{"id":38276,"date":"2026-01-16T00:00:18","date_gmt":"2026-01-15T16:00:18","guid":{"rendered":"https:\/\/naipnews.naipo.com\/?p=38276"},"modified":"2026-01-15T13:57:34","modified_gmt":"2026-01-15T05:57:34","slug":"%e4%bb%a5%e5%ae%9e%e4%be%8b%e5%88%86%e4%ba%ab%ef%bc%8c%e5%8f%b0%e5%8e%82%e7%9a%84%e8%90%a5%e4%b8%9a%e7%a7%98%e5%af%86%e5%8f%af%e9%80%8f%e8%bf%87%e7%be%8e%e5%9b%bd%e6%b3%95%e5%be%8b%e5%8f%96%e5%be%97","status":"publish","type":"post","link":"https:\/\/naipnews.naipo.com\/zh-hans\/38276\/","title":{"rendered":"\u4ee5\u5b9e\u4f8b\u5206\u4eab\uff0c\u53f0\u5382\u7684\u8425\u4e1a\u79d8\u5bc6\u53ef\u900f\u8fc7\u7f8e\u56fd\u6cd5\u5f8b\u53d6\u5f97\u4fdd\u969c"},"content":{"rendered":"
\"\"
\u56fe\u7247\u6765\u6e90 : shutterstock\u3001\u8fbe\u5fd7\u5f71\u50cf<\/figcaption><\/figure>\n

\u8fd1\u65e5\u5916\u4f20\u4e00\u77e5\u540d\u53f0\u5382\u906d\u524d\u9ad8\u9636\u4e3b\u7ba1\u5c06\u76f8\u5173\u5236\u7a0b\u6280\u672f\u8425\u4e1a\u79d8\u5bc6\u643a\u5f80\u7f8e\u56fd\u3002\u672c\u6587\u6b32\u4ecb\u7ecd\u4e00\u4ef6\u53cc\u65b9\u4e3b\u8981\u5f53\u4e8b\u4eba\u7686\u4e3a\u53f0\u5382\u7684\u7f8e\u56fd\u8425\u4e1a\u79d8\u5bc6\u4fb5\u5bb3\u7ea0\u7eb7\u6848\u3002<\/p><\/blockquote>\n

\u4ece\u4e13\u5229\u6218\u6253\u5230\u8425\u4e1a\u79d8\u5bc6\u8bc9\u8bbc<\/span><\/p>\n

\u8fd1\u5e74\uff0c\u300c\u533b\u7597\u5668\u6750\u300d\u6210\u4e3a\u53f0\u6e7e\u5730\u533a\u751f\u7269\u6280\u672f\u65b0\u5174\u4ea7\u4e1a\u4e4b\u4e00\u3002\u5176\u4e2d\uff0c\u8840\u7cd6\u68c0\u6d4b\u5668\u6750\u4e0e\u7cd6\u5c3f\u75c5\u8bd5\u7eb8\u662f\u4e3b\u8981\u51fa\u53e3\u4ea7\u54c1\u3002\u5728\u7ade\u4e89\u7684\u73af\u5883\u4e2d\uff0c\u5f15\u53d1\u77e5\u8bc6\u4ea7\u6743\u4e89\u8bae\u662f\u53ef\u9884\u89c1\u7684\u3002\u5728\u300a\u53f0\u667a\u6167\u8d22\u4ea7\u6cd5\u96622009\u5e74\u5ea6\u6c11\u4e13\u8bc9\u5b57\u7b2c65\u53f7\u6c11\u4e8b\u5224\u51b3<\/a>\u300b\uff08\u6cf0\u535a\u6848\uff09\u4e2d\uff0cTTC\u516c\u53f8\u63a7\u544aOKBC\u516c\u53f8\u4fb5\u5bb3\u5176\u65b0\u578b\u4e13\u5229\u7b2cM262706\u53f7\u300c\u7535\u5316\u5b66\u751f\u7269\u611f\u6d4b\u8bd5\u7eb8\u300d\uff0c\u5373\u3002TTC\u53e6\u4e8e2012\u5e74\u5728\u7f8e\u56fd\u5bf9OKBC\u63d0\u8d77\u4e13\u5229\u4fb5\u6743\u8bc9\u8bbc\u3002<\/p>\n

\u5728TTC\u7684\u4e13\u5229\u8bc9\u8bbc\u4e2d\uff0c\u8fd8\u6709\u4e00\u4f4d\u7b2c\u4e09\u4eba\u7f8e\u56fd\u516c\u53f8DDI\u662fTTC\u7684\u5ba2\u6237\u3002\u6839\u636e\u300a\u53f0\u667a\u6167\u8d22\u4ea7\u6cd5\u96622009\u5e74\u5ea6\u6c11\u4e13\u6297\u5b57\u7b2c17\u53f7\u6c11\u4e8b\u88c1\u5b9a<\/a>\u300b\uff0cOKBC\u5c06\u5176\u4fb5\u6743\u8840\u7cd6\u8bd5\u7247\u4ea7\u54c1\u4f9b\u5e94\u7ed9DDI\uff0c\u5e76\u4fdd\u8bc1\u8be5\u8bd5\u7247\u4ea7\u54c1\u53ef\u517c\u5bb9\u4e8eTTC\u4e4b\u8840\u7cd6\u6d4b\u8bd5\u673a\u3002\u6cf0\u535a\u6848\u540e\u56e0\u7cfb\u4e89\u65b0\u578b\u4e13\u5229\u88ab\u8ba4\u5b9a\u4e3a\u4e0d\u5177\u8fdb\u6b65\u6027\uff0c\u5373\u6240\u8bf7\u53d1\u660e\u4e0e\u4e60\u77e5\u6280\u672f\u6bd4\u8f83\u800c\u8a00\u5c5e\u719f\u77e5\u6b64\u6280\u827a\u8005\u80fd\u8f7b\u6613\u5b8c\u6210\u8005\uff0c\u4ee5\u81f4TTC\u8d25\u8bc9\u3002\u53e6\u53cc\u65b9\u5728\u7f8e\u56fd\u7684\u8bc9\u8bbc\u540e\u6765\u4ee5\u548c\u89e3\u6536\u573a[1]<\/a>\u3002<\/p>\n

