{"id":141,"date":"2016-07-16T11:48:27","date_gmt":"2016-07-16T03:48:27","guid":{"rendered":"http:\/\/www.t-med.cn\/en\/?p=141"},"modified":"2016-07-16T11:48:27","modified_gmt":"2016-07-16T03:48:27","slug":"a-comprehensive-analysis-of-us-medical-device-regulations-and-regulatory-approach","status":"publish","type":"post","link":"https:\/\/www.t-med.cn\/en\/?p=141","title":{"rendered":"A comprehensive analysis of US medical device regulations and regulatory 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\/>\n\u5728\u7f8e\u56fd\uff0c\u533b\u7597\u5668\u68b0\u7684\u4e0a\u5e02\u524d\u5ba1\u6279\u7531FDA\u603b\u90e8\u8fdb\u884c\u7edf\u4e00\u7ba1\u7406\uff0c\u867d\u7136\u6709\u4e00\u90e8\u5206\u4ea7\u54c1\u53ef\u7531\u7b2c\u4e09\u65b9\u673a\u6784\u8fdb\u884c\u5ba1\u8bc4\uff0c\u4f46\u6700\u7ec8\u7684\u6279\u51c6\u6743\u90fd\u8fd8\u662f\u5728FDA\u603b\u90e8\uff0c\u5927\u533a\u529e\u516c\u5ba4\u548c\u5730\u533a\u529e\u516c\u5ba4\u7b49\u5730\u65b9\u6d3e\u9a7b\u673a\u6784\u90fd\u6ca1\u6709\u4e0a\u5e02\u524d\u5ba1\u6279\u7684\u6743\u9650\u3002\u800c\u5730\u65b9\u6d3e\u9a7b\u673a\u6784\u4e3b\u8981\u662f\u5728\u65e5\u5e38\u76d1\u7ba1\u4e2d\u53d1\u6325\u4f5c\u7528\uff0c\u4ed6\u4eec\u5728\u6cd5\u5f8b\u6388\u4e88\u7684\u804c\u8d23\u8303\u56f4\u5185\u5b8c\u6210\u81ea\u5df1\u7684\u5de5\u4f5c\uff0c\u5e76\u534f\u52a9FDA\u603b\u90e8\u5b8c\u6210\u4e00\u4e9b\u5176\u4ed6\u5de5\u4f5c\u3002<\/p>\n<p><strong>\u4e09\u3001\u4ea7\u54c1\u5206\u7c7b<\/strong><br \/>\nFDA\u5bf9\u533b\u7597\u5668\u68b0\u5b9e\u884c\u5206\u7c7b\u7ba1\u7406\uff0c\u6839\u636e\u98ce\u9669\u7b49\u7ea7\u548c\u7ba1\u7406\u7a0b\u5ea6\u628a\u533b\u7597\u5668\u68b0\u5206\u62103\u7c7b\u8fdb\u884c\u4e0a\u5e02\u524d\u7ba1\u7406\u3002FDA\u4ece\u79d1\u5b66\u3001\u5de5\u7a0b\u548c\u4e34\u5e8a\u4e13\u5bb6\u4ee5\u53ca\u6d88\u8d39\u8005\u548c\u5de5\u4e1a\u7ec4\u7ec7\u63a8\u8350\u7684\u5019\u9009\u4eba\u4e2d\u6311\u9009\u51fa\u4e00\u4e9b\u4e13\u5bb6\u7ec4\u6210\u5206\u7c7b\u4e13\u5bb6\u59d4\u5458\u4f1a\uff0c\u5176\u4e2d\u6d88\u8d39\u8005\u548c\u5de5\u4e1a\u7ec4\u7ec7\u4ee3\u8868\u6ca1\u6709\u6295\u7968\u6743\u3002FDA\u4f1a\u6839\u636e\u4e13\u5bb6\u59d4\u5458\u4f1a\u7684\u5efa\u8bae\u6700\u7ec8\u51b3\u5b9a\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u7684\u8be6\u7ec6\u5206\u7c7b\uff0c\u5728\u5b9a\u671f\u516c\u5e03\u8fd9\u4e9b\u5206\u7c7b\u7ed3\u679c\u7684\u540c\u65f6\uff0c\u6bcf\u5e74\u8fd8\u4f1a\u5bf9\u6cd5\u89c4\u4ee3\u7801\u5e93\u8fdb\u884c\u66f4\u65b0\u3002<br \/>\nI\u7c7b\u4ea7\u54c1\u4e3a\u201c\u666e\u901a\u7ba1\u7406\uff08General Controls\uff09\u201d\u4ea7\u54c1\uff0c\u662f\u6307\u98ce\u9669\u5c0f\u6216\u65e0\u98ce\u9669\u7684\u4ea7\u54c1\uff0c\u5982\u533b\u7528\u624b\u5957\u3001\u538b\u820c\u677f\u3001\u624b\u52a8\u624b\u672f\u5668\u68b0\u7b49\uff0c\u8fd9\u7c7b\u4ea7\u54c1\u7ea6\u5360\u5168\u90e8\u533b\u7597\u5668\u68b0\u768430%\u3002FDA\u5bf9\u8fd9\u4e9b\u4ea7\u54c1\u5927\u591a\u8c41\u514d\u4e0a\u5e02\u524d\u901a\u544a\u7a0b\u5e8f\uff0c\u4e00\u822c\u751f\u4ea7\u4f01\u4e1a\u5411FDA\u63d0\u4ea4\u8bc1\u660e\u5176\u7b26\u5408GMP\u5e76\u8fdb\u884c\u767b\u8bb0\u540e\uff0c\u4ea7\u54c1\u5373\u53ef\u4e0a\u5e02\u9500\u552e\u3002<br \/>\nII\u7c7b\u4ea7\u54c1\u4e3a\u201c\u666e\u901a+\u7279\u6b8a\u7ba1\u7406\uff08General &amp; Special Controls\uff09\u201d\u4ea7\u54c1\uff0c\u5176\u7ba1\u7406\u662f\u5728\u201c\u666e\u901a\u7ba1\u7406\u201d\u7684\u57fa\u7840\u4e0a\uff0c\u8fd8\u8981\u901a\u8fc7\u5b9e\u65bd\u6807\u51c6\u7ba1\u7406\u6216\u7279\u6b8a\u7ba1\u7406\uff0c\u4ee5\u4fdd\u8bc1\u8d28\u91cf\u548c\u5b89\u5168\u6709\u6548\u6027\u7684\u4ea7\u54c1\uff0c\u8fd9\u7c7b\u4ea7\u54c1\u7ea6\u5360\u5168\u90e8\u533b\u7597\u5668\u68b0\u768462%\u3002FDA\u53ea\u5bf9\u5c11\u91cf\u7684II\u7c7b\u4ea7\u54c1\u8c41\u514d\u4e0a\u5e02\u524d\u901a\u544a\u7a0b\u5e8f\uff0c\u5176\u4f59\u5927\u591a\u6570\u4ea7\u54c1\u5747\u8981\u6c42\u8fdb\u884c\u4e0a\u5e02\u524d\u901a\u544a\uff08510K\uff09\u3002\u751f\u4ea7\u4f01\u4e1a\u987b\u5728\u4ea7\u54c1\u4e0a\u5e02\u524d90\u5929\u5411FDA\u63d0\u51fa\u7533\u8bf7\uff0c\u901a\u8fc7510K\u5ba1\u67e5\u540e\uff0c\u4ea7\u54c1\u624d\u80fd\u591f\u4e0a\u5e02\u9500\u552e\u3002<br \/>\nIII\u7c7b\u4ea7\u54c1\u4e3a\u201c\u4e0a\u5e02\u524d\u6279\u51c6\u7ba1\u7406\uff08Pre-market