{"id":52921,"date":"2021-09-29T12:26:33","date_gmt":"2021-09-29T16:26:33","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/"},"modified":"2021-10-12T10:51:17","modified_gmt":"2021-10-12T14:51:17","slug":"medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/","title":{"rendered":"\u6240\u6709\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u53ca\u836f\u54c1\u4f01\u4e1a\u5fc5\u987b\u57282021\u5e7410\u67081\u65e5\u81f32021\u5e7412\u670831\u65e5\u671f\u95f4\u66f4\u65b0\u5176FDA\u6ce8\u518c"},"content":{"rendered":"<p>\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40(FDA)\u8981\u6c42\u751f\u4ea7\u548c\u5206\u9500\u9884\u671f\u5728\u7f8e\u56fd\u4f7f\u7528\u7684\u533b\u7597\u5668\u68b0\u548c\u836f\u54c1\u7684\u4f01\u4e1a\u6bcf\u5e74\u9700\u66f4\u65b0\u5176FDA\u6ce8\u518c\u3002\u8fd9\u4e9b\u4f01\u4e1a\u5fc5\u987b\u57282021\u5e7410\u67081\u65e5\u81f32021\u5e7412\u670831\u65e5\u4e4b\u95f4\u5c06\u5176\u6ce8\u518c\u66f4\u65b0\u81f32022\u5e74\u3002<\/p>\n<p>\u7ee7\u7eed\u9605\u8bfb\uff0c\u4e86\u89e3\u66f4\u65b0\u8981\u6c42\uff0c\u4ee5\u53ca\u5982\u679c\u9519\u8fc7\u4e86\u66f4\u65b0\u671f\u9650\u4f1a\u6709\u54ea\u4e9b\u540e\u679c\u3002<\/p>\n<p><strong>\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u66f4\u65b0\u8981\u6c42<\/strong><\/p>\n<p>\u6240\u6709\u5df2\u5728FDA\u6ce8\u518c\u7684\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u5fc5\u987b\u6307\u5b9a\u4e00\u4e2a\u5b98\u65b9\u8054\u7edc\u4eba\u8d1f\u8d23\u5e74\u5ea6\u6ce8\u518c\u3002\u6b64\u5916\uff0c\u975e\u7f8e\u56fd\u7684\u4f01\u4e1a\u8fd8\u5fc5\u987b\u6307\u5b9a\u4e00\u4e2a\u7f8e\u56fd\u4ee3\u7406\u3002\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u5fc5\u987b\u5728FDA\u7edf\u4e00\u6ce8\u518c\u548c\u5217\u540d\u7cfb\u7edf(FURLS)\u4e2d\u5217\u51fa\u4ed6\u4eec\u7684\u7f8e\u56fd\u4ee3\u7406\u3002\u5982\u679c\u4f01\u4e1a\u5728\u7cfb\u7edf\u4e2d\u5217\u51fa\u7684\u4ee3\u7406\u672a\u80fd\u572810\u5929\u4e4b\u5185\u901a\u8fc7\u7cfb\u7edf\u63a5\u53d7\u4ee3\u7406\u4eba\u6307\u5b9a\uff0c\u4f01\u4e1a\u5fc5\u987b\u91cd\u65b0\u5217\u51fa\u53e6\u4e00\u4e2a\u4ee3\u7406\u3002\u5728\u4ee3\u7406\u4eba\u63a5\u53d7\u6307\u5b9a\u4e4b\u524d\uff0c\u4f01\u4e1a\u7684\u6ce8\u518c\u7eed\u671f\u5c1a\u672a\u5b8c\u6210\u3002<\/p>\n<p>FDA\u8981\u6c42\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u6bcf\u5e74\u9700\u8981\u652f\u4ed8\u5b98\u65b9\u8d39\u7528\u30022022\u8d22\u5e74\u7684\u5b98\u65b9\u8d39\u7528\u4e3a5,672\u7f8e\u5143\uff0c\u6bd42021\u8d22\u5e74\u76845,546\u7a0d\u9ad8\u4e00\u4e9b\u3002<\/p>\n<p><strong>\u836f\u54c1\u4f01\u4e1a\u6ce8\u518c\u66f4\u65b0\u8981\u6c42<\/strong><\/p>\n<p>\u836f\u54c1\u4f01\u4e1a\u5fc5\u987b\u6307\u5b9aFDA\u53ef\u4ee5\u5c31\u4f01\u4e1a\u6ce8\u518c\u4fe1\u606f\u8054\u7cfb\u7684\u6ce8\u518c\u8054\u7cfb\u4eba\u3002\u975e\u7f8e\u56fd\u7684\u4f01\u4e1a\u8fd8\u5fc5\u987b\u6307\u5b9a\u4e00\u4e2a\u7f8e\u56fd\u4ee3\u7406\u3002<\/p>\n<p>\u4f5c\u4e3a\u66f4\u65b0\u7684\u4e00\u90e8\u5206\uff0c\u5df2\u6ce8\u518c\u7684\u836f\u54c1\u4f01\u4e1a\u540c\u65f6\u8fd8\u8981\u5bf9\u5728\u672c\u5e74\u5ea6\u5185\u6ca1\u6709\u66f4\u65b0\u7684\u5217\u540d\u9012\u4ea4\u4e00\u4e2a\u201c\u65e0\u53d8\u66f4\u901a\u77e5\u201d\u4ee5\u8bc1\u660e\u4ea7\u54c1\u4fe1\u606f\u6216\u6807\u7b7e\u6ca1\u6709\u53d8\u66f4\u3002\u8be5\u901a\u77e5\u5fc5\u987b\u4ee5\u7ed3\u6784\u5316\u4ea7\u54c1\u6807\u7b7e(SPL)\u683c\u5f0f\u63d0\u4ea4\u3002<\/p>\n<p>2021\u5e74\uff0cFDA\u6839\u636e\u300aOTC\u4e13\u8bba\u7528\u6237\u8d39\u7528\u6cd5\u6848(OMUFA)\u300b\uff0c\u5bf9\u751f\u4ea7\u6216\u52a0\u5de5\u5927\u591a\u6570OTC\u836f\u54c1\u6210\u54c1\u5242\u578b\u7684\u5df2\u6ce8\u518c\u4f01\u4e1a\u5f81\u6536\u4e86OMUFA\u8d39\u7528\u3002\u4f01\u4e1a\u5728\u6ce8\u518c\u65f6\u4e0d\u9700\u8981\u7f34\u7eb3OMUFA\u8d39\u7528\uff0c\u4f46\u662f\u57282021\u5e74\u671f\u95f4\u8fdb\u884c\u6ce8\u518c\u7684\u4f01\u4e1a\u52302022\u5e746\u6708\u5c06\u6709\u53ef\u80fd\u9700\u8981\u7f34\u7eb3\u8fd9\u7b14\u8d39\u7528\u3002<\/p>\n<p><strong>\u9519\u8fc7\u66f4\u65b0\u671f\u9650\u7684\u540e\u679c<\/strong><\/p>\n<p>\u672a\u80fd\u572812\u670831\u65e5\u622a\u6b62\u65e5\u671f\u4e4b\u524d\u5b8c\u6210\u66f4\u65b0\u7684\u6ce8\u518c\u5c06\u88abFDA\u89c6\u4e3a\u201c\u8fc7\u671f\u201d\u3002 \u6839\u636e\u4ee5\u5f80\u7684\u60ef\u4f8b\uff0cFDA\u4f1a\u5728\u66f4\u65b0\u671f\u9650\u622a\u6b62\u540e\u4e0d\u4e45\u5c31\u5c06\u672a\u80fd\u5b8c\u6210\u66f4\u65b0\u7684\u4f01\u4e1a\u4ece\u5176\u6570\u636e\u5e93\u4e2d\u79fb\u9664\u3002\u4f8b\u5982\uff0c\u57282021\u5e742\u6708\uff0cFDA\u6ce8\u9500\u4e8631%\u7684\u533b\u7597\u5668\u68b0\u6ce8\u518c\uff0c\u539f\u56e0\u662f\u4f01\u4e1a\u672a\u80fd\u5982\u671f\u66f4\u65b0\u3002<\/p>\n<p>\u5728\u7f8e\u56fd\u9500\u552e\u6ce8\u518c\u5df2\u8fc7\u671f\u7684\u533b\u7597\u5668\u68b0\u6216\u836f\u54c1\u662f\u88ab\u7981\u6b62\u7684\u884c\u4e3a\uff0c\u800c\u4e14\u53ef\u80fd\u4f1a\u4f7f\u4f01\u4e1a\u6240\u6709\u8005\u53d7\u5230\u6c11\u4e8b\u6216\u5211\u4e8b\u5904\u7f5a\u3002FDA\u53ef\u80fd\u4f1a\u5411\u751f\u4ea7\u548c\u5411\u7f8e\u56fd\u9500\u552e\u672a\u7ecf\u6709\u6548\u6ce8\u518c\u7684\u533b\u7597\u5668\u68b0\u6216\u836f\u54c1\u4f01\u4e1a\u53d1\u51fa\u8b66\u544a\u4fe1\u3002\u6ce8\u518c\u8fc7\u671f\u7684\u4f01\u4e1a\u51fa\u53e3\u5230\u7f8e\u56fd\u7684\u8d27\u7269\u5728\u62b5\u8fbe\u7f8e\u56fd\u6e2f\u53e3\u65f6\u5c06\u6709\u53ef\u80fd\u88abFDA\u62d2\u7edd\u5165\u5883\u3002\u53ca\u65f6\u66f4\u65b0\u6ce8\u518c\u53ef\u4ee5\u5e2e\u52a9\u907f\u514d\u4ee3\u4ef7\u9ad8\u6602\u7684\u6263\u8d27\u6216\u8005\u5176\u4ed6\u6267\u6cd5\u884c\u52a8\u3002<\/p>\n<p>Registrar Corp\u53ef\u4ee5\u534f\u52a9\u66f4\u65b0\u8d35\u53f8\u7684\u533b\u7597\u5668\u68b0\u6216\u836f\u54c1\u4f01\u4e1a\u6ce8\u518c\uff0c\u5411FDA\u4ee3\u7f34\u5b98\u65b9\u8d39\u7528\uff0c\u5e76\u4e14\u4e3a\u8d35\u53f8\u51fa\u5177\u7b2c\u4e09\u65b9\u7684\u6ce8\u518c\u8bc1\u660e\u3002\u6b64\u5916\uff0cRegistrar Corp\u8fd8\u53ef\u4ee5\u62c5\u4efb\u8d35\u53f8\u7684\u5b98\u65b9\u8054\u7edc\u4eba\u6216\u6ce8\u518c\u8054\u7edc\u4eba\u53ca\u7f8e\u56fd\u4ee3\u7406\u3002<\/p>\n<p><a href=\"https:\/\/regstaging.wpengine.com\/fda-medical-devices\/registration\/renew\/?lead_source=blog\">\u70b9\u51fb\u6b64\u5904\u66f4\u65b0\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u6ce8\u518c<\/a><\/p>\n<p><a href=\"https:\/\/regstaging.wpengine.com\/zh\/fda-drugs\/registration\/?lead_source=blog\">\u70b9\u51fb\u6b64\u5904\u66f4\u65b0\u836f\u54c1\u4f01\u4e1a\u6ce8\u518c<\/a><\/p>\n<p>\u6216\u8005\uff0c\u60a8\u4e5f\u53ef\u4ee5\u81f4\u7535+1-757-224-0177\uff0c\u6216\u901a\u8fc7<a href=\"https:\/\/regstaging.wpengine.com\/livechat\">https:\/\/regstaging.wpengine.com\/livechat<\/a>\u4e0e\u6211\u4eec\u5168\u5929\u5019\u5728\u7ebf\u7684\u6cd5\u89c4\u987e\u95ee\u5373\u65f6\u8054\u7cfb\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40(FDA)\u8981\u6c42\u751f\u4ea7\u548c\u5206\u9500\u9884\u671f\u5728\u7f8e\u56fd\u4f7f\u7528\u7684\u533b\u7597\u5668\u68b0\u548c\u836f\u54c1\u7684\u4f01\u4e1a\u6bcf\u5e74\u9700\u66f4\u65b0\u5176FDA\u6ce8\u518c\u3002\u8fd9\u4e9b\u4f01\u4e1a\u5fc5\u987b\u57282021\u5e7410\u67081\u65e5\u81f32021\u5e7412\u670831\u65e5\u4e4b\u95f4\u5c06\u5176\u6ce8\u518c\u66f4\u65b0\u81f32022\u5e74\u3002 \u7ee7\u7eed\u9605\u8bfb\uff0c\u4e86\u89e3\u66f4\u65b0\u8981\u6c42\uff0c\u4ee5\u53ca\u5982\u679c\u9519\u8fc7\u4e86\u66f4\u65b0\u671f\u9650\u4f1a\u6709\u54ea\u4e9b\u540e\u679c\u3002 \u533b\u7597\u5668\u68b0\u4f01\u4e1a\u66f4\u65b0\u8981\u6c42 \u6240\u6709\u5df2\u5728FDA\u6ce8\u518c\u7684\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u5fc5\u987b\u6307\u5b9a\u4e00\u4e2a\u5b98\u65b9\u8054\u7edc\u4eba\u8d1f\u8d23\u5e74\u5ea6\u6ce8\u518c\u3002\u6b64\u5916\uff0c\u975e\u7f8e\u56fd\u7684\u4f01\u4e1a\u8fd8\u5fc5\u987b\u6307\u5b9a\u4e00\u4e2a\u7f8e\u56fd\u4ee3\u7406\u3002\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u5fc5\u987b\u5728FDA\u7edf\u4e00\u6ce8\u518c\u548c\u5217\u540d\u7cfb\u7edf(FURLS)\u4e2d\u5217\u51fa\u4ed6\u4eec\u7684\u7f8e\u56fd\u4ee3\u7406\u3002\u5982\u679c\u4f01\u4e1a\u5728\u7cfb\u7edf\u4e2d\u5217\u51fa\u7684\u4ee3\u7406\u672a\u80fd\u572810\u5929\u4e4b\u5185\u901a\u8fc7\u7cfb\u7edf\u63a5\u53d7\u4ee3\u7406\u4eba\u6307\u5b9a\uff0c\u4f01\u4e1a\u5fc5\u987b\u91cd\u65b0\u5217\u51fa\u53e6\u4e00\u4e2a\u4ee3\u7406\u3002\u5728\u4ee3\u7406\u4eba\u63a5\u53d7\u6307\u5b9a\u4e4b\u524d\uff0c\u4f01\u4e1a\u7684\u6ce8\u518c\u7eed\u671f\u5c1a\u672a\u5b8c\u6210\u3002 FDA\u8981\u6c42\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u6bcf\u5e74\u9700\u8981\u652f\u4ed8\u5b98\u65b9\u8d39\u7528\u30022022\u8d22\u5e74\u7684\u5b98\u65b9\u8d39\u7528\u4e3a5,672\u7f8e\u5143\uff0c\u6bd42021\u8d22\u5e74\u76845,546\u7a0d\u9ad8\u4e00\u4e9b\u3002 \u836f\u54c1\u4f01\u4e1a\u6ce8\u518c\u66f4\u65b0\u8981\u6c42 \u836f\u54c1\u4f01\u4e1a\u5fc5\u987b\u6307\u5b9aFDA\u53ef\u4ee5\u5c31\u4f01\u4e1a\u6ce8\u518c\u4fe1\u606f\u8054\u7cfb\u7684\u6ce8\u518c\u8054\u7cfb\u4eba\u3002\u975e\u7f8e\u56fd\u7684\u4f01\u4e1a\u8fd8\u5fc5\u987b\u6307\u5b9a\u4e00\u4e2a\u7f8e\u56fd\u4ee3\u7406\u3002 \u4f5c\u4e3a\u66f4\u65b0\u7684\u4e00\u90e8\u5206\uff0c\u5df2\u6ce8\u518c\u7684\u836f\u54c1\u4f01\u4e1a\u540c\u65f6\u8fd8\u8981\u5bf9\u5728\u672c\u5e74\u5ea6\u5185\u6ca1\u6709\u66f4\u65b0\u7684\u5217\u540d\u9012\u4ea4\u4e00\u4e2a\u201c\u65e0\u53d8\u66f4\u901a\u77e5\u201d\u4ee5\u8bc1\u660e\u4ea7\u54c1\u4fe1\u606f\u6216\u6807\u7b7e\u6ca1\u6709\u53d8\u66f4\u3002\u8be5\u901a\u77e5\u5fc5\u987b\u4ee5\u7ed3\u6784\u5316\u4ea7\u54c1\u6807\u7b7e(SPL)\u683c\u5f0f\u63d0\u4ea4\u3002 2021\u5e74\uff0cFDA\u6839\u636e\u300aOTC\u4e13\u8bba\u7528\u6237\u8d39\u7528\u6cd5\u6848(OMUFA)\u300b\uff0c\u5bf9\u751f\u4ea7\u6216\u52a0\u5de5\u5927\u591a\u6570OTC\u836f\u54c1\u6210\u54c1\u5242\u578b\u7684\u5df2\u6ce8\u518c\u4f01\u4e1a\u5f81\u6536\u4e86OMUFA\u8d39\u7528\u3002\u4f01\u4e1a\u5728\u6ce8\u518c\u65f6\u4e0d\u9700\u8981\u7f34\u7eb3OMUFA\u8d39\u7528\uff0c\u4f46\u662f\u57282021\u5e74\u671f\u95f4\u8fdb\u884c\u6ce8\u518c\u7684\u4f01\u4e1a\u52302022\u5e746\u6708\u5c06\u6709\u53ef\u80fd\u9700\u8981\u7f34\u7eb3\u8fd9\u7b14\u8d39\u7528\u3002 \u9519\u8fc7\u66f4\u65b0\u671f\u9650\u7684\u540e\u679c \u672a\u80fd\u572812\u670831\u65e5\u622a\u6b62\u65e5\u671f\u4e4b\u524d\u5b8c\u6210\u66f4\u65b0\u7684\u6ce8\u518c\u5c06\u88abFDA\u89c6\u4e3a\u201c\u8fc7\u671f\u201d\u3002 \u6839\u636e\u4ee5\u5f80\u7684\u60ef\u4f8b\uff0cFDA\u4f1a\u5728\u66f4\u65b0\u671f\u9650\u622a\u6b62\u540e\u4e0d\u4e45\u5c31\u5c06\u672a\u80fd\u5b8c\u6210\u66f4\u65b0\u7684\u4f01\u4e1a\u4ece\u5176\u6570\u636e\u5e93\u4e2d\u79fb\u9664\u3002\u4f8b\u5982\uff0c\u57282021\u5e742\u6708\uff0cFDA\u6ce8\u9500\u4e8631%\u7684\u533b\u7597\u5668\u68b0\u6ce8\u518c\uff0c\u539f\u56e0\u662f\u4f01\u4e1a\u672a\u80fd\u5982\u671f\u66f4\u65b0\u3002 \u5728\u7f8e\u56fd\u9500\u552e\u6ce8\u518c\u5df2\u8fc7\u671f\u7684\u533b\u7597\u5668\u68b0\u6216\u836f\u54c1\u662f\u88ab\u7981\u6b62\u7684\u884c\u4e3a\uff0c\u800c\u4e14\u53ef\u80fd\u4f1a\u4f7f\u4f01\u4e1a\u6240\u6709\u8005\u53d7\u5230\u6c11\u4e8b\u6216\u5211\u4e8b\u5904\u7f5a\u3002FDA\u53ef\u80fd\u4f1a\u5411\u751f\u4ea7\u548c\u5411\u7f8e\u56fd\u9500\u552e\u672a\u7ecf\u6709\u6548\u6ce8\u518c\u7684\u533b\u7597\u5668\u68b0\u6216\u836f\u54c1\u4f01\u4e1a\u53d1\u51fa\u8b66\u544a\u4fe1\u3002\u6ce8\u518c\u8fc7\u671f\u7684\u4f01\u4e1a\u51fa\u53e3\u5230\u7f8e\u56fd\u7684\u8d27\u7269\u5728\u62b5\u8fbe\u7f8e\u56fd\u6e2f\u53e3\u65f6\u5c06\u6709\u53ef\u80fd\u88abFDA\u62d2\u7edd\u5165\u5883\u3002\u53ca\u65f6\u66f4\u65b0\u6ce8\u518c\u53ef\u4ee5\u5e2e\u52a9\u907f\u514d\u4ee3\u4ef7\u9ad8\u6602\u7684\u6263\u8d27\u6216\u8005\u5176\u4ed6\u6267\u6cd5\u884c\u52a8\u3002 Registrar Corp\u53ef\u4ee5\u534f\u52a9\u66f4\u65b0\u8d35\u53f8\u7684\u533b\u7597\u5668\u68b0\u6216\u836f\u54c1\u4f01\u4e1a\u6ce8\u518c\uff0c\u5411FDA\u4ee3\u7f34\u5b98\u65b9\u8d39\u7528\uff0c\u5e76\u4e14\u4e3a\u8d35\u53f8\u51fa\u5177\u7b2c\u4e09\u65b9\u7684\u6ce8\u518c\u8bc1\u660e\u3002\u6b64\u5916\uff0cRegistrar Corp\u8fd8\u53ef\u4ee5\u62c5\u4efb\u8d35\u53f8\u7684\u5b98\u65b9\u8054\u7edc\u4eba\u6216\u6ce8\u518c\u8054\u7edc\u4eba\u53ca\u7f8e\u56fd\u4ee3\u7406\u3002 \u70b9\u51fb\u6b64\u5904\u66f4\u65b0\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u6ce8\u518c \u70b9\u51fb\u6b64\u5904\u66f4\u65b0\u836f\u54c1\u4f01\u4e1a\u6ce8\u518c \u6216\u8005\uff0c\u60a8\u4e5f\u53ef\u4ee5\u81f4\u7535+1-757-224-0177\uff0c\u6216\u901a\u8fc7https:\/\/regstaging.wpengine.com\/livechat\u4e0e\u6211\u4eec\u5168\u5929\u5019\u5728\u7ebf\u7684\u6cd5\u89c4\u987e\u95ee\u5373\u65f6\u8054\u7cfb\u3002<\/p>\n","protected":false},"author":30,"featured_media":52621,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"content-type":"","om_disable_all_campaigns":false,"inline_featured_image":false,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[69,68],"tags":[],"class_list":{"0":"post-52921","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medical-devices-zh","8":"category-drugs-zh","9":"entry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.9 (Yoast SEO v25.5) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>\u6240\u6709\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u53ca\u836f\u54c1\u4f01\u4e1a\u5fc5\u987b\u57282021\u5e7410\u67081\u65e5\u81f32021\u5e7412\u670831\u65e5\u671f\u95f4\u66f4\u65b0\u5176FDA\u6ce8\u518c - Registrar<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u6240\u6709\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u53ca\u836f\u54c1\u4f01\u4e1a\u5fc5\u987b\u57282021\u5e7410\u67081\u65e5\u81f32021\u5e7412\u670831\u65e5\u671f\u95f4\u66f4\u65b0\u5176FDA\u6ce8\u518c\" \/>\n<meta property=\"og:description\" content=\"\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40(FDA)\u8981\u6c42\u751f\u4ea7\u548c\u5206\u9500\u9884\u671f\u5728\u7f8e\u56fd\u4f7f\u7528\u7684\u533b\u7597\u5668\u68b0\u548c\u836f\u54c1\u7684\u4f01\u4e1a\u6bcf\u5e74\u9700\u66f4\u65b0\u5176FDA\u6ce8\u518c\u3002\u8fd9\u4e9b\u4f01\u4e1a\u5fc5\u987b\u57282021\u5e7410\u67081\u65e5\u81f32021\u5e7412\u670831\u65e5\u4e4b\u95f4\u5c06\u5176\u6ce8\u518c\u66f4\u65b0\u81f32022\u5e74\u3002 \u7ee7\u7eed\u9605\u8bfb\uff0c\u4e86\u89e3\u66f4\u65b0\u8981\u6c42\uff0c\u4ee5\u53ca\u5982\u679c\u9519\u8fc7\u4e86\u66f4\u65b0\u671f\u9650\u4f1a\u6709\u54ea\u4e9b\u540e\u679c\u3002 \u533b\u7597\u5668\u68b0\u4f01\u4e1a\u66f4\u65b0\u8981\u6c42 \u6240\u6709\u5df2\u5728FDA\u6ce8\u518c\u7684\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u5fc5\u987b\u6307\u5b9a\u4e00\u4e2a\u5b98\u65b9\u8054\u7edc\u4eba\u8d1f\u8d23\u5e74\u5ea6\u6ce8\u518c\u3002\u6b64\u5916\uff0c\u975e\u7f8e\u56fd\u7684\u4f01\u4e1a\u8fd8\u5fc5\u987b\u6307\u5b9a\u4e00\u4e2a\u7f8e\u56fd\u4ee3\u7406\u3002\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u5fc5\u987b\u5728FDA\u7edf\u4e00\u6ce8\u518c\u548c\u5217\u540d\u7cfb\u7edf(FURLS)\u4e2d\u5217\u51fa\u4ed6\u4eec\u7684\u7f8e\u56fd\u4ee3\u7406\u3002\u5982\u679c\u4f01\u4e1a\u5728\u7cfb\u7edf\u4e2d\u5217\u51fa\u7684\u4ee3\u7406\u672a\u80fd\u572810\u5929\u4e4b\u5185\u901a\u8fc7\u7cfb\u7edf\u63a5\u53d7\u4ee3\u7406\u4eba\u6307\u5b9a\uff0c\u4f01\u4e1a\u5fc5\u987b\u91cd\u65b0\u5217\u51fa\u53e6\u4e00\u4e2a\u4ee3\u7406\u3002\u5728\u4ee3\u7406\u4eba\u63a5\u53d7\u6307\u5b9a\u4e4b\u524d\uff0c\u4f01\u4e1a\u7684\u6ce8\u518c\u7eed\u671f\u5c1a\u672a\u5b8c\u6210\u3002 FDA\u8981\u6c42\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u6bcf\u5e74\u9700\u8981\u652f\u4ed8\u5b98\u65b9\u8d39\u7528\u30022022\u8d22\u5e74\u7684\u5b98\u65b9\u8d39\u7528\u4e3a5,672\u7f8e\u5143\uff0c\u6bd42021\u8d22\u5e74\u76845,546\u7a0d\u9ad8\u4e00\u4e9b\u3002 \u836f\u54c1\u4f01\u4e1a\u6ce8\u518c\u66f4\u65b0\u8981\u6c42 \u836f\u54c1\u4f01\u4e1a\u5fc5\u987b\u6307\u5b9aFDA\u53ef\u4ee5\u5c31\u4f01\u4e1a\u6ce8\u518c\u4fe1\u606f\u8054\u7cfb\u7684\u6ce8\u518c\u8054\u7cfb\u4eba\u3002\u975e\u7f8e\u56fd\u7684\u4f01\u4e1a\u8fd8\u5fc5\u987b\u6307\u5b9a\u4e00\u4e2a\u7f8e\u56fd\u4ee3\u7406\u3002 \u4f5c\u4e3a\u66f4\u65b0\u7684\u4e00\u90e8\u5206\uff0c\u5df2\u6ce8\u518c\u7684\u836f\u54c1\u4f01\u4e1a\u540c\u65f6\u8fd8\u8981\u5bf9\u5728\u672c\u5e74\u5ea6\u5185\u6ca1\u6709\u66f4\u65b0\u7684\u5217\u540d\u9012\u4ea4\u4e00\u4e2a\u201c\u65e0\u53d8\u66f4\u901a\u77e5\u201d\u4ee5\u8bc1\u660e\u4ea7\u54c1\u4fe1\u606f\u6216\u6807\u7b7e\u6ca1\u6709\u53d8\u66f4\u3002\u8be5\u901a\u77e5\u5fc5\u987b\u4ee5\u7ed3\u6784\u5316\u4ea7\u54c1\u6807\u7b7e(SPL)\u683c\u5f0f\u63d0\u4ea4\u3002 2021\u5e74\uff0cFDA\u6839\u636e\u300aOTC\u4e13\u8bba\u7528\u6237\u8d39\u7528\u6cd5\u6848(OMUFA)\u300b\uff0c\u5bf9\u751f\u4ea7\u6216\u52a0\u5de5\u5927\u591a\u6570OTC\u836f\u54c1\u6210\u54c1\u5242\u578b\u7684\u5df2\u6ce8\u518c\u4f01\u4e1a\u5f81\u6536\u4e86OMUFA\u8d39\u7528\u3002\u4f01\u4e1a\u5728\u6ce8\u518c\u65f6\u4e0d\u9700\u8981\u7f34\u7eb3OMUFA\u8d39\u7528\uff0c\u4f46\u662f\u57282021\u5e74\u671f\u95f4\u8fdb\u884c\u6ce8\u518c\u7684\u4f01\u4e1a\u52302022\u5e746\u6708\u5c06\u6709\u53ef\u80fd\u9700\u8981\u7f34\u7eb3\u8fd9\u7b14\u8d39\u7528\u3002 \u9519\u8fc7\u66f4\u65b0\u671f\u9650\u7684\u540e\u679c \u672a\u80fd\u572812\u670831\u65e5\u622a\u6b62\u65e5\u671f\u4e4b\u524d\u5b8c\u6210\u66f4\u65b0\u7684\u6ce8\u518c\u5c06\u88abFDA\u89c6\u4e3a\u201c\u8fc7\u671f\u201d\u3002 \u6839\u636e\u4ee5\u5f80\u7684\u60ef\u4f8b\uff0cFDA\u4f1a\u5728\u66f4\u65b0\u671f\u9650\u622a\u6b62\u540e\u4e0d\u4e45\u5c31\u5c06\u672a\u80fd\u5b8c\u6210\u66f4\u65b0\u7684\u4f01\u4e1a\u4ece\u5176\u6570\u636e\u5e93\u4e2d\u79fb\u9664\u3002\u4f8b\u5982\uff0c\u57282021\u5e742\u6708\uff0cFDA\u6ce8\u9500\u4e8631%\u7684\u533b\u7597\u5668\u68b0\u6ce8\u518c\uff0c\u539f\u56e0\u662f\u4f01\u4e1a\u672a\u80fd\u5982\u671f\u66f4\u65b0\u3002 \u5728\u7f8e\u56fd\u9500\u552e\u6ce8\u518c\u5df2\u8fc7\u671f\u7684\u533b\u7597\u5668\u68b0\u6216\u836f\u54c1\u662f\u88ab\u7981\u6b62\u7684\u884c\u4e3a\uff0c\u800c\u4e14\u53ef\u80fd\u4f1a\u4f7f\u4f01\u4e1a\u6240\u6709\u8005\u53d7\u5230\u6c11\u4e8b\u6216\u5211\u4e8b\u5904\u7f5a\u3002FDA\u53ef\u80fd\u4f1a\u5411\u751f\u4ea7\u548c\u5411\u7f8e\u56fd\u9500\u552e\u672a\u7ecf\u6709\u6548\u6ce8\u518c\u7684\u533b\u7597\u5668\u68b0\u6216\u836f\u54c1\u4f01\u4e1a\u53d1\u51fa\u8b66\u544a\u4fe1\u3002\u6ce8\u518c\u8fc7\u671f\u7684\u4f01\u4e1a\u51fa\u53e3\u5230\u7f8e\u56fd\u7684\u8d27\u7269\u5728\u62b5\u8fbe\u7f8e\u56fd\u6e2f\u53e3\u65f6\u5c06\u6709\u53ef\u80fd\u88abFDA\u62d2\u7edd\u5165\u5883\u3002\u53ca\u65f6\u66f4\u65b0\u6ce8\u518c\u53ef\u4ee5\u5e2e\u52a9\u907f\u514d\u4ee3\u4ef7\u9ad8\u6602\u7684\u6263\u8d27\u6216\u8005\u5176\u4ed6\u6267\u6cd5\u884c\u52a8\u3002 