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\u4ec0\u4e48\u662f\u4eba\u5de5\u667a\u80fd\u548c\u673a\u5668\u5b66\u4e60\uff1f<\/h3>\n\n\n\n

\u4eba\u5de5\u667a\u80fd\uff1a\u53c8\u79f0\u673a\u5668\u667a\u80fd\uff0c\u6307\u7531\u4eba\u5236\u9020\u51fa\u6765\u7684\u673a\u5668\u6240\u8868\u73b0\u51fa\u6765\u7684\u667a\u80fd\uff0c\u6216\u8005\u8bf4\uff0c<\/a>\u662f\u6307\u7528\u666e\u901a\u8ba1\u7b97\u673a\u7a0b\u5e8f\u6765\u5448\u73b0\u4eba\u7c7b\u667a\u80fd\u7684\u6280\u672f\u3002\u4eba\u5de5\u667a\u80fd\u7cfb\u7edf\u901a\u8fc7\u8ba1\u7b97\u673a\u7a0b\u5e8f\uff0c\u53ef\u4ee5\u6b63\u786e\u89e3\u8bfb\u5916\u90e8\u6570\u636e\u6216\u611f\u77e5\u73af\u5883\uff0c\u8fdb\u884c\u5b66\u4e60\uff0c\u5e76\u5229\u7528\u8fc7\u5f80\u7ecf\u9a8c\u548c\u5185\u7f6e\u7684\u6784\u5efa\u6a21\u578b\u505a\u51fa\u5408\u7406\u51b3\u7b56\uff0c\u4ece\u800c\u8fbe\u6210\u9884\u5b9a\u76ee\u6807\u3002<\/p>\n\n\n\n

\u673a\u5668\u5b66\u4e60\uff1a\u662f\u6307\u673a\u5668\u4ece\u7528\u6237\u548c\u8f93\u5165\u6570\u636e\u7b49\u5904\u83b7\u5f97\u77e5\u8bc6\uff0c\u4ece\u800c\u8ba9\u673a\u5668\u81ea\u52a8\u5730\u53bb\u5224\u65ad\u548c\u8f93\u51fa\u76f8\u5e94\u7684\u7ed3\u679c\u3002\u673a\u5668\u5b66\u4e60\u53ef\u4ee5\u5e2e\u52a9\u89e3\u51b3\u66f4\u591a\u95ee\u9898\u3001\u51cf\u5c11\u9519\u8bef\uff0c\u63d0\u9ad8\u89e3\u51b3\u95ee\u9898\u7684\u6548\u7387\u3002\u5bf9\u4e8e\u4eba\u5de5\u667a\u80fd\u6765\u8bf4\uff0c\u673a\u5668\u5b66\u4e60\u662f\u5176\u5b9e\u73b0\u529f\u80fd\u7684\u57fa\u672c\u8981\u6c42\u3002<\/p>\n\n\n\n

\u4eba\u5de5\u667a\u80fd\u548c\u673a\u5668\u5b66\u4e60\u6280\u672f\u5728\u73b0\u5b9e\u4e2d\u7684\u5e94\u7528\u6848\u4f8b\u5305\u62ec\u76ae\u80a4\u6210\u50cf\u7cfb\u7edf\u53ef\u4ee5\u4f7f\u7528\u7b97\u6cd5\u4e3a\u60a3\u8005\u63d0\u4f9b\u76ae\u80a4\u764c\u7684\u8bca\u65ad\uff0c\u548c\u4eba\u5de5\u667a\u80fd\u4f20\u611f\u5668\u53ef\u4ee5\u9884\u4f30\u5fc3\u810f\u75c5\u53d1\u75c5\u51e0\u7387\u7b49\u3002<\/p>\n\n\n\n

\u4eba\u5de5\u667a\u80fd\u548c\u673a\u5668\u5b66\u4e60 (AI\/ML) \u5982\u4f55\u6539\u53d8\u533b\u7597\u5668\u68b0\uff1f<\/a><\/h3>\n\n\n\n

\u4eba\u5de5\u667a\u80fd\/\u673a\u5668\u5b66\u4e60\u6280\u672f\u80fd\u591f\u4ece\u533b\u7597\u4fdd\u5065\u8fc7\u7a0b\u4e2d\u751f\u6210\u7684\u5927\u91cf\u6570\u636e\u4e2d\u8fdb\u884c\u5b66\u4e60\uff0c\u5e76\u5feb\u901f\u505a\u51fa\u54cd\u5e94\uff0c\u63d0\u51fa\u65b0\u7684\u91cd\u8981\u89c1\u89e3\u3002 \u533b\u7597\u8bbe\u5907\u5236\u9020\u5546\u53ef\u4ee5\u5229\u7528\u8fd9\u4e9b\u6280\u672f\u6765\u521b\u65b0\u4ea7\u54c1\uff0c\u4ee5\u66f4\u597d\u5730\u670d\u52a1\u533b\u7597\u9886\u57df\uff0c\u6539\u5584\u60a3\u8005\u62a4\u7406\u3002<\/p>\n\n\n\n

