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September 30 of each year ends FDA Fiscal Year or FY. As a result of this change, there is an adjustment in the FDA fee rates.

For the FY 2020, the standard and small business values increased by 6% when compared to the fee rates for the FY 2019:

Check the Annual Adjustment of FDA

Application type FY 2019 FY 2020
Standard ($) Small Business Standard ($) Small Business
510(k) 10.953 2.738 11.594 2.899
513(g) 4.349 2.175 4.603 2.302
PMA/PDP/PMR/BLA 322.147 80.537 340.995 85.249
De Novo 96.644 24.161 102.299 25.575
PMA Annual Report 11.275 2.819 11.935 2.984
Annual Establishment Registration Fee 4.884   5.236  

The fee values for fiscal year 2020 are effective in October 1, 2019.

Please note that the FDA small business application is an annual process, valid as of September 30.

Important: The fee reduction benefit for businesses that qualify as small business does not apply to the Annual Establishment Registration Fee.

For more information on rate reduction, check out RA Passarini blog: https://passarini.com.br/en/possibility-of-reducing-fda-registration-fees-for-medical-devices/ 

Any questions?

Contact us.

For more information and explanations about it, send us an e-mail: [email protected]

Passarini Regulatory Affairs

Published: 08/05/2019

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