{"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%96%97%e5%99%a8%e6%a2%b0%e6%8f%90%e4%ba%a4%e9%80%94%e5%be%84","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/medical-device-submission-pathways\/","title":{"rendered":"\u533b\u7597\u5668\u68b0\u63d0\u4ea4\u9014\u5f84\u7ec8\u6781\u6307\u5357\u2026"},"content":{"rendered":"<p>\u533b\u7597\u5668\u68b0\u9886\u57df\u4e0d\u65ad\u53d1\u5c55\uff0c\u9700\u8981\u5f3a\u6709\u529b\u7684\u76d1\u7ba1\u9014\u5f84\u6765\u6279\u51c6\u8fd9\u4e9b\u521b\u65b0\u89e3\u51b3\u65b9\u6848\u3002\u5bf9\u4e8e\u533b\u7597\u5668\u68b0\u884c\u4e1a\u7684\u76d1\u7ba1\u4e8b\u52a1\u4e13\u4e1a\u4eba\u5458\u6765\u8bf4\uff0c\u8fd9\u4e00\u70b9\u5c24\u5176\u91cd\u8981\u3002\u6d4f\u89c8\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40 (FDA) \u6cd5\u89c4\u4ee5\u83b7\u5f97\u5668\u68b0\u8bb8\u53ef\u6216\u6279\u51c6\u662f\u4e00\u4e2a\u590d\u6742\u4f46\u81f3\u5173\u91cd\u8981\u7684\u8fc7\u7a0b\u3002\u5728\u8fd9\u7bc7\u6587\u7ae0\u4e2d\uff0c\u6211\u4eec\u5c06\u63d0\u4f9b\u5168\u9762\u7684\u63d0\u4ea4\u9014\u5f84\u6982\u8ff0\uff0c\u5305\u62ec\u89e3\u91ca\u4e3a\u4ec0\u4e48\u4e86\u89e3\u8fd9\u4e9b\u9014\u5f84\u81f3\u5173\u91cd\u8981\u3001510(k)\u3001De Novo \u548c\u4e0a\u5e02\u524d\u6279\u51c6 (PMA) \u9014\u5f84\u7684\u4ecb\u7ecd\uff0c\u4ee5\u53ca\u63d0\u4ea4\u652f\u6301\u7684\u63d0\u793a\u3002<\/p>\n<p><em>\u514d\u8d23\u58f0\u660e\uff1a\u5c3d\u7ba1\u67d0\u4e9b I \u7c7b\u548c II \u7c7b\u5668\u68b0\u4e0d\u9700\u8981 FDA \u6279\u51c6\uff0c\u5e76\u4e14\u53ef\u4ee5\u901a\u8fc7\u6b63\u786e\u7684\u5f00\u53d1\u6d41\u7a0b\u548c\u5f3a\u5927\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb (QMS) \u63a8\u5411\u5e02\u573a\uff0c\u4f46\u8bf7\u52a1\u5fc5\u8bb0\u4f4f\uff0c\u968f\u7740\u5668\u68b0\u7b49\u7ea7\u4ece I \u7c7b\u5347\u81f3 III \u7c7b\uff0c\u76d1\u7ba1\u63a7\u5236\u4e5f\u4f1a\u52a0\u5f3a\u3002\u8bf7\u52a1\u5fc5\u67e5\u9605 FDA \u6307\u5357\uff0c\u4e86\u89e3\u4efb\u4f55\u4f8b\u5916\u60c5\u51b5\u5e76\u786e\u4fdd\u5408\u89c4\u3002 <\/em><\/p>\n<h2>\u4e86\u89e3\u533b\u7597\u5668\u68b0\u63d0\u4ea4\u9014\u5f84\uff08\u53ca\u5176\u91cd\u8981\u6027\uff09<\/h2>\n<p>\u63d0\u4ea4\u9014\u5f84\u662f FDA \u4e3a\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u5236\u5b9a\u7684\u76d1\u7ba1\u6d41\u7a0b\uff0c\u4ee5\u786e\u4fdd\u8fd9\u4e9b\u5668\u68b0\u5728\u4e0a\u5e02\u524d\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002\u4e86\u89e3\u8fd9\u4e9b\u9014\u5f84\u81f3\u5173\u91cd\u8981\uff0c\u56e0\u4e3a\u5b83\u63d0\u4f9b\u4e86\u4ece\u5f00\u53d1\u5230\u4e0a\u5e02\u7684\u5e73\u7a33\u8fc7\u6e21\uff0c\u4f7f\u60a3\u8005\u80fd\u591f\u66f4\u5feb\u5730\u4f7f\u7528\u8fd9\u4e9b\u5668\u68b0\u