{"id":4424,"date":"2025-09-04T13:58:28","date_gmt":"2025-09-04T05:58:28","guid":{"rendered":"https:\/\/rohs.ac.cn\/?p=4424"},"modified":"2025-09-04T13:58:28","modified_gmt":"2025-09-04T05:58:28","slug":"%e8%8e%b7%e5%be%97fda%e8%ae%a4%e8%af%81%e7%9a%84%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0","status":"publish","type":"post","link":"https:\/\/rohs.ac.cn\/?p=4424","title":{"rendered":"\u83b7\u5f97fda\u8ba4\u8bc1\u7684\u533b\u7597\u5668\u68b0"},"content":{"rendered":"

\u4e00\u3001\u83b7\u5f97FDA\u8ba4\u8bc1\u7684\u533b\u7597\u5668\u68b0\uff1a\u5b9a\u4e49\u3001\u6d41\u7a0b\u4e0e\u5e02\u573a\u610f\u4e49<\/strong><\/p>\n

\u83b7\u5f97FDA\u8ba4\u8bc1\u7684\u533b\u7597\u5668\u68b0\u662f\u6307\u901a\u8fc7\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08Food and Drug Administration\uff0c\u7b80\u79f0FDA\uff09\u4e25\u683c\u5ba1\u67e5\u5e76\u83b7\u51c6\u5728\u7f8e\u56fd\u5e02\u573a\u9500\u552e\u548c\u4f7f\u7528\u7684\u533b\u7597\u8bbe\u5907\u53ca\u76f8\u5173\u4ea7\u54c1\u3002<\/p>\n<\/p>\n

FDA\u4f5c\u4e3a\u5168\u7403\u6700\u5177\u6743\u5a01\u6027\u7684\u533b\u7597\u4ea7\u54c1\u76d1\u7ba1\u673a\u6784\u4e4b\u4e00\uff0c\u5176\u8ba4\u8bc1\u8fc7\u7a0b\u4ee5\u79d1\u5b66\u6027\u548c\u4e25\u8c28\u6027\u8457\u79f0\uff0c\u65e8\u5728\u786e\u4fdd\u533b\u7597\u5668\u68b0\u7684\u5b89\u5168\u6027\u3001\u6709\u6548\u6027\u548c\u8d28\u91cf\u53ef\u9760\u6027\u3002<\/p>\n<\/p>\n

\u5bf9\u4e8e\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u800c\u8a00\uff0c\u83b7\u5f97FDA\u8ba4\u8bc1\u4e0d\u4ec5\u662f\u8fdb\u5165\u7f8e\u56fd\u5e02\u573a\u7684\u6cd5\u5b9a\u524d\u63d0\uff0c\u66f4\u662f\u4ea7\u54c1\u6280\u672f\u5148\u8fdb\u6027\u548c\u56fd\u9645\u7ade\u4e89\u529b\u7684\u91cd\u8981\u6807\u5fd7\u3002<\/p>\n<\/p>\n

\u8fd9\u4e00\u8ba4\u8bc1\u5728\u5168\u7403\u8303\u56f4\u5185\u5177\u6709\u9ad8\u5ea6\u7684\u8ba4\u53ef\u5ea6\uff0c\u5e38\u5e38\u88ab\u5176\u4ed6\u56fd\u5bb6\u548c\u5730\u533a\u7684\u76d1\u7ba1\u673a\u6784\u4f5c\u4e3a\u53c2\u8003\u4f9d\u636e\uff0c\u56e0\u6b64\u5bf9\u4f01\u4e1a\u62d3\u5c55\u56fd\u9645\u5e02\u573a\u5177\u6709\u6218\u7565\u610f\u4e49\u3002<\/p>\n<\/p>\n

\u4e8c\u3001FDA\u533b\u7597\u5668\u68b0\u5206\u7c7b\u4e0e\u8ba4\u8bc1\u8def\u5f84<\/strong><\/p>\n

FDA\u6839\u636e\u533b\u7597\u5668\u68b0\u7684\u98ce\u9669\u7b49\u7ea7\u5c06\u5176\u5206\u4e3a\u4e09\u7c7b\uff08Class I, II, III\uff09\uff0c\u5e76\u636e\u6b64\u89c4\u5b9a\u4e0d\u540c\u7684\u5ba1\u67e5\u8981\u6c42\u548c\u8ba4\u8bc1\u8def\u5f84\u3002<\/p>\n<\/p>\n

