{"id":56113,"date":"2022-10-07T08:41:44","date_gmt":"2022-10-07T12:41:44","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-announces-new-medical-device-user-fees-for-fy-2023\/"},"modified":"2022-12-01T14:54:02","modified_gmt":"2022-12-01T19:54:02","slug":"fda-announces-new-medical-device-user-fees-for-fy-2023","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/zh\/fda-announces-new-medical-device-user-fees-for-fy-2023\/","title":{"rendered":"FDA\u5ba3\u5e032023\u8d22\u5e74\u533b\u7597\u5668\u68b0\u5b98\u8d39"},"content":{"rendered":"<p>\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40(FDA)\u6839\u636e\u300a\u533b\u7597\u5668\u68b0\u7528\u6237\u8d39\u7528\u4fee\u6b63\u6848\u300b(MDUFA)\u5ba3\u5e03\u4e862023\u8d22\u5e74\u7684\u8d39\u7528\u3002<\/p>\n<p>2023\u8d22\u5e74\u4ece2022\u5e7410\u67081\u65e5\u5f00\u59cb\uff0c\u52302023\u5e749\u670830\u65e5\u7ed3\u675f\u3002\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u5fc5\u987b\u652f\u4ed8\u8d39\u7528\uff0c\u4ee5\u6301\u7eed\u7b26\u5408FDA\u7684\u8981\u6c42\u3002<\/p>\n<p><strong>\u533b\u7597\u5668\u68b0\u8d39\u7528<\/strong><\/p>\n<p>FDA\u8981\u6c42\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u652f\u4ed8\u7684\u8d39\u7528\u5305\u62ec:<\/p>\n<ul>\n<li>\u67d0\u4e9b\u7c7b\u578b\u7684\u533b\u7597\u5668\u68b0\u7533\u8bf7<\/li>\n<li>III\u7c7b\u5668\u68b0\u7684\u5b9a\u671f\u62a5\u544a<\/li>\n<li>\u4f01\u4e1a\u5e74\u5ea6\u6ce8\u518c<\/li>\n<\/ul>\n<p>\u6700\u8fd1\u4e00\u4e2a\u7eb3\u7a0e\u5e74\u5ea6\u7684\u603b\u9500\u552e\u989d\u4f4e\u4e8e1\u4ebf\u7f8e\u5143\u7684\u4f01\u4e1a\u53ef\u4ee5\u4f5c\u4e3a\u5c0f\u4f01\u4e1a\u7533\u8bf7\u51cf\u514d\u8d39\u7528\u3002\u603b\u9500\u552e\u989d\u4f4e\u4e8e3000\u4e07\u7f8e\u5143\u7684\u4f01\u4e1a\u53ef\u4ee5\u83b7\u5f97\u9996\u6b21\u4e0a\u5e02\u524d\u7533\u8bf7\u6216\u62a5\u544a\u7684\u8c41\u514d\u3002\u5982\u679c\u60a8\u57282022\u8d22\u5e74\u7b26\u5408\u51cf\u514d\u8d39\u7528\u7684\u8d44\u683c\uff0c\u60a8\u5fc5\u987b\u5728\u7eed\u671f\u671f\u95f4\u5411FDA\u91cd\u65b0\u63d0\u4ea4\u60a8\u7684\u4fe1\u606f\u4ee5\u4fdd\u6301\u7b26\u5408\u8d44\u683c\u3002<\/p>\n<p>\u6240\u6709\u89c4\u6a21\u7684\u4f01\u4e1a\u6ce8\u518c\u90fd\u662f\u4e00\u81f4\u7684\uff0c\u5fc5\u987b\u4ed8\u8d39\u624d\u80fd\u5b8c\u6210\u6ce8\u518c\u3002\u5bf9\u4e8e\u4f01\u4e1a\u6ce8\u518c\u8d39\uff0c\u5c0f\u578b\u516c\u53f8\u3001\u4f01\u4e1a\u6216\u56e2\u4f53\u6ca1\u6709\u51cf\u514d\u3002\u516c\u53f8\u5fc5\u987b\u4e3a\u5176\u62e5\u6709\u7684\u5904\u7406\u533b\u7597\u5668\u68b0\u7279\u5b9a\u529f\u80fd\u7684\u6bcf\u4e2a\u7269\u7406\u4f4d\u7f6e\u4e0a\u7684\u4f01\u4e1a\u652f\u4ed8\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u6ce8\u518c\u8d39\u3002<\/p>\n<p>2023\u8d22\u5e74\u7684\u6240\u6709\u533b\u7597\u5668\u68b0\u5b98\u65b9\u8d39\u7528\u76f8\u8f83\u4e8e2022\u8d22\u5e74\u5747\u6709\u6240\u4e0a\u6da8\u3002FDA\u5c06\u6b64\u6b21\u4e0a\u6da8\u5f52\u56e0\u4e8e\u53bb\u5e74\u7684\u901a\u8fc7\u81a8\u80c0\u3002<\/p>\n<p><strong>2023\u8d22\u5e74MDUFA\u8d39\u7528<\/strong><\/p>\n<table