3002<\/p>\n<p>\u4e3a\u4e86\u6210\u529f\u9a7e\u9a6d\u63d0\u4ea4\u9014\u5f84\uff0c\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u5fc5\u987b\u9996\u5148\u786e\u5b9a\u54ea\u79cd\u9014\u5f84\u6700\u9002\u5408\u5176\u4ea7\u54c1\u3002\u7136\u540e\uff0c\u4ed6\u4eec\u9700\u8981\u7f16\u5236\u4e00\u4efd\u7b26\u5408\u8be5\u7279\u5b9a\u9014\u5f84\u6807\u51c6\u7684\u8be6\u7ec6\u63d0\u4ea4\u6587\u4ef6\u3002FDA \u63d0\u4f9b\u4e86\u5168\u9762\u7684\u6307\u5bfc\u6587\u4ef6\u3001\u9a8c\u6536\u6e05\u5355\u548c\u6d41\u7a0b\u56fe\u6765\u534f\u52a9\u8fd9\u4e00\u8fc7\u7a0b\u3002\u6bcf\u79cd\u9014\u5f84\u90fd\u6709\u72ec\u7279\u7684\u8981\u6c42\uff0c\u8fd9\u4e9b\u8981\u6c42\u53d6\u51b3\u4e8e\u591a\u79cd\u56e0\u7d20\uff0c\u4f8b\u5982\u5668\u68b0\u7684\u98ce\u9669\u5206\u7c7b\u53ca\u5176\u4e0e\u73b0\u6709\u5408\u6cd5\u9500\u552e\u5668\u68b0\u7684\u76f8\u4f3c\u6027\u6216\u4e0d\u76f8\u4f3c\u6027\u3002\u4ee5\u4e0b\u662f\u6bcf\u79cd\u9014\u5f84\u7684\u7b80\u8981\u56de\u987e\uff1a<\/p>\n<h2>1. 510\uff08k\uff09\u9014\u5f84<\/h2>\n<p>510(k) \u9014\u5f84\u4ee5\u300a\u8054\u90a6\u98df\u54c1\u3001\u836f\u54c1\u548c\u5316\u5986\u54c1\u6cd5\u300b\u7b2c 510(k) \u6761\u547d\u540d\u3002\u5b83\u8981\u6c42\u5236\u9020\u5546\u63d0\u4ea4\u4e0a\u5e02\u524d\u901a\u77e5\uff0c\u8bc1\u660e\u8be5\u8bbe\u5907\u4e0e\u5408\u6cd5\u4e0a\u5e02\u7684\u8bbe\u5907\uff08\u8c13\u8bcd\u8bbe\u5907\uff09\u57fa\u672c\u7b49\u540c\u3002\u76ee\u7684\u662f\u8868\u660e\u65b0\u8bbe\u5907\u5177\u6709\u76f8\u4f3c\u7684\u6280\u672f\u7279\u6027\uff0c\u5e76\u6253\u7b97\u7528\u4f5c\u8c13\u8bcd\u8bbe\u5907\u3002<\/p>\n<p>\u4e3a\u4e86\u901a\u8fc7\u8fd9\u79cd\u9014\u5f84\u83b7\u5f97\u6279\u51c6\uff0c\u5236\u9020\u5546\u5fc5\u987b\u51c6\u5907\u4e00\u4efd\u5168\u9762\u7684\u63d0\u4ea4\u6587\u4ef6\uff0c\u5176\u4e2d\u5305\u62ec\u6709\u5173\u65b0\u8bbe\u5907\u7684\u9884\u671f\u7528\u9014\u3001\u8bbe\u8ba1\u7279\u70b9\u3001\u5fc5\u8981\u65f6\u7684\u6d4b\u8bd5\u6216\u4e34\u5e8a\u7814\u7a76\u7684\u6027\u80fd\u6570\u636e\u3001\u6807\u7b7e\u8be6\u7ec6\u4fe1\u606f\u7b49\u4fe1\u606f\u3002FDA \u4f1a\u5ba1\u67e5\u6b64\u63d0\u4ea4\u6587\u4ef6\u4ee5\u786e\u5b9a\u65b0\u8bbe\u5907\u4e0e\u5176\u8c13\u8bcd\u4e4b\u95f4\u662f\u5426\u5b58\u5728\u5b9e\u8d28\u7b49\u540c\u6027\u3002<\/p>\n<h3>\u8c01\u6709\u8d44\u683c\u4eab\u53d7 510(k) \u9014\u5f84\uff1f<\/h3>\n<p>510(k) \u9014\u5f84\u9002\u7528\u4e8e\u62e5\u6709\u672a\u88ab\u5f52\u7c7b\u4e3a\u9ad8\u98ce\u9669\u4e14\u5177\u6709\u5408\u6cd5\u4e0a\u5e02\u6761\u4ef6\u7684\u533b\u7597\u5668\u68b0\u7684\u5236\u9020\u5546\u3002\u8be5\u5668\u68b0\u4e0d\u4ec5\u5fc5\u987b\u4e0e\u4e0a\u5e02\u6761\u4ef6\u5177\u6709\u76f8\u4f3c\u7684\u6280\u672f\u7279\u6027\uff0c\u800c\u4e14\u5177\u6709\u76f8\u540c\u7684\u9884\u671f\u7528\u9014\u3002\u8be5\u9014\u5f84\u6700\u5e38\u7528\u4e8e