\u503c\u5f97\u6ce8\u610f\u8005\u662f\uff0cTTC\u66fe\u57282012\u5e74\u4e8e\u7f8e\u56fd\u5317\u5361\u7f57\u83b1\u7eb3\u5dde\u6cd5\u9662\u5bf9OKBC\u63d0\u8d77\u6c11\u4e8b\u8bc9\u8bbc\uff0c\u800c\u8bf7\u6c42\u6743\u4e4b\u4e00\u4e3aOKBC\u7684\u8425\u4e1a\u79d8\u5bc6\u4fb5\u5bb3\u884c\u4e3a\uff0c\u8fdd\u53cd\u5dde\u6cd5\uff08N.C. Gen. Stat.\uff09\u00a7 66-152\u4e0e\u00a7 66-153\u3002\u867d\u8be5\u8bc9\u8bbc\u6848\u4ef6\u4e8e2016\u5e74\u7ecf\u53cc\u65b9\u548c\u89e3\u800c\u843d\u5e55[2]<\/a>\uff0c\u4f46\u7559\u4e0b\u540c\u5e74\u7684TaiDoc\u6848[3]<\/a>\u63ed\u793a\u76f8\u5173\u4fb5\u6743\u5386\u53f2\u3002<\/p>\n

TTC\u4e0eDDI\u4e4b\u5408\u4f5c<\/span><\/p>\n

TTC\u4e3a\u8840\u7cd6\u4eea\u5236\u9020\u5546\uff0c\u4e8e2005\u5e74\u8d77\u4e0eDDI\u5408\u4f5c\uff0c\u5e76\u7531DDI\u72ec\u5bb6\u7ecf\u9500\u5176\u751f\u4ea7\u4e4b\u8840\u7cd6\u4eea\u3002\u4e0d\u8fc7\uff0cTTC\u7684\u8840\u7cd6\u4eea\u7cfb\u4f7f\u7528DDI\u7684\u5546\u6807\u300cProdigy\u300d\u6765\u4f5c\u4e3a\u5176\u4eea\u5668\u540d\u79f0\u30022006\u5e743\u67081\u65e5\uff0cTTC\u4e0eDDI\u6b63\u5f0f\u7b7e\u8ba2\u72ec\u5bb6\u9500\u552e\u5408\u7ea6\uff0c\u7531DDI\u72ec\u5bb6\u5728\u7f8e\u56fd\u9500\u552e\u300cProdigy\u300d\u8840\u7cd6\u4eea\u3002\u8be5\u72ec\u5bb6\u9500\u552e\u5408\u7ea6\u6709\u4fdd\u5bc6\u6761\u6b3e\uff0c\u5373\u5408\u7ea6\u7b2c17\u6761\u7b2c1\u9879\u89c4\u5b9a\u300c\u53cc\u65b9\u8ba4\u77e5\u5728\u5c65\u884c\u5408\u7ea6\u4e49\u52a1\u7684\u8fc7\u7a0b\u4e2d\uff0c\u5176\u4f1a\u6536\u5230\u5bf9\u53e6\u4e00\u65b9\u800c\u8a00\u5c5e\u673a\u5bc6\u7684\u4e14\u6709\u4ef7\u503c\u7684\u4fe1\u606f\u3002\u53cc\u65b9\u540c\u610f\u9664\u975e\u662f\u4e3a\u4e86\u5c65\u884c\u672c\u5408\u7ea6\uff0c\u5176\u4e0d\u4f1a\u5229\u7528\u8be5\u4fe1\u606f\uff0c\u4ee5\u53ca\u53cc\u65b9\u540c\u610f\u4e0d\u4f1a\u5c06\u8be5\u4fe1\u606f\u63ed\u9732\u7ed9\u7b2c\u4e09\u65b9\u300d\u3002<\/p>\n