Class I\u7c7b\u5668\u68b0\u98ce\u9669\u6700\u4f4e\uff0c\u4f8b\u5982\u538b\u820c\u677f\u3001\u5f39\u6027\u7ef7\u5e26\u7b49\uff0c\u5927\u591a\u901a\u8fc7\u8c41\u514d\u65b9\u5f0f\u6216\u8fdb\u884c\u7b80\u5355\u6ce8\u518c\u5373\u53ef\u4e0a\u5e02\u3002<\/p>\n<\/p>\n

Class II\u7c7b\u5668\u68b0\u98ce\u9669\u4e2d\u7b49\uff0c\u5982\u8f93\u6db2\u6cf5\u3001\u9690\u5f62\u773c\u955c\u7b49\uff0c\u901a\u5e38\u9700\u8981\u63d0\u4ea4510(k)\u9884\u5e02\u901a\u544a\uff0c\u8bc1\u660e\u65b0\u4ea7\u54c1\u4e0e\u5df2\u5408\u6cd5\u4e0a\u5e02\u7684 predicate device\uff08\u5bf9\u6bd4\u5668\u68b0\uff09\u5177\u6709\u5b9e\u8d28\u7b49\u540c\u6027\u3002<\/p>\n<\/p>\n

Class III\u7c7b\u5668\u68b0\u98ce\u9669\u6700\u9ad8\uff0c\u5305\u62ec\u5fc3\u810f\u8d77\u640f\u5668\u3001\u4eba\u5de5\u5fc3\u810f\u74e3\u819c\u7b49\u7ef4\u6301\u751f\u547d\u6216\u690d\u5165\u4f53\u5185\u7684\u4ea7\u54c1\uff0c\u8fd9\u7c7b\u4ea7\u54c1\u5fc5\u987b\u7ecf\u8fc7\u66f4\u4e3a\u4e25\u683c\u7684PMA\uff08Premarket Approval\uff0c\u4e0a\u5e02\u524d\u6279\u51c6\uff09\u6d41\u7a0b\uff0c\u9700\u8981\u63d0\u4f9b\u5145\u5206\u7684\u79d1\u5b66\u8bc1\u636e\u548c\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\uff0c\u4ee5\u8bc1\u660e\u5176\u5b89\u5168\u6709\u6548\u3002<\/p>\n<\/p>\n

\u9009\u62e9\u6b63\u786e\u7684\u8ba4\u8bc1\u8def\u5f84\u662f\u4f01\u4e1a\u6210\u529f\u83b7\u5f97FDA\u6279\u51c6\u7684\u5173\u952e\u7b2c\u4e00\u6b65\uff0c\u4efb\u4f55\u8bef\u5224\u90fd\u53ef\u80fd\u5bfc\u81f4\u7533\u8bf7\u88ab\u62d2\u6216\u9879\u76ee\u5ef6\u671f\u3002<\/p>\n<\/p>\n

\u4e09\u3001\u8be6\u8ff0FDA\u8ba4\u8bc1\u7684\u6838\u5fc3\u6d41\u7a0b\u4e0e\u6b65\u9aa4<\/strong><\/p>\n

\u83b7\u5f97FDA\u8ba4\u8bc1\u7684\u533b\u7597\u5668\u68b0\u9700\u8981\u7ecf\u5386\u4e00\u4e2a\u591a\u9636\u6bb5\u3001\u7cfb\u7edf\u5316\u7684\u590d\u6742\u8fc7\u7a0b\u3002<\/p>\n<\/p>\n

\u9996\u5148\uff0c\u4f01\u4e1a\u5fc5\u987b\u8fdb\u884c\u4ea7\u54c1\u5206\u7c7b\uff0c\u660e\u786e\u5176\u98ce\u9669\u7b49\u7ea7\u548c\u5bf9\u5e94\u7684\u7533\u62a5\u8def\u5f84\u3002<\/p>\n<\/p>\n

