{"id":4337,"date":"2025-09-04T13:58:22","date_gmt":"2025-09-04T05:58:22","guid":{"rendered":"https:\/\/rohs.ac.cn\/?p=4337"},"modified":"2025-09-04T13:58:22","modified_gmt":"2025-09-04T05:58:22","slug":"%e5%81%9a%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0fda%e8%ae%a4%e8%af%81%e9%9c%80%e8%a6%81%e5%a4%9a%e5%b0%91%e9%92%b1","status":"publish","type":"post","link":"https:\/\/rohs.ac.cn\/?p=4337","title":{"rendered":"\u505a\u533b\u7597\u5668\u68b0fda\u8ba4\u8bc1\u9700\u8981\u591a\u5c11\u94b1"},"content":{"rendered":"

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\u505a\u533b\u7597\u5668\u68b0FDA\u8ba4\u8bc1\u9700\u8981\u591a\u5c11\u94b1\u4e3b\u8981\u53d6\u51b3\u4e8e\u51e0\u4e2a\u6838\u5fc3\u8d39\u7528\u9879\u76ee\u3002\u9996\u5148\u662fFDA\u5b98\u65b9\u6536\u53d6\u7684\u7533\u8bf7\u8d39\uff0c\u8fd9\u4e9b\u8d39\u7528\u6bcf\u5e74\u90fd\u4f1a\u8c03\u6574\u3002\u4f8b\u5982\uff0c2023\u8d22\u5e74\uff0c\u6807\u51c6510(k)\u7533\u8bf7\u7684\u5b98\u65b9\u8d39\u7528\u4e3a\u7ea6$19,870\u7f8e\u5143\uff0c\u800cPMA\u7533\u8bf7\u7684\u8d39\u7528\u9ad8\u8fbe$483,560\u7f8e\u5143\u3002\u5c0f\u578b\u4f01\u4e1a\u53ef\u80fd\u6709\u8d44\u683c\u4eab\u53d7\u8d39\u7528\u51cf\u514d\uff0c510(k)\u8d39\u7528\u53ef\u964d\u81f3\u7ea6$4,968\u7f8e\u5143\uff0cPMA\u8d39\u7528\u964d\u81f3$120,890\u7f8e\u5143\u3002\u56e0\u6b64\uff0c\u4f01\u4e1a\u89c4\u6a21\u662f\u5f71\u54cd\u603b\u6210\u672c\u7684\u91cd\u8981\u56e0\u7d20\u3002<\/p>\n<\/p>\n

\u9664\u4e86\u5b98\u65b9\u7533\u8bf7\u8d39\uff0c\u7b2c\u4e09\u65b9\u670d\u52a1\u6210\u672c\u662f\u53e6\u4e00\u5927\u652f\u51fa\u3002\u8bb8\u591a\u4f01\u4e1a\u9009\u62e9\u8058\u8bf7FDA\u54a8\u8be2\u516c\u53f8\u6216\u6cd5\u5f8b\u987e\u95ee\u6765\u534f\u52a9\u51c6\u5907\u7533\u8bf7\u6750\u6599\uff0c\u8d39\u7528\u4ece$10,000\u5230$100,000\u4ee5\u4e0a\u4e0d\u7b49\uff0c\u5177\u4f53\u53d6\u51b3\u4e8e\u9879\u76ee\u7684\u590d\u6742\u6027\u3002\u4f8b\u5982\uff0c\u7b80\u5355\u7684Class I\u8bbe\u5907\u53ef\u80fd\u53ea\u9700\u51e0\u5343\u7f8e\u5143\u7684\u54a8\u8be2\u8d39\uff0c\u800c\u590d\u6742\u7684Class III\u8bbe\u5907\u53ef\u80fd\u9700\u8981\u5168\u9762\u7684\u6280\u672f\u652f\u6301\uff0c\u5305\u62ec\u4e34\u5e8a\u8bd5\u9a8c\u7ba1\u7406\u3001\u6587\u6863\u7f16\u5199\u548c\u5408\u89c4\u5ba1\u6838\uff0c\u8fd9\u4e9b\u670d\u52a1\u8d39\u7528\u53ef\u80fd\u8d85\u8fc7$50,000\u3002<\/p>\n<\/p>\n

