u719f\u6089\u7a0b\u5ea6<\/h3>\n<p>\u9996\u6b21\u8fa6\u7406<strong>FDA \u98df\u54c1\u8a3b\u518a<\/strong>\u7684<strong>\u53f0\u7063<\/strong>\u696d\u8005\uff0c\u5efa\u8b70\u9810\u7559\u66f4\u591a\u6642\u9593\u5b78\u7fd2\u7cfb\u7d71\u64cd\u4f5c\u3002**<a href=\"https:\/\/www.fda.gov\/food\/food-facility-registration\/registration-training-materials\" target=\"_blank\" rel=\"noopener noreferrer\">FDA\u5b98\u65b9\u6559\u5b78\u5f71\u7247<\/a>**\u63d0\u4f9b\u8a73\u7d30\u7684\u64cd\u4f5c\u6307\u5f15\u3002<\/p>\n<hr \/>\n<h2>FDA \u8a3b\u518a\u5b8c\u6210\u5f8c\u7684\u6ce8\u610f\u4e8b\u9805<\/h2>\n<h3>\u8a3b\u518a\u66f4\u65b0\u8207\u7dad\u8b77<\/h3>\n<p><strong>FDA \u98df\u54c1\u8a3b\u518a<\/strong>\u4e26\u975e\u4e00\u6b21\u6027\u4f5c\u696d\uff0c<strong>\u53f0\u7063<\/strong>\u4f01\u696d\u9700\u6ce8\u610f\uff1a<\/p>\n<ul>\n<li><strong>\u5169\u5e74\u66f4\u65b0\u4e00\u6b21<\/strong>\uff1a\u6bcf\u500b\u5076\u6578\u5e74\u768410\u67081\u65e5\u81f312\u670831\u65e5\u671f\u9593\u66f4\u65b0<\/li>\n<li><strong>\u8cc7\u6599\u8b8a\u66f4\u5373\u6642\u66f4\u65b0<\/strong>\uff1a\u516c\u53f8\u540d\u7a31\u3001\u5730\u5740\u3001\u7522\u54c1\u985e\u5225\u8b8a\u66f4\u9700\u65bc60\u5929\u5167\u66f4\u65b0<\/li>\n<li><strong>\u4fdd\u6301\u5e33\u865f\u6709\u6548<\/strong>\uff1a\u5b9a\u671f\u767b\u5165\u907f\u514d\u5e33\u865f\u88ab\u505c\u7528<\/li>\n<\/ul>\n<h3>\u4e8b\u524d\u901a\u5831\uff08Prior Notice\uff09\u5be6\u52d9<\/h3>\n<p>\u53d6\u5f97\u8a3b\u518a\u865f\u5f8c\uff0c\u6bcf\u6b21\u51fa\u8ca8\u524d\u4ecd\u9700\u9032\u884c<strong>\u4e8b\u524d\u901a\u5831<\/strong>\uff1a<\/p>\n<ol>\n<li><strong>\u901a\u5831\u6642\u6a5f<\/strong>\uff1a\u8ca8\u7269\u62b5\u9054\u7f8e\u570b\u6e2f\u53e3\u524d\n<ul>\n<li>\u6d77\u904b\uff1a\u81f3\u5c114\u5c0f\u6642\u524d<\/li>\n<li>\u7a7a\u904b\uff1a\u81f3\u5c114\u5c0f\u6642\u524d<\/li>\n<li>\u9678\u904b\uff1a\u81f3\u5c112\u5c0f\u6642\u524d<\/li>\n<li>\u570b\u969b\u90f5\u4ef6\uff1a\u81f3\u5c114\u5c0f\u6642\u524d<\/li>\n<\/ul>\n<\/li>\n<li><strong>\u901a\u5831\u5167\u5bb9<\/strong>\uff1a\u7522\u54c1\u63cf\u8ff0\u3001\u6578\u91cf\u3001\u88fd\u9020\u5546\u3001\u9032\u53e3\u5546\u8cc7\u8a0a<\/li>\n<li><strong>\u901a\u5831\u78ba\u8a8d<\/strong>\uff1a\u6536\u5230PN\u78ba\u8a8d\u865f\u78bc\uff08Confirmation Number\uff09<\/li>\n<\/ol>\n<blockquote><p><strong>\u91cd\u8981\u8b66\u793a<\/strong>\uff1a\u672a\u5b8c\u6210\u4e8b\u524d\u901a\u5831\u7684\u8ca8\u7269\u5c07\u88ab<strong>\u7f8e\u570b\u6d77\u95dc\u6263\u7559<\/strong>\uff0c\u7522\u751f\u984d\u5916\u5009\u5132\u8207\u8655\u7406\u8cbb\u7528\u3002<\/p><\/blockquote>\n<hr \/>\n<h2>\u53f0\u7063\u696d\u8005\u5e38\u898b\u554f\u984c\u8655\u7406<\/h2>\n<h3>\u5982\u4f55\u9078\u64c7\u7f8e\u570b\u4ee3\u7406\u4eba<\/h3>\n<p>\u7f8e\u570b\u4ee3\u7406\u4eba\uff08US