User Fees for FY2022
FDA于今年8月6日更新了 FY2022 的 User Fee 。
与FY2021相比，设施的注册费用上升了2.2%，以510(k)审查费用为基准上升了约2.5%。
- FY2022 User Fee如下所示.
企业注册费用：$5,672
| 申请类型 | 手续费标准 | 中小企业减免手续费 |
| 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 III device (PMAs,PDPs, and PMRs) | $13,120 | $3,280 |
* 享受中小企业减免优惠，需通过Small Business Determination(SMD)确认是否属于对象，
以及Small Business的相关标准可通过以下链接确认。
Reduced Medical Device User Fees: SBD Program
CDRH’s Small Business Program determines whether a business is qualified and certified as a “small business” and eligible for a reduced fee.
www.fda.gov
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