\u968f\u540e\uff0c\u8fdb\u5165\u5b9e\u8d28\u6027\u7684\u51c6\u5907\u9636\u6bb5\uff0c\u4f01\u4e1a\u9700\u5efa\u7acb\u5e76\u8fd0\u884c\u7b26\u5408FDA QSR\uff08Quality System Regulation\uff09\/\u533b\u7597\u5668\u68b0\u8d28\u91cf\u4f53\u7cfb\u6cd5\u89c4\uff0821 CFR Part 820\uff09\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff0c\u786e\u4fdd\u4ece\u8bbe\u8ba1\u3001\u5f00\u53d1\u3001\u751f\u4ea7\u5230\u552e\u540e\u670d\u52a1\u7684\u5168\u6d41\u7a0b\u90fd\u5904\u4e8e\u53d7\u63a7\u72b6\u6001\u3002<\/p>\n<\/p>\n

\u5bf9\u4e8e\u9700\u8981\u4e34\u5e8a\u6570\u636e\u652f\u6301\u7684II\u7c7b\u548cIII\u7c7b\u5668\u68b0\uff0c\u4f01\u4e1a\u5fc5\u987b\u5728\u7f8e\u56fd\u8fdb\u884c\u4e25\u683c\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff08IDE\u7533\u8bf7\uff09\uff0c\u5e76\u6536\u96c6\u548c\u5206\u6790\u5b89\u5168\u6027\u4e0e\u6709\u6548\u6027\u6570\u636e\u3002<\/p>\n<\/p>\n

\u51c6\u5907\u5de5\u4f5c\u5b8c\u6210\u540e\uff0c\u4f01\u4e1a\u5411FDA\u63d0\u4ea4\u76f8\u5e94\u7684\u7533\u8bf7\u6587\u4ef6\uff0c\u5982510(k)\u3001De Novo\u6216PMA\u7533\u8bf7\u3002<\/p>\n<\/p>\n

FDA\u7684\u8bc4\u5ba1\u56e2\u961f\u5c06\u5bf9\u63d0\u4ea4\u7684\u6d77\u91cf\u6280\u672f\u6587\u4ef6\u8fdb\u884c\u8be6\u7ec6\u5ba1\u67e5\uff0c\u5e76\u53ef\u80fd\u63d0\u51fa\u4e00\u7cfb\u5217\u95ee\u9898\u8981\u6c42\u4f01\u4e1a\u8865\u5145\u7b54\u590d\u3002<\/p>\n<\/p>\n

\u6b64\u5916\uff0cFDA\u901a\u5e38\u4f1a\u5b89\u6392\u5bf9\u751f\u4ea7\u5de5\u5382\u8fdb\u884c\u73b0\u573a\u5ba1\u6838\uff08Inspection\uff09\uff0c\u4ee5\u6838\u5b9e\u8d28\u91cf\u4f53\u7cfb\u7684\u5b9e\u9645\u8fd0\u884c\u60c5\u51b5\u3002<\/p>\n<\/p>\n

\u53ea\u6709\u6210\u529f\u901a\u8fc7\u6587\u4ef6\u8bc4\u5ba1\u548c\u73b0\u573a\u68c0\u67e5\uff0c\u4f01\u4e1a\u6700\u7ec8\u624d\u80fd\u83b7\u5f97FDA\u7684\u6279\u51c6\u4fe1\uff08Clearance or Approval Letter\uff09\uff0c\u4ece\u800c\u5408\u6cd5\u5730\u5728\u4ea7\u54c1\u4e0a\u6807\u6ce8\u201cFDA\u6279\u51c6\u201d\u6216\u201cFDA\u8bb8\u53ef\u201d\uff0c\u5e76\u5728\u7f8e\u56fd\u5e02\u573a\u8fdb\u884c\u5546\u4e1a\u63a8\u5e7f\u3002<\/p>\n<\/p>\n

\u56db\u3001FDA\u8ba4\u8bc1\u5bf9\u4f01\u4e1a\u548c\u6d88\u8d39\u8005\u7684\u6838\u5fc3\u4ef7\u503c<\/strong><\/p>\n

\u5bf9\u4e8e\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u800c\u8a00\uff0c\u83b7\u5f97FDA\u8ba4\u8bc1\u6240\u5e26\u6765\u7684\u4ef7\u503c\u662f\u5168\u65b9\u4f4d\u548c\u6df1\u8fdc\u7684\u3002<\/p>\n<\/p>\n

