{"id":3673,"date":"2021-09-09T23:37:01","date_gmt":"2021-09-09T23:37:01","guid":{"rendered":"http:\/\/deepfda.com\/?page_id=3673"},"modified":"2024-10-19T20:09:29","modified_gmt":"2024-10-19T20:09:29","slug":"%e7%be%8e%e5%9b%bdfda-de-novo%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0","status":"publish","type":"page","link":"https:\/\/deepfda.com\/us\/%e7%be%8e%e5%9b%bdfda-de-novo%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0\/","title":{"rendered":"FDA De Novo Medical Devices"},"content":{"rendered":"

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\u533b\u7597\u5668\u68b0<\/span>\u7f8e\u56fdFDA DE-NOVO\u533b\u7597\u5668\u68b0<\/span><\/span><\/h3>
DE-NOVO\u533b\u7597\u5668\u68b0<\/div><\/header>
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De Novo \u00a0\u662f\u4e00\u79cd\u5bf9\u65b0\u578b\u533b\u7597\u5668\u68b0\u8fdb\u884c\u5206\u7c7b\u7684\u9014\u5f84\uff0c\u8fd9\u4e9b\u533b\u7597\u5668\u68b0\u4ec5\u901a\u8fc7\u4e00\u822c\u63a7\u5236\u6216\u4e00\u822c\u548c\u7279\u6b8a\u63a7\u5236\u5c31\u53ef\u4ee5\u4e3a\u9884\u671f\u7528\u9014\u63d0\u4f9b\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u5408\u7406\u4fdd\u8bc1\uff0c\u4f46\u5e02\u573a\u4e0a\u53c8\u6ca1\u6709\u5176\u4ed6\u4e4b\u524d\u5408\u6cd5\u9500\u552e\u7684\u8bbe\u5907\u3002 \u6545\u6b64\uff0c\u4eceDe Novo\u5206\u7c7b\u662f\u4e00\u79cd\u57fa\u4e8e\u98ce\u9669\u7684\u5206\u7c7b\u8fc7\u7a0b\u3002<\/p>\n

\u901a\u8fc7 De Novo \u5206\u7c7b\u8bf7\u6c42,\u5f52\u7c7b\u4e3a I \u7c7b\u6216 II \u7c7b\u7684\u5668\u68b0\u53ef\u4ee5\u4e0a\u5e02\u9500\u552e\u5e76\u7528\u4f5c\u672a\u6765\u4e0a\u5e02\u524d\u901a\u77e5 [510(k)] \u63d0\u4ea4\u7684\u521d\u59cb\u53c2\u7167\u3002<\/p>\n

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\u533b\u7597\u5668\u68b0<\/span>\u5411\u7f8e\u56fdFDA \u63d0\u4ea4 De Novo \u7533\u8bf7<\/span><\/span><\/h3>
\u5411\u7f8e\u56fdFDA \u63d0\u4ea4 De Novo \u7533\u8bf7\uff0c\u4ee5\u5bf9\u5176\u8bbe\u5907\u5206\u7c7b\u4e3a I \u7c7b\u6216 II \u7c7b\u8fdb\u884c\u57fa\u4e8e\u98ce\u9669\u7684\u8bc4\u4f30\u3002<\/div><\/header>
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\u9009\u9879 1\uff1a\u5728\u6536\u5230\u5bf9 510(k) \u63d0\u4ea4\u7684\u9ad8\u7ea7\u522b\u975e\u5b9e\u8d28\u7b49\u6548 (NSE) \u786e\u5b9a\u540e\u3002<\/p>\n

\u9009\u9879 2\uff1a\u7531\u7533\u8bf7\u8005\u6765\u51b3\u5b9a\uff0c\u5f53\u5e02\u573a\u4e0a\u6ca1\u6709\u5408\u6cd5\u9500\u552e\u7b49\u540c\u7684\u5176\u4ed6\u8bbe\u5907\u53ef\u4f5c\u4e3a\u786e\u5b9a\u5b9e\u8d28\u7b49\u6548\u6027\u7684\u4f9d\u636e\u65f6\u3002<\/p>\n