\u6b64\u5916\uff0c\u5982\u679c\u4ea7\u54c1\u9700\u8981\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u76f8\u5173\u8d39\u7528\u5c06\u663e\u8457\u589e\u52a0\u3002\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6210\u672c\u53d6\u51b3\u4e8e\u7814\u7a76\u89c4\u6a21\u3001\u6301\u7eed\u65f6\u95f4\u548c\u5730\u70b9\uff0c\u53ef\u80fd\u4ece\u51e0\u4e07\u7f8e\u5143\u5230\u6570\u767e\u4e07\u7f8e\u5143\u3002\u5176\u4ed6\u6f5c\u5728\u8d39\u7528\u5305\u62ec\u4ea7\u54c1\u6d4b\u8bd5\uff08\u5982\u751f\u7269\u76f8\u5bb9\u6027\u3001\u7535\u6c14\u5b89\u5168\u6d4b\u8bd5\uff09\u3001\u8d28\u91cf\u4f53\u7cfb\u5ba1\u6838\uff08QSR\/GMP compliance\uff09\u4ee5\u53ca\u540e\u7eed\u7684\u7ef4\u62a4\u8d39\u7528\uff08\u5982\u5e74\u5ea6\u6ce8\u518c\u8d39\uff0c\u7ea6$7,000\u7f8e\u5143\u6bcf\u5e74\uff09\u3002\u603b\u4f53\u800c\u8a00\uff0c\u505a\u533b\u7597\u5668\u68b0FDA\u8ba4\u8bc1\u9700\u8981\u591a\u5c11\u94b1\u662f\u4e00\u4e2a\u7efc\u5408\u8ba1\u7b97\uff0c\u603b\u6210\u672c\u53ef\u80fd\u5728$20,000\u5230$500,000+\u4e4b\u95f4\u3002<\/p>\n<\/p>\n

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\u505a\u533b\u7597\u5668\u68b0FDA\u8ba4\u8bc1\u9700\u8981\u591a\u5c11\u94b1\u8fd8\u53d7\u5230\u591a\u79cd\u53d8\u91cf\u7684\u5f71\u54cd\u3002\u4ea7\u54c1\u7684\u6280\u672f\u590d\u6742\u6027\u548c\u521b\u65b0\u7a0b\u5ea6\u662f\u5173\u952e\u56e0\u7d20\u3002\u5168\u65b0\u6216\u9ad8\u98ce\u9669\u8bbe\u5907\u901a\u5e38\u9700\u8981\u66f4\u5168\u9762\u7684\u6570\u636e\u652f\u6301\uff0c\u4ece\u800c\u589e\u52a0\u6d4b\u8bd5\u548c\u6587\u6863\u6210\u672c\u3002\u76f8\u53cd\uff0c\u7c7b\u4f3c\u4e8e\u5df2\u4e0a\u5e02\u4ea7\u54c1\u7684\u8bbe\u5907\u53ef\u4ee5\u901a\u8fc7510(k)\u8def\u5f84\u5f15\u7528predicate device\uff0c\u51cf\u5c11\u4e00\u4e9b\u5de5\u4f5c\u91cf\u3002<\/p>\n<\/p>\n

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\u56db\u3001\u5b9e\u7528\u5efa\u8bae\uff1a\u5982\u4f55\u4f18\u5316\u9884\u7b97\u5e76\u6210\u529f\u83b7\u5f97FDA\u8ba4\u8bc1<\/strong><\/p>\n

\u4e3a\u4e86\u63a7\u5236\u505a\u533b\u7597\u5668\u68b0FDA\u8ba4\u8bc1\u9700\u8981\u591a\u5c11\u94b1\uff0c\u4f01\u4e1a\u53ef\u4ee5\u91c7\u53d6\u4e00\u4e9b\u4f18\u5316\u7b56\u7565\u3002\u9996\u5148\uff0c\u5c3d\u65e9\u8fdb\u884c\u4ea7\u54c1\u5206\u7c7b\u548c\u8def\u5f84\u786e\u5b9a\uff0c\u4ee5\u907f\u514d\u9519\u8bef\u7533\u8bf7\u5e26\u6765\u7684\u989d\u5916\u6210\u672c\u3002\u5229\u7528FDA\u7684\u9884\u63d0\u4ea4\uff08Pre-Submission\uff09\u4f1a\u8bae\uff08\u8d39\u7528\u7ea6$10,000-$20,000\uff09\u53ef\u4ee5\u83b7\u53d6\u5b98\u65b9\u53cd\u9988\uff0c\u51cf\u5c11\u540e\u7eed\u98ce\u9669\u3002<\/p>\n<\/p>\n

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