{"id":16481,"date":"2020-11-03T12:29:03","date_gmt":"2020-11-03T11:29:03","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=16481"},"modified":"2023-01-24T15:02:02","modified_gmt":"2023-01-24T14:02:02","slug":"fda-7-fees-increase-for-fy-2021","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2020\/11\/03\/fda-7-fees-increase-for-fy-2021\/","title":{"rendered":"FDA: 7% fees increase for 2021"},"content":{"rendered":"\n

FDA has published fee schedule<\/strong> for the 2021 fiscal year (FY 2021)<\/strong> from October 1, 2020 through September 30, 2021, providing for a 7% increase in fees<\/strong> for medical device companies. The detail here below:<\/p>\n\n\n\n

\"FDA
FDA 7% fees increase for 2021<\/figcaption><\/figure>\n\n\n\n

Standard Fee<\/strong><\/h2>\n\n\n\n
Application Type<\/strong> <\/td>Standard Fee<\/strong> <\/td><\/tr>
510(k) <\/td>$ 12,432 <\/td><\/tr>
513(g) <\/td>$ 4,936 <\/td><\/tr>
PMA, PDP, PMR, BLA <\/td>$ 365,657 <\/td><\/tr>
De Novo Classification Request <\/td>$ 109,697 <\/td><\/tr>
Panel-track Supplement <\/td>$ 274,243 <\/td><\/tr>
180-Day Supplement <\/td>$ 54,849 <\/td><\/tr>
Real-Time Supplement                  <\/td>$ 25,596 <\/td><\/tr>
BLA Efficacy Supplement <\/td>$ 365,657 <\/td><\/tr>
30-Day Notice   <\/td>$ 5,851 <\/td><\/tr>
Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) <\/td>$ 12,798 <\/td><\/tr><\/tbody><\/table>\n\n\n\n

Special Fee for small businesses<\/strong><\/h2>\n\n\n\n

Than the standard fees, lower tariffs are applicable to small and medium-sized companies as established in the \u201cSmall Business Determination (SBD)\u201d <\/strong>program which defines the qualification criteria of the company as \u201csmall business\u201d thus benefiting from reduced tariffs<\/strong> for applications. In particular:<\/p>\n\n\n\n
Application Type<\/strong> <\/td>Small Business Fee<\/strong> <\/td><\/tr>
510(k) <\/td>$ 3,108 <\/td><\/tr>
513(g) <\/td>$ 2,468 <\/td><\/tr>
PMA, PDP, PMR, BLA <\/td>$ 91,414 <\/td><\/tr>
De Novo Classification Request <\/td>$ 27,424 <\/td><\/tr>
Panel-track Supplement <\/td>$ 68,561 <\/td><\/tr>
180-Day Supplement <\/td>$ 13,712 <\/td><\/tr>
Real-Time Supplement   <\/td>$ 6,399 <\/td><\/tr>
BLA Efficacy Supplement <\/td>$ 91,414 <\/td><\/tr>
30-Day Notice   <\/td>$ 2,926 <\/td><\/tr>
Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) <\/td>$ 3,200 <\/td><\/tr><\/tbody><\/table>\n\n\n\n

The establishment registration fee increases too<\/strong><\/h2>\n\n\n\n

Compared to 2020 ($ 5,236), for 2021 fiscal year it is also expected an increase<\/strong> in the annual establishment registration fee<\/strong>, which is equal to $5,546 (U.S.) for each factory.
In this case, there are no exemptions or reductions<\/strong>: all factories must pay the registration fee. <\/p>\n\n\n\n

Thema<\/strong> is able to perform all the FDA requirements for the FY 2021.<\/p>\n\n\n\n

Discover all our services<\/a><\/strong> and contact us<\/a><\/strong> for more information!<\/p>\n\n\n\n

Source: <\/em><\/p>\n\n\n\n

FDA user fee programs<\/a> <\/p>\n","protected":false},"excerpt":{"rendered":"

FDA has published fee schedule for the 2021 fiscal year (FY 2021) from October 1, 2020 through September 30, 2021, providing […]<\/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":[2,1513],"tags":[],"class_list":["post-16481","post","type-post","status-publish","format-standard","hentry","category-news-en","category-us-agent-en"],"acf":[],"yoast_head":"\nFDA: 7% fees increase for 2021 fiscal year FY 2021<\/title>\n<meta name=\"description\" content=\"FDA has published fee schedule for the 2021 fiscal year (FY 2021) from October 1, 2020 through September 30, 2021, providing for a 7% increase in fees ...\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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