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?
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For more information and explanations about it, send us an e-mail: [email protected]
Passarini Regulatory Affairs
Published: 08/05/2019
