On August 2, 2021, the US FDA officially announced the fee standard for 2022. Among them, the annual fee for FDA enterprise registration and device listing and 510(K) declaration fee have a greater impact on Chinese manufacturers, and both of these fees have been slightly increased.
Application | 2022 | 2021 | ||
Standard Fees | Small Business Fees | Standard Fees | Small Business Fees | |
510 (k) Fee | $12,745 | $3,186 | $12,432 | $3,108 |
FDA Registration Annual Fee | $5,672 | $5,672 | $5,546 | $5,546 |
We remind our customers that: 1) Each year between October 1 and December 31, you need to update your FDA registration to ensure that it continues to be valid for the following year; 2) Results of 510 (K) small business qualification applications cannot be used across fiscal years. Please properly arrange the time for the declaration of small business qualification based on your company's 510 (K) declaration schedule.
Fees for other related FDA programs, the specific fees are as follows:
Application | Standard Fees | Small Business Fees |
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 |
Premarket Report | $374,858 | $93,714 |
30-Day Notice | $5,998 | $2,999 |
Annual Fee for Periodic Reporting on a Class I device (PMAs, PDPs, and PMRs) | $13,120 | $3,280 |
Annual Establishment Registration Fee | $5,672 | |