class=\"feeTable statistics\" style=\"border: 1px solid grey; border-spacing: 0px !important;\" border=\"1\" width=\"100%\">\n<tbody>\n<tr>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"229\"><strong>\u8d39\u7528\u7c7b\u578b<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" colspan=\"2\" width=\"196\"><strong>2022<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" colspan=\"2\" width=\"213\"><strong>2023<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"229\">\u5e74\u5ea6\u4f01\u4e1a\u6ce8\u518c<\/td>\n<td colspan=\"2\" width=\"196\">5,546\u7f8e\u5143<\/td>\n<td colspan=\"2\" width=\"213\">6,493\u7f8e\u5143<\/td>\n<\/tr>\n<tr>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"229\"><strong>\u7533\u8bf7\u8d39<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"90\"><strong>\u6807\u51c6<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"106\"><strong>\u5c0f\u578b\u4f01\u4e1a<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"106\"><strong>\u6807\u51c6<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"106\"><strong>\u5c0f\u578b\u4f01\u4e1a<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"229\">510(k)<\/td>\n<td width=\"90\">12,745\u7f8e\u5143<\/td>\n<td width=\"106\">3,186\u7f8e\u5143<\/td>\n<td width=\"106\">19,870\u7f8e\u5143<\/td>\n<td width=\"106\">4,967\u7f8e\u5143<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">513(g)<\/td>\n<td width=\"90\">5,061\u7f8e\u5143<\/td>\n<td width=\"106\">2,530\u7f8e\u5143<\/td>\n<td width=\"106\">5,961\u7f8e\u5143<\/td>\n<td width=\"106\">2,980\u7f8e\u5143<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">\u91cd\u65b0\u5206\u7c7b<\/td>\n<td width=\"90\">112,457\u7f8e\u5143<\/td>\n<td width=\"106\">28,114\u7f8e\u5143<\/td>\n<td width=\"106\">441,547\u7f8e\u5143<\/td>\n<td width=\"106\">$10,387\u7f8e\u5143<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">PMA, PDP, PMR, BLA<\/td>\n<td width=\"90\">374,858\u7f8e\u5143<\/td>\n<td width=\"106\">93,714\u7f8e\u5143<\/td>\n<td width=\"106\">132,464\u7f8e\u5143<\/td>\n<td width=\"106\">33,116\u7f8e\u5143<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">Panel-track\u8865\u5145\u62a5\u544a<\/td>\n<td width=\"90\">281,143\u7f8e\u5143<\/td>\n<td width=\"106\">70,286\u7f8e\u5143<\/td>\n<td width=\"106\">353,238\u7f8e\u5143<\/td>\n<td width=\"106\">88,309\u7f8e\u5143<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">180-day \u8865\u5145\u62a5\u544a<\/td>\n<td width=\"90\">56,229\u7f8e\u5143<\/td>\n<td width=\"106\">14,057\u7f8e\u5143<\/td>\n<td width=\"106\">66,232\u7f8e\u5143<\/td>\n<td width=\"106\">16,558\u7f8e\u5143<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">Real-time\u8865\u5145\u62a5\u544a<\/td>\n<td