\u4e3a\u8ba9\u8840\u7cd6\u4eea\u5f97\u4ee5\u8fdb\u53e3\u7f8e\u56fd\u5e76\u5728\u7f8e\u56fd\u9500\u552e\uff0c\u5236\u9020\u5546\u6216\u4ee3\u7406\u5546\u5fc5\u987b\u5411\u7f8e\u56fd\u836f\u7269\u66a8\u98df\u54c1\u7ba1\u7406\u5c40\uff08FDA\uff09\u5448\u62a5510(k)\u7a97\u4f53[4]<\/a>\u3002\u6839\u636eFDA CFR 21 \u00a7 807.92(a)\uff0c510(k)\u7a97\u4f53\u4f1a\u8bb0\u8f7d\u8840\u7cd6\u4eea\u7684\u76f8\u5173\u6280\u672f\u4fe1\u606f\u3002\u5728\u7b7e\u7f72\u72ec\u5bb6\u9500\u552e\u5408\u7ea6\u4e4b\u524d\uff0cTTC\u66fe\u4ee5DDI\u4e3a\u540d\u4e49\u5411FDA\u5448\u62a5\u4e24\u6b21510(k)\u7a97\u4f53\uff0c\u800c\u8be5\u4e8c\u4efd\u7a97\u4f53\u4e8e2006\u5e747\u6708\u95f4\u4e3aFDA\u6240\u8ba4\u53ef\u3002TTC\u4e3b\u5f20\u8be5\u4e8c\u4efd\u7a97\u4f53\u4e2d\u7684\u4fe1\u606f\u4e3a\u673a\u5bc6\u6570\u636e\u3002\u53e6\u5728\u5408\u7ea6\u7b7e\u7f72\u540e\uff0cTTC\u518d\u4ee5DDI\u4e3a\u540d\uff0c\u4e8e2007\u5e7410\u6708\u95f4\u5411FDA\u5448\u62a5\u7b2c\u4e09\u4ef6510(k)\u7a97\u4f53\u3002<\/p>\n

DDI\u4e0eOKBC\u4e4b\u5408\u4f5c<\/span><\/p>\n

2007\u5e749\u6708\u95f4\uff0cDDI\u5f00\u59cb\u8bc4\u4f30\u5916\u627e\u5176\u4ed6\u516c\u53f8\u751f\u4ea7\u300cProdigy\u300d\u8840\u7cd6\u4eea\u3002\u6700\u540e\uff0cDDI\u9009\u62e9OKBC\u4e3a\u5408\u4f5c\u5bf9\u8c61\u3002\u867d\u7136OKBC\u77e5\u9053TTC\u662fDDI\u7684\u300cProdigy\u300d\u8840\u7cd6\u4eea\u5236\u9020\u5546\uff0c\u4f46OKBC\u4e3b\u5f20\u5176\u4e0d\u6e05\u695a\u4e8c\u8005\u95f4\u5951\u7ea6\u4e49\u52a1\u3002\u4e0eDDI\u63a5\u89e6\u521d\u671f\uff0cOKBC\u5e76\u672a\u751f\u4ea7\u8840\u7cd6\u4eea\u3002\u800c\u540e\uff0cDDI\u5148\u5c06TTC\u7684\u8840\u7cd6\u4eea\u5bc4\u7ed9OKBC\u30022007\u5e749\u670817\u65e5\u65f6\uff0cOKBC\u56de\u590d\u5176\u53ef\u751f\u4ea7\u76f8\u540c\u4ea7\u54c1\u3002<\/p>\n

\u51e0\u5929\u540e\uff0cOKBC\u518d\u6b21\u8be2\u95eeDDI\u800c\u5e0c\u671b\u80fd\u6709\u66f4\u591a\u8840\u7cd6\u4eea\u6837\u54c1\u4f9b\u7814\u7a76\u53c2\u8003\uff0c\u5e76\u4e14\u5e0c\u671b\u83b7\u5f97\u7535\u8def\u56fe\u3001\u6d41\u7a0b\u56fe\u3001\u7f16\u7801\u6570\u636e\u4e0e\u8bed\u97f3\u5185\u5b58\u5927\u5c0f\u7b49\u4fe1\u606f\u3002\u5728\u540c\u4e00\u6b21\u8be2\u95ee\u4e2d\uff0cOKBC\u8868\u793a\u5e0c\u671b\u80fd\u4fee\u6539\u8840\u7cd6\u4eea\u7684\u5916\u89c2\uff0c\u4ee5\u6709\u522b\u4e8eTTC\u7684\u4ea7\u54c1\u3002<\/p>\n

\u8425\u4e1a\u79d8\u5bc6\u4fb5\u5bb3\u884c\u4e3a<\/span><\/p>\n

\u6839\u636eOKBC\u8981\u6c42\uff0cDDI\u5bc4\u9001\u66f4\u591a\u8840\u7cd6\u4eea\u6837\u54c1\u7ed9OKBC\uff0c\u5e76\u4e14\u63d0\u4f9b\u7f16\u7801\u6570\u636e\u3002DDI\u53c8\u63d0\u4f9b\u66f4\u591a\u6587\u4ef6\uff0c\u800c\u8be5\u6587\u4ef6\u4e0a\u9762\u6709\u6807\u8bb0TTC\u7684\u673a\u5bc6\u6570\u636e \u2014 TTC\u6307\u63a7OKBC\u5229\u7528\u8fd9\u4e9b\u673a\u5bc6\u6570\u636e\u6765\u5f00\u53d1\u8840\u7cd6\u4eea\u3002<\/p>\n

