FDA has officially announced the updated medical device fees for the 2022 fiscal year (October 1, 2021 – September 30, 2022).
All medical device manufacturers, importers, and distributors must pay an annual establishment registration fee to FDA. Please do not wait until the last minute to pay these fees! The Device Facility User Fee (DFUF) is $5,672 this year and must be paid between October 1, 2021, and December 31, 2021. Additionally, FDA collects user fees for certain medical device submissions.
It is also important to note that the Center for Devices and Radiological Health (CDRH) is now accepting Small Business Determination Requests. If granted, certain small businesses can acquire fee reductions and fee waivers for some types of submissions. “Small business” is defined as a business with $100 million or less in gross receipts or sales, including receipts or sales from its affiliates.
The below table are the FY2022 User Fees for Medical Device Submissions:
| Application Type | Standard Fee | Small Business Fee† |
| 510(k) ‡ | $12,745 | $3,186 |
| 513(g) | $5,061 | $2,530 |
| PMA, PDP, PMR, BLA | $374,858 | $93,714 |
| De Novo Classification Request | $112,457 | $28,114 |
| Panel-track Supplement | $281,143 | $70,286 |
| 180-Day Supplement | $56,229 | $14,057 |
| Real-Time Supplement | $26,240 | $6,560 |
| BLA Efficacy Supplement | $374,858 | $93,714 |
| 30-Day Notice | $5,998 | $2,999 |
| Annual Fee for Periodic reporting on a Class device (PMAs, PDPs, and PMRs) | $13,120 | $3,280 |
Manufacturers, importers, and distributors failing to pay the relevant fees risk being detained at the border. Don’t let that happen to you. FDAImports can help you navigate this process and ensure you are registered correctly and on time.