width=\"90\">26,240\u7f8e\u5143<\/td>\n<td width=\"106\">6,560\u7f8e\u5143<\/td>\n<td width=\"106\">30,908\u7f8e\u5143<\/td>\n<td width=\"106\">7,727\u7f8e\u5143<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">BLA efficacy\u8865\u5145\u62a5\u544a<\/td>\n<td width=\"90\">374,858\u7f8e\u5143<\/td>\n<td width=\"106\">93,714\u7f8e\u5143<\/td>\n<td width=\"106\">441,547\u7f8e\u5143<\/td>\n<td width=\"106\">110,387\u7f8e\u5143<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">PMA\u5e74\u5ea6\u62a5\u544a<\/td>\n<td width=\"90\">13,120\u7f8e\u5143<\/td>\n<td width=\"106\">3,280\u7f8e\u5143<\/td>\n<td width=\"106\">15,454\u7f8e\u5143<\/td>\n<td width=\"106\">3,864\u7f8e\u5143<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u5728\u4f01\u4e1a\u652f\u4ed8\u8db3\u989d\u8d39\u7528\u4e4b\u524d\uff0c\u4f01\u4e1a\u6ce8\u518c\u5c06\u4f1a\u88abFDA\u89c6\u4e3a\u4e0d\u5b8c\u6574\u3002\u5982\u679cFDA\u572812\u670831\u65e5\u622a\u6b62\u65e5\u671f\u524d\u6ca1\u6709\u6536\u5230\u8d35\u53f8\u7684\u8d39\u7528\uff0c\u8d35\u53f8\u5c06\u4f1a\u88abFDA\u4ece\u6570\u636e\u5e93\u4e2d\u5220\u9664\uff0c\u5bfc\u81f4\u8d35\u53f8\u7684\u6ce8\u518c\u65e0\u6548\u3002Registrar Corp\u53ef\u4ee5\u5e2e\u52a9\u60a8\u786e\u5b9a\u8d35\u53f8\u9700\u8981\u7f34\u7eb3\u54ea\u4e9b\u8d39\u7528\uff0c\u5e76\u5e2e\u52a9\u60a8\u5411FDA\u652f\u4ed8\u8d39\u7528\u3002<\/p>\n<div class=\"callout-row text-center margin-bottom\">\n<h3>\u83b7\u5f97FDA\u5408\u89c4\u65b9\u9762\u7684\u5e2e\u52a9<\/h3>\n<p>Registrar Corp\u7684\u6cd5\u89c4\u4e13\u5bb6\u53ef\u4ee5\u5e2e\u52a9\u60a8\u9075\u5b88FDA\u7684\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u3002<\/p>\n<p>\u6709\u5173FDA\u6cd5\u89c4\u8981\u6c42\u7684\u66f4\u591a\u5e2e\u52a9\uff0c\u8bf7\u81f4\u7535:+1-757-224-0177\uff0c\u6216\u53d1\u9001\u7535\u5b50\u90ae\u4ef6\u81f3<a href=\"mailto:info@registrarcorp.com\">info@registrarcorp.com\uff0c<\/a>\u6216\u8005\u901a\u8fc7:<a href=\"http:\/\/regstaging.wpengine.com\/livechat\">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<p class=\"btn-row\"><a class=\"btn btn-red-white\" href=\"https:\/\/regstaging.wpengine.com\/zh\/fda-medical-devices\/?lead_source=blog\">\u83b7\u5f97\u5e2e\u52a9<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40(FDA)\u6839\u636e\u300a\u533b\u7597\u5668\u68b0\u7528\u6237\u8d39\u7528\u4fee\u6b63\u6848\u300b(MDUFA)\u5ba3\u5e03\u4e862023\u8d22\u5e74\u7684\u8d39\u7528\u3002 2023\u8d22\u5e74\u4ece2022\u5e7410\u67081\u65e5\u5f00\u59cb\uff0c\u52302023\u5e749\u670830\u65e5\u7ed3\u675f\u3002\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u5fc5\u987b\u652f\u4ed8\u8d39\u7528\uff0c\u4ee5\u6301\u7eed\u7b26\u5408FDA\u7684\u8981\u6c42\u3002 \u533b\u7597\u5668\u68b0\u8d39\u7528 FDA\u8981\u6c42\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u652f\u4ed8\u7684\u8d39\u7528\u5305\u62ec: \u67d0\u4e9b\u7c7b\u578b\u7684\u533b\u7597\u5668\u68b0\u7533\u8bf7 