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 for medical device companies. The detail here below:
Standard Fee
| Application Type | Standard Fee |
| 510(k) | $ 12,432 |
| 513(g) | $ 4,936 |
| PMA, PDP, PMR, BLA | $ 365,657 |
| De Novo Classification Request | $ 109,697 |
| Panel-track Supplement | $ 274,243 |
| 180-Day Supplement | $ 54,849 |
| Real-Time Supplement | $ 25,596 |
| BLA Efficacy Supplement | $ 365,657 |
| 30-Day Notice | $ 5,851 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) | $ 12,798 |
Special Fee for small businesses
Than the standard fees, lower tariffs are applicable to small and medium-sized companies as established in the “Small Business Determination (SBD)” program which defines the qualification criteria of the company as “small business” thus benefiting from reduced tariffs for applications. In particular:
| Application Type | Small Business Fee |
| 510(k) | $ 3,108 |
| 513(g) | $ 2,468 |
| PMA, PDP, PMR, BLA | $ 91,414 |
| De Novo Classification Request | $ 27,424 |
| Panel-track Supplement | $ 68,561 |
| 180-Day Supplement | $ 13,712 |
| Real-Time Supplement | $ 6,399 |
| BLA Efficacy Supplement | $ 91,414 |
| 30-Day Notice | $ 2,926 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) | $ 3,200 |
The establishment registration fee increases too
Compared to 2020 ($ 5,236), for 2021 fiscal year it is also expected an increase in the annual establishment registration fee, which is equal to $5,546 (U.S.) for each factory.
In this case, there are no exemptions or reductions: all factories must pay the registration fee.
Thema is able to perform all the FDA requirements for the FY 2021.
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