FDA \u5982\u4f55\u8003\u8651\u5bf9\u5e26\u6709\u4eba\u5de5\u667a\u80fd\u548c\u673a\u5668\u5b66\u4e60\u529f\u80fd\u7684\u533b\u7597\u5668\u68b0\u7684\u76d1\u7ba1\uff1f<\/h3>\n\n\n\n

\u4eba\u5de5\u667a\u80fd\u548c\u673a\u5668\u5b66\u4e60\u7684\u53d1\u5c55\u53ca\u5176\u5728\u533b\u7597\u5668\u68b0\u9886\u57df\u7684\u5e94\u7528\uff0c\u5bf9FDA \u7684\u4f20\u7edf\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u6a21\u5f0f\u63d0\u51fa\u4e86\u6311\u6218\u3002<\/p>\n\n\n\n

2019 \u5e74 4 \u6708 2 \u65e5\uff0cFDA \u53d1\u5e03\u4e86\u4e00\u4efd\u8ba8\u8bba\u6587\u4ef6 – \u201c\u4eba\u5de5\u667a\u80fd\/\u673a\u5668\u5b66\u4e60 (AI\/ML) \u7684\u8f6f\u4ef6\u4f5c\u4e3a\u533b\u7597\u5668\u68b0 (SaMD)\u7684\u53d8\u66f4\u76d1\u7ba1\u6846\u67b6\u201d\uff0c\u8be5\u6587\u4ef6\u63d0\u51fa\u4e86SaMD\u7c7b\u533b\u7597\u8bbe\u5907\u53d8\u66f4\u7684\u6280\u672f\u5ba1\u67e5\u7684\u65b9\u6cd5\u8349\u6848\u3002<\/p>\n\n\n\n

2021 \u5e74 1 \u6708\uff0cFDA \u53d1\u5e03\u4e86\u201c\u4eba\u5de5\u667a\u80fd\u548c\u673a\u5668\u5b66\u4e60\u8f6f\u4ef6\u4f5c\u4e3a\u533b\u7597\u5668\u68b0\uff08AI\/ML SaMD\uff09\u884c\u52a8\u8ba1\u5212\u201d\u3002 \u6839\u636e\u8be5\u884c\u52a8\u8ba1\u5212\uff0cFDA \u968f\u540e\u53d1\u5e03\u4e86\u4ee5\u4e0b\u6587\u4ef6\uff1a<\/p>\n\n\n\n

2021 \u5e74 10 \u6708 – \u6307\u5bfc\u539f\u5219\uff1a\u533b\u7597\u5668\u68b0\u5f00\u53d1\u7684\u826f\u597d\u673a\u5668\u5b66\u4e60\u5b9e\u8df5\uff1a<\/p>\n\n\n\n

2023 \u5e74 4 \u6708 – \u4e0a\u5e02\u524d\u7533\u62a5\u6307\u5357\u8349\u6848\uff1a\u5e26\u4eba\u5de5\u667a\u80fd\/\u673a\u5668\u5b66\u4e60 (AI\/ML)\u529f\u80fd\u7684\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u7684\u9884\u5b9a\u53d8\u66f4\u63a7\u5236\u8ba1\u5212<\/p>\n\n\n\n

2023 \u5e74 10 \u6708 – \u4e0a\u5e02\u524d\u7533\u62a5\u6307\u5357\uff1a\u5e26\u4eba\u5de5\u667a\u80fd\/\u673a\u5668\u5b66\u4e60 (AI\/ML)\u529f\u80fd\u7684\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u7684\u9884\u5b9a\u53d8\u66f4\u63a7\u5236\u8ba1\u5212<\/p>\n\n\n\n

2024 \u5e74 3 \u6708 15 \u65e5\uff0cFDA \u53d1\u5e03\u4e86\u300a\u4eba\u5de5\u667a\u80fd\u548c\u533b\u7597\u4ea7\u54c1\uff1aCBER\u3001CDER\u3001CDRH \u548c OCP \u5982\u4f55\u591a\u4e2d\u5fc3\u5408\u4f5c\u300b\uff0c\u4ee3\u8868\u4e86 FDA \u5bf9\u4eba\u5de5\u667a\u80fd\u7684\u534f\u8c03\u65b9\u6cd5\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"

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