\u4fb5\u5bb3\u8d77\u6e90<\/strong><\/span><\/p>\n

2007\u5e749\u670826\u65e5\u65f6\uff0cOKBC\u8054\u7cfbDDI\uff0c\u5e76\u8868\u793a\u5176\u4e0d\u6e05\u695a\u4ea7\u54c1\u4e2d\u7684\u7f16\u7801\u8868\uff0c\u6545\u8981\u6c42DDI\u63d0\u4f9b\u7f16\u7801\u5361\u53ca\u76f8\u5173\u53c2\u6570\u3002\u56e0\u800c\uff0cDDI\u5c06TTC\u5236\u7a0b\u6570\u636e\u63d0\u4f9b\u7ed9OKBC\uff0c\u800cTTC\u4e3b\u5f20\u8be5\u4e9b\u6570\u636e\u5177\u673a\u5bc6\u6027\u5e76\u5c5e\u4e8e\u5176\u8425\u4e1a\u79d8\u5bc6\u3002\u4e4b\u540e\uff0cOKBC\u4ecd\u7ee7\u7eed\u8981\u6c42DDI\u63d0\u4f9bTTC\u7684\u7f16\u7801\u8868\uff0c\u5e76\u751a\u81f3\u66fe\u6307\u5bfcDDI\u5e94\u5982\u4f55\u5411TTC\u7d22\u53d6\u5176\u6240\u9700\u8981\u7684\u6280\u672f\u4fe1\u606f\u3002\u540c\u65f6\uff0cOKBC\u4ea6\u5411DDI\u8be2\u95eeTTC\u4ea7\u54c1\u7684\u62a5\u4ef7\u4fe1\u606f\u3002<\/p>\n

OKBC\u548cDDI\u57282007\u5e74\u5e95\u66fe\u4e92\u76f8\u62dc\u8bbf\uff0c\u5e76\u4e3e\u884c\u76f8\u5173\u4f1a\u8bae\u8ba8\u8bba\u672a\u6765\u7684\u5546\u4e1a\u5408\u4f5c\u3002\u7ec8\u4e8e\u57282008\u5e744\u670823\u65e5\uff0c\u53cc\u65b9\u6b63\u5f0f\u7b7e\u7ea6\uff0c\u7531OKBC\u4e13\u95e8\u4f9b\u5e94\u8840\u7cd6\u4eea\u7ed9DDI\u30022008\u5e747\u6708\u95f4\uff0cDDI\u786e\u8ba4\u5c06\u8fdb\u53e3OKBC\u6240\u5236\u9020\u7684\u8840\u7cd6\u4eea\uff0c\u4e14\u8be5\u8840\u7cd6\u4eea\u7684\u8fdb\u53e3\u4f9d\u636e\u662f\u524d\u8ff0\u7684\u7b2c\u4e09\u4efd510(k)\u7a97\u4f53\u30022008\u5e74\u81f32014\u5e74\u4e4b\u95f4\uff0cDDI\u548cOKBC\u7b49\u7686\u672a\u5411FDA\u5448\u62a5\u65b0\u7684510(k)\u7a97\u4f53\u30022008\u5e748\u6708\u8d77\uff0cOKBC\u5f00\u59cb\u4f9b\u5e94\u8bd5\u7eb8\uff0c\u4f46\u5176\u8840\u7cd6\u4eea\u8fd8\u672a\u7814\u53d1\u5b8c\u6210\u3002\u56e0\u6b64\uff0cDDI\u53c8\u63a5\u89e6HLC\u516c\u53f8\u4ee5\u534f\u52a9\u751f\u4ea7\u300cProdigy\u300d\u8840\u7cd6\u4eea\uff0c\u6b64\u60c5\u51b5\u4e3aOKBC\u6240\u77e5\u6089\u3002\u4e09\u65b9\u57282008\u5e74\u95f4\u66fe\u5171\u540c\u8ba8\u8bba\u7814\u53d1\u8840\u7cd6\u4eea\u4e8b\u9879\u3002\u6700\u540e\uff0cDDI\u6307\u793aHLC\u7814\u53d1\u514d\u8c03\u7801\u8840\u7cd6\u4eea\uff0c\u800c\u6b64\u7c7b\u673a\u5668\u548cTTC\u751f\u4ea7\u7684\u8840\u7cd6\u4eea\u76f8\u540c\u3002DDI\u53e6\u8981\u6c42OKBC\u53d1\u5c55\u8bed\u97f3\u578b\u8840\u7cd6\u4eea\u3002<\/p>\n

2008\u5e748\u6708\uff0c\u8be5\u4e09\u4efd510(k)\u7a97\u4f53\u7ec8\u83b7\u5f97FDA\u8ba4\u53ef\uff0c\u800cDDI\u5c06\u8be5\u4efd\u7a97\u4f53\u8f6c\u4f20\u7ed9OKBC\u548cHLC\uff0c\u5e76\u6307\u79f0\u76f8\u5173\u6280\u672f\u4fe1\u606f\u90fd\u63ed\u9732\u5728\u7a97\u4f53\u4e2d\u3002\u7ec8\u4e8e\uff0cOKBC\u4e8e2008\u5e7411\u670826\u65e5\u5f00\u59cb\u63d0\u4f9b\u8bed\u97f3\u578b\u8840\u7cd6\u4eea\uff0c\u800cHLC\u5219\u5728\u540c\u5e7412\u670816\u65e5\u8d77\u4f9b\u5e94\u514d\u8c03\u7801\u8840\u7cd6\u4eea\u3002\u7136\u800c\uff0cDDI\u4ecd\u6301\u7eed\u4eceTTC\u5904\u91c7\u8d2d\u8bd5\u7eb8\uff0c\u76f4\u5230\u540c\u5e7412\u67088\u65e5\u4e3a\u6b62\u3002<\/p>\n

