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FDA\uff08\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff09\u4f5c\u4e3a\u5168\u7403\u6700\u5177\u6743\u5a01\u7684\u76d1\u7ba1\u673a\u6784\u4e4b\u4e00\uff0c\u5176\u8ba4\u8bc1\u8fc7\u7a0b\u4e25\u683c\u800c\u590d\u6742\uff0c\u6d89\u53ca\u4ea7\u54c1\u5206\u7c7b\u3001\u6d4b\u8bd5\u3001\u7533\u8bf7\u63d0\u4ea4\u548c\u5ba1\u6838\u7b49\u591a\u4e2a\u73af\u8282\u3002<\/p>\n<\/p>\n

\u672c\u6587\u5c06\u6df1\u5165\u63a2\u8ba8\u533b\u7597\u5668\u68b0FDA\u8ba4\u8bc1\u7684\u5168\u8fc7\u7a0b\uff0c\u5305\u62ec\u5176\u91cd\u8981\u6027\u3001\u5206\u7c7b\u7cfb\u7edf\u3001\u7533\u8bf7\u6b65\u9aa4\u4ee5\u53ca\u5e38\u89c1\u6311\u6218\uff0c\u65e8\u5728\u4e3a\u76f8\u5173\u4f01\u4e1a\u63d0\u4f9b\u5b9e\u7528\u6307\u5357\u3002<\/p>\n<\/p>\n

\u533b\u7597\u5668\u68b0FDA\u8ba4\u8bc1\u6982\u8ff0<\/strong><\/p>\n

\u533b\u7597\u5668\u68b0FDA\u8ba4\u8bc1\u662f\u6307\u4ea7\u54c1\u901a\u8fc7FDA\u7684\u5ba1\u6838\uff0c\u83b7\u5f97\u5728\u7f8e\u56fd\u5e02\u573a\u9500\u552e\u548c\u4f7f\u7528\u7684\u8bb8\u53ef\u3002<\/p>\n<\/p>\n

\u8fd9\u4e00\u8fc7\u7a0b\u57fa\u4e8e\u7f8e\u56fd\u300a\u8054\u90a6\u98df\u54c1\u3001\u836f\u54c1\u548c\u5316\u5986\u54c1\u6cd5\u6848\u300b\u7684\u89c4\u5b9a\uff0c\u65e8\u5728\u786e\u4fdd\u533b\u7597\u5668\u68b0\u5bf9\u516c\u4f17\u5065\u5eb7\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002<\/p>\n<\/p>\n

\u6839\u636e\u98ce\u9669\u7b49\u7ea7\uff0cFDA\u5c06\u533b\u7597\u5668\u68b0\u5206\u4e3a\u4e09\u7c7b\uff1aClass I\uff08\u4f4e\u98ce\u9669\uff09\u3001Class II\uff08\u4e2d\u7b49\u98ce\u9669\uff09\u548cClass III\uff08\u9ad8\u98ce\u9669\uff09\uff0c\u6bcf\u7c7b\u4ea7\u54c1\u5bf9\u5e94\u4e0d\u540c\u7684\u8ba4\u8bc1\u8def\u5f84\u548c\u8981\u6c42\u3002<\/p>\n<\/p>\n

\u4f8b\u5982\uff0cClass I\u4ea7\u54c1\u53ef\u80fd\u53ea\u9700\u8fdb\u884c\u4e00\u822c\u63a7\u5236\uff0c\u5982\u6ce8\u518c\u548c\u5217\u540d\uff0c\u800cClass III\u4ea7\u54c1\u5219\u9700\u7ecf\u8fc7\u4e25\u683c\u7684Premarket Approval\uff08PMA\uff09\u6d41\u7a0b\u3002<\/p>\n<\/p>\n

\u533b\u7597\u5668\u68b0FDA\u8ba4\u8bc1\u7684\u91cd\u8981\u6027<\/strong><\/p>\n

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\u5728\u7f8e\u56fd\uff0c\u672a\u7ecfFDA\u8ba4\u8bc1\u7684\u533b\u7597\u5668\u68b0\u4e0d\u5f97\u4e0a\u5e02\u9500\u552e\uff0c\u5426\u5219\u53ef\u80fd\u5bfc\u81f4\u6cd5\u5f8b\u5904\u7f5a\u3001\u4ea7\u54c1\u53ec\u56de\u6216\u5e02\u573a\u7981\u5165\u3002<\/p>\n<\/p>\n