\u5728\u5411 FDA \u63d0\u4ea4 De Novo \u7533\u8bf7\u4e4b\u524d\uff0c\u534f\u52a9\u60a8\u63d0\u4ea4\u6216\u9884\u63d0\u4ea4\u76f8\u5e94\u6587\u4ef6\u9001\u8fbe\u5230\u4e0a\u5e02\u524d\u5ba1\u67e5\u90e8\u95e8\u5e76\u83b7\u5f97\u53cd\u9988\u3002<\/p>\n

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\u6570\u636e\u6574\u7406\u5206\u6790<\/span>\u533b\u7597\u5668\u68b0\u7533\u8bf7\u6240\u9700\u7684\u6d4b\u8bd5\u6570\u636e<\/span><\/span><\/h3><\/header>
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\u534f\u540c\u5168\u7403\u5408\u4f5c\u4f19\u4f34\u63d0\u4f9b\u5177\u6709\u5305\u62ecISO, GLP,FDA\u89c4\u8303\u7684\u6280\u672f\u6587\u4ef6\uff0c\u7528\u4ee5\u63d0\u4ea4\u533b\u7597\u5668\u68b0\u7533\u8bf7\u6240\u9700\u7684\u6d4b\u8bd5\u6570\u636e\uff0c\u5e76\u5229\u7528\u5df2\u77e5\u6570\u636e\u4e3a\u76d1\u7ba1\u673a\u6784\u67b6\u6784\u5b8c\u6574\u7684\u6570\u636e\u94fe\uff0c\u8ba9\u533b\u7597\u5668\u68b0\u6570\u636e\u6e05\u6670\uff0c\u53ef\u63a7\u63d0\u4ea4\u4e0e\u76d1\u7ba1\u673a\u6784<\/p>\n

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\u533b\u7597\u5668\u68b0<\/span>FDA\u5bf9De Novo\u5b9e\u8d28\u6027\u5ba1\u67e5<\/span><\/span><\/h3>
FDA\u533b\u7597\u5668\u68b0\u4ea4\u6362\u5f0f\u95ee\u7b54\u5ba1\u67e5<\/div><\/header>
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FDA \u5bf9\u5408\u6cd5\u4e0a\u5e02\u7684\u5668\u68b0\u7c7b\u578b\u8fdb\u884c\u5206\u7c7b\u5ba1\u67e5\uff0c\u5206\u6790\u662f\u5426\u5b58\u5728\u73b0\u6709\u7684\u5408\u6cd5\u4e0a\u5e02\u7684\u540c\u7c7b\u5668\u68b0\u3002 \u6b64\u4fe1\u606f\u7528\u4e8e\u786e\u8ba4\u60a8\u7684\u8bbe\u5907\u7b26\u5408 De Novo \u5206\u7c7b\u7684\u6761\u4ef6\u3002<\/p>\n

\u5206\u7c7b\u5ba1\u67e5\u5b8c\u6210\u540e\uff0cFDA \u5c06\u5f00\u59cb\u5bf9 De Novo \u8bf7\u6c42\u8fdb\u884c\u5b9e\u8d28\u6027\u5ba1\u67e5\u3002 \u5728\u5bf9 De Novo \u8bf7\u6c42\u8fdb\u884c\u5b9e\u8d28\u6027\u5ba1\u67e5\u671f\u95f4\uff0c\u9996\u5e2d\u5ba1\u67e5\u5458\u53ef\u4ee5\u901a\u8fc7\u4ea4\u4e92\u5f0f\u5ba1\u67e5\u5145\u5206\u89e3\u51b3\u7684\u7f3a\u9677\uff0c\u800c\u4e0d\u9700\u8981\u6b63\u5f0f\u8bf7\u6c42\u63d0\u4f9b\u989d\u5916\u4fe1\u606f\u3002<\/p>\n

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\u63d0\u4f9b\u4f53\u5916\uff0c\u4f53\u5185\u4ee5\u53ca\u9632\u62a4\u578b\u533b\u7597\u5668\u68b0\u7684FDA\u5168\u7a0b\u7533\u8bf7\u670d\u52a1<\/span><\/span><\/h1><\/header>
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\u8054\u7edc\u6211\u4eec\u533b\u7597\u5668\u68b0\u56e2\u961f<\/span><\/span><\/a><\/div>
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