\u56e0\u8981\u8bc1\u660e510(k)\u7a97\u4f53\uff0c\u4fb5\u5bb3\u4e8b\u4ef6\u7206\u53d1<\/strong><\/span><\/p>\n

\u56e0\u4e3a\u8be5\u4e09\u4efd510(k)\u7a97\u4f53\u662fOKBC\u8840\u7cd6\u4eea\u7684\u8fdb\u53e3\u4f9d\u636e\uff0cDDI\u5fc5\u987b\u8bc1\u660eOKBC\u548cTTC\u8bd5\u7eb8\u76f8\u540c\u3002\u5982\u679c\u4e8c\u8005\u6240\u7528\u7684\u5316\u5b66\u539f\u7406\u4e0d\u540c\uff0cDDI\u5fc5\u987b\u5448\u62a5\u65b0\u7684510(k)\u7a97\u4f53\u3002\u4f46DDI\u4e0d\u613f\u610f\u8fd9\u6837\u505a\uff0c\u56e0\u800c\u57282009\u5e741\u6708\u8981\u6c42OKBC\u914d\u5408\u586b\u5199\u300c\u4f9b\u8d27\u5546\u66f4\u6362\u300d\u7a97\u4f53\u3002TTC\u4e3b\u5f20OKBC\u5728\u8be5\u7a97\u4f53\u4e2d\u58f0\u660e\u5176\u8840\u7cd6\u4eea\u548c\u8bd5\u7eb8\u4ea7\u54c1\u662f\u76f8\u540c\u4e8eTTC\u3002\u4f46\u5bf9\u6b64\uff0cOKBC\u7684\u4ee3\u8868\u4eba\u8868\u793a\uff0c\u4e8c\u8005\u4ea7\u54c1\u65e0\u8bba\u5728\u8bd5\u7eb8\u7528\u7684\u5316\u5b66\u539f\u7406\u6216\u4eea\u5668\u7528\u7684\u7b97\u6cd5\u7b49\uff0c\u7686\u662f\u4e0d\u76f8\u540c\u7684\u3002\u53e6\u57281\u6708\u671f\u95f4\uff0cOKBC\u5df2\u5f97\u77e5DDI\u4e0eTTC\u95f4\u7684\u4fdd\u5bc6\u7ea6\u5b9a\u3002\u56e0\u6b64\uff0cTTC\u4e3b\u5f20OKBC\u7adf\u7136\u7ee7\u7eed\u5229\u7528\u5176\u673a\u5bc6\u4fe1\u606f\uff0c\u7814\u53d1\u8840\u7cd6\u4eea\u53ca\u8bd5\u7eb8\uff0c\u5e76\u7528\u4e8e\u51c6\u5907\u76f8\u5173\u8d44\u6599\uff0c\u4ee5\u5728\u540c\u5e743\u6708\u95f4\u534f\u52a9\u5448\u62a5510(k)\u7a97\u4f53\u3002<\/p>\n

\u9488\u5bf92011\u5e748\u6708\u95f4DDI\u6240\u5448\u62a5\u7684510(k)\u7a97\u4f53\uff0cOKBC\u4ee5TTC\u6240\u5236\u4f5c\u7684\u98ce\u9669\u8bc4\u4f30\u62a5\u544a\u6765\u4f5c\u4e3a\u5448\u62a5\u4fe1\u606f\u7684\u57fa\u7840\u3002\u8be5\u8bc4\u4f30\u62a5\u544a\u662fOKBC\u8981\u6c42DDI\u63d0\u4f9b\u7684\uff0c\u4e14\u8be5\u62a5\u544a\u4e0a\u6709\u4fdd\u5bc6\u58f0\u660e\uff0c\u5373\u300c\u672c\u6587\u4ef6\u5185\u7684\u4fe1\u606f\u5c5e\u8425\u4e1a\u79d8\u5bc6\u3001\u4e14\u5177\u673a\u5bc6\u6027\u3002\u672c\u6863\u6848\u7684\u5185\u5bb9\u5728\u672a\u7ecfTTC\u7684\u4e66\u9762\u540c\u610f\u4e0b\uff0c\u4e0d\u5f97\u4ee5\u4efb\u4f55\u65b9\u5f0f\u590d\u5236\uff0c\u4e5f\u4e0d\u5f97\u4e8e\u516c\u53f8\u6216\u4e3b\u7ba1\u673a\u5173\u4e4b\u5916\u6d41\u901a\u300d\u3002<\/p>\n