\u6b64\u5916\uff0cFDA\u8ba4\u8bc1\u88ab\u89c6\u4e3a\u5168\u7403\u9ec4\u91d1\u6807\u51c6\uff0c\u8bb8\u591a\u5176\u4ed6\u56fd\u5bb6\u5728\u5ba1\u6279\u533b\u7597\u5668\u68b0\u65f6\u4f1a\u53c2\u8003FDA\u7684\u51b3\u7b56\uff0c\u4ece\u800c\u7b80\u5316\u4e86\u8fdb\u5165\u5176\u4ed6\u5e02\u573a\u7684\u6d41\u7a0b\u3002<\/p>\n<\/p>\n

\u5bf9\u4e8e\u60a3\u8005\u548c\u533b\u7597\u4ece\u4e1a\u8005\u6765\u8bf4\uff0cFDA\u8ba4\u8bc1\u610f\u5473\u7740\u4ea7\u54c1\u7ecf\u8fc7\u79d1\u5b66\u8bc4\u4f30\uff0c\u53ef\u9760\u6027\u548c\u5b89\u5168\u6027\u6709\u4fdd\u969c\u3002<\/p>\n<\/p>\n

\u533b\u7597\u5668\u68b0FDA\u8ba4\u8bc1\u7684\u5206\u7c7b\u7cfb\u7edf<\/strong><\/p>\n

FDA\u6839\u636e\u98ce\u9669\u6c34\u5e73\u5c06\u533b\u7597\u5668\u68b0\u5206\u4e3a\u4e09\u7c7b\uff0c\u8fd9\u4e00\u5206\u7c7b\u51b3\u5b9a\u4e86\u8ba4\u8bc1\u7684\u5177\u4f53\u8def\u5f84\u3002<\/p>\n<\/p>\n

Class I\u8bbe\u5907\u5305\u62ec\u5982\u533b\u7528\u624b\u5957\u6216\u7ef7\u5e26\u7b49\u4f4e\u98ce\u9669\u4ea7\u54c1\uff0c\u901a\u5e38\u53ea\u9700\u8fdb\u884c\u4e00\u822c\u63a7\u5236\uff0c\u5982\u4f01\u4e1a\u6ce8\u518c\u3001\u4ea7\u54c1\u5217\u540d\u548c\u9075\u5b88\u8d28\u91cf\u4f53\u7cfb\u6cd5\u89c4\uff08QSR\uff09\u3002<\/p>\n<\/p>\n

Class II\u8bbe\u5907\uff0c\u5982\u8840\u7cd6\u4eea\u6216X\u5149\u673a\uff0c\u5c5e\u4e8e\u4e2d\u7b49\u98ce\u9669\uff0c\u9700\u8981\u989d\u5916\u7684\u7279\u6b8a\u63a7\u5236\uff0c\u53ef\u80fd\u5305\u62ec\u6027\u80fd\u6807\u51c6\u3001\u4e0a\u5e02\u540e\u76d1\u6d4b\u6216510(k)\u9884\u5e02\u901a\u77e5\uff0c\u4ee5\u8bc1\u660e\u5176\u4e0e\u5df2\u4e0a\u5e02\u4ea7\u54c1\u7684\u5b9e\u8d28\u7b49\u6548\u6027\u3002<\/p>\n<\/p>\n

Class III\u8bbe\u5907\uff0c\u5982\u5fc3\u810f\u8d77\u640f\u5668\u6216\u690d\u5165\u5f0f\u5668\u68b0\uff0c\u662f\u9ad8\u98ce\u9669\u4ea7\u54c1\uff0c\u5fc5\u987b\u901a\u8fc7PMA\u7533\u8bf7\uff0c\u63d0\u4ea4\u5168\u9762\u7684\u79d1\u5b66\u8bc1\u636e\uff0c\u5305\u62ec\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\uff0c\u4ee5\u8bc1\u660e\u5176\u5b89\u5168\u6709\u6548\u3002<\/p>\n<\/p>\n

\u533b\u7597\u5668\u68b0FDA\u8ba4\u8bc1\u7684\u7533\u8bf7\u6b65\u9aa4<\/strong><\/p>\n

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\u5176\u6b21\uff0c\u6839\u636e\u5206\u7c7b\u9009\u62e9\u9002\u5f53\u7684\u7533\u8bf7\u8def\u5f84\uff0c\u4f8b\u5982510(k)\u3001PMA\u6216De Novo\u5206\u7c7b\u8bf7\u6c42\u3002<\/p>\n<\/p>\n

\u5bf9\u4e8e510(k)\u7533\u8bf7\uff0c\u5236\u9020\u5546\u9700\u63d0\u4ea4\u6587\u4ef6\u8bc1\u660e\u65b0\u4ea7\u54c1\u4e0e\u5df2\u4e0a\u5e02\u7684predicate device\u5b9e\u8d28\u7b49\u6548\uff0c\u5305\u62ec\u6280\u672f\u89c4\u683c\u3001\u6d4b\u8bd5\u6570\u636e\u548c\u6807\u7b7e\u4fe1\u606f\u3002<\/p>\n<\/p>\n