Registrar Corp\u53ef\u4ee5\u534f\u52a9\u66f4\u65b0\u8d35\u53f8\u7684\u533b\u7597\u5668\u68b0\u6216\u836f\u54c1\u4f01\u4e1a\u6ce8\u518c\uff0c\u5411FDA\u4ee3\u7f34\u5b98\u65b9\u8d39\u7528\uff0c\u5e76\u4e14\u4e3a\u8d35\u53f8\u51fa\u5177\u7b2c\u4e09\u65b9\u7684\u6ce8\u518c\u8bc1\u660e\u3002\u6b64\u5916\uff0cRegistrar Corp\u8fd8\u53ef\u4ee5\u62c5\u4efb\u8d35\u53f8\u7684\u5b98\u65b9\u8054\u7edc\u4eba\u6216\u6ce8\u518c\u8054\u7edc\u4eba\u53ca\u7f8e\u56fd\u4ee3\u7406\u3002 \u70b9\u51fb\u6b64\u5904\u66f4\u65b0\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u6ce8\u518c \u70b9\u51fb\u6b64\u5904\u66f4\u65b0\u836f\u54c1\u4f01\u4e1a\u6ce8\u518c \u6216\u8005\uff0c\u60a8\u4e5f\u53ef\u4ee5\u81f4\u7535+1-757-224-0177\uff0c\u6216\u901a\u8fc7https:\/\/regstaging.wpengine.com\/livechat\u4e0e\u6211\u4eec\u5168\u5929\u5019\u5728\u7ebf\u7684\u6cd5\u89c4\u987e\u95ee\u5373\u65f6\u8054\u7cfb\u3002\" \/>\n<meta property=\"og:url\" content=\"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/\" \/>\n<meta property=\"og:site_name\" content=\"Registrar\" \/>\n<meta property=\"article:published_time\" content=\"2021-09-29T16:26:33+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-10-12T14:51:17+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2021\/09\/flat-lay-health-still-life-arrangement-with-copy-space-scaled-e1632932697588.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1440\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Mason Grandusky\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Mason Grandusky\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/\"},\"author\":{\"name\":\"Mason Grandusky\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/#\/schema\/person\/5460f453ed04f326b4ef5280009675f2\"},\"headline\":\"\u6240\u6709\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u53ca\u836f\u54c1\u4f01\u4e1a\u5fc5\u987b\u57282021\u5e7410\u67081\u65e5\u81f32021\u5e7412\u670831\u65e5\u671f\u95f4\u66f4\u65b0\u5176FDA\u6ce8\u518c\",\"datePublished\":\"2021-09-29T16:26:33+00:00\",\"dateModified\":\"2021-10-12T14:51:17+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/\"},\"wordCount\":33,\"publisher\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/#organization\"},\"image\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2021\/09\/flat-lay-health-still-life-arrangement-with-copy-space-scaled-e1632932697588.jpg\",\"articleSection\":[\"\u533b\u7597\u5668\u68b0\",\"\u836f\u54c1\"],\"inLanguage\":\"zh\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/\",\"url\":\"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/\",\"name\":\"\u6240\u6709\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u53ca\u836f\u54c1\u4f01\u4e1a\u5fc5\u987b\u57282021\u5e7410\u67081\u65e5\u81f32021\u5e7412\u670831\u65e5\u671f\u95f4\u66f4\u65b0\u5176FDA\u6ce8\u518c - Registrar\",\"isPartOf\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2021\/09\/flat-lay-health-still-life-arrangement-with-copy-space-scaled-e1632932697588.jpg\",\"datePublished\":\"2021-09-29T16:26:33+00:00\",\"dateModified\":\"2021-10-12T14:51:17+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/#breadcrumb\"},\"inLanguage\":\"zh\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"zh\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/#primaryimage\",\"url\":\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2021\/09\/flat-lay-health-still-life-arrangement-with-copy-space-scaled-e1632932697588.jpg\",\"contentUrl\":\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2021\/09\/flat-lay-health-still-life-arrangement-with-copy-space-scaled-e1632932697588.jpg\",\"width\":2560,\"height\":1440},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/legacy.registrarcorp.com\/zh\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"\u6240\u6709\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u53ca\u836f\u54c1\u4f01\u4e1a\u5fc5\u987b\u57282021\u5e7410\u67081\u65e5\u81f32021\u5e7412\u670831\u65e5\u671f\u95f4\u66f4\u65b0\u5176FDA\u6ce8\u518c\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/#website\",\"url\":\"https:\/\/legacy.registrarcorp.com\/zh\/\",\"name\":\"Registrar\",\"description\":\"Assistance with U.S. FDA Regulations\",\"publisher\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/legacy.registrarcorp.com\/zh\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"zh\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/#organization\",\"name\":\"Registrar Corp\",\"url\":\"https:\/\/legacy.registrarcorp.com\/zh\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"zh\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2019\/12\/regcorp_logo.png\",\"contentUrl\":\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2019\/12\/regcorp_logo.png\",\"width\":1326,\"height\":330,\"caption\":\"Registrar Corp\"},\"image\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/#\/schema\/logo\/image\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/#\/schema\/person\/5460f453ed04f326b4ef5280009675f2\",\"name\":\"Mason Grandusky\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"zh\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/20ae894ac7fdae57b794f1b1792f9c9f1920bc809d0aab245d70e0aa7c997266?