Agent\uff09\u662f<strong>FDA \u98df\u54c1\u8a3b\u518a<\/strong>\u7684\u5fc5\u8981\u689d\u4ef6\u3002<strong>\u53f0\u7063<\/strong>\u696d\u8005\u53ef\u900f\u904e\uff1a<\/p>\n<ul>\n<li><strong>\u5c08\u696d\u4ee3\u7406\u670d\u52d9\u516c\u53f8<\/strong>\uff1a\u5e74\u8cbb\u7d041,000-3,000\u7f8e\u5143<\/li>\n<li><strong>\u7f8e\u570b\u9032\u53e3\u5546\u64d4\u4efb<\/strong>\uff1a\u8207\u8cbf\u6613\u5925\u4f34\u5354\u5546<\/li>\n<li><strong>\u5831\u95dc\u884c\u63a8\u85a6<\/strong>\uff1a\u6574\u5408\u670d\u52d9\u65b9\u6848<\/li>\n<\/ul>\n<h3>\u9a57\u8b49\u8a3b\u518a\u771f\u507d<\/h3>\n<p>\u6839\u64da**<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/furls\/\" target=\"_blank\" rel=\"noopener noreferrer\">FDA\u5b98\u65b9\u67e5\u8a62\u7cfb\u7d71<\/a><strong>\uff0c\u4efb\u4f55\u4eba\u90fd\u53ef\u4ee5\u900f\u904e\u8a3b\u518a\u865f\u78bc\u67e5\u8a62\u8a2d\u65bd\u8a3b\u518a\u72c0\u614b\uff0c\u78ba\u4fdd<\/strong>FDA \u98df\u54c1\u8a3b\u518a**\u7684\u6709\u6548\u6027\u3002<\/p>\n<hr \/>\n<h2>\u7d50\u8ad6<\/h2>\n<p><strong>FDA \u98df\u54c1\u8a3b\u518a \u8981\u591a\u4e45 \u53f0\u7063<\/strong>\u4f01\u696d\u80fd\u5b8c\u6210\uff1f\u6839\u64da\u672c\u6587\u7684\u5be6\u52d9\u5206\u6790\uff0c\u6a19\u6e96\u6d41\u7a0b\u7d04\u9700<strong>5-7\u500b\u5de5\u4f5c\u5929<\/strong>\u5b8c\u6210\u7dda\u4e0a\u8a3b\u518a\uff0c\u4f46\u5f9e\u8cc7\u6599\u6e96\u5099\u5230\u5b8c\u6574\u8a2d\u5b9a\u4e8b\u524d\u901a\u5831\u7cfb\u7d71\uff0c\u5efa\u8b70\u9810\u7559<strong>2-4\u9031<\/strong>\u7684\u4f5c\u696d\u6642\u9593\u3002\u95dc\u9375\u5728\u65bc\u63d0\u524d\u6e96\u5099\u5b8c\u6574\u8cc7\u6599\u3001\u9078\u64c7\u9069\u5408\u7684\u8fa6\u7406\u65b9\u5f0f\uff0c\u4ee5\u53ca\u6b63\u78ba\u7406\u89e3FDA\u8a3b\u518a\u4e26\u975e\u4e00\u6b21\u6027\u4f5c\u696d\uff0c\u800c\u662f\u9700\u8981\u6301\u7e8c\u7dad\u8b77\u7684\u6cd5\u898f\u8981\u6c42\u3002<\/p>\n<p><strong>\u7acb\u5373\u884c\u52d5\u5efa\u8b70<\/strong>\uff1a<\/p>\n<ol>\n<li><strong>\u8a55\u4f30\u51fa\u53e3\u8a08\u756b<\/strong>\uff1a\u78ba\u8a8d\u7522\u54c1\u985e\u5225\u8207\u76ee\u6a19\u5e02\u5834\u6642\u7a0b<\/li>\n<li><strong>\u6e96\u5099\u5fc5\u8981\u6587\u4ef6<\/strong>\uff1a\u82f1\u6587\u516c\u53f8\u8cc7\u6599\u3001\u7522\u54c1\u6e05\u55ae\u3001\u8ca0\u8cac\u4eba\u8cc7\u8a0a<\/li>\n<li><strong>\u9078\u5b9a\u8fa6\u7406\u65b9\u5f0f<\/strong>\uff1a\u4f9d\u516c\u53f8\u8cc7\u6e90\u6c7a\u5b9a\u81ea\u8fa6\u6216\u59d4\u8a17\u5c08\u696d\u670d\u52d9<\/li>\n<li><strong>\u9810\u7559\u5145\u8db3\u6642\u9593<\/strong>\uff1a\u81f3\u5c11\u5728\u51fa\u53e3\u524d1\u500b\u6708\u958b\u59cb\u6e96\u5099\u4f5c\u696d<\/li>\n<\/ol>\n<p>\u900f\u904e\u6b63\u78ba\u7684\u6642\u7a0b\u898f\u5283\u8207\u5b8c\u6574\u7684\u6e96\u5099\u5de5\u4f5c\uff0c<strong>\u53f0\u7063<\/strong>\u98df\u54c1\u696d\u8005\u53ef\u4ee5\u9806\u5229\u5b8c\u6210<strong>FDA \u98df\u54c1\u8a3b\u518a<\/strong>\uff0c\u958b\u555f\u7f8e\u570b\u5e02\u5834\u7684\u8cbf\u6613\u6a5f\u6703\u3002<\/p>\n<hr \/>\n<h2>\u5e38\u898b\u554f\u984c FAQ<\/h2>\n<h3>Q1\uff1aFDA \u98df\u54c1\u8a3b\u518a\u9700\u8981\u591a\u4e45\u6642\u9593\u624d\u80fd\u5b8c\u6210\uff1f<\/h3>\n<p><strong>\u53f0\u7063<\/strong>\u4f01\u696d\u8fa6\u7406<strong>FDA \u98df\u54c1\u8a3b\u518a \u8981\u591a\u4e45<\/strong>\uff1f\u7dda\u4e0a\u8a3b\u518a\u6d41\u7a0b\u672c\u8eab\u53ea\u97001-2\u500b\u5de5\u4f5c\u5929\uff0c\u7cfb\u7d71\u6703\u5373\u6642\u751f\u6210\u8a3b\u518a\u865f\u78bc\u3002\u4f46\u5305\u542b\u8cc7\u6599\u6e96\u5099\u3001\u7f8e\u570b\u4ee3\u7406\u4eba\u78ba\u8a8d\u3001\u4e8b\u524d\u901a\u5831\u7cfb\u7d71\u8a2d\u5b9a\u7b49\u5b8c\u6574\u6d41\u7a0b\uff0c\u4e00\u822c\u9700\u89812-3\u9031\u3002\u5efa\u8b70\u5728\u9810\u8a08\u51fa\u53e3\u524d\u81f3\u5c111\u500b\u6708\u958b\u59cb\u6e96\u5099\uff0c\u78ba\u4fdd\u6709\u5145\u8db3\u6642\u9593\u8655\u7406\u53ef\u80fd\u7684\u7a81\u767c\u72c0\u6cc1\u3002<\/p>\n<h3>Q2\uff1aFDA \u8a3b\u518a\u5b8c\u6210\u5f8c\u6703\u6536\u5230\u8b49\u66f8\u55ce\uff1f<\/h3>\n<p><strong>FDA \u98df\u54c1\u8a3b\u518a<\/strong>\u5b8c\u6210\u5f8c<strong>\u4e0d\u6703\u6838\u767c\u5be6\u9ad4\u8b49\u66f8<\/strong>\u3002FDA\u50c5\u63d0\u4f9b11\u4f4d\u6578\u7684\u8a3b\u518a\u865f\u78bc\uff08Registration Number\uff09\u53ca\u7cfb\u7d71\u81ea\u52d5\u767c\u9001\u7684\u78ba\u8a8d\u90f5\u4ef6\u3002\u696d\u8005\u53ef\u900f\u904e**<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/furls\/\" target=\"_blank\" rel=\"noopener noreferrer\">FDA\u5b98\u65b9\u67e5\u8a62\u7cfb\u7d71<\/a><strong>\u8f38\u5165\u8a3b\u518a\u865f\u78bc\uff0c\u5217\u5370\u67e5\u8a62\u7d50\u679c\u4f5c\u70ba\u8a3b\u518a\u8b49\u660e\u3002\u90e8\u5206<\/strong>\u53f0\u7063**\u696d\u8005\u6703\u5c07\u67e5\u8a62\u756b\u9762\u8207\u78ba\u8a8d\u90f5\u4ef6\u6574\u7406\u6210\u6587\u4ef6\uff0c\u4f5c\u70ba\u5411\u5ba2\u6236\u8b49\u660e\u7684\u8cc7\u6599\u3002<\/p>\n<h3>Q3\uff1a\u8a3b\u518a\u8cbb\u7528\u5927\u7d04\u9700\u8981\u591a\u5c11\uff1f<\/h3>\n<p><strong>FDA \u98df\u54c1\u8a3b\u518a<\/strong>\u4f46\u5be6\u52d9\u4e0a\u6703\u7522\u751f\u4ee5\u4e0b\u8cbb\u7528\uff1a(1) \u7f8e\u570b\u4ee3\u7406\u4eba\u5e74\u8cbb\uff1a\u7d041,000-3,000\u7f8e\u5143\uff1b(2) \u5982\u59d4\u8a17\u9867\u554f\u516c\u53f8\u8fa6\u7406\uff1a20,000-45,000\u5143\u65b0\u53f0\u5e63\u670d\u52d9\u8cbb\uff1b(3) \u4e8b\u524d\u901a\u5831\u7cfb\u7d71\u8a2d\u5b9a\u8cbb\u7528\uff1a2,000-5,000\u5143\u65b0\u53f0\u5e63\u3002<\/p>\n<h3>Q4\uff1a\u8a3b\u518a\u5b8c\u6210\u5f8c\u9700\u8981\u5b9a\u671f\u66f4\u65b0\u55ce\uff1f<\/h3>\n<p>\u662f\u7684\uff0c<strong>FDA 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