The US Food and Drug Administration (FDA) has published the fee rates corresponding to fiscal year 2022 (FY2022) starting October 1st 2021 and ending September 30th, 2022, envisaging a 2.5% tax increase for Medical Devices companies.

Therefore, Medical Devices companies are liable to pay these taxes comply with FDA requirements.

FDA has increased fees for 2022 fiscal year by 2.5%

Standard FDA fees for Medical Devices FY2022

Application Type Standard Fee
510(k) $ 12,745
513(g) $ 5,061
PMA, PDP, PMR, BLA $ 374,858
De Novo Classification $ 112,457
Panel-track Supplement $ 281,143
180-day Supplement $ 56,229
Real-time Supplement $ 26,240
30-day Notice $ 5,998
PMA Annual Report $ 13,120

Small Business FDA fees for Medical Devices FY2022

SMEs with a total turnover of 100 million dollars or less can qualify as Small Business so they can benefit from reduced fees for applications. In particular:

Application Type Small Business Fee
510(k) $ 3,186
513(g) $ 2,530
PMA, PDP, PMR, BLA $ 93,714
De Novo Classification $ 28,114
Panel-track Supplement $ 70,286
180-day Supplement $ 14,057
Real-time Supplement $ 6,560
30-day Notice $ 2,999
PMA Annual Report $ 3,280

Establishment registration fee is expected to increase too

Compared to 2021 ($ 5,546), for 2022 fiscal year, the establishment registration fee, which is $ 5,672 for every establishment, is expected to increase too.

In this case though, it is not possible to benefit from reduced fees or exemptions: every establishment has to pay its own registration fee.

Choose Thema to carry out obligations required by FDA

Thanks to THEMA USA and strategic partnership with US companies, Thema is able to run every obligation required for 2022 fiscal year by FDA. In addition, it provides U.S Agent and U.S Initial Importer services too.

For further information, do not hesitate to contact us!


Medical Device User Fee Rates for Fiscal Year 2022, FDA, August 2, 2021