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/20ae894ac7fdae57b794f1b1792f9c9f1920bc809d0aab245d70e0aa7c997266?s=96&d=mm&r=g\",\"caption\":\"Mason Grandusky\"},\"url\":\"https:\/\/legacy.registrarcorp.com\/zh\/author\/mgrandusky\/\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"\u6240\u6709\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u53ca\u836f\u54c1\u4f01\u4e1a\u5fc5\u987b\u57282021\u5e7410\u67081\u65e5\u81f32021\u5e7412\u670831\u65e5\u671f\u95f4\u66f4\u65b0\u5176FDA\u6ce8\u518c - Registrar","robots":{"index":"noindex","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"og_locale":"zh_CN","og_type":"article","og_title":"\u6240\u6709\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u53ca\u836f\u54c1\u4f01\u4e1a\u5fc5\u987b\u57282021\u5e7410\u67081\u65e5\u81f32021\u5e7412\u670831\u65e5\u671f\u95f4\u66f4\u65b0\u5176FDA\u6ce8\u518c","og_description":"\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40(FDA)\u8981\u6c42\u751f\u4ea7\u548c\u5206\u9500\u9884\u671f\u5728\u7f8e\u56fd\u4f7f\u7528\u7684\u533b\u7597\u5668\u68b0\u548c\u836f\u54c1\u7684\u4f01\u4e1a\u6bcf\u5e74\u9700\u66f4\u65b0\u5176FDA\u6ce8\u518c\u3002\u8fd9\u4e9b\u4f01\u4e1a\u5fc5\u987b\u57282021\u5e7410\u67081\u65e5\u81f32021\u5e7412\u670831\u65e5\u4e4b\u95f4\u5c06\u5176\u6ce8\u518c\u66f4\u65b0\u81f32022\u5e74\u3002 \u7ee7\u7eed\u9605\u8bfb\uff0c\u4e86\u89e3\u66f4\u65b0\u8981\u6c42\uff0c\u4ee5\u53ca\u5982\u679c\u9519\u8fc7\u4e86\u66f4\u65b0\u671f\u9650\u4f1a\u6709\u54ea\u4e9b\u540e\u679c\u3002 \u533b\u7597\u5668\u68b0\u4f01\u4e1a\u66f4\u65b0\u8981\u6c42 \u6240\u6709\u5df2\u5728FDA\u6ce8\u518c\u7684\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u5fc5\u987b\u6307\u5b9a\u4e00\u4e2a\u5b98\u65b9\u8054\u7edc\u4eba\u8d1f\u8d23\u5e74\u5ea6\u6ce8\u518c\u3002\u6b64\u5916\uff0c\u975e\u7f8e\u56fd\u7684\u4f01\u4e1a\u8fd8\u5fc5\u987b\u6307\u5b9a\u4e00\u4e2a\u7f8e\u56fd\u4ee3\u7406\u3002\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u5fc5\u987b\u5728FDA\u7edf\u4e00\u6ce8\u518c\u548c\u5217\u540d\u7cfb\u7edf(FURLS)\u4e2d\u5217\u51fa\u4ed6\u4eec\u7684\u7f8e\u56fd\u4ee3\u7406\u3002\u5982\u679c\u4f01\u4e1a\u5728\u7cfb\u7edf\u4e2d\u5217\u51fa\u7684\u4ee3\u7406\u672a\u80fd\u572810\u5929\u4e4b\u5185\u901a\u8fc7\u7cfb\u7edf\u63a5\u53d7\u4ee3\u7406\u4eba\u6307\u5b9a\uff0c\u4f01\u4e1a\u5fc5\u987b\u91cd\u65b0\u5217\u51fa\u53e6\u4e00\u4e2a\u4ee3\u7406\u3002\u5728\u4ee3\u7406\u4eba\u63a5\u53d7\u6307\u5b9a\u4e4b\u524d\uff0c\u4f01\u4e1a\u7684\u6ce8\u518c\u7eed\u671f\u5c1a\u672a\u5b8c\u6210\u3002 FDA\u8981\u6c42\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u6bcf\u5e74\u9700\u8981\u652f\u4ed8\u5b98\u65b9\u8d39\u7528\u30022022\u8d22\u5e74\u7684\u5b98\u65b9\u8d39\u7528\u4e3a5,672\u7f8e\u5143\uff0c\u6bd42021\u8d22\u5e74\u76845,546\u7a0d\u9ad8\u4e00\u4e9b\u3002 \u836f\u54c1\u4f01\u4e1a\u6ce8\u518c\u66f4\u65b0\u8981\u6c42 \u836f\u54c1\u4f01\u4e1a\u5fc5\u987b\u6307\u5b9aFDA\u53ef\u4ee5\u5c31\u4f01\u4e1a\u6ce8\u518c\u4fe1\u606f\u8054\u7cfb\u7684\u6ce8\u518c\u8054\u7cfb\u4eba\u3002\u975e\u7f8e\u56fd\u7684\u4f01\u4e1a\u8fd8\u5fc5\u987b\u6307\u5b9a\u4e00\u4e2a\u7f8e\u56fd\u4ee3\u7406\u3002 \u4f5c\u4e3a\u66f4\u65b0\u7684\u4e00\u90e8\u5206\uff0c\u5df2\u6ce8\u518c\u7684\u836f\u54c1\u4f01\u4e1a\u540c\u65f6\u8fd8\u8981\u5bf9\u5728\u672c\u5e74\u5ea6\u5185\u6ca1\u6709\u66f4\u65b0\u7684\u5217\u540d\u9012\u4ea4\u4e00\u4e2a\u201c\u65e0\u53d8\u66f4\u901a\u77e5\u201d\u4ee5\u8bc1\u660e\u4ea7\u54c1\u4fe1\u606f\u6216\u6807\u7b7e\u6ca1\u6709\u53d8\u66f4\u3002\u8be5\u901a\u77e5\u5fc5\u987b\u4ee5\u7ed3\u6784\u5316\u4ea7\u54c1\u6807\u7b7e(SPL)\u683c\u5f0f\u63d0\u4ea4\u3002 