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(Software as medical device)\u3001\u4eba\u5de5\u667a\u80fd\u4ea6\u662f\u76ee\u524d\u71b1\u9580\u7684\u9818\u57df\uff0c\u7dad\u5dde\u516c\u53f8\u53ef\u5354\u52a9\u91ab\u7642\u8edf\u9ad4\/\u4eba\u5de5\u667a\u80fd\u516c\u53f8\u65bc\u7522\u54c1\u7814\u767c\u904e\u7a0b\u4e2d\uff0c\u7d66\u4e88\u9069\u7576\u7684\u5354\u52a9\u8207\u8aee\u8a62\uff0c\u7b26\u5408\u570b\u5167\u3001\u5916\u7684\u4e3b\u7ba1\u6a5f\u95dc\u6cd5\u898f\uff0c\u8fc5\u901f\u7684\u5b8c\u6210\u4e3b\u7ba1\u6a5f\u7ba1\u767b\u8a18\u3002<\/p>\n\n\n\n<p>\u8cc7\u6599\u4f86\u6e90\uff1a<a href=\"https:\/\/www.fda.gov\/medical-devices\/medical-device-regulatory-science-research-programs-conducted-osel\/artificial-intelligence-program-research-aiml-based-medical-devices\">https:\/\/www.fda.gov\/medical-devices\/medical-device-regulatory-science-research-programs-conducted-osel\/artificial-intelligence-program-research-aiml-based-medical-devices<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u7f8e\u570b\u98df\u54c1\u85e5\u54c1\u7ba1\u7406\u5c40\uff08FDA\uff09\u7684\u91ab\u7642\u5668\u68b0\u8207\u653e\u5c04\u5065\u5eb7\u4e2d\u5fc3\uff08CDRH\uff09\u4e0b\u7684\u4eba\u5de5\u667a\u80fd\u8a08\u756b\uff0c\u662f\u8a72\u4e2d\u5fc3\u79d1\u5b78\u8207\u5de5\u7a0b\u5be6\u9a57\u5ba4\u8fa6\u516c 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