III\u7c7b\u5668\u68b0\u7684\u5b9a\u671f\u62a5\u544a \u4f01\u4e1a\u5e74\u5ea6\u6ce8\u518c \u6700\u8fd1\u4e00\u4e2a\u7eb3\u7a0e\u5e74\u5ea6\u7684\u603b\u9500\u552e\u989d\u4f4e\u4e8e1\u4ebf\u7f8e\u5143\u7684\u4f01\u4e1a\u53ef\u4ee5\u4f5c\u4e3a\u5c0f\u4f01\u4e1a\u7533\u8bf7\u51cf\u514d\u8d39\u7528\u3002\u603b\u9500\u552e\u989d\u4f4e\u4e8e3000\u4e07\u7f8e\u5143\u7684\u4f01\u4e1a\u53ef\u4ee5\u83b7\u5f97\u9996\u6b21\u4e0a\u5e02\u524d\u7533\u8bf7\u6216\u62a5\u544a\u7684\u8c41\u514d\u3002\u5982\u679c\u60a8\u57282022\u8d22\u5e74\u7b26\u5408\u51cf\u514d\u8d39\u7528\u7684\u8d44\u683c\uff0c\u60a8\u5fc5\u987b\u5728\u7eed\u671f\u671f\u95f4\u5411FDA\u91cd\u65b0\u63d0\u4ea4\u60a8\u7684\u4fe1\u606f\u4ee5\u4fdd\u6301\u7b26\u5408\u8d44\u683c\u3002 \u6240\u6709\u89c4\u6a21\u7684\u4f01\u4e1a\u6ce8\u518c\u90fd\u662f\u4e00\u81f4\u7684\uff0c\u5fc5\u987b\u4ed8\u8d39\u624d\u80fd\u5b8c\u6210\u6ce8\u518c\u3002\u5bf9\u4e8e\u4f01\u4e1a\u6ce8\u518c\u8d39\uff0c\u5c0f\u578b\u516c\u53f8\u3001\u4f01\u4e1a\u6216\u56e2\u4f53\u6ca1\u6709\u51cf\u514d\u3002\u516c\u53f8\u5fc5\u987b\u4e3a\u5176\u62e5\u6709\u7684\u5904\u7406\u533b\u7597\u5668\u68b0\u7279\u5b9a\u529f\u80fd\u7684\u6bcf\u4e2a\u7269\u7406\u4f4d\u7f6e\u4e0a\u7684\u4f01\u4e1a\u652f\u4ed8\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u6ce8\u518c\u8d39\u3002 2023\u8d22\u5e74\u7684\u6240\u6709\u533b\u7597\u5668\u68b0\u5b98\u65b9\u8d39\u7528\u76f8\u8f83\u4e8e2022\u8d22\u5e74\u5747\u6709\u6240\u4e0a\u6da8\u3002FDA\u5c06\u6b64\u6b21\u4e0a\u6da8\u5f52\u56e0\u4e8e\u53bb\u5e74\u7684\u901a\u8fc7\u81a8\u80c0\u3002 2023\u8d22\u5e74MDUFA\u8d39\u7528 \u8d39\u7528\u7c7b\u578b 2022 2023 \u5e74\u5ea6\u4f01\u4e1a\u6ce8\u518c 5,546\u7f8e\u5143 6,493\u7f8e\u5143 \u7533\u8bf7\u8d39 \u6807\u51c6 \u5c0f\u578b\u4f01\u4e1a \u6807\u51c6 \u5c0f\u578b\u4f01\u4e1a 510(k) 12,745\u7f8e\u5143 3,186\u7f8e\u5143 19,870\u7f8e\u5143 4,967\u7f8e\u5143 513(g) 5,061\u7f8e\u5143 2,530\u7f8e\u5143 5,961\u7f8e\u5143 2,980\u7f8e\u5143 \u91cd\u65b0\u5206\u7c7b 112,457\u7f8e\u5143 28,114\u7f8e\u5143 441,547\u7f8e\u5143 $10,387\u7f8e\u5143 PMA, PDP, PMR, BLA 374,858\u7f8e\u5143 93,714\u7f8e\u5143 132,464\u7f8e\u5143 33,116\u7f8e\u5143 Panel-track\u8865\u5145\u62a5\u544a 281,143\u7f8e\u5143 70,286\u7f8e\u5143 353,238\u7f8e\u5143 88,309\u7f8e\u5143 180-day \u8865\u5145\u62a5\u544a 56,229\u7f8e\u5143 14,057\u7f8e\u5143 66,232\u7f8e\u5143<\/p>\n","protected":false},"author":31,"featured_media":55637,"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],"tags":[],"class_list":{"0":"post-56113","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medical-devices-zh","8":"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>FDA\u5ba3\u5e032023\u8d22\u5e74\u533b\u7597\u5668\u68b0\u5b98\u8d39 - Registrar<\/title>\n<meta name=\"robots\" content=\"noindex, 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