II \u7c7b\u5668\u68b0\uff0c\u5c3d\u7ba1\u4e00\u4e9b I \u7c7b\u548c III \u7c7b\u5668\u68b0\u4e5f\u53ef\u80fd\u7b26\u5408\u6761\u4ef6\u3002<\/p>\n<h2>2. \u4ece\u5934\u9014\u5f84\uff08513(f)(2) \u8282\uff09<\/h2>\n<p>De Novo \u9014\u5f84\u4e3a\u6ca1\u6709\u5408\u6cd5\u4e0a\u5e02\u524d\u63d0\u7684\u65b0\u578b\u533b\u7597\u5668\u68b0\u63d0\u4f9b\u4e86\u53e6\u4e00\u79cd\u9014\u5f84\uff0c\u53ef\u4ee5\u8bc1\u660e\u5b9e\u8d28\u7b49\u6548\u6027\u3002\u901a\u8fc7\u6b64\u9014\u5f84\uff0c\u5236\u9020\u5546\u53ef\u4ee5\u6839\u636e\u5176\u98ce\u9669\u72b6\u51b5\u8981\u6c42\u5c06\u5176\u5668\u68b0\u5f52\u7c7b\u4e3a I \u7c7b\u3001II \u7c7b\u6216 III \u7c7b\u3002<\/p>\n<p>\u5236\u9020\u5546\u63d0\u4ea4 De Novo \u7533\u8bf7\uff0c\u5176\u4e2d\u5305\u542b\u6709\u5173\u5176\u8bbe\u5907\u7684\u9884\u671f\u7528\u9014\u3001\u6280\u672f\u7279\u6027\u3001\u975e\u4e34\u5e8a\u8bd5\u9a8c\u6216\u4e34\u5e8a\u7814\u7a76\uff08\u5982\u679c\u9002\u7528\uff09\u7684\u5b89\u5168\u6570\u636e\u4ee5\u53ca\u6807\u7b7e\u4fe1\u606f\uff08\u5305\u62ec\u4f7f\u7528\u6307\u5f81\u548c\u7981\u5fcc\u75c7\uff08\u5982\u679c\u6709\uff09\uff09\u7684\u8be6\u7ec6\u4fe1\u606f\u3002\u5728 FDA \u5de5\u7a0b\u6216\u533b\u5b66\u7b49\u76f8\u5173\u9886\u57df\u7684\u4e13\u5bb6\u5ba1\u67e5\u8bbe\u5907\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u65b9\u9762\u540e\uff0cFDA \u5c06\u51b3\u5b9a\u662f\u5426\u6388\u4e88 De Novo \u5206\u7c7b\uff0c\u4ece\u800c\u4e3a\u8bbe\u5907\u5efa\u7acb\u65b0\u7684\u76d1\u7ba1\u5206\u7c7b\u3002<\/p>\n<h3>\u8c01\u6709\u8d44\u683c\u83b7\u5f97 De Novo \u9014\u5f84\uff1f<\/h3>\n<p>De Novo \u9014\u5f84\u662f\u4e13\u95e8\u4e3a\u65b0\u578b\u4e14\u76ee\u524d\u6ca1\u6709\u5408\u6cd5\u4e0a\u5e02\u6761\u4ef6\u7684\u5668\u68b0\u91cf\u8eab\u5b9a\u5236\u7684\u3002\u8fd9\u4e9b\u5668\u68b0\u901a\u5e38\u662f\u4f4e\u98ce\u9669\u81f3\u4e2d\u7b49\u98ce\u9669\u7684\u5668\u68b0\uff0c\u7531\u4e8e\u7f3a\u4e4f\u6761\u4ef6\u6700\u521d\u88ab\u5f52\u7c7b\u4e3a III \u7c7b\uff08\u9ad8\u98ce\u9669\uff09\uff0c\u4f46\u4e0d\u7b26\u5408 III \u7c7b\u7684\u5b9a\u4e49\u3002\u901a\u8fc7 De Novo \u9014\u5f84\uff0c\u5728\u5bf9\u5668\u68b0\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u8fdb\u884c\u57fa\u4e8e\u98ce\u9669\u7684\u8bc4\u4f30\u540e\uff0c\u8fd9\u4e9b\u5668\u68b0\u53ef\u4ee5\u91cd\u65b0\u5f52\u7c7b\u4e3a I \u7c7b\u6216 II \u7c7b\u3002\u5efa\u8bae\u5728\u5f00\u53d1\u9636\u6bb5\u4e0e FDA \u8054\u7cfb\u5e76\u5b89\u6392\u9884\u5ba1\u4f1a\u8bae\uff0c\u4ee5\u5c31\u5206\u7c7b\u3001\u4e0a\u5e02\u9014\u5f84\u548c\u4e34\u5e8a\u8ba1\u5212\u8fbe\u6210\u4e00\u81f4\u3002<\/p>\n<h2>3. PMA \u9014\u5f84<\/h2>\n<p>\u4e0a\u5e02\u524d\u6279\u51c6\uff08PMA\uff09\u9014\u5f84\u662f\u533b\u7597\u5668\u68b0\u6700\u4e25\u683c\u7684\u76d1\u7ba1\u9014\u5f84\uff0c\u9002\u7528\u4e8e\u9ad8\u98ce\u9669\u5668\u68b0\u6216\u6ca1\u6709\u5408\u6cd5\u4e0a\u5e02\u7684\u540c\u7c7b\u5668\u68b0\u53ef\u4f9b\u6bd4\u8f83\u7684\u5668\u68b0\u3002<\/p>\n<p>\u4e3a\u4e86\u83b7\u5f97 PMA \u6279\u51c6\uff0c\u5236\u9020\u5546\u5fc5\u987b\u901a\u8fc7\u4e34\u5e8a\u8bd5\u9a8c\u3001\u975e\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u3001\u5236\u9020\u4fe1\u606f\uff08\u5305\u62ec\u8d28\u91cf\u63a7\u5236\u63aa\u65bd\u548c\u8bbe\u65bd\u68c0\u67e5\uff09\u4ee5\u53ca\u6807\u7b7e\u7ec6\u8282\uff08\u5982\u9002\u7528\uff0c\u5982\u4f7f\u7528\u6307\u5f81\u548c\u8b66\u544a\u6216\u7981\u5fcc\u75c7\uff09\u63d0\u4f9b\u5168\u9762\u7684\u79d1\u5b66\u8bc1\u636e\uff0c\u8bc1\u660e\u5176\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002FDA \u4f1a\u8be6\u7ec6\u5ba1\u67e5\u8fd9\u4efd\u8be6\u5c3d\u7684\u7533\u8bf7\uff0c\u5e76\u6839\u636e\u5236\u9020\u5546\u63d0\u4f9b\u7684\u79d1\u5b66\u8bc1\u636e\u8bc4\u4f30\u505a\u51fa\u51b3\u5b9a\u3002\u5982\u679c\u901a\u8fc7\u6b64\u9014\u5f84\u83b7\u5f97\u6279\u51c6\uff0cPMA \u7533\u8bf7\u5c06\u5141\u8bb8\u76f8\u5173\u8bbe\u5907\u4e0a\u5e02\u3002<\/p>\n<h3>\u8c01\u6709\u8d44\u683c\u83b7\u5f97 PMA \u9014\u5f84\uff1f<\/h3>\n<p>PMA \u9014\u5f84\u9002\u7528\u4e8e III \u7c7b\u533b\u7597\u5668\u68b0\uff0c\u8fd9\u4e9b\u5668\u68b0\u901a\u5e38\u662f\u9ad8\u98ce\u9669\u5668\u68b0\u6216\u652f\u6301\u6216\u7ef4\u6301\u4eba\u7c7b\u751f\u547d\u7684\u5668\u68b0\u3002\u8fd9\u4e9b\u5668\u68b0\u6ca1\u6709\u9002\u5408\u7528\u4e8e 510(k) \u63d0\u4ea4\u7684\u6761\u4ef6\uff0c\u5e76\u4e14\u4e0e\u8be5\u5668\u68b0\u76f8\u5173\u7684\u6f5c\u5728\u98ce\u9669\u65e0\u6cd5\u901a\u8fc7\u4e00\u822c\u6216\u7279\u6b8a\u63a7\u5236\u6765\u63a7\u5236\u3002\u4f8b\u5b50\u53ef\u80fd\u5305\u62ec\u5fc3\u810f\u74e3\u819c\u3001\u7845\u80f6\u586b\u5145\u4e73\u623f\u690d\u5165\u7269\u548c\u690d\u5165\u5f0f\u5c0f\u8111\u523a\u6fc0\u5668\u3002\u901a\u8fc7\u6b64\u9014\u5f84\u5bfb\u6c42\u6279\u51c6\u7684\u5236\u9020\u5546\u5fc5\u987b\u63d0\u4f9b\u5927\u91cf\u4e34\u5e8a\u8bc1\u636e\u6765\u8bc1\u660e\u8be5\u5668\u68b0\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002<\/p>\n<p><strong>\u4f60\u9700\u8981\u8bb0\u4f4f\u7684\u662f\uff1a<\/strong> \u5bf9\u4e8e 510(k) \u7533\u8bf7\uff0c\u5236\u9020\u5546\u5fc5\u987b\u8bc1\u660e\u5176\u8bbe\u5907\u4e0e\u540c\u7c7b\u8bbe\u5907\u57fa\u672c\u76f8\u540c\u3002\u800c De Novo \u7684\u8981\u6c42\u5219\u6d89\u53ca\u8bc1\u660e\u65b0\u578b\u3001\u4f4e\u98ce\u9669\u81f3\u4e2d\u7b49\u98ce\u9669\u8bbe\u5907\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002\u76f8\u6bd4\u4e4b\u4e0b\uff0cPMA \u9014\u5f84\u8981\u6c42\u5236\u9020\u5546\u901a\u8fc7\u79d1\u5b66\u6570\u636e\u63d0\u4f9b\u8bbe\u5907\u9884\u671f\u7528\u9014\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u5b9e\u8d28\u6027\u8bc1\u636e\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\uff08k\uff09\u9014\u5f84<\/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\">\u4ece\u5934\u9014\u5f84<\/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 \u9014\u5f84<\/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\">\u9002\u7528\u4e8e\u4e0e\u5408\u6cd5\u9500\u552e\u7684\u8bbe\u5907\u57fa\u672c\u7b49\u540c\u7684\u8bbe\u5907\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u9002\u7528\u4e8e\u7f3a\u4e4f\u8c13\u8bcd\u7684\u65b0\u578b\u3001\u4f4e\u98ce\u9669\u81f3\u4e2d\u7b49\u98ce\u9669\u7684\u8bbe\u5907\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u5bf9\u4e8e\u7ef4\u6301\u6216\u652f\u6301\u4eba\u7c7b\u751f\u547d\u7684\u9ad8\u98ce\u9669\u8bbe\u5907\uff0c\u5bf9\u4e8e\u9632\u6b62\u4eba\u7c7b\u5065\u5eb7\u635f\u5bb3\u5177\u6709\u91cd\u8981\u610f\u4e49\uff0c\u6216\u5b58\u5728\u6f5c\u5728\u7684\u4e0d\u5408\u7406\u75be\u75c5\u6216\u4f24\u5bb3\u98ce\u9669\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td data-celllook=\"16\"><b><span data-contrast=\"auto\">\u8d44\u683c<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u6700\u5e38\u89c1\u4e8e II \u7c7b\u8bbe\u5907\uff0c\u4f46\u4e00\u4e9b I \u7c7b\u548c III \u7c7b\u8bbe\u5907\u4e5f\u53ef\u80fd\u7b26\u5408\u6761\u4ef6\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u901a\u5e38\u9002\u7528\u4e8e\u4f4e\u98ce\u9669\u81f3\u4e2d\u7b49\u98ce\u9669\u8bbe\u5907\uff0c\u7531\u4e8e\u7f3a\u4e4f\u8c13\u8bcd\u6700\u521d\u88ab\u5f52\u7c7b\u4e3a III \u7c7b\uff0c\u4f46\u4e0d\u7b26\u5408 III \u7c7b\u7684\u5b9a\u4e49\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">III \u7c7b\u533b\u7597\u5668\u68b0\uff0c\u5373\u9ad8\u98ce\u9669\u533b\u7597\u5668\u68b0\u6216\u652f\u6301\u6216\u7ef4\u6301\u4eba\u7c7b\u751f\u547d\u7684\u533b\u7597\u5668\u68b0\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td data-celllook=\"16\"><b><span data-contrast=\"auto\">\u6295\u7a3f\u8981\u6c42<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u4e0a\u5e02\u524d\u901a\u77e5\uff0c\u5fc5\u987b\u8bc1\u660e\u4e0e\u8c13\u8bcd\u8bbe\u5907\u5b9e\u8d28\u7b49\u540c\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">De Novo \u8bf7\u6c42\uff0c\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u8bc1\u660e\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u4e0a\u5e02\u524d\u6279\u51c6\u7533\u8bf7\uff0c\u6765\u81ea\u4e34\u5e8a\u8bd5\u9a8c\u7684\u5168\u9762\u79d1\u5b66\u8bc1\u636e\u8bc1\u660e\u5176\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td data-celllook=\"16\"><b><span data-contrast=\"auto\">FDA \u8bc4\u4f30<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">FDA \u786e\u5b9a\u65b0\u8bbe\u5907\u4e0e\u5176\u8c13\u8bcd\u4e4b\u95f4\u7684\u5b9e\u8d28\u7b49\u540c\u6027\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">FDA \u4e13\u5bb6\u5ba1\u67e5\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u65b9\u9762\uff0c\u786e\u5b9a\u662f\u5426\u6388\u4e88 De Novo \u5206\u7c7b\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u5e7f\u6cdb\u7684 FDA \u5ba1\u67e5\uff0c\u8bc4\u4f30\u5236\u9020\u5546\u63d0\u4f9b\u7684\u79d1\u5b66\u8bc1\u636e\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td data-celllook=\"16\"><b><span data-contrast=\"auto\">\u4e0a\u5e02\u540e\u76d1\u7763<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u5236\u9020\u5546\u5fc5\u987b\u8ddf\u8e2a\u5e76\u5411 FDA \u62a5\u544a\u67d0\u4e9b\u7c7b\u578b\u7684\u4e0a\u5e02\u540e\u76d1\u6d4b\u6570\u636e\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u5236\u9020\u5546\u53ef\u80fd\u8fd8\u9700\u8981\u8fdb\u884c\u4e0a\u5e02\u540e\u76d1\u6d4b\u7814\u7a76\u4ee5\u6536\u96c6\u989d\u5916\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u6570\u636e\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u5236\u9020\u5546\u901a\u5e38\u9700\u8981\u8fdb\u884c\u6279\u51c6\u540e\u7814\u7a76\u4ee5\u9a8c\u8bc1\u8bbe\u5907\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td data-celllook=\"16\"><b><span data-contrast=\"auto\">\u5927\u4f53\u65f6\u95f4<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u901a\u5e38\u4e3a 90 \u5929\uff0c\u4f46\u53ef\u80fd\u56e0\u7533\u8bf7\u7684\u5b8c\u6574\u6027\u548c FDA \u7684\u67e5\u8be2\u800c\u6709\u6240\u4e0d\u540c\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u4ece\u6536\u5230\u5b8c\u6574\u7684 De Novo \u8bf7\u6c42\u8d77\u5927\u7ea6\u9700\u8981 120 \u5929\uff08\u7ea6 4 \u4e2a\u6708\uff09\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u6839\u636e\u8bbe\u5907\u7684\u590d\u6742\u6027\u548c\u5e94\u7528\u7a0b\u5e8f\u7684\u5b8c\u6574\u6027\uff0c\u8fd9\u53ef\u80fd\u9700\u8981\u516d\u4e2a\u6708\u5230\u4e00\u5e74\u6216\u66f4\u957f\u65f6\u95f4\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td data-celllook=\"16\"><b><span data-contrast=\"auto\">\u6210\u672c<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u9700\u652f\u4ed8\u7528\u6237\u8d39\u7528\uff0c\u901a\u5e38\u4f4e\u4e8e