发布日期：2021-09-13
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，确定2022财年医疗设备FDA注册年费为5672美金。
User Fees for FY2022
Annual Establishment Registration Fee: $5,672
FDA2022财年指（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，医疗设备企业需要更新FDA注册并缴纳新财年年费以确保下一年FDA注册持续处于有效状态。
FDA还公布其他2020财年年费如下：
Other fees for Fiscal Year 2022 (October 1, 2021 through September 30, 2022) are:
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 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.
宁波捷通检测提供专业高效FDA注册服务，详情敬请联系我们！