PMA\u7533\u8bf7\u5219\u66f4\u4e3a\u590d\u6742\uff0c\u8981\u6c42\u63d0\u4ea4\u4e34\u5e8a\u8bd5\u9a8c\u7ed3\u679c\u3001\u5236\u9020\u7ec6\u8282\u548c\u98ce\u9669\u5206\u6790\uff0c\u5ba1\u6838\u65f6\u95f4\u53ef\u80fd\u957f\u8fbe\u6570\u6708\u751a\u81f3\u6570\u5e74\u3002<\/p>\n<\/p>\n

\u5728\u6574\u4e2a\u8fc7\u7a0b\u4e2d\uff0c\u4f01\u4e1a\u5fc5\u987b\u5efa\u7acb\u5e76\u7ef4\u62a4\u8d28\u91cf\u4f53\u7cfb\uff0c\u7b26\u5408FDA\u768421 CFR Part 820\u6cd5\u89c4\uff0c\u4ee5\u786e\u4fdd\u4ea7\u54c1\u4ece\u8bbe\u8ba1\u5230\u751f\u4ea7\u7684\u5168\u7a0b\u63a7\u5236\u3002<\/p>\n<\/p>\n

\u5e38\u89c1\u6311\u6218\u4e0e\u5e94\u5bf9\u7b56\u7565<\/strong><\/p>\n

\u533b\u7597\u5668\u68b0FDA\u8ba4\u8bc1\u8fc7\u7a0b\u4e2d\uff0c\u4f01\u4e1a\u5e38\u9762\u4e34\u6311\u6218\uff0c\u5982\u5206\u7c7b\u4e0d\u660e\u786e\u3001\u6d4b\u8bd5\u6570\u636e\u4e0d\u8db3\u6216\u5ba1\u6838\u5ef6\u8fdf\u3002<\/p>\n<\/p>\n

\u4f8b\u5982\uff0c\u65b0\u5174\u6280\u672f\u5982AI\u9a71\u52a8\u7684\u8bbe\u5907\u53ef\u80fd\u96be\u4ee5\u627e\u5230predicate device\uff0c\u5bfc\u81f4510(k)\u8def\u5f84\u53d7\u963b\uff0c\u8fd9\u65f6\u53ef\u8003\u8651De Novo\u7533\u8bf7\uff0c\u4e13\u95e8\u7528\u4e8e\u65b0\u578b\u4f4e\u81f3\u4e2d\u7b49\u98ce\u9669\u8bbe\u5907\u3002<\/p>\n<\/p>\n

\u6b64\u5916\uff0c\u6587\u5316\u5dee\u5f02\u548c\u8bed\u8a00\u969c\u788d\u53ef\u80fd\u5f71\u54cd\u4e0eFDA\u7684\u6c9f\u901a\uff0c\u5efa\u8bae\u8058\u8bf7\u4e13\u4e1a\u987e\u95ee\u6216\u6cd5\u5f8b\u56e2\u961f\u534f\u52a9\u3002<\/p>\n<\/p>\n

\u4e3a\u4e86\u7f29\u77ed\u65f6\u95f4\uff0c\u4f01\u4e1a\u5e94\u63d0\u524d\u89c4\u5212\uff0c\u8fdb\u884c\u5145\u5206\u7684\u9884\u6d4b\u8bd5\u548c\u6587\u6863\u51c6\u5907\uff0c\u5e76\u5229\u7528FDA\u7684Pre-Submission\u7a0b\u5e8f\u83b7\u53d6\u53cd\u9988\u3002<\/p>\n<\/p>\n

\u4e0a\u5e02\u540e\u76d1\u6d4b\u4e5f\u662f\u5173\u952e\uff0cFDA\u8981\u6c42\u62a5\u544a\u4e0d\u826f\u4e8b\u4ef6\u548c\u8fdb\u884c\u5b9a\u671f\u5ba1\u6838\uff0c\u4ee5\u7ef4\u6301\u8ba4\u8bc1\u72b6\u6001\u3002<\/p>\n<\/p>\n

\u7ed3\u8bba<\/strong><\/p>\n

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\u901a\u8fc7\u9075\u5faa\u6b63\u786e\u7684\u8def\u5f84\u5e76\u5e94\u5bf9\u6f5c\u5728\u6311\u6218\uff0c\u4f01\u4e1a\u53ef\u4ee5\u6210\u529f\u83b7\u5f97\u8ba4\u8bc1\uff0c\u62d3\u5c55\u7f8e\u56fd\u5e02\u573a\u3002<\/p>\n<\/p>\n

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