2021\u5e74\uff0cFDA\u6839\u636e\u300aOTC\u4e13\u8bba\u7528\u6237\u8d39\u7528\u6cd5\u6848(OMUFA)\u300b\uff0c\u5bf9\u751f\u4ea7\u6216\u52a0\u5de5\u5927\u591a\u6570OTC\u836f\u54c1\u6210\u54c1\u5242\u578b\u7684\u5df2\u6ce8\u518c\u4f01\u4e1a\u5f81\u6536\u4e86OMUFA\u8d39\u7528\u3002\u4f01\u4e1a\u5728\u6ce8\u518c\u65f6\u4e0d\u9700\u8981\u7f34\u7eb3OMUFA\u8d39\u7528\uff0c\u4f46\u662f\u57282021\u5e74\u671f\u95f4\u8fdb\u884c\u6ce8\u518c\u7684\u4f01\u4e1a\u52302022\u5e746\u6708\u5c06\u6709\u53ef\u80fd\u9700\u8981\u7f34\u7eb3\u8fd9\u7b14\u8d39\u7528\u3002 \u9519\u8fc7\u66f4\u65b0\u671f\u9650\u7684\u540e\u679c \u672a\u80fd\u572812\u670831\u65e5\u622a\u6b62\u65e5\u671f\u4e4b\u524d\u5b8c\u6210\u66f4\u65b0\u7684\u6ce8\u518c\u5c06\u88abFDA\u89c6\u4e3a\u201c\u8fc7\u671f\u201d\u3002 \u6839\u636e\u4ee5\u5f80\u7684\u60ef\u4f8b\uff0cFDA\u4f1a\u5728\u66f4\u65b0\u671f\u9650\u622a\u6b62\u540e\u4e0d\u4e45\u5c31\u5c06\u672a\u80fd\u5b8c\u6210\u66f4\u65b0\u7684\u4f01\u4e1a\u4ece\u5176\u6570\u636e\u5e93\u4e2d\u79fb\u9664\u3002\u4f8b\u5982\uff0c\u57282021\u5e742\u6708\uff0cFDA\u6ce8\u9500\u4e8631%\u7684\u533b\u7597\u5668\u68b0\u6ce8\u518c\uff0c\u539f\u56e0\u662f\u4f01\u4e1a\u672a\u80fd\u5982\u671f\u66f4\u65b0\u3002 \u5728\u7f8e\u56fd\u9500\u552e\u6ce8\u518c\u5df2\u8fc7\u671f\u7684\u533b\u7597\u5668\u68b0\u6216\u836f\u54c1\u662f\u88ab\u7981\u6b62\u7684\u884c\u4e3a\uff0c\u800c\u4e14\u53ef\u80fd\u4f1a\u4f7f\u4f01\u4e1a\u6240\u6709\u8005\u53d7\u5230\u6c11\u4e8b\u6216\u5211\u4e8b\u5904\u7f5a\u3002FDA\u53ef\u80fd\u4f1a\u5411\u751f\u4ea7\u548c\u5411\u7f8e\u56fd\u9500\u552e\u672a\u7ecf\u6709\u6548\u6ce8\u518c\u7684\u533b\u7597\u5668\u68b0\u6216\u836f\u54c1\u4f01\u4e1a\u53d1\u51fa\u8b66\u544a\u4fe1\u3002\u6ce8\u518c\u8fc7\u671f\u7684\u4f01\u4e1a\u51fa\u53e3\u5230\u7f8e\u56fd\u7684\u8d27\u7269\u5728\u62b5\u8fbe\u7f8e\u56fd\u6e2f\u53e3\u65f6\u5c06\u6709\u53ef\u80fd\u88abFDA\u62d2\u7edd\u5165\u5883\u3002\u53ca\u65f6\u66f4\u65b0\u6ce8\u518c\u53ef\u4ee5\u5e2e\u52a9\u907f\u514d\u4ee3\u4ef7\u9ad8\u6602\u7684\u6263\u8d27\u6216\u8005\u5176\u4ed6\u6267\u6cd5\u884c\u52a8\u3002 Registrar Corp\u53ef\u4ee5\u534f\u52a9\u66f4\u65b0\u8d35\u53f8\u7684\u533b\u7597\u5668\u68b0\u6216\u836f\u54c1\u4f01\u4e1a\u6ce8\u518c\uff0c\u5411FDA\u4ee3\u7f34\u5b98\u65b9\u8d39\u7528\uff0c\u5e76\u4e14\u4e3a\u8d35\u53f8\u51fa\u5177\u7b2c\u4e09\u65b9\u7684\u6ce8\u518c\u8bc1\u660e\u3002\u6b64\u5916\uff0cRegistrar Corp\u8fd8\u53ef\u4ee5\u62c5\u4efb\u8d35\u53f8\u7684\u5b98\u65b9\u8054\u7edc\u4eba\u6216\u6ce8\u518c\u8054\u7edc\u4eba\u53ca\u7f8e\u56fd\u4ee3\u7406\u3002 \u70b9\u51fb\u6b64\u5904\u66f4\u65b0\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u6ce8\u518c \u70b9\u51fb\u6b64\u5904\u66f4\u65b0\u836f\u54c1\u4f01\u4e1a\u6ce8\u518c \u6216\u8005\uff0c\u60a8\u4e5f\u53ef\u4ee5\u81f4\u7535+1-757-224-0177\uff0c\u6216\u901a\u8fc7https:\/\/regstaging.wpengine.com\/livechat\u4e0e\u6211\u4eec\u5168\u5929\u5019\u5728\u7ebf\u7684\u6cd5\u89c4\u987e\u95ee\u5373\u65f6\u8054\u7cfb\u3002","og_url":"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/","og_site_name":"Registrar","article_published_time":"2021-09-29T16:26:33+00:00","article_modified_time":"2021-10-12T14:51:17+00:00","og_image":[{"width":2560,"height":1440,"url":"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2021\/09\/flat-lay-health-still-life-arrangement-with-copy-space-scaled-e1632932697588.jpg","type":"image\/jpeg"}],"author":"Mason Grandusky","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Mason Grandusky"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/#article","isPartOf":{"@id":"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/"},"author":{"name":"Mason Grandusky","@id":"https:\/\/legacy.registrarcorp.com\/zh\/#\/schema\/person\/5460f453ed04f326b4ef5280009675f2"},"headline":"\u6240\u6709\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u53ca\u836f\u54c1\u4f01\u4e1a\u5fc5\u987b\u57282021\u5e7410\u67081\u65e5\u81f32021\u5e7412\u670831\u65e5\u671f\u95f4\u66f4\u65b0\u5176FDA\u6ce8\u518c","datePublished":"2021-09-29T16:26:33+00:00","dateModified":"2021-10-12T14:51:17+00:00","mainEntityOfPage":{"@id":"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/"},"wordCount":33,"publisher":{"@id":"https:\/\/legacy.registrarcorp.com\/zh\/#organization"},"image":{"@id":"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/#primaryimage"},"thumbnailUrl":"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2021\/09\/flat-lay-health-still-life-arrangement-with-copy-space-scaled-e1632932697588.jpg","articleSection":["\u533b\u7597\u5668\u68b0","\u836f\u54c1"],"inLanguage":"zh"},{"@type":"WebPage","@id":"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/","url":"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/","name":"\u6240\u6709\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u53ca\u836f\u54c1\u4f01\u4e1a\u5fc5\u987b\u57282021\u5e7410\u67081\u65e5\u81f32021\u5e7412\u670831\u65e5\u671f\u95f4\u66f4\u65b0\u5176FDA\u6ce8\u518c - Registrar","isPartOf":{"@id":"https:\/\/legacy.registrarcorp.com\/zh\/#website"},"primaryImageOfPage":{"@id":"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/#primaryimage"},"image":{"@id":"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/#primaryimage"},"thumbnailUrl":"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2021\/09\/flat-lay-health-still-life-arrangement-with-copy-space-scaled-e1632932697588.jpg","datePublished":"2021-09-29T16:26:33+00:00","dateModified":"2021-10-12T14:51:17+00:00","breadcrumb":{"@id":"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/#breadcrumb"},"inLanguage":"zh","potentialAction":[{"@type":"ReadAction","target":["https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/"]}]},{"@type":"ImageObject","inLanguage":"zh","@id":"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/#primaryimage","url":"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2021\/09\/flat-lay-health-still-life-arrangement-with-copy-space-scaled-e1632932697588.jpg","contentUrl":"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2021\/09\/flat-lay-health-still-life-arrangement-with-copy-space-scaled-e1632932697588.jpg","width":2560,"height":1440},{"@type":"BreadcrumbList","@id":"https:\/\/legacy.registrarcorp.com\/zh\/medical-device-and-drug-companies-must-renew-their-fda-registrations-between-oct-1-2021-and-dec-31-2021\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/legacy.registrarcorp.com\/zh\/"},{"@type":"ListItem","position":2,"name":"\u6240\u6709\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u53ca\u836f\u54c1\u4f01\u4e1a\u5fc5\u987b\u57282021\u5e7410\u67081\u65e5\u81f32021\u5e7412\u670831\u65e5\u671f\u95f4\u66f4\u65b0\u5176FDA\u6ce8\u518c"}]},{"@type":"WebSite","@id":"https:\/\/legacy.registrarcorp.com\/zh\/#website","url":"https:\/\/legacy.registrarcorp.com\/zh\/","name":"Registrar","description":"Assistance with U.S. FDA Regulations","publisher":{"@id":"https:\/\/legacy.registrarcorp.com\/zh\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/legacy.registrarcorp.com\/zh\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"zh"},{"@type":"Organization","@id":"https:\/\/legacy.registrarcorp.com\/zh\/#organization","name":"Registrar Corp","url":"https:\/\/legacy.registrarcorp.com\/zh\/","logo":{"@type":"ImageObject","inLanguage":"zh","@id":"https:\/\/legacy.registrarcorp.com\/zh\/#\/schema\/logo\/image\/","url":"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2019\/12\/regcorp_logo.png","contentUrl":"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2019\/12\/regcorp_logo.png","width":1326,"height":330,"caption":"Registrar Corp"},"image":{"@id":"https:\/\/legacy.registrarcorp.com\/zh\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/legacy.registrarcorp.com\/zh\/#\/schema\/person\/5460f453ed04f326b4ef5280009675f2","name":"Mason Grandusky","image":{"@type":"ImageObject","inLanguage":"zh","@id":"https:\/\/legacy.registrarcorp.com\/zh\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/20ae894ac7fdae57b794f1b1792f9c9f1920bc809d0aab245d70e0aa7c997266?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/20ae894ac7fdae57b794f1b1792f9c9f1920bc809d0aab245d70e0aa7c997266?s=96&d=mm&r=g","caption":"Mason Grandusky"},"url":"https:\/\/legacy.registrarcorp.com\/zh\/author\/mgrandusky\/"}]}},"_links":{"self":[{"href":"https:\/\/legacy.registrarcorp.com\/zh\/wp-json\/wp\/v2\/posts\/52921","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/legacy.registrarcorp.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/legacy.registrarcorp.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/legacy.registrarcorp.com\/zh\/wp-json\/wp\/v2\/users\/30"}],"replies":[{"embeddable":true,"href":"https:\/\/legacy.registrarcorp.com\/zh\/wp-json\/wp\/v2\/comments?post=52921"}],"version-history":[{"count":0,"href":"https:\/\/legacy.registrarcorp.com\/zh\/wp-json\/wp\/v2\/posts\/52921\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/legacy.registrarcorp.com\/zh\/wp-json\/wp\/v2\/media\/52621"}],"wp:attachment":[{"href":"https:\/\/legacy.registrarcorp.com\/zh\/wp-json\/wp\/v2\/media?parent=52921"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/legacy.registrarcorp.com\/zh\/wp-json\/wp\/v2\/categories?post=52921"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/legacy.registrarcorp.com\/zh\/wp-json\/wp\/v2\/tags?post=52921"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}