Approval\uff0cPMA\uff09\u201d\u4ea7\u54c1\uff0c\u662f\u6307\u5177\u6709\u8f83\u9ad8\u98ce\u9669\u6216\u5371\u5bb3\u6027\uff0c\u6216\u662f\u652f\u6301\u6216\u7ef4\u62a4\u751f\u547d\u7684\u4ea7\u54c1\uff0c\u4f8b\u5982\u4eba\u5de5\u5fc3\u810f\u74e3\u819c\u3001\u5fc3\u810f\u8d77\u640f\u5668\u3001\u4eba\u5de5\u6676\u4f53\u3001\u4eba\u5de5\u8840\u7ba1\u7b49\uff0c\u8fd9\u7c7b\u4ea7\u54c1\u7ea6\u5360\u5168\u90e8\u533b\u7597\u5668\u68b0\u76848%\u3002FDA\u5bf9\u6b64\u7c7b\u4ea7\u54c1\u91c7\u7528\u4e0a\u5e02\u524d\u6279\u51c6\u5236\u5ea6\uff0c\u751f\u4ea7\u4f01\u4e1a\u5728\u4ea7\u54c1\u4e0a\u5e02\u524d\u5fc5\u987b\u5411FDA\u63d0\u4ea4PMA\u7533\u8bf7\u4e66\u53ca\u76f8\u5173\u8d44\u6599\uff0c\u8bc1\u660e\u4ea7\u54c1\u8d28\u91cf\u7b26\u5408\u8981\u6c42\uff0c\u5728\u4e34\u5e8a\u4f7f\u7528\u4e2d\u5b89\u5168\u6709\u6548\u3002FDA\u5728\u6536\u5230PMA\u7533\u8bf7\u540e45\u5929\u5185\u901a\u77e5\u751f\u4ea7\u4f01\u4e1a\u662f\u5426\u5bf9\u6b64\u7533\u8bf7\u7acb\u6848\u5ba1\u67e5\uff0c\u5e76\u5728180\u5929\uff08\u4e0d\u5305\u62ec\u751f\u4ea7\u4f01\u4e1a\u91cd\u65b0\u8865\u5145\u8d44\u6599\u7684\u65f6\u95f4\uff09\u5185\u5bf9\u63a5\u53d7\u7684\u7533\u8bf7\u505a\u51fa\u662f\u5426\u6279\u51c6\u7684\u51b3\u5b9a\uff0c\u53ea\u6709\u5f53FDA\u505a\u51fa\u6279\u51c6\u7533\u8bf7\u7684\u51b3\u5b9a\u540e\uff0c\u8be5\u4ea7\u54c1\u624d\u80fd\u4e0a\u5e02\u9500\u552e\u3002<br \/>\n\u603b\u4f53\u6765\u8bb2\uff0cFDA\u603b\u90e8\u5bf9\u8fd160%\u7684\u533b\u7597\u5668\u68b0\u8fdb\u884c\u4e0a\u5e02\u524d\u901a\u544a\uff08510K\uff09\u6216\u8005\u4e0a\u5e02\u524d\u6279\u51c6\uff08PMA\uff09\u7684\u5ba1\u67e5\u3002<\/p>\n<p><strong>\u56db\u3001\u6ce8\u518c\u5f62\u5f0f\u53ca\u5ba1\u6279\u8fc7\u7a0b<\/strong><br \/>\n\u5728\u524d\u9762\u6211\u4eec\u5df2\u7ecf\u63d0\u5230FDA\u6309\u98ce\u9669\u7b49\u7ea7\u5bf9\u533b\u7597\u5668\u68b0\u5b9e\u884c\u5206\u7c7b\u7ba1\u7406\uff0c\u5e76\u7531FDA\u603b\u90e8\u5bf9\u8fd160%\u7684\u533b\u7597\u5668\u68b0\u8fdb\u884c\u4e0a\u5e02\u524d\u901a\u544a\uff08510K\uff09\u6216\u8005\u4e0a\u5e02\u524d\u6279\u51c6\uff08PMA\uff09\u7684\u5ba1\u67e5\uff0c\u4e0b\u9762\uff0c\u5c06\u9010\u9879\u5730\u5bf9\u4e0d\u540c\u79cd\u7c7b\u4ea7\u54c1\u7684\u6ce8\u518c\u5f62\u5f0f\u548c\u5ba1\u6279\u8fc7\u7a0b\u8fdb\u884c\u8be6\u7ec6\u63cf\u8ff0\u3002<br \/>\n\uff08\u4e00\uff09 \u8c41\u514d\u4e0a\u5e02\u524d\u901a\u544a\u7684\u4ea7\u54c1<br \/>\n\u7edd\u5927\u591a\u6570\u7684I\u7c7b\u4ea7\u54c1\u548c\u5c11\u91cfII\u7c7b\u4ea7\u54c1\u5c5e\u4e8e\u8c41\u514d\u4e0a\u5e02\u524d\u901a\u544a\u7684\u4ea7\u54c1\uff0c\u8fd9\u7c7b\u4ea7\u54c1\u4e0a\u5e02\u65e0\u9700\u7ecf\u8fc7FDA\u5ba1\u6279\uff0c\u53ea\u9700\u751f\u4ea7\u4f01\u4e1a\u786e\u8ba4\u5176\u4ea7\u54c1\u7b26\u5408\u76f8\u5173\u89c4\u5b9a\uff0c\u5982\uff1a\u4ea7\u54c1\u8bf4\u660e\u4e66\u3001\u6807\u7b7e\u548c\u5305\u88c5\u6807\u8bc6\u7b26\u540821CFR801\u3001809\u3001812\u7684\u8981\u6c42\uff0c\u4ea7\u54c1\u8bbe\u8ba1\u548c\u751f\u4ea7\u7b26\u540821CFR820\u7684\u8981\u6c42\u7b49\uff0c\u5e76\u7531\u751f\u4ea7\u4f01\u4e1a\u5411FDA\u63d0\u4ea4\u4fdd\u8bc1\u5176\u4ea7\u54c1\u7b26\u5408GMP\u7684\u5907\u6848\u8868\u540e\uff0c\u8fd9\u7c7b\u4ea7\u54c1\u5c31\u80fd\u591f\u4e0a\u5e02\u9500\u552e\u3002<\/p>\n<p>\uff08\u4e8c\uff09\u9700\u8981\u8fdb\u884c\u4e0a\u5e02\u524d\u901a\u544a\uff08510K\uff09\u7684\u4ea7\u54c1<br \/>\n1.\u4e0a\u5e02\u524d\u901a\u544a\uff08510K\uff09\u7684\u6d41\u7a0b<br \/>\n510K\u662f\u6307\u901a\u8fc7\u5bf9\u62df\u4e0a\u5e02\u4ea7\u54c1\u4e0e\u5df2\u4e0a\u5e02\u4ea7\u54c1\u5728\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u65b9\u9762\u8fdb\u884c\u6bd4\u8f83\uff0c\u5728\u5f97\u51fa\u5b9e\u8d28\u6027\u7b49\u540c\uff08Substantial Equivalence\uff0c\u7b80\u79f0SE\uff09\u7ed3\u8bba\u7684\u524d\u63d0\u4e0b\uff0c\u8fdb\u800c\u83b7\u5f97\u62df\u4e0a\u5e02\u4ea7\u54c1\u53ef\u4ee5\u5408\u6cd5\u9500\u552e\u7684\u4e0a\u5e02\u524d\u901a\u544a\u7684\u4e00\u6761\u6cd5\u89c4\u8def\u5f84\u3002\u7edd\u5927\u591a\u6570II\u7c7b\u4ea7\u54c1\u5c5e\u4e8e\u9700\u8981\u8fdb\u884c\u4e0a\u5e02\u524d\u901a\u544a\uff08510K\uff09\u7684\u4ea7\u54c1\uff0c\u8fd9\u7c7b\u4ea7\u54c1\u662f\u5728\u666e\u901a\u7ba1\u7406\u7684\u57fa\u7840\u4e0a\u589e\u52a0\u4e00\u4e9b\u7279\u6b8a\u8981\u6c42\uff0c\u5982\uff1a\u5bf9\u6807\u8bc6\u7684\u7279\u6b8a\u8981\u6c42\u3001\u7b26\u5408\u67d0\u4e9b\u6027\u80fd\u6807\u51c6\u3001\u7b26\u5408FDA\u7684\u6307\u5357\u7b49\uff0c\u4ee5\u786e\u4fdd\u5176\u4e34\u5e8a\u4f7f\u7528\u4e2d\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002\u8fd9\u7c7b\u4ea7\u54c1\u901a\u5e38\u8981\u7531\u7533\u8bf7\u4eba\u63d0\u4ea4\u8d44\u6599\u8bc1\u660e\u5176\u4e0e\u5df2\u4e0a\u5e02\u4ea7\u54c1\u5b9e\u8d28\u6027\u7b49\u540c\uff08SE\uff09\uff0c\u7ecf\u8fc7FDA\u5ba1\u67e5\u5e76\u53d6\u5f97510K\u786e\u8ba4\u4fe1\u540e\u65b9\u53ef\u4e0a\u5e02\u9500\u552e\u3002\u540c\u65f6\uff0c\u56e0\u5176\u6240\u6d89\u53ca\u7684\u5177\u4f53\u60c5\u51b5\u4e0d\u540c\uff0c\u4e0a\u5e02\u524d\u901a\u544a\u53c8\u5206\u4e3a\u4f20\u7edf510K\uff08Traditional 510K\uff09\u3001\u7b80\u7565510K\uff08Abbreviated 510K\uff09\u548c\u7279\u6b8a510K\uff08Special 510K\uff09\u4e09\u4e2a\u7c7b\u578b\u3002\u4e0b\u9762\u5c06\u5728\u88681\u4e2d\u7ed9\u51fa\u8fd9\u4e09\u79cd\u4e0d\u540c\u7c7b\u578b\u7533\u8bf7\u7684\u5177\u4f53\u5185\u5bb9\u3002<\/p>\n<table width=\"670\" cellspacing=\"0\" cellpadding=\"0\" data-sort=\"sortDisabled\">\n<tbody>\n<tr>\n<td width=\"33\"><\/td>\n<td width=\"180\">\u4f20\u7edf510K<\/td>\n<td width=\"100\">\u7b80\u7565510K<\/td>\n<td