\u5b83\u6253\u5f00\u4e86\u89c4\u6a21\u5de8\u5927\u7684\u7f8e\u56fd\u533b\u7597\u5e02\u573a\u5927\u95e8\uff0c\u4e3a\u4f01\u4e1a\u5e26\u6765\u76f4\u63a5\u7684\u7ecf\u6d4e\u6536\u76ca\u548c\u4e1a\u52a1\u589e\u957f\u673a\u4f1a\u3002<\/p>\n<\/p>\n

\u66f4\u91cd\u8981\u7684\u662f\uff0cFDA\u8ba4\u8bc1\u662f\u5168\u7403\u5e02\u573a\u7684\u201c\u91d1\u5b57\u62db\u724c\u201d\u548c\u201c\u901a\u884c\u8bc1\u201d\uff0c\u80fd\u6781\u5927\u5730\u589e\u5f3a\u5408\u4f5c\u4f19\u4f34\u3001\u4e34\u5e8a\u533b\u751f\u53ca\u6295\u8d44\u8005\u7684\u4fe1\u5fc3\uff0c\u63d0\u5347\u54c1\u724c\u58f0\u8a89\u548c\u516c\u53f8\u4f30\u503c\u3002<\/p>\n<\/p>\n

\u4e3a\u4e86\u7ef4\u6301\u8ba4\u8bc1\uff0c\u4f01\u4e1a\u5fc5\u987b\u6301\u7eed\u4f18\u5316\u5176\u7814\u53d1\u548c\u751f\u4ea7\u6d41\u7a0b\uff0c\u8fd9\u53cd\u8fc7\u6765\u53c8\u9a71\u52a8\u4e86\u6280\u672f\u521b\u65b0\u548c\u4ea7\u54c1\u8d28\u91cf\u7684\u4e0d\u65ad\u63d0\u5347\u3002<\/p>\n<\/p>\n

\u5bf9\u4e8e\u6d88\u8d39\u8005\u548c\u533b\u62a4\u4eba\u5458\u6765\u8bf4\uff0c\u4f7f\u7528\u83b7\u5f97FDA\u8ba4\u8bc1\u7684\u533b\u7597\u5668\u68b0\u610f\u5473\u7740\u4ed6\u4eec\u4f7f\u7528\u7684\u662f\u7ecf\u8fc7\u4e16\u754c\u4e0a\u6700\u4e25\u683c\u6807\u51c6\u4e4b\u4e00\u9a8c\u8bc1\u7684\u4ea7\u54c1\u3002<\/p>\n<\/p>\n

\u8fd9\u63d0\u4f9b\u4e86\u81f3\u5173\u91cd\u8981\u7684\u5b89\u5168\u4fdd\u969c\uff0c\u6700\u5927\u7a0b\u5ea6\u5730\u964d\u4f4e\u4e86\u56e0\u4ea7\u54c1\u7f3a\u9677\u6216\u5931\u6548\u800c\u5e26\u6765\u7684\u6f5c\u5728\u98ce\u9669\uff0c\u786e\u4fdd\u4e86\u8bca\u7597\u8fc7\u7a0b\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\uff0c\u4ece\u800c\u4fdd\u62a4\u4e86\u516c\u4f17\u5065\u5eb7\u3002<\/p>\n<\/p>\n

\u4e94\u3001\u4f01\u4e1a\u9762\u4e34\u7684\u6311\u6218\u4e0e\u5e94\u5bf9\u7b56\u7565<\/strong><\/p>\n

\u5c3d\u7ba1FDA\u8ba4\u8bc1\u597d\u5904\u4f17\u591a\uff0c\u4f46\u4f01\u4e1a\u5728\u8fd9\u4e00\u8fc7\u7a0b\u4e2d\u4e5f\u9762\u4e34\u7740\u8bf8\u591a\u4e25\u5cfb\u6311\u6218\u3002<\/p>\n<\/p>\n

