發布日期：2021-09-13
2021年8月2日，美國食品藥品監督管理局(FDA)公布了2022財年 (2021年10月1日至2022年9月30日) 醫療設備用戶收費標準，確定2022財年醫療設備FDA注冊年費為5672美金。
User Fees for FY2022
Annual Establishment Registration Fee: $5,672
FDA2022財年指（2021年10月1日至2022年 9月30日），每年10月1日到12月31日期間，醫療設備企業需要更新FDA注冊并繳納新財年年費以確保下一年FDA注冊持續處于有效狀態。
FDA還公布其他2020財年年費如下：
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.
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