PMA\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u9700\u652f\u4ed8\u7528\u6237\u8d39\u7528\uff0c\u901a\u5e38\u4f4e\u4e8e PMA \u4f46\u9ad8\u4e8e 510(k)\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<td data-celllook=\"0\"><span data-contrast=\"auto\">\u8003\u8651\u5230\u5ba1\u67e5\u7684\u590d\u6742\u6027\u548c\u5f7b\u5e95\u6027\uff0c\u7528\u6237\u8d39\u7528\u6700\u9ad8\u3002<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2>\u5982\u4f55\u5bfc\u822a\u533b\u7597\u5668\u68b0\u7684\u63d0\u4ea4\u8def\u5f84<\/h2>\n<p>\u9075\u5faa\u8fd9\u4e9b\u9014\u5f84\u9700\u8981\u4ed4\u7ec6\u89c4\u5212\u3001\u5168\u9762\u8bb0\u5f55\u548c\u4e25\u683c\u6d4b\u8bd5\u3002\u6bcf\u6761\u9014\u5f84\u90fd\u6709\u72ec\u7279\u7684\u8981\u6c42\u3002\u4f8b\u5982\uff0c510(k) \u9014\u5f84\u9700\u8981\u4e0e\u65e2\u5b9a\u8bbe\u5907\u5b9e\u8d28\u7b49\u6548\u7684\u8bc1\u636e\u3002De Novo \u9014\u5f84\u9700\u8981\u8bc1\u660e\u65b0\u578b\u8bbe\u5907\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\uff0c\u800c PMA \u9014\u5f84\u5219\u9700\u8981\u6765\u81ea\u4e34\u5e8a\u8bd5\u9a8c\u7684\u5927\u91cf\u79d1\u5b66\u8bc1\u636e\u3002<\/p>\n<p>RegASK \u53ef\u63d0\u4f9b\u652f\u6301\uff1a<\/p>\n<ol>\n<li><strong>\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7684\u51c6\u5907\u3001\u7ef4\u62a4\u548c\u5ba1\u6838<\/strong>\uff1a\u5f3a\u5927\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb (QMS) \u5bf9\u4e8e\u533b\u7597\u5668\u68b0\u516c\u53f8\u6765\u8bf4\u81f3\u5173\u91cd\u8981\uff0c\u4ee5\u786e\u4fdd\u5176\u8bbe\u5907\u59cb\u7ec8\u5982\u4e00\u7684\u8d28\u91cf\u3001\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002RegASK \u4f5c\u4e3a\u6218\u7565\u5408\u4f5c\u4f19\u4f34\u4ecb\u5165\uff0c\u5728 QMS \u7684\u51c6\u5907\u548c\u7ef4\u62a4\u65b9\u9762\u63d0\u4f9b\u4e13\u5bb6\u6307\u5bfc\uff0c\u786e\u4fdd\u5176\u7b26\u5408\u6240\u6709\u76d1\u7ba1\u57fa\u51c6\u3002\u6211\u4eec\u7684\u56e2\u961f\u4e86\u89e3\u5ba1\u8ba1\u51c6\u5907\u7684\u91cd\u8981\u6027\uff0c\u534f\u52a9\u516c\u53f8\u786e\u4fdd\u4ed6\u4eec\u59cb\u7ec8\u4e3a\u4efb\u4f55\u76d1\u7ba1\u5ba1\u67e5\u505a\u597d\u51c6\u5907\u3002<\/li>\n<li><strong>\u63d0\u4ea4\u524d<\/strong>\uff1a\u9884\u63d0\u4ea4\u6d41\u7a0b\u5305\u62ec\u5728\u5b9e\u9645\u63d0\u4ea4\u76d1\u7ba1\u6587\u4ef6\u4e4b\u524d\u4e0e FDA \u63a5\u6d3d\u3002\u5b83\u63d0\u4f9b\u4e86\u4e00\u4e2a\u673a\u4f1a\u6765\u83b7\u5f97\u4e0e\u60a8\u7684\u8bbe\u5907\u3001\u4e34\u5e8a\u7814\u7a76\u548c\u5373\u5c06\u8fdb\u884c\u7684\u6b63\u5f0f\u63d0\u4ea4\u76f8\u5173\u7684\u5177\u4f53\u95ee\u9898\u548c\u8981\u7d20\u7684\u53cd\u9988\u3002\u6b64\u6b65\u9aa4\u5c06\u5e2e\u52a9\u60a8\u51b3\u5b9a\u6700\u9002\u5408\u60a8\u8bbe\u5907\u7684\u76d1\u7ba1\u9014\u5f84\uff0c\u65e0\u8bba\u662f 