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:

FDA 7% fees increase for 2021
FDA 7% fees increase for 2021

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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FDA user fee programs