TTC\u4e3b\u5f20OKBC\u4e8e2012\u5e743\u6708\u95f4\u5229\u7528\u5176\u673a\u5bc6\u4fe1\u606f\u6765\u56de\u590dFDA\u7684\u8d28\u8be2\u3002\u53e6\u57282012\u5e7412\u6708\u95f4\uff0c\u5c31\u524d\u8ff0FDA\u6240\u8ba4\u53ef\u4e4b\u4e09\u4efd510(k)\u7a97\u4f53\uff08TTC\u85c9DDI\u540d\u6240\u7533\u8bf7\u8005\uff09\uff0cDDI\u5c06\u8be5\u7a97\u4f53\u7684\u6240\u6709\u4eba\u8f6c\u8ba9\u7ed9OKBC\u3002<\/p>\n

\u7cfb\u4e89\u8425\u4e1a\u79d8\u5bc6\u8303\u56f4<\/span><\/p>\n

\u5317\u5361\u7f57\u83b1\u7eb3\u5dde\u6cd5\u9662\u6240\u754c\u5b9a\u4e4b\u7cfb\u4e89\u8425\u4e1a\u79d8\u5bc6\u6d89\u53caTTC\u8840\u7cd6\u4eea\u7684\u7535\u8def\u56fe\u3001\u6d41\u7a0b\u56fe\u3001\u7f16\u7801\u6570\u636e\u6216\u7b97\u6cd5\u3001\u8bed\u97f3\u5185\u5b58\u5927\u5c0f\u3001\u76f8\u5173\u5b9e\u9a8c\u6216\u6d4b\u8bd5\u6570\u636e\u4e0e\u8840\u7cd6\u4eea\u4ea7\u54c1\u62a5\u4ef7\u7b49\u4fe1\u606f\uff0c\u5176\u8bb0\u5f55\u4e8eTTC\u7684\u5185\u90e8\u6587\u4ef6\u6216\u5448\u62a5\u7ed9FDA\u7684\u6587\u4ef6\u3002<\/p>\n

\u8be5\u4e9b\u4fe1\u606f\u56e0\u5c5e\u6280\u672f\u3001\u7a0b\u5e8f\u6216\u5176\u4ed6\u53ef\u7528\u4e8e\u751f\u4ea7\u3001\u9500\u552e\u6216\u7ecf\u8425\u4e4b\u4fe1\u606f\uff0c\u800c\u4ea6\u4e3a\u53f0\u300a\u8425\u4e1a\u79d8\u5bc6\u6cd5\u300b\u6240\u4fdd\u62a4\u76ee\u6807\u3002\u5176\u6b21\uff0c\u4ee5\u6280\u672f\u4fe1\u606f\u4e3a\u4f8b\uff0c\u8be5\u4e9b\u4fe1\u606f\u5e94\u7b26\u5408\u8425\u4e1a\u79d8\u5bc6\u4e09\u8981\u4ef6\u3002\u8840\u7cd6\u4eea\u4e43\u533b\u7597\u5668\u6750\u7684\u91cd\u70b9\u4ea7\u54c1\uff0c\u6545\u7528\u4e8e\u751f\u4ea7\u8840\u7cd6\u4eea\u7684\u6280\u672f\u4fe1\u606f\u5e94\u5177\u7ecf\u6d4e\u4ef7\u503c\u3002\u76f8\u5173\u5b9e\u9a8c\u6570\u636e\u6216\u6d4b\u8bd5\u6570\u636e\u4e5f\u4e00\u6837\uff0c\u56e0\u4e3a\u8be5\u4e9b\u6570\u636e\u662f\u53d6\u5f97\u5408\u6cd5\u9500\u552e\u8bb8\u53ef\u8bc1\u7684\u57fa\u7840\u3002\u53e6\u6570\u636e\u6570\u636e\u53ef\u80fd\u63ed\u793a\u5b9e\u9a8c\u6216\u68c0\u6d4b\u65b9\u6cd5 \u2014 \u53ef\u80fd\u975e\u5c5e\u4e8e\u4e00\u822c\u516c\u5f00\u7684\u79d1\u5b66\u77e5\u8bc6\u53ef\u5f97\uff0c\u800c\u662f\u4ea7\u751f\u4e8e\u8bb8\u53ef\u8bc1\u7533\u8bf7\u4eba\u6216\u76f8\u5173\u5668\u6750\u5236\u9020\u5546\u7b49\u4e0e\u4e3b\u7ba1\u673a\u5173\u95f4\u8ba8\u8bba\u4e4b\u7ed3\u679c\u3002\u6b64\u5916\uff0cTTC\u4ea6\u80fd\u4e3e\u51fa\u7814\u53d1\u6216\u5b9e\u9a8c\u82b1\u8d39\uff0c\u4ee5\u5de6\u8bc1\u7cfb\u4e89\u8425\u4e1a\u79d8\u5bc6\u7684\u4ef7\u503c\u3002<\/p>\n

\u5373\u4f7fTTC\u5c06\u6280\u672f\u6587\u4ef6\u4ea4\u7ed9DDI\uff0c\u4f46\u56e0\u53cc\u65b9\u7b7e\u6709\u4fdd\u5bc6\u534f\u8bae\u4e14\u6587\u4ef6\u4e0a\u6709\u4fdd\u5bc6\u6807\u793a\uff0c\u6545\u8be5\u6280\u672f\u6587\u4ef6\u5e94\u6709\u79d8\u5bc6\u6027\u53ca\u6ee1\u8db3\u5408\u7406\u4fdd\u5bc6\u63aa\u65bd\u3002\u53e6\u5c31\u5448\u62a5\u7ed9FDA\u7684\u6587\u4ef6\uff0c\u76f8\u5173\u4fe1\u606f\u56e0FDA\u5185\u90e8\u4f5c\u4e1a\u7684\u4fe1\u606f\u4fdd\u5bc6\u673a\u5236\u800c\u4ecd\u7ef4\u6301\u79d8\u5bc6\u72b6\u6001[5]<\/a>\u3002<\/p>\n