510(k)\u3001De Novo \u8fd8\u662f PMA\u3002RegASK \u53ef\u4ee5\u534f\u52a9\u60a8\u5b8c\u6210\u6b64\u6b65\u9aa4\uff0c\u5e2e\u52a9\u60a8\u6f84\u6e05\u4efb\u4f55\u4e0d\u786e\u5b9a\u6027\u6216\u89e3\u51b3\u6709\u5173\u5373\u5c06\u8fdb\u884c\u7684\u6b63\u5f0f\u63d0\u4ea4\u7684\u4efb\u4f55\u6f5c\u5728\u95ee\u9898\u3002<\/li>\n<li><strong>\u6d41\u7a0b\u56fe\uff1a<\/strong> RegASK 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data-line-height=\"xs\">\u4e0e\u6211\u4eec\u7684\u4e13\u5bb6\u4ea4\u8c08<\/h2>\n<span class=\"scroll-to\" data-label=\"Scroll to: #contact-us\" data-bullet=\"true\" data-link=\"#contact-us\" data-title=\"contact us\"><a name=\"contact-us\"><\/a><\/span>\n\n\t<section class=\"section\" id=\"section_979111098\">\n\t\t<div class=\"section-bg fill\" >\n\t\t\t\t\t\t\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n\n<div class=\"row\"  id=\"row-1695636974\">\n\n\n\t<div id=\"col-108441934\" class=\"col medium-10 small-12 large-10\"  >\n\t\t\t\t<div class=\"col-inner text-center\"  >\n\t\t\t\n\t\t\t\n\n\n\n<script charset=\"utf-8\" type=\"text\/javascript\" src=\"\/\/js.hsforms.net\/forms\/embed\/v2.js\"><\/script>\n<script>\n  hbspt.forms.create({\n    region: \"na1\",\n    portalId: \"20908020\",\n    formId: \"0af2c091-f9d4-497e-812e-14d3abddf395\"\n  });\n<\/script>\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n<\/div>\n\n\t\t<\/div>\n\n\t\t\n<style>\n#section_979111098 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  background-color: rgb(242,246,253);\n}\n<\/style>\n\t<\/section>\n\t\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>The ever-evolving landscape of medical devices requires robust regulatory pathways to approve these innovative solutions. This fact is especially true for regulatory affairs professionals in the medical device industry. Navigating through the United States Food and Drug Administration (FDA) regulations to get clearance or approval for your device is a complex but crucial process. In&#8230;<\/p>","protected":false},"author":39,"featured_media":2204,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,28],"tags":[],"class_list":["post-4493","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-medical-devices-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Guide for Medical Device Submission Pathways | RegASK<\/title>\n<meta name=\"description\" content=\"Navigate the complexities of medical device submissions with RegASK&#039;s ultimate guide to pathways and regulations.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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