发布时间:2024年8月1日
FDA公布2025财年收费案
来源:FDA
美国当地时间2024年8月1日发布了FDA 2025财年(2024年10月1日~2025年9月30日)的FDA各项服务的收费案。
FDA2025财年费率比2024财年继续保持上涨,FDA公司年度认证费用由2024财年的USD7653提升到2025财年的USD9280; FDA510K审核费小企业费率由原来的USD5440提高到USD6084。
Important Information on Medical Device User Fees for Fiscal Year 2025
(适用于FDA 2025财年:2024年10月1日至2025年9月30日)
User Fees for FY 2025
主要费率:
FDA医疗器械公司年度认证费Annual Establishment Registration Fee: $9,280
项目 |
2025财年(2024.10.01-2025.09.30) |
2024财年(2023.10.01-2024.09.30) |
医疗器械公司年度认证费 |
USD 9280 (无减免) |
USD 7653个公司(无减免) |
FDA510(K)审核费(每个510K申请) |
USD 24335 (标准收费) USD 6084 (FDA小企业费率) |
USD 21760 (标准收费) USD 5440 (小企业费率) |
* FDA小企业资质指的是公司最近税收年度的总收入或销售额未超过1亿美金,并需要提前至少1个月申请FDA小企业资质认证后才能享受优惠;
其他费率:
Other fees for Fiscal Year 2025 (October 1, 2024, through September 30, 2025) are:
Application Type |
Standard Fee |
Small Business Fee† |
510(k)‡ |
$24,335 |
$6,084 |
513(g) |
$7,301 |
$3,650 |
PMA, PDP, PMR, BLA |
$540,783 |
$135,196 |
De Novo Classification Request |
$162,235 |
$40,559 |
Panel-track Supplement |
$432,626 |
$108,157 |
180-Day Supplement |
$81,117 |
$20,279 |
Real-Time Supplement |
$37,855 |
$9,464 |
BLA Efficacy Supplement |
$540,783 |
$135,196 |
30-Day Notice |
$8,653 |
$4,326 |
Annual Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs) |
$18,927 |
$4,732 |
† Small Business Fee: For businesses certified by the Center for Devices and Radiological Health (CDRH) as a small business. For more information, see the section Small Businesses below.
‡ 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.
IRC将从2024年10月开始按照该费率为所有客人进行2025年度认证和受理新认证申请。
IRC编译整理
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