\u8fd8\u539f\u5de5\u7a0b\u6297\u8fa9\u4e4b\u4e0d\u80fd<\/span><\/p>\n

\u300c\u8fd8\u539f\u5de5\u7a0b\u300d\uff0c\u7cfb\u300c\u6307\u5bf9\u4e00\u9879\u4ea7\u54c1\u8fdb\u884c\u62c6\u5378\u3001\u6d4b\u91cf\u3001\u5206\u6790\u3001\u7814\u7a76\uff0c\u4ee5\u83b7\u5f97\u8be5\u4ea7\u54c1\u4e4b\u76f8\u5173\u6280\u672f\u4fe1\u606f\u300d\uff0c\u800c\u82e5\u300c\u7b2c\u4e09\u4eba\u4ee5\u5408\u6cd5\u624b\u6bb5\u53d6\u5f97\u8425\u4e1a\u79d8\u5bc6\u6240\u9644\u7740\u4e4b\u7269\u540e\uff0c\u4ee5\u300e\u8fd8\u539f\u5de5\u7a0b\u300f\u65b9\u5f0f\u53d6\u5f97\u540c\u6837\u4e4b\u8425\u4e1a\u79d8\u5bc6\uff0c\u6b64\u4e3a\u7b2c\u4e09\u4eba\u81ea\u884c\u7814\u7a76\u5f00\u53d1\u53d6\u5f97\u4e4b\u6210\u679c\uff0c\u5e76\u975e\u4e0d\u516c\u5e73\u7ade\u4e89\u884c\u4e3a\u300d[6]<\/a>\u3002<\/p>\n

\u7cfb\u4e89\u4fe1\u606f\u4e0d\u662f\u9760\u53d6\u5f97TTC\u8840\u7cd6\u4eea\u8fdb\u884c\u8fd8\u539f\u5de5\u7a0b\u6240\u80fd\u8f7b\u6613\u5f97\u77e5\uff0c\u6b64\u7531OKBC\u4e0d\u65ad\u900f\u8fc7DDI\u53bb\u7d22\u53d6TTC\u7684\u6280\u672f\u6587\u4ef6\u5f97\u8bc1\u3002\u51b5\u4e14\u76f8\u5173\u5b9e\u9a8c\u6216\u6d4b\u8bd5\u6570\u636e\u4e0d\u53ef\u80fd\u900f\u8fc7\u516c\u5f00\u7ba1\u9053\u53d6\u5f97\uff0c\u800cOKBC\u4ec5\u80fd\u900f\u8fc7DDI\u516c\u53f8\u4ee5\u4e0d\u6b63\u5f53\u65b9\u6cd5\u83b7\u5f97\uff0c\u6545OKBC\u4e0d\u80fd\u4e3b\u5f20\u8fd8\u539f\u5de5\u7a0b\u6297\u8fa9\u3002\u56e0\u6b64\uff0c\u7cfb\u4e89\u4fe1\u606f\u65e0\u8bba\u662f\u5168\u90e8\u6216\u90e8\u5206\u7686\u4e3a\u8425\u4e1a\u79d8\u5bc6\u3002<\/p>\n

\u5907\u6ce8\uff1a<\/p>\n

    \n
  1. [1]<\/a> https:\/\/www.moneydj.com\/kmdj\/news\/newsviewer.aspx?a=6ec443c2-1ac3-47e0-9930-20e9b8ed3dcc<\/a>\u3002<\/li>\n
  2. [2]<\/a> https:\/\/www.okbiotech.com\/en\/2-2603-0\/news\/OK-Biotech-and-Taidoc-Technology-signed-a-settlement-agreement-of-the-lawsuit-on-31st-May-2016-Please-refer-to-the-Market-Observation-Post-System-for-more-information-id34733.html<\/a>\u3002<\/li>\n
  3. [3]<\/a> TaiDoc Tech. Corp. v. OK Biotech Co., No. 12 CVS 20909, 2016 WL 1221425 (N.C. Super. Mar. 28, 2016).<\/li>\n
  4. [4]<\/a> FDA 510(k)\u7a97\u4f53<\/a>\u3002<\/li>\n
  5. [5]<\/a> Ping-Hsun Chen, Trade Secret Protection on Technical Information in a Premarket Notification Submission for a Medical Device After TaiDoc Tech. Corp. v. OK Biotech Co.<\/em>, 36 Biotechnology Law Report 93 (2017).<\/li>\n
  6. [6]<\/a> \u53f0\u667a\u6167\u8d22\u4ea7\u6cd5\u96622019\u5e74\u5ea6\u5211\u667a\u4e0a\u8bc9\u5b57\u7b2c37\u53f7\u5211\u4e8b\u5224\u51b3<\/a>\/\u7406\u7531\/\u8d30\/\u4e09\/(\u4e8c)\/1\/(1)\u3002<\/li>\n<\/ol>\n

