The US FDA released the 2022 user fees for certain medical device submissions and establishment registration. On August 2, 2021, the FDA announced the FY2022 user fees in a Federal Register notice titled Medical Device User Fee Rates for Fiscal Year 2022. FY2022 User fees are required for the following types of medical device submissions:
FY2022 User Fees | Standard fee | Small business fee |
| Premarket application (a PMA, PDP, or BLA) | $ 374,858 | $ 93,714 |
| Premarket report | $ 374,858 | $ 93,714 |
| Efficacy supplement (to an approved BLA) | $ 374,858 | $ 93,714 |
| Panel-track supplement | $ 281,143 | $ 70,286 |
| De novo classification request | $ 112,457 | $ 28,114 |
| 180-day supplement | $ 56,229 | $ 14,057 |
| Real-time supplement | $ 26,240 | $ 6,560 |
| 510(k) premarket notification submission | $ 12,745 | $ 3,186 |
| 30-day notice | $ 5,998 | $ 2,999 |
| 513(g) request for classification information | $5,061 | $ 2,530 |
| Annual Fees: | ||
| Annual fee for periodic reporting on a class III device | $ 13,120 | $ 3,280 |
| Annual establishment registration fee | $ 5,672 | $ 5,672 |
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Want to understand FY2022 user fees more? See our post Breakdown of FDA’s Medical Device User Fees