valign=\"top\" width=\"163\">\u7279\u6b8a510K<\/td>\n<\/tr>\n<tr>\n<td width=\"47\">\u9002\u7528\u60c5\u51b5<\/td>\n<td width=\"185\">1. \u4e0d\u9002\u7528\u4e8e\u7279\u6b8a510K\u548c\u7b80\u7565510K\u3002<\/p>\n<p>2. \u62df\u4e0a\u5e02\u4ea7\u54c1\u7b2c\u4e00\u6b21\u8fdb\u5165\u5e02\u573a\u3002<\/p>\n<p>3. \u5bf9\u4ea7\u54c1\u9884\u671f\u7528\u9014\u6709\u91cd\u5927\u6539\u53d8\u6216\u5177\u6709\u65b0\u7684\u9884\u671f\u7528\u9014\u3002<\/td>\n<td width=\"108\">1. \u7279\u6b8a\u63a7\u5236\u5df2\u7ecf\u786e\u7acb\u3002<\/p>\n<p>2. FDA\u5df2\u6709\u6307\u5357\u6587\u4ef6\u3002<\/p>\n<p>3. \u76f8\u5173\u6807\u51c6\u5df2\u88abFDA\u8ba4\u53ef\u3002<\/td>\n<td width=\"164\">1. \u5bf9\u5df2\u7ecf\u6279\u51c6\u7684\u4ea7\u54c1\u8fdb\u884c\u6539\u53d8\uff0c\u4f46\u6539\u53d8\u4e0d\u6d89\u53ca\u5bf9\u4ea7\u54c1\u9884\u671f\u7528\u9014\u548c\u79d1\u5b66\u6280\u672f\u4ea7\u751f\u91cd\u5927\u5f71\u54cd\u3002<\/p>\n<p>2. \u6458\u8981\u4fe1\u606f\u662f\u57fa\u4e8e\u8bbe\u8ba1\u63a7\u5236\u7684\u3002<\/td>\n<\/tr>\n<tr>\n<td width=\"58\">\u6240\u63d0\u4ea4\u7684\u8d44\u6599<\/td>\n<td width=\"181\">1. \u4e00\u822c\u4fe1\u606f\uff0c\u5305\u62ec\uff1a\u4ea7\u54c1\u540d\u79f0\uff0c\u751f\u4ea7\u5355\u4f4d\u548c\u706d\u83cc\u5355\u4f4d\u540d\u79f0\u3001\u5730\u5740\u3001\u6ce8\u518c\u53f7\u53ca\u4ea7\u54c1\u5206\u7c7b\u3002<\/p>\n<p>2. \u6458\u8981\u4e0e\u8bc1\u660e\uff0c\u5305\u62ec\uff1a\u6458\u8981\uff0c\u771f\u5b9e\u6027\u53ca\u51c6\u786e\u6027\u58f0\u660e\uff0c\u9884\u671f\u7528\u9014\u58f0\u660e\u3002<\/p>\n<p>3. 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\/>\n\uff081\uff09\u5982\u672a\u53d1\u73b0\u8be5PMA\u7533\u8bf7\u5177\u670921CFR814.45\u4e2d\u89c4\u5b9a\u7684\u4efb\u610f\u4e00\u79cd\u62d2\u7edd\u6279\u51c6\u7684\u60c5\u5f62\uff0c\u5219FDA\u5c06\u4e3a\u7533\u8bf7\u4eba\u53d1\u5e03\u4e00\u9879\u6279\u51c6\u8be5PMA\u7533\u8bf7\u7684\u6307\u4ee4\uff0c\u5e76\u7ed9\u7533\u8bf7\u4eba\u5bc4\u53bb\u53ef\u6279\u51c6\u4fe1\u4ef6\uff0c\u53ef\u6279\u51c6\u4fe1\u4ef6\u4e2d\u5305\u62ecFDA\u8981\u6c42\u7533\u8bf7\u4eba\u63d0\u4f9b\u7684\u4fe1\u606f\u6216\u4e3a\u83b7\u5f97\u6279\u51c6\u8981\u6c42\u7533\u8bf7\u4eba\u7b26\u5408\u7684\u6761\u4ef6\u3002\u7533\u8bf7\u4eba\u5728\u6536\u5230\u53ef\u6279\u51c6\u4fe1\u4ef6\u540e\u53ef\u5411FDA\u505a\u51fa\u6309\u7167\u4fe1\u4ef6\u8981\u6c42\u4fee\u6b63\u8be5PMA\uff0c\u6216\u8005\u7533\u8bf7\u518d\u5ba1\u67e5\uff0c\u6216\u64a4\u9500\u8be5PMA\u7533\u8bf7\u7684\u7b54\u590d\u3002<br \/>\n\uff082\uff09\u5982\u8ba4\u4e3a\u8be5PMA\u7533\u8bf7\u5177\u670921CFR814.45\u4e2d\u89c4\u5b9a\u7684\u4e00\u79cd\u6216\u51e0\u79cd\u62d2\u7edd\u6279\u51c6\u7684\u60c5\u5f62\uff0c\u5219FDA\u5c06\u7ed9\u7533\u8bf7\u4eba\u5bc4\u53bb\u4e0d\u53ef\u6279\u51c6\u4fe1\u4ef6\uff0c\u4e0d\u53ef\u6279\u51c6\u4fe1\u4ef6\u4e2d\u5305\u62ec\u7533\u8bf7\u4e2d\u5b58\u5728\u7684\u7f3a\u9677\u3001\u9002\u7528\u4f9d\u636e\u53ca\u786e\u5b9a\u8be5PMA\u53ef\u88ab\u6279\u51c6\u8981\u6c42\u7533\u8bf7\u4eba\u91c7\u53d6\u7684\u63aa\u65bd\u3002\u7533\u8bf7\u4eba\u5728\u6536\u5230\u4e0d\u53ef\u6279\u51c6\u4fe1\u4ef6\u540e\u53ef\u5411FDA\u505a\u51fa\u6309\u7167\u4fe1\u4ef6\u8981\u6c42\u4fee\u6b63\u8be5PMA\uff0c\u6216\u8005\u7533\u8bf7\u518d\u5ba1\u67e5\uff0c\u6216\u8005\u64a4\u9500\u8be5PMA\u7533\u8bf7\u7684\u7b54\u590d\u3002<\/p>\n<p>3.PMA\u4fee\u6b63<br \/>\n\u5728PMA\u7533\u8bf7\u5df2\u88ab\u7acb\u6848\u4e4b\u540e\uff0c\u7533\u8bf7\u4eba\u53ef\u4ee5\u5bf9\u5c1a\u672a\u505a\u51fa\u6700\u540e\u51b3\u5b9a\u7684PMA\u7533\u8bf7\u6216PMA\u8865\u5145\u7533\u8bf7\u4e3b\u52a8\u8fdb\u884c\u4fee\u6539\uff0c\u4f46\u5e94\u8bf4\u660e\u63d0\u4ea4\u4fee\u6539\u7684\u539f\u56e0\u3002FDA\u4e5f\u53ef\u8981\u6c42\u7533\u8bf7\u4eba\u4fee\u6b63PMA\u7533\u8bf7\u6216PMA\u8865\u5145\u7533\u8bf7\u4e2d\u7684\u4efb\u4f55\u4fe1\u606f\u4ee5\u4fbf\u4e8eFDA\u6216\u9002\u5f53\u7684\u987e\u95ee\u59d4\u5458\u4f1a\u5b8c\u6210\u5bf9\u4e0a\u8ff0\u7533\u8bf7\u7684\u5ba1\u67e5\u3002<\/p>\n<p>4.PMA\u5224\u5b9a<br \/>\n\u6839\u636e\u7533\u8bf7\u4eba\u7b54\u590d\u7684\u4e0d\u540c\uff0cFDA\u4e5f\u4f1a\u505a\u51fa\u4e0b\u5217\u4e0d\u540c\u7684\u5224\u5b9a\uff1a<br \/>\n\uff081\uff09\u7533\u8bf7\u4eba\u6839\u636e\u4fe1\u4ef6\u8981\u6c42\u63d0\u4ea4\u4e86PMA\u4fee\u6b63\uff0c\u4e14\u7ecf\u8fc7\u5ba1\u67e5\u7b26\u5408\u76f8\u5173\u8981\u6c42\uff0cFDA\u4f1a\u53d1\u7ed9\u7533\u8bf7\u4ebaPMA\u6279\u51c6\u4fe1\uff0c\u4e00\u822c\u5728\u8be5\u6279\u51c6\u4fe1\u5185FDA\u4f1a\u6309\u716721CFR814.82\u7684\u89c4\u5b9a\u589e\u52a0\u5bf9\u8be5PMA\u6279\u51c6\u540e\u7684\u8981\u6c42\u3002<br \/>\n\uff082\uff09\u7533\u8bf7\u4eba\u672a\u5728180\u5929\u5185\u4ee5\u4e66\u9762\u5f62\u5f0f\u5bf9FDA\u53d1\u51fa\u7684\u4e66\u9762\u4fee\u6b63\u3001\u53ef\u6279\u51c6\u6216\u4e0d\u53ef\u6279\u51c6\u4fe1\u4ef6\u8fdb\u884c\u7b54\u590d\uff0c\u6216\u4ee5\u4e66\u9762\u5f62\u5f0f\u901a\u77e5FDA\u5df2\u64a4\u9500\u8be5PMA\u7533\u8bf7\uff0cFDA\u5c06\u4f1a\u4f5c\u51fa\u64a4\u9500\u8be5PMA\u7684\u51b3\u5b9a\u3002<br \/>\n\uff083\uff09\u5982\u679c\u7533\u8bf7\u4eba\u6309\u7167\u53ef\u6279\u51c6\u6216\u4e0d\u53ef\u6279\u51c6\u4fe1\u4ef6\u7684\u8981\u6c42\u9012\u4ea4\u4e86\u4fee\u6b63\uff0c\u4f46\u5728\u6cd5\u89c4\u4e2d\u4f9d\u7136\u6709\u62d2\u7edd\u6279\u51c6\u7684\u6839\u636e\uff1b\u6216\u7533\u8bf7\u4eba\u4ee5\u4e66\u9762\u5f62\u5f0f\u901a\u77e5FDA\u5c06\u4e0d\u9012\u4ea4\u8981\u6c42\u7684\u4fee\u6b63\u7684\uff0cFDA\u5c06\u4f1a\u505a\u51fa\u62d2\u7edd\u6279\u51c6\u8be5PMA\u7684\u51b3\u5b9a\u3002<\/p>\n<p>5.PMA\u518d\u9012\u4ea4<br \/>\nPMA\u7533\u8bf7\u6216PMA\u8865\u5145\u7533\u8bf7\u88ab\u64a4\u9500\u6216\u8005PMA\u7533\u8bf7\u6216PMA\u8865\u5145\u7533\u8bf7\u88ab\u62d2\u7edd\u6279\u51c6\u540e\uff0c\u7533\u8bf7\u4eba\u53ef\u4ee5\u5bf9\u4e0a\u8ff0\u7533\u8bf7\u518d\u6b21\u9012\u4ea4\uff0c\u4f46\u5e94\u4e0e21CFR814.20\u6216814.39\u7684\u8981\u6c42\u4e00\u81f4\uff0c\u5e76\u4e14\u5305\u62ec\u7b2c\u4e00\u6b21\u9012\u4ea4\u65f6\u5206\u6d3e\u7684PMA\u7f16\u53f7\u548c\u7533\u8bf7\u4eba\u518d\u6b21\u9012\u4ea4\u8be5\u7533\u8bf7\u7684\u539f\u56e0\u3002<\/p>\n<p>\uff08\u56db\uff09\u53ef\u7531\u7b2c\u4e09\u65b9\uff08Third Party\uff09\u5ba1\u6838\u7684\u4ea7\u54c1<br \/>\n\u5bf9\u4e8e\u5360\u670960%\u7f8e\u56fd\u5e02\u573a\u4efd\u989d\u7684II\u7c7b\u4ea7\u54c1\uff0cFDA\u5728\u9ebb\u9189\u3001\u5fc3\u8840\u7ba1\u3001\u4e34\u5e8a\u5316\u5b66\u3001\u7259\u79d1\u3001\u8033\u9f3b\u5589\u3001\u80a0\u80c3\u3001\u6574\u5f62\u5916\u79d1\u3001\u5e38\u89c4\u8bbe\u5907\u3001\u8840\u6db2\u5b66\u3001\u514d\u75ab\u5b66\u3001\u5fae\u751f\u7269\u5b66\u3001\u795e\u7ecf\u5b66\u3001\u4ea7\u79d1\u3001\u773c\u79d1\u3001\u75c5\u7406\u5b66\u3001\u7269\u7406\u6cbb\u7597\u5b66\u3001\u653e\u5c04\u5b66\u548c\u6bd2\u7269\u5b66\u7b4915\u7c7b\u4ea7\u54c1\u8303\u7574\u4e2d\uff0c\u62bd\u53d6\u4e86\u90e8\u5206\u4ea7\u54c1\uff08I\u7c7b\u548cII\u7c7b\u9700\u8981\u5b8c\u6210510\uff08K\uff09\u7533\u62a5\u65b9\u80fd\u8fdb\u5165\u7f8e\u56fd\u5e02\u573a\u3001\u4e0d\u5c5e\u4e8e\u690d\u5165\u5f0f\u3001\u652f\u6301\u6216\u7ef4\u62a4\u751f\u547d\u8bbe\u5907\u3001\u4e14\u4e0d\u9700\u8981\u8fdb\u884c\u4eba\u4f53\u4e34\u5e8a\u7814\u7a76\u7684\u4ea7\u54c1\uff09\u6388\u6743\u7ed9\u4e8611\u5bb6\u673a\u6784\uff08\u88682\u6240\u793a\uff09\u8fdb\u884c\u7b2c\u4e09\u65b9\u5ba1\u6838\uff0c\u4ece\u800c\u52a0\u5feb\u4e86\u8fd9\u7c7b\u4ea7\u54c1\u5b8c\u6210\u7f8e\u56fd\u5e02\u573a\u51c6\u5165\u7684\u8fdb\u5ea6\u3002\uff08\u5f53\u7136\uff0c\u5bf9\u4e8e\u53ef\u7531\u7b2c\u4e09\u65b9\u5ba1\u6838\u7684\u533b\u7597\u5668\u68b0\uff0c\u5236\u9020\u5546\u4ecd\u7136\u53ef\u4ee5\u5411FDA\u76f4\u63a5\u7533\u8bf7\u5e02\u573a\u51c6\u5165\u5ba1\u6838\uff0c\u800c\u5e76\u975e\u5fc5\u987b\u8981\u7ecf\u7531\u7b2c\u4e09\u65b9\u673a\u6784\u3002\uff09<\/p>\n<table width=\"670\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td width=\"50\" height=\"37\">BRITISH STANDARDS INSTITUTION<\/td>\n<td width=\"50\" height=\"37\">TUV SUD AMERICA, INC.<\/td>\n<\/tr>\n<tr>\n<td width=\"50\" height=\"48\">CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL<\/td>\n<td width=\"50\" height=\"48\">UNDERWRITERS LABORATORIES, INC.<\/td>\n<\/tr>\n<tr>\n<td width=\"50\" height=\"34\">CITECH<\/td>\n<td width=\"50\" height=\"34\">CHEIROON BV<\/td>\n<\/tr>\n<tr>\n<td width=\"50\" height=\"33\">INTERTEK TESTING SERVICES<\/td>\n<td width=\"50\" height=\"33\">KEMA QUALITY B.V.<\/td>\n<\/tr>\n<tr>\n<td width=\"50\" height=\"40\">NIOM &#8211; SCANDINAVIAN INSTITUTE OF DENTAL MATERIALS<\/td>\n<td width=\"50\" height=\"40\">REGULATORY TECHNOLOGY SERVICES, LLC<\/td>\n<\/tr>\n<tr>\n<td width=\"50\" height=\"30\">TUV RHEINLAND OF NORTH AMERICA, INC.<\/td>\n<td width=\"50\" height=\"30\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u88682 FDA\u6388\u6743\u7b2c\u4e09\u65b9\u5ba1\u6838\u673a\u6784\u5217\u8868<\/p>\n<p>1.\u6210\u4e3aFDA\u6388\u6743\u7b2c\u4e09\u65b9\u5ba1\u6838\u673a\u6784\u5e94\u5177\u5907\u7684\u8d44\u683c<br \/>\n\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u53ca\u5316\u5986\u54c1\u6cd5\u6848FD&amp;C Act\u7b2c704\u6761\u6b3e\u89c4\u5b9a\u4e86\u6210\u4e3aFDA\u6388\u6743\u7b2c\u4e09\u65b9\u5ba1\u6838\u673a\u6784\u5e94\u6ee1\u8db3\u7684\u57fa\u672c\u8981\u6c42\uff1a<br \/>\n\uff081\uff09\u5fc5\u987b\u662f\u5408\u6cd5\u7684\u5b9e\u4f53\u673a\u6784\uff0c\u4f46\u4e0d\u5f97\u96b6\u5c5e\u4e8e\u8054\u90a6\u653f\u5e9c\u3002\u5fc5\u987b\u662f\u4e0d\u53d7\u5236\u9020\u5546\u3001\u4f9b\u5e94\u5546\u6216\u5356\u4e3b\u63a7\u5236\u7684\u72ec\u7acb\u7ec4\u7ec7\uff0c\u4e0d\u548c\u5236\u9020\u5546\u3001\u4f9b\u5e94\u5546\u548c\u5356\u4e3b\u4e4b\u95f4\u6709\u7ec4\u7ec7\u7ed3\u6784\u4e0a\u3001\u5b9e\u9645\u6027\u7684\u548c\u8d22\u52a1\u4e0a\u7684\u5229\u76ca\u5173\u7cfb\uff0c\u5e76\u4e14\u4e0d\u4ece\u4e8b\u533b\u7597\u5668\u68b0\u7684\u8bbe\u8ba1\u3001\u88c5\u914d\u3001\u9500\u552e\u6216\u7ef4\u4fee\u5de5\u4f5c\u3002<br \/>\n\uff082\uff09\u5fc5\u987b\u6709\u8db3\u591f\u7684\u62e5\u6709\u5ba1\u6838\u548c\u68c0\u67e5\u7ecf\u9a8c\u3001\u6280\u5de7\u53ca\u53d7\u8fc7\u5fc5\u987b\u57f9\u8bad\u548c\u6559\u80b2\u7684\u5de5\u4f5c\u4eba\u5458\uff0cFDA\u8981\u6c42\u7b2c\u4e09\u65b9\u5ba1\u6838\u673a\u6784\u5de5\u4f5c\u4eba\u5458\u5e94\u5f53\u719f\u6089\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u53ca\u5316\u5986\u54c1\u6cd5\u6848\uff08FD&amp;C Act\uff09\u3001\u516c\u4f17\u5065\u5eb7\u670d\u52a1\u6cd5\uff08Public Health Service Act\uff09\u4ee5\u53ca21CFR\u76f8\u5173\u6cd5\u89c4\u7684\u8981\u6c42\u3002<br \/>\n\uff083\uff09FDA\u5c06\u91c7\u7528TPRB\uff08Third Party Recognition Board\uff09\u7a0b\u5e8f\u6765\u8bc4\u4f30\u7533\u62a5\u673a\u6784\u662f\u5426\u5177\u5907\u7b2c\u4e09\u65b9\u5ba1\u6838\u80fd\u529b\u3002<br \/>\n2.FDA\u6388\u6743\u7b2c\u4e09\u65b9\u5ba1\u6838\u673a\u6784\u5e02\u573a\u51c6\u5165\u5ba1\u6838\u6d41\u7a0b\uff1a<br \/>\n\u7b2c\u4e09\u65b9\u673a\u6784\u5728\u5bf9\u5236\u9020\u5546\u9012\u4ea4\u7684\u5e02\u573a\u51c6\u5165\u6587\u6863\u8fdb\u884c\u521d\u6b65\u5ba1\u6838\u540e\uff0c\u5c06\u5ba1\u6838\u610f\u89c1\u3001\u5efa\u8bae\u4ee5\u53ca510\uff08K\uff09\u6587\u6863\u8f6c\u4ea4\u7ed9FDA\uff0c\u6309\u7167\u6cd5\u89c4\u7684\u8981\u6c42\uff0cFDA\u5fc5\u987b\u572830\u5929\u4e4b\u5185\u4f5c\u51fa\u662f\u5426\u9881\u53d1\u5e02\u573a\u51c6\u5165\u8bb8\u53ef\u4fe1\u7684\u51b3\u5b9a\u3002\u9009\u62e9FDA\u6388\u6743\u7b2c\u4e09\u65b9\u5ba1\u6838\u673a\u6784\u4e0e\u9009\u62e9\u76f4\u63a5\u5411FDA\u9012\u4ea4\u5e02\u573a\u51c6\u5165\u5ba1\u6838\u5dee\u5f02\u8868\u5982\u4e0b\u6240\u793a\uff1a<\/p>\n<table width=\"670\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td width=\"8\">\u7f16\u53f7<\/td>\n<td width=\"33\">\u9879\u76ee\u540d\u79f0<\/td>\n<td width=\"42\">\u9009\u62e9FDA\u6388\u6743\u7b2c\u4e09\u65b9\u5ba1\u6838\u673a\u6784<\/td>\n<td width=\"15\">\u76f4\u63a5\u5411FDA\u9012\u4ea4<\/td>\n<\/tr>\n<tr>\n<td width=\"8\">1<\/td>\n<td width=\"33\">FDA User Fee<\/p>\n<p>\uff082007\u5e74\u8d22\u653f\u5e74\uff09<\/td>\n<td width=\"42\">\u4e00\u822c\u662fFDA User Fee\u76842-3\u500d<\/td>\n<td width=\"15\">4180\u7f8e\u5143<\/td>\n<\/tr>\n<tr>\n<td width=\"8\">2<\/td>\n<td width=\"33\">\u5e02\u573a\u51c6\u5165\u6587\u6863\u5ba1\u6838\u65f6\u95f4<\/td>\n<td width=\"42\">\u7b2c\u4e09\u65b9\u673a\u6784\u4e00\u822c\u572830\u5929\u4e4b\u5185\u5b8c\u6210\u6587\u6863\u5ba1\u6838\uff0c\u5e76\u5c06\u5ba1\u6838\u610f\u89c1\u53cd\u9988\u7ed9FDA\u540e\uff0c\u82e5FDA\u65e0\u8865\u5145\u95ee\u9898\u7684\u8981\u6c42\uff0c\u5219\u4f1a\u572830\u5929\u4e4b\u5185\uff08\u4e00\u822c\u662f15\u5929\uff09\u9881\u53d1\u5e02\u573a\u51c6\u5165\u8bb8\u53ef\u4fe1\u3002<\/td>\n<td width=\"15\">90\u5929<\/td>\n<\/tr>\n<tr>\n<td width=\"8\">3<\/td>\n<td width=\"33\">\u8865\u5145\u95ee\u9898\u7684\u56de\u590d\u65f6\u95f4\uff08\u82e5\u6709\uff09<\/td>\n<td width=\"42\">\u7b2c\u4e09\u65b9\u4f1a\u91c7\u53d6\u53ca\u65f6\u4ea4\u6d41\u7684\u65b9\u5f0f<\/td>\n<td width=\"15\">30\u5929<\/td>\n<\/tr>\n<tr>\n<td width=\"8\">4<\/td>\n<td width=\"33\">\u8865\u5145\u95ee\u9898\u56de\u590d\u540eFDA\u9881\u53d1\u5e02\u573a\u51c6\u5165\u8bb8\u53ef\u4fe1\u65f6\u95f4<\/td>\n<td width=\"42\">30\u5929\uff08\u4e00\u822c\u662f15\u5929\uff09<\/td>\n<td width=\"15\">\u6cd5\u89c4\u89c4\u5b9a\u4e3a90\u5929\uff08\u4e00\u822c\u662f60\u5929\uff09<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>3.FDA\u5bf9\u7b2c\u4e09\u65b9\u5ba1\u6838\u673a\u6784\u7684\u76d1\u7ba1<br \/>\n\u96b6\u5c5e\u4e8eFDA\u5668\u68b0\u548c\u653e\u5c04\u536b\u751f\u4e2d\u5fc3\uff08CDRH\uff09\u7684\u6295\u8bc9\u76d1\u7763\u529e\u516c\u5ba4\uff08OC\uff09\u5c06\u5bf9FDA\u6388\u6743\u7684\u7b2c\u4e09\u65b9\u5ba1\u6838\u673a\u6784\u4f9d\u6cd5\u8fdb\u884c\u76d1\u7ba1\u3002<br \/>\nFDA\u5c06\u4f1a\u5bf9\u7531\u7b2c\u4e09\u65b9\u5ba1\u6838\u673a\u6784\u5b8c\u6210\u7684\u5ba1\u6838\u9879\u76ee\u8fdb\u884c\u590d\u5ba1\uff0c\u5e76\u5b9a\u671f\u5bf9\u7b2c\u4e09\u65b9\u5ba1\u6838\u673a\u6784\u8fdb\u884c\u68c0\u67e5\uff0c\u4ee5\u786e\u4fdd\u5b83\u4eec\u6309\u7167\u6cd5\u89c4\u7684\u8981\u6c42\u8fdb\u884c\u76f8\u5173\u5ba1\u6838\u5de5\u4f5c\u5e76\u8bb0\u5f55\u8fc7\u7a0b\u3002\u5f53\u6709\u8db3\u591f\u7684\u8bc1\u636e\u8868\u660e\uff0c\u7b2c\u4e09\u65b9\u5ba1\u6838\u673a\u6784\u4e0e\u7533\u62a5\u8005\u4e4b\u95f4\u5b58\u5728\u7740\u5229\u76ca\u5173\u7cfb\uff0cFDA\u5c06\u4f1a\u6309\u7167FD&amp;C Act 704\u6761\u6b3e\u7684\u8981\u6c42\u542f\u52a8\u64a4\u9500\u7b2c\u4e09\u65b9\u5ba1\u6838\u673a\u6784\u8d44\u683c\u7684\u7a0b\u5e8f\u3002<br \/>\nFD&amp;C Act 