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FDA2022财年收费标准已定,略有增长!Annual Establishment Registration Fee: $5,672.

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发表时间:2021-08-11 13:20

2021年8月2日,美国食品药品监督管理局(FDA)公布了2022财年(2021年10月1日至2022年9月30日)医疗设备用户收费标准。FDA2022财年为(2021年10月1日至2022年 9月30日),每年10月1日到12月31日期间,企业需要更新FDA注册以确保下一年持续处于有效状态。

User Fees for FY2022

Annual Establishment Registration Fee:   $5,672

Other fees for Fiscal Year 2022 (October 1, 2021 through September 30, 2022) are:


Application TypeStandard FeeSmall 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 III device (PMAs,PDPs, and PMRs)$13,120$3,280


Small Business Fee: For businesses certified by the Center for Devices and Radiological Health (CDRH) as a small business..

510(k) Fees: All types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer.


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