{"id":10072,"date":"2019-08-07T11:39:17","date_gmt":"2019-08-07T09:39:17","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=10072"},"modified":"2023-01-24T14:59:19","modified_gmt":"2023-01-24T13:59:19","slug":"usa-fda-announces-medical-device-user-fees-fy-2020","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2019\/08\/07\/usa-fda-announces-medical-device-user-fees-fy-2020\/","title":{"rendered":"USA: FDA announces medical device user fees FY 2020"},"content":{"rendered":"\n

FDA announced the updated medical device user fees for the fiscal year 2019\/2020<\/a>, which apply from October 1, 2019, through September 30, 2020.\u00a0 <\/p>\n\n\n\n

\"\"
USA: FDA medical device user fees FY 2020<\/em><\/figcaption><\/figure>\n\n\n\n

Establishment Registration Fee<\/strong><\/p>\n\n\n\n

For the FY 2020, the amount for each establishment registration is set\nat $5,236<\/strong> after adjustment. This fee shall be paid between October 1 and\nDecember 31, 2019. There is no small business rate for the annual establishment\nregistration fee; all establishments pay the same fee.<\/p>\n\n\n\n

FY2020 user fees for applications<\/strong><\/p>\n\n\n\n
\n Application Type<\/strong>\n <\/td>\n Standard Fee 2019<\/strong>\n <\/td>\n Small Business Fee 2019<\/strong>\n <\/td><\/tr>
\n 510(k)\n <\/td>\n $11,594\n <\/td>\n $2,899\n <\/td><\/tr>
\n 513(g)\n <\/td>\n $4,603\n <\/td>\n $2,302\n <\/td><\/tr>
\n De Novo classification\n <\/td>\n $102,299\n <\/td>\n $25,575\n <\/td><\/tr>
\n PMA, PDP, PMR, BLA\n <\/td>\n $340,995\n <\/td>\n $85,249\n <\/td><\/tr>
\n Panel-track supplement\n <\/td>\n $255,747\n <\/td>\n $63,937\n <\/td><\/tr>
\n 180-day supplement\n <\/td>\n $51,149\n <\/td>\n $12,787\n <\/td><\/tr>
\n Real-time supplement\n <\/td>\n $23,870\n <\/td>\n $5,968\n <\/td><\/tr>
\n BLA efficacy supplement\n <\/td>\n $340,995\n <\/td>\n $85,249\n <\/td><\/tr>
\n Annual Report\n <\/td>\n $11,935\n <\/td>\n $2,984\n <\/td><\/tr>
\n 30-day notice\n <\/td>\n $5,456  \n <\/td>\n $2,728\n <\/td><\/tr><\/tbody><\/table>\n\n\n\n

The updated amounts refer to all applications submitted to the FDA after October 1, 2019.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

FDA announced the updated medical device user fees for the fiscal year 2019\/2020, which apply from October 1, 2019, through September […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-10072","post","type-post","status-publish","format-standard","hentry","category-news-en"],"acf":[],"yoast_head":"\nUSA: FDA announces medical device user fees FY 2020 - Thema Med<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.thema-med.com\/en\/2019\/08\/07\/usa-fda-announces-medical-device-user-fees-fy-2020\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"USA: FDA announces medical device user fees FY 2020 - 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