704\u6761\u6b3e\u89c4\u5b9a\uff0c\u5f53\u7b2c\u4e09\u65b9\u5ba1\u6838\u673a\u6784\u672a\u6309\u7167\u6807\u51c6\u548c\u6cd5\u89c4\u7684\u8981\u6c42\u5c65\u884c\u7a0b\u5e8f\uff0c\u5bf9\u516c\u4f17\u5065\u5eb7\u5e26\u6765\u5a01\u80c1\uff0c\u6216\u4e0e\u8bbe\u5907\u5236\u9020\u5546\u7b49\u673a\u6784\u4e4b\u95f4\u5b58\u5728\u5229\u76ca\u5173\u7cfb\u65f6\uff0cFDA\u5c06\u4f1a\u64a4\u9500\u7b2c\u4e09\u65b9\u5ba1\u6838\u673a\u6784\u8d44\u683c\u3002\u800c\u622a\u6b62\u5230\u76ee\u524d\u4e3a\u6b62\uff0cFDA\u5c1a\u672a\u5bf9\u5df2\u7ecf\u6388\u6743\u7684\u7b2c\u4e09\u65b9\u5ba1\u6838\u673a\u6784\u505a\u51fa\u64a4\u9500\u8d44\u683c\u7684\u5224\u5b9a\u3002<br \/>\n<strong>\u4e94\u3001\u4e34\u5e8a\u7814\u7a76\u7684\u7ba1\u7406<\/strong><br \/>\n\u5728\u7f8e\u56fd\uff0c\u670910%-15%\u7684II\u7c7b\u4ea7\u54c1\u5728\u7533\u8bf7\u4e0a\u5e02\u524d\u901a\u544a\uff08510K\uff09\u53ca\u5168\u90e8III\u7c7b\u4ea7\u54c1\u5728\u7533\u8bf7\u4e0a\u5e02\u524d\u6279\u51c6\uff08PMA\uff09\u65f6\uff0c\u90fd\u5fc5\u987b\u63d0\u4ea4\u4e34\u5e8a\u7814\u7a76\u8d44\u6599\u3002<br \/>\n\u5bf9\u4e8e\u9700\u8981\u63d0\u4ea4\u4e34\u5e8a\u7814\u7a76\u8d44\u6599\u7684\u4ea7\u54c1\uff0c\u6839\u636e\u5176\u98ce\u9669\u7a0b\u5ea6\u7684\u4e0d\u540c\uff0c\u53c8\u5206\u4e3a\u5177\u6709\u91cd\u5927\u98ce\u9669\u7684\u5668\u68b0\uff08Significant Risk Device\uff09\u548c\u4e0d\u5177\u6709\u91cd\u5927\u98ce\u9669\u7684\u5668\u68b0\uff08Non-Significant Risk Device\uff09\u3002\u5176\u4e2d\uff0c\u5177\u6709\u91cd\u5927\u98ce\u9669\u7684\u5668\u68b0\u5728\u8fdb\u884c\u4e34\u5e8a\u7814\u7a76\u524d\uff0c\u8bd5\u9a8c\u53d1\u8d77\u4eba\u5fc5\u987b\u5411FDA\u548c\u673a\u6784\u5ba1\u67e5\u59d4\u5458\u4f1a\uff08Institutional Review Board\uff0c\u7b80\u79f0IRB\uff09\u63d0\u51fa\u7533\u8bf7\uff0c\u5728\u7ecf\u8fd9\u4e24\u4e2a\u673a\u6784\u5ba1\u67e5\u5e76\u83b7\u5f97\u6279\u51c6\u540e\uff0c\u4e34\u5e8a\u7814\u7a76\u65b9\u53ef\u5f00\u5c55\u3002\u800c\u4e0d\u5177\u6709\u91cd\u5927\u98ce\u9669\u7684\u5668\u68b0\u5728\u8fdb\u884c\u4e34\u5e8a\u7814\u7a76\u524d\uff0c\u8bd5\u9a8c\u53d1\u8d77\u4eba\u53ea\u9700\u5411IRB\u63d0\u51fa\u7533\u8bf7\uff0c\u7ecf\u5ba1\u67e5\u83b7\u5f97\u6279\u51c6\u540e\u4e34\u5e8a\u7814\u7a76\u5373\u53ef\u5f00\u5c55\u3002\u4e0b\u9762\u5c06\u5bf9\u8fd9\u4e24\u79cd\u4e0d\u540c\u7684\u4e34\u5e8a\u7814\u7a76\u7ba1\u7406\u65b9\u5f0f\u8fdb\u884c\u7b80\u8981\u7684\u8bf4\u660e\u3002<br \/>\n\uff08\u4e00\uff09 \u5177\u6709\u91cd\u5927\u98ce\u9669\u7684\u5668\u68b0\uff08Significant Risk Device\uff09<br \/>\n\u572821CFR812.3\u4e2d\uff0c\u5bf9\u5177\u6709\u91cd\u5927\u98ce\u9669\u7684\u5668\u68b0\u5b9a\u4e49\u4e3a\uff1a\u690d\u5165\u4eba\u4f53\uff0c\u7528\u4e8e\u652f\u6301\u6216\u7ef4\u6301\u751f\u547d\uff0c\u5bf9\u4e8e\u8bca\u65ad\u3001\u6cbb\u7597\u3001\u51cf\u8f7b\u6216\u5904\u7406\u75be\u75c5\u6709\u91cd\u8981\u4f5c\u7528\u6216\u8005\u9632\u6b62\u4eba\u4f53\u5065\u5eb7\u53d7\u5230\u635f\u5bb3\u7684\u5668\u68b0\u3002<br \/>\n\u5982\u679c\u8bd5\u9a8c\u53d1\u8d77\u4eba\u5224\u65ad\u62df\u8fdb\u884c\u4e34\u5e8a\u7814\u7a76\u7684\u5668\u68b0\u4e3a\u5177\u6709\u91cd\u5927\u98ce\u9669\u7684\u5668\u68b0\uff0c\u90a3\u4e48\u8bd5\u9a8c\u53d1\u8d77\u4eba\u5e94\u5f53\u6309\u716721CFR812.20\u7684\u8981\u6c42\u5411FDA\u63d0\u4ea4\u4e00\u4efd\u5b8c\u6574\u7684IDE \uff08Investigational Device Exemptions\uff09\u7533\u8bf7\u7684\u540c\u65f6\uff0c\u6309\u716721CFR812. 25\u548c21CFR812.27\u7684\u8981\u6c42\u5411IRB\u63d0\u4ea4\u4e34\u5e8a\u7814\u7a76\u8ba1\u5212\u548c\u9884\u5148\u7814\u7a76\u62a5\u544a\u3002<br \/>\nFDA\u5728\u6536\u5230\u53d1\u8d77\u4eba\u9012\u4ea4\u7684IDE\u7533\u8bf7\u540e\uff0c\u5c06\u4f1a\u901a\u77e5\u53d1\u8d77\u4eba\u53d7\u5230\u7533\u8bf7\u7684\u65e5\u671f\uff0c\u5e76\u7ed9\u4e88\u8be5IDE\u7533\u8bf7\u4e00\u4e2a\u7f16\u53f7\u3002\u800cIRB\u5728\u6536\u5230\u53d1\u8d77\u4eba\u9012\u4ea4\u7684\u4e34\u5e8a\u7814\u7a76\u8ba1\u5212\u548c\u9884\u5148\u7814\u7a76\u62a5\u544a\u540e\uff0c\u4f1a\u5bf9\u8fd9\u4e9b\u8d44\u6599\u8fdb\u884c\u5ba1\u67e5\uff0c\u5e76\u6709\u6743\u4f5c\u51fa\u6279\u51c6\u3001\u8981\u6c42\u6539\u8fdb\u548c\u62d2\u7edd\u6279\u51c6\u7684\u51b3\u5b9a\uff0c\u800c\u8fd9\u4e9b\u51b3\u5b9a\u90fd\u5c06\u88ab\u53d1\u9001\u7ed9FDA\u3002\u901a\u5e38FDA\u4f1a\u6839\u636eIRB\u7684\u5efa\u8bae\u5e76\u4f9d\u636e21CFR812.30\u7684\u89c4\u5b9a\u572830\u65e5\u5185\u4f5c\u51fa\u6279\u51c6\u3001\u6709\u6761\u4ef6\u6279\u51c6\u3001\u62d2\u7edd\u6279\u51c6\u6216\u64a4\u9500\u6279\u51c6\u7684\u51b3\u5b9a\uff0c\u4e66\u9762\u901a\u77e5\u53d1\u8d77\u4eba\u3002\u5982\u53d1\u8d77\u4eba\u6536\u5230\u62d2\u7edd\u6279\u51c6\u6216\u64a4\u9500\u6279\u51c6\u7684\u901a\u77e5\uff0c\u5982\u53d1\u8d77\u4eba\u5bf9\u4e0a\u8ff0\u901a\u77e5\u6301\u6709\u5f02\u8bae\uff0c\u53ef\u4ee5\u4f9d\u636e21CFR\u7b2c16\u90e8\u5206\u7684\u89c4\u5b9a\u63d0\u8bf7\u542c\u8bc1\u3002<br \/>\n\u5728IDE\u7533\u8bf7\u88abFDA\u6279\u51c6\u4e4b\u540e\uff0c\u53d1\u8d77\u4eba\u5fc5\u987b\u4fdd\u8bc1\u8fdb\u884c\u4e34\u5e8a\u7814\u7a76\u7684\u5668\u68b0\u7b26\u540821CFR812.5\uff08\u6807\u7b7e\uff09\u300121CFR812.43\uff08\u6311\u9009\u7814\u7a76\u548c\u76d1\u7ba1\u4eba\u5458\uff09\u300121CFR50\uff08\u53d7\u8bd5\u8005\u77e5\u60c5\u540c\u610f\u4e66\uff09\u300121CFR812.46\uff08\u76d1\u7ba1\u7814\u7a76\uff09\u300121CFR812.7\uff08\u7981\u6b62\u5ba3\u4f20\u548c\u5176\u4ed6\u884c\u4e3a\u7684\u7981\u4ee4\uff09\u300121CFR812.140\uff08\u8bb0\u5f55\uff09\u548c21CFR812.150\uff08\u62a5\u544a\uff09\u7684\u8981\u6c42\u540e\uff0c\u65b9\u53ef\u5f00\u5c55\u4e34\u5e8a\u7814\u7a76\u3002\u5728\u4e34\u5e8a\u7814\u7a76\u7684\u8fc7\u7a0b\u4e2d\uff0cIRB\u5e94\u5f53\u6309\u716721CFR56\u90e8\u5206\u7684\u89c4\u5b9a\u5bf9\u4e34\u5e8a\u7814\u7a76\u8fdb\u884c\u6301\u7eed\u5ba1\u67e5\uff0cFDA\u5728\u4e34\u5e8a\u7814\u7a76\u7684\u8fc7\u7a0b\u4e2d\uff0c\u53ef\u4ee5\u5bf9\u8bf8\u5982\u8bbe\u5907\u5b58\u5728\u7684\u4efb\u4f55\u573a\u6240\u3001\u8bb0\u5f55\u4ee5\u53ca\u75c5\u4eba\u8bb0\u5f55\u7b49\u5185\u5bb9\u8fdb\u884c\u4efb\u4f55\u65b9\u5f0f\u7684\u68c0\u67e5\uff0c\u59cb\u7ec8\u786e\u4fdd\u4e34\u5e8a\u7814\u7a76\u7b26\u5408\u6cd5\u89c4\u8981\u6c42\u3002<\/p>\n<p>\uff08\u4e8c\uff09 \u5177\u6709\u975e\u91cd\u5927\u98ce\u9669\u7684\u5668\u68b0\uff08Non-Significant Risk Device\uff09<br \/>\n\u5177\u6709\u975e\u91cd\u5927\u98ce\u9669\u7684\u5668\u68b0\u5373\u662f\u9664\u5177\u6709\u91cd\u5927\u98ce\u9669\u5668\u68b0\u4ee5\u5916\u7684\u5668\u68b0\uff0c\u6b64\u7c7b\u5668\u68b0\u8fdb\u884c\u4e34\u5e8a\u7814\u7a76\u4e0d\u5fc5\u5411FDA\u63d0\u4ea4IDE\u7533\u8bf7\uff0c\u53ea\u9700\u6309\u716721CFR812.2\uff08b\uff09\u7684\u8981\u6c42\u76f4\u63a5\u5411IRB\u63d0\u4ea4\u7b80\u7565IDE\u7533\u8bf7\uff0c\u5e76\u63d0\u4ea4\u62df\u8fdb\u884c\u4e34\u5e8a\u7814\u7a76\u7684\u5730\u70b9\u548c\u5224\u65ad\u62df\u8fdb\u884c\u4e34\u5e8a\u7814\u7a76\u7684\u5668\u68b0\u4e0d\u5177\u6709\u91cd\u5927\u98ce\u9669\u7684\u4f9d\u636e\u3002\u5982\u679cIRB\u4e0d\u540c\u610f\u5e76\u4e14\u5224\u65ad\u8be5\u5668\u68b0\u5177\u6709\u91cd\u5927\u98ce\u9669\uff0c\u53d1\u8d77\u4eba\u5fc5\u987b\u57285\u4e2a\u5de5\u4f5c\u65e5\u5185\u5c06\u6b64\u4fe1\u606f\u62a5\u544a\u7ed9FDA\uff0cFDA\u5982\u679c\u5224\u65ad\u8be5\u5668\u68b0\u4e3a\u5177\u6709\u975e\u91cd\u5927\u98ce\u9669\u7684\u5668\u68b0\uff0c\u5e76\u4e14\u5728\u6b64\u95ee\u9898\u4e0a\u4e0eIRB\u8fdb\u884c\u6c9f\u901a\u5e76\u53d6\u5f97\u4e00\u81f4\u610f\u89c1\uff0c\u5c06\u4f1a\u6279\u51c6\u8fd9\u4e2aIDE\u7533\u8bf7\u3002<br \/>\n\u800c\u4e00\u65e6IDE\u7533\u8bf7\u88abFDA\u6216IRB\u6279\u51c6\u4e4b\u540e\uff0c\u53d1\u8d77\u4eba\u4e5f\u5fc5\u987b\u4fdd\u8bc1\u8fdb\u884c\u4e34\u5e8a\u7814\u7a76\u7684\u5668\u68b0\u7b26\u540821CFR812.5\uff08\u6807\u7b7e\uff09\u3001IRB\u7684\u6279\u51c6\u300121CFR50\uff08\u77e5\u60c5\u540c\u610f\u4e66\uff0c\u9664\u975eIRB\u6839\u636e21CFR56.109C\u7684\u8981\u6c42\u4e88\u4ee5\u8c41\u514d\uff0921CFR812.46\uff08\u76d1\u7ba1\u7814\u7a76\uff09\u300121CFR812.140\uff08\u8bb0\u5f55\uff09\u300121CFR812.150\uff08\u62a5\u544a\uff09\u3001\u7814\u7a76\u8005\u7684\u8bb0\u5f55\u548c\u62a5\u544a\u4ee5\u53ca21CFR812.7\uff08\u7981\u6b62\u5ba3\u4f20\u548c\u5176\u4ed6\u884c\u4e3a\u7684\u7981\u4ee4\uff09\u7684\u8981\u6c42\u540e\uff0c\u65b9\u53ef\u5f00\u5c55\u4e34\u5e8a\u7814\u7a76\u3002\u5728\u4e34\u5e8a\u7814\u7a76\u7684\u8fc7\u7a0b\u4e2d\uff0cIRB\u5e94\u5f53\u6309\u716721CFR56\u90e8\u5206\u7684\u89c4\u5b9a\u5bf9\u4e34\u5e8a\u7814\u7a76\u8fdb\u884c\u6301\u7eed\u5ba1\u67e5\uff0cFDA\u5728\u4e34\u5e8a\u7814\u7a76\u7684\u8fc7\u7a0b\u4e2d\uff0c\u53ef\u4ee5\u5bf9\u8bf8\u5982\u8bbe\u5907\u5b58\u5728\u7684\u4efb\u4f55\u573a\u6240\u3001\u8bb0\u5f55\u4ee5\u53ca\u75c5\u4eba\u8bb0\u5f55\u7b49\u5185\u5bb9\u8fdb\u884c\u4efb\u4f55\u65b9\u5f0f\u7684\u68c0\u67e5\uff0c\u59cb\u7ec8\u786e\u4fdd\u4e34\u5e8a\u7814\u7a76\u7b26\u5408\u6cd5\u89c4\u8981\u6c42\u3002<br \/>\n\u4efb\u4f55\u4e00\u4e2a\u88ab\u6279\u51c6\u7684\u4e34\u5e8a\u7814\u7a76\u5728\u5f00\u59cb\u540e\u8fdb\u884c\u7684\u8fc7\u7a0b\u4e2d\uff0c\u5982\u679c\u9700\u8981\u5bf9\u4e34\u5e8a\u7814\u7a76\u8ba1\u5212\u6709\u6240\u6539\u53d8\uff0c\u5e94\u5f53\u6309\u716721CFR812.35\u7684\u89c4\u5b9a\u5411FDA\u6216\u8005IRB\u63d0\u4ea4\u76f8\u5e94\u7684\u8d44\u6599\uff0c\u5982\u9700FDA\u7684\u6279\u51c6\uff0c\u4e34\u5e8a\u7814\u7a76\u5e94\u5f53\u5728FDA\u6279\u51c6\u540e\u65b9\u53ef\u7ee7\u7eed\u8fdb\u884c\u3002<\/p>\n<p><strong>\u516d\u3001\u4e0a\u5e02\u540e\u76d1\u7ba1<\/strong><br \/>\nFDA\u8981\u6c42\u751f\u4ea7\u4f01\u4e1a\u4fdd\u8bc1\u4ea7\u54c1\u662f\u5728\u7b26\u5408GMP\u8981\u6c42\u7684\u6761\u4ef6\u4e0b\u751f\u4ea7\u51fa\u6765\u7684\u3002\u5728\u4ea7\u54c1\u4e0a\u5e02\u540e\uff0cFDA\u4f1a\u901a\u8fc7\u8d28\u91cf\u4f53\u7cfb\u68c0\u67e5\uff0c\u5efa\u7acb\u8ffd\u6eaf\u5236\u5ea6\uff0c\u4e0d\u826f\u4e8b\u4ef6\u62a5\u544a\uff0c\u53ec\u56de\u7b49\u624b\u6bb5\u6765\u8fdb\u884c\u76d1\u7ba1\u3002<br \/>\n\uff08\u4e00\uff09\u8d28\u91cf\u4f53\u7cfb\u68c0\u67e5<br \/>\n\u5bf9\u4e8eI\u7c7b\u4ea7\u54c1\uff0cFDA\u4e00\u822c\u6bcf\u56db\u5e74\u68c0\u67e5\u4e00\u6b21\u8d28\u91cf\u4f53\u7cfb\uff0c\u5bf9\u4e8eII\u3001III\u7c7b\u4ea7\u54c1\uff0cFDA\u4e00\u822c\u6bcf\u4e24\u5e74\u68c0\u67e5\u4e00\u6b21\u8d28\u91cf\u4f53\u7cfb\u3002\u4f46\u82e5\u53d1\u73b0\u95ee\u9898\uff0cFDA\u53ef\u968f\u65f6\u5bf9\u751f\u4ea7\u4f01\u4e1a\u8fdb\u884c\u68c0\u67e5\u3002\u5e76\u4e14\uff0cFDA\u53ef\u901a\u8fc7\u53d1\u8b66\u544a\u4fe1\u3001\u6263\u62bc\u4ea7\u54c1\u3001\u5f3a\u5236\u53ec\u56de\u4ea7\u54c1\u7b49\u624b\u6bb5\u8fdb\u884c\u884c\u653f\u5904\u7f5a\uff0c\u8fd8\u53ef\u4ee5\u901a\u8fc7\u65b0\u95fb\u5a92\u4ecb\u5f71\u54cd\u751f\u4ea7\u4f01\u4e1a\u3002<br \/>\n\uff08\u4e8c\uff09\u8ffd\u6eaf\u5236\u5ea6<br \/>\n\u7f8e\u56fd\u8054\u90a6\u6cd5\u89c421CFR821\u90e8\u5206\u89c4\u5b9a\u4e86\u5bf9\u4e8e\u5728\u8bbe\u5907\u5355\u4f4d\u5916\u4f7f\u7528\u7684\u7528\u4e8e\u652f\u6301\u3001\u7ef4\u6301\u751f\u547d\u7684\u8bbe\u5907\u6216\u6c38\u4e45\u690d\u5165\u6027\u8bbe\u5907\uff0c\u4f8b\u5982\uff1a\u5fc3\u8840\u7ba1\u6c38\u4e45\u8d77\u640f\u7535\u6781\uff0c\u4eba\u5de5\u5fc3\u810f\u74e3\u819c\uff0c\u76f4\u6d41\u9664\u98a4\u5668\u7b49\uff0c\u4ea7\u54c1\u5236\u9020\u5546\u548c\u9500\u552e\u5546\u5e94\u5f53\u5efa\u7acb\u8ffd\u6eaf\u5236\u5ea6\uff0c\u786e\u4fdd\u4ea7\u54c1\u4ece\u751f\u4ea7\u5f00\u59cb\uff0c\u5230\u9500\u552e\u7f51\u7edc\uff08\u5305\u62ec\u6279\u53d1\u5546\u3001\u96f6\u552e\u5546\u3001\u79df\u8d41\u5546\u3001\u5176\u4ed6\u5546\u4e1a\u4f01\u4e1a\u3001\u8bbe\u5907\u4f7f\u7528\u5355\u4f4d\u548c\u5f97\u5230\u8bb8\u53ef\u7684\u4ece\u4e1a\u8005\uff09\uff0c\u5230\u4f7f\u7528\u8bbe\u5907\u7684\u60a3\u8005\u8fd9\u4e00\u7cfb\u5217\u73af\u8282\u90fd\u662f\u53ef\u8ffd\u6eaf\u7684\uff0c\u4fdd\u8bc1\u5df2\u4e0a\u5e02\u4ea7\u54c1\u7684\u6709\u6548\u6027\u3002<br \/>\n\uff08\u4e09\uff09 \u4e0d\u826f\u4e8b\u4ef6\u62a5\u544a<br \/>\n\u7f8e\u56fd\u8054\u90a6\u6cd5\u89c421CFR803\u90e8\u5206\u89c4\u5b9a\u4e86\u4e0d\u826f\u4e8b\u4ef6\u62a5\u544a\u5236\u5ea6\uff0c\u8981\u6c42\u533b\u7597\u5668\u68b0\u7684\u5236\u9020\u5546\u3001\u8fdb\u53e3\u5546\u548c\u4f7f\u7528\u5355\u4f4d\uff0c\u5fc5\u987b\u5bf9\u5df2\u7ecf\u9020\u6210\u7684\u6b7b\u4ea1\u548c\u4e25\u91cd\u4f24\u5bb3\u4e8b\u4ef6\uff0c\u6216\u6b63\u5728\u5f15\u8d77\u5e76\u53ef\u80fd\u9020\u6210\u7684\u6b7b\u4ea1\u548c\u4e25\u91cd\u4f24\u5bb3\u4e8b\u4ef6\u7684\u533b\u7597\u5668\u68b0\uff0c\u5fc5\u987b\u5efa\u7acb\u548c\u7ef4\u62a4\u4e0d\u826f\u4e8b\u4ef6\u6863\u6848\uff0c\u5e76\u5411FDA\u63d0\u4ea4\u8be6\u7ec6\u7684\u62a5\u544a\u3002\u540c\u65f6\uff0c\u8fd8\u8981\u6c42\u533b\u7597\u5668\u68b0\u5206\u9500\u5546\u4e5f\u8981\u4fdd\u7559\u4e0d\u826f\u4e8b\u4ef6\u8bb0\u5f55\u3002<\/p>\n<p>\uff08\u56db\uff09 \u53ec\u56de<br 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\/>\n\uff08\u4e00\uff09\u51fa\u53e3\u8bc1\u660e\uff08CFG\uff09<br \/>\n\u4e3a\u4e86\u4f7f\u7f8e\u56fd\u751f\u4ea7\u4f01\u4e1a\u751f\u4ea7\u7684\u533b\u7597\u5668\u68b0\u80fd\u591f\u51fa\u53e3\u5230\u4e16\u754c\u5176\u4ed6\u56fd\u5bb6\u6216\u5730\u533a\uff0cFDA\u4f1a\u7ed9\u62df\u51fa\u53e3\u7684\u5668\u68b0\u5f00\u5177\u81f4\u5916\u56fd\u653f\u5e9c\u8bc1\u4e66\uff08CERTIFICATE TO FOREIGN GOVERNMENT\uff0c\u7b80\u79f0CFG\uff09\uff0c\u5728\u8fd9\u4e2a\u8bc1\u4e66\u4e0a\u4f1a\u8bb0\u8f7d\u6709\u4e0b\u5217\u4fe1\u606f\uff1a<br \/>\n\uff081\uff09\u8bc1\u4e66\u7f16\u53f7\uff1b<br \/>\n\uff082\uff09\u4ea7\u54c1\u540d\u79f0\uff08\u5982\u62df\u51fa\u53e3\u7684\u4ea7\u54c1\u8f83\u591a\uff0c\u4f1a\u4ee5\u9644\u9875\u5f62\u5f0f\u5217\u51fa\uff09\uff1b<br \/>\n\uff083\uff09\u751f\u4ea7\u4f01\u4e1a\u6216\u8005\u5206\u9500\u5546\u7684\u540d\u79f0\u548c\u5730\u5740\uff1b<br \/>\n\uff084\uff09\u6240\u8f7d\u4ea7\u54c1\u5728\u7f8e\u56fd\u5e02\u573a\u4e0a\u5df2\u6709\u9500\u552e\uff1b<br 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width=\"38\">\u4e0a\u5e02\u524d\u6279\u51c6<\/p>\n<p>\u5305\u62ecPMA\u3001PDP\u3001PMR\u3001BLA\u7533\u8bf7<\/td>\n<td width=\"8\">\u2460<\/td>\n<td width=\"17\">185,000\u7f8e\u5143<\/td>\n<td width=\"35\">46,250\u7f8e\u5143<\/td>\n<\/tr>\n<tr>\n<td width=\"38\">\u5c0f\u7ec4\u8ffd\u8e2aPMA\u8865\u5145\u7533\u8bf7<\/td>\n<td width=\"8\">\u2461<\/td>\n<td width=\"17\">138,750\u7f8e\u5143<\/td>\n<td width=\"35\">34,688\u7f8e\u5143<\/td>\n<\/tr>\n<tr>\n<td width=\"38\">180\u5929PMA\u8865\u5145\u7533\u8bf7<\/td>\n<td width=\"8\">\u2462<\/td>\n<td width=\"17\">27,750\u7f8e\u5143<\/td>\n<td width=\"35\">6,938\u7f8e\u5143<\/td>\n<\/tr>\n<tr>\n<td width=\"38\">\u5b9e\u65f6PMA\u8865\u5145\u7533\u8bf7<\/td>\n<td width=\"8\">\u2463<\/td>\n<td width=\"17\">12,950\u7f8e\u5143<\/td>\n<td width=\"35\">3,237\u7f8e\u5143<\/td>\n<\/tr>\n<tr>\n<td width=\"38\">\u4e0a\u5e02\u524d\u901a\u544a\uff08510K\uff09\u7533\u8bf7<\/td>\n<td width=\"8\"><\/td>\n<td width=\"17\">3,404\u7f8e\u5143<\/td>\n<td 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