\u9996\u5148\u662f\u65f6\u95f4\u548c\u91d1\u94b1\u7684\u9ad8\u6602\u6210\u672c\uff0c\u6574\u4e2a\u8ba4\u8bc1\u5468\u671f\u53ef\u80fd\u957f\u8fbe\u6570\u5e74\uff0c\u6295\u5165\u8d44\u91d1\u53ef\u8fbe\u6570\u767e\u4e07\u751a\u81f3\u4e0a\u5343\u4e07\u7f8e\u5143\uff0c\u5bf9\u4f01\u4e1a\u7684\u8d22\u529b\u662f\u5de8\u5927\u8003\u9a8c\u3002<\/p>\n<\/p>\n

\u5176\u6b21\u662f\u6280\u672f\u548c\u6cd5\u89c4\u7684\u590d\u6742\u6027\uff0c\u7533\u8bf7\u6750\u6599\u51c6\u5907\u8981\u6c42\u6781\u9ad8\uff0c\u4efb\u4f55\u7ec6\u5fae\u7684\u758f\u6f0f\u6216\u6570\u636e\u4e0d\u5145\u5206\u90fd\u53ef\u80fd\u5bfc\u81f4\u8bc4\u5ba1\u5ef6\u8fdf\u6216\u7533\u8bf7\u88ab\u62d2\u3002<\/p>\n

p> <\/p>\n

\u6b64\u5916\uff0c\u6587\u5316\u548c\u6c9f\u901a\u7684\u969c\u788d\u4e5f\u4e0d\u5bb9\u5ffd\u89c6\uff0c\u4e2d\u7f8e\u4e4b\u95f4\u7684\u65f6\u5dee\u3001\u8bed\u8a00\u5dee\u5f02\u548c\u76d1\u7ba1\u601d\u7ef4\u7684\u4e0d\u540c\u90fd\u53ef\u80fd\u6210\u4e3a\u9879\u76ee\u63a8\u8fdb\u7684\u963b\u529b\u3002<\/p>\n<\/p>\n

\u4e3a\u6210\u529f\u5e94\u5bf9\u8fd9\u4e9b\u6311\u6218\uff0c\u4f01\u4e1a\u53ef\u4ee5\u91c7\u53d6\u591a\u9879\u7b56\u7565\uff1a\u5c3d\u65e9\u4e0eFDA\u8fdb\u884c\u9884\u63d0\u4ea4\u4f1a\u8bae\u6c9f\u901a\uff0c\u660e\u786e\u76d1\u7ba1\u671f\u671b\uff1b\u8058\u8bf7\u719f\u6089FDA\u6cd5\u89c4\u548c\u6d41\u7a0b\u7684\u8d44\u6df1\u4e13\u5bb6\u6216\u54a8\u8be2\u673a\u6784\uff1b\u6295\u8d44\u6784\u5efa\u5f3a\u5927\u4e14\u5408\u89c4\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff1b\u5e76\u5229\u7528\u6570\u5b57\u5316\u5de5\u5177\u8fdb\u884c\u9ad8\u6548\u7684\u6587\u6863\u7ba1\u7406\u548c\u9879\u76ee\u8ffd\u8e2a\u3002<\/p>\n<\/p>\n

\u516d\u3001\u5c55\u671b\u672a\u6765\uff1aFDA\u8ba4\u8bc1\u7684\u65b0\u8d8b\u52bf<\/strong><\/p>\n

\u5168\u7403\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u73af\u5883\u6b63\u5904\u4e8e\u5feb\u901f\u6f14\u53d8\u4e4b\u4e2d\uff0cFDA\u7684\u8bc4\u5ba1\u653f\u7b56\u548c\u91cd\u70b9\u4e5f\u5728\u4e0d\u65ad\u8c03\u6574\u3002<\/p>\n<\/p>\n

\u8fd1\u5e74\u6765\uff0c\u6570\u5b57\u5316\u5065\u5eb7\uff08Digital Health\uff09\u4ea7\u54c1\uff0c\u5982\u533b\u7597APP\u548cAI\u8f85\u52a9\u8bca\u65ad\u8f6f\u4ef6\uff0c\u5df2\u6210\u4e3aFDA\u76d1\u7ba1\u548c\u8ba4\u8bc1\u7684\u65b0\u7126\u70b9\uff0c\u4e3a\u6b64FDA\u63a8\u51fa\u4e86\u8f6f\u4ef6\u9884\u8ba4\u8bc1\u8ba1\u5212\u7b49\u65b0\u7684\u8bd5\u70b9\u9879\u76ee\u3002<\/p>\n<\/p>\n

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