    \u8d23\u4efb\u7f16\u8f91\uff1a\u5362\u9880<\/strong><\/p>\n

    \u3010\u672c\u6587\u4ec5\u53cd\u6620\u4e13\u5bb6\u4f5c\u8005\u610f\u89c1\uff0c\u4e0d\u4ee3\u8868\u672c\u62a5\u7acb\u573a\u3002\u3011<\/strong><\/p>\n\n\n\n
    \n\n\n\n
    \"\"<\/td>\n<\/td>\n\n\n\n\n\n\n\n
    \u4f5c\u8005\uff1a<\/strong><\/td>\n\u9648\u79c9\u8bad<\/strong><\/td>\n<\/tr>\n
    \u73b0\u4efb\uff1a<\/strong><\/td>\n(\u53f0\u6e7e) \u653f\u6cbb\u5927\u5b66\u79d1\u6280\u7ba1\u7406\u4e0e\u667a\u6167\u8d22\u4ea7\u7814\u7a76\u6240\u6559\u6388<\/td>\n<\/tr>\n
    \u7ecf\u5386\uff1a<\/strong><\/td>\n(\u53f0\u6e7e) \u53f0\u5317\u79d1\u6280\u5927\u5b66\u667a\u6167\u8d22\u4ea7\u6743\u7814\u7a76\u6240\u52a9\u7406\u6559\u6388
    \n\u534e\u90a6\u7535\u5b50\u516c\u53f8\u5236\u7a0b\u5de5\u7a0b\u5e08
    \n\u8054\u534e\u7535\u5b50\u516c\u53f8\u5236\u7a0b\u6574\u5408\u7814\u53d1\u5de5\u7a0b\u5e08
    \n\u53f0\u6e7e\u8302\u7845\u7535\u5b50\u516c\u53f8\u4e13\u5229\u5de5\u7a0b\u5e08
    \n\u79b9\u817e\u56fd\u9645\u667a\u6743\u516c\u53f8\u4e13\u5229\u5de5\u7a0b\u5e08
    \n\u5a01\u76db\u7535\u5b50\u516c\u53f8\u4e13\u5229\u5de5\u7a0b\u5e08
    \n\u4e9a\u592a\u56fd\u9645\u4e13\u5229\u5546\u6807\u4e8b\u52a1\u6240\u4e13\u6848\u526f\u7406<\/td>\n<\/tr>\n
    \u5b66\u5386\uff1a<\/strong><\/td>\n\u7f8e\u56fd\u5723\u8def\u6613\u534e\u76db\u987f\u5927\u5b66\u6cd5\u5f8b\u535a\u58eb
    \n\u7f8e\u56fd\u5723\u8def\u6613\u534e\u76db\u987f\u5927\u5b66\u667a\u6167\u8d22\u4ea7\u66a8\u79d1\u6280\u6cd5\u5f8b\u6cd5\u5b66\u7855\u58eb
    \n(\u53f0\u6e7e) \u653f\u6cbb\u5927\u5b66\u6cd5\u5f8b\u79d1\u9645\u6574\u5408\u7814\u7a76\u6240\u6cd5\u5b66\u7855\u58eb
    \n\u53f0\u6e7e\u5927\u5b66\u5316\u5de5\u6240\u7855\u58eb
    \n\u53f0\u6e7e\u5927\u5b66\u5316\u5de5\u7cfb<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

    \u8fd1\u65e5\u5916\u4f20\u4e00\u77e5\u540d\u53f0\u5382\u906d\u524d\u9ad8\u9636\u4e3b\u7ba1\u5c06\u76f8\u5173\u5236\u7a0b\u6280\u672f\u8425\u4e1a\u79d8\u5bc6\u643a\u5f80\u7f8e\u56fd\u3002\u672c\u6587\u6b32\u4ecb\u7ecd\u4e00\u4ef6\u53cc\u65b9\u4e3b\u8981\u5f53\u4e8b\u4eba\u7686\u4e3a\u53f0\u5382\u7684\u7f8e\u56fd\u8425\u4e1a\u79d8\u5bc6\u4fb5\u5bb3\u7ea0\u7eb7\u6848\u3002<\/p>\n","protected":false},"author":10,"featured_media":3483,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[251,268,253,266],"tags":[2524,2529,2530,2531,1534,2525,2526,2527,1789,2528],"author_name1":[332],"class_list":{"0":"post-38276","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-251","8":"category-268","9":"category-253","10":"category-266","11":"tag-510k","12":"tag-fda-zh-hans","13":"tag-fda-cfr-21-zh-hans","14":"tag-n-c-gen-stat-zh-hans","15":"tag-1534","16":"tag-2525","17":"tag-2526","18":"tag-2527","19":"tag-1789","20":"tag-2528","21":"author_name1--zh-hans"},"_links":{"self":[{"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/posts\/38276","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/users\/10"}],"replies":[{"embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/comments?post=38276"}],"version-history":[{"count":1,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/posts\/38276\/revisions"}],"predecessor-version":[{"id":38277,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/posts\/38276\/revisions\/38277"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/media\/3483"}],"wp:attachment":[{"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/media?parent=38276"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/categories?post=38276"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/tags?post=38276"},{"taxonomy":"author_name1","embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/author_name1?post=38276"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}