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FDA establishment registration fee FY 2021

12

Aug

2020

FDA registration fee FY 2021

FDA has published the annual establishment registration fee for FY 2021, which will be effective from October 1, 2020. The FDA registration fee for each medical device establishment is $5,546.

All medical device establishments intended to register/renew their facility are required to pay the establishment registration fee. Waivers or reductions for small establishments, businesses, or groups do not apply to the annual establishment registration fee.

Other medical device regulatory application fees for FY 2021.

Application TypeStandard FeeSmall Business Fee
510(k)$11,594$2,899
513(g)$4,603$2,302
PMA, PDP, PMR, BLA$340,995$85,249
De Novo Classification Request$102,299$25,575
Panel-track Supplement$255,747$63,937
180-Day Supplement$51,149$12,787
Real-Time Supplement$23,870$5,968
BLA Efficacy Supplement$340,995$85,249
30-Day Notice$5,456$2,728
Annual Fee for Periodic
Reporting on a Class III device
(PMAs, PDPs, and PMRs)
$11,935$2,984
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