发布时间：2020-08-05
更新日期：2020-08-05
FDA公布2021财年收费案
来源：FDA
FDA于美国当地时间2020年8月3日公布了2021财年(2020年10月1日 – 2021年9月30日)的FDA各项服务的收费案。
FDA2021财年费率比2020财年收费微涨，FDA公司年度认证费用由2020财年的USD5236提升到2021财年的USD5,546； FDA510K审核费标准费率由原来的USD11594提高到USD12432(小企业费率同步提高)。
Important Information on Medical Device User Fees for Fiscal Year 2021
(适用于FDA 2021财年：2020年10月1日至2021年9月30日)
主要费率：
|
项目 |
2020财年(2019.10.01-2020.09.30) |
2021财年(2020.10.01-2021.09.30) |
|
医疗器械公司注册年度认证费 |
USD5,236个制造商(无减免) |
USD5,546个制造商(无减免) |
|
FDA510(K)审核费(每个510K申请) |
USD11,594 (标准收费) USD2,899 (FDA认证为小企业资质的公司享受该优惠收费) |
USD12,432 (标准收费) USD 3,108 (FDA认证为小企业资质的公司享受该优惠收费) |
* 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1-2个月申请FDA小企业资质认证后才能享受优惠；
Small Business: This is defined as having gross receipts or sales of no more than $100 million for the most recent tax year. In addition, if a small business has gross receipts or sales of $30 million or less, it is eligible to have the fee waived for its first PMA, PDP, PMR or BLA.
其他费率：
FY 2021 MDUFA User Fees
The Fees for Fiscal Year 2021 (October 1, 2020 through September 30, 2021) are as follows:
|
Application Type |
Standard Fee |
Small Business Fee† |
|
510(k)‡ |
$12,432 |
$3,108 |
|
513(g) |
$4,936 |
$2,468 |
|
PMA, PDP, PMR, BLA |
$365,657 |
$91,414 |
|
De Novo Classification Request |
$109,697 |
$27,424 |
|
Panel-track Supplement |
$274,243 |
$68,561 |
|
180-Day Supplement |
$54,849 |
$13,712 |
|
Real-Time Supplement |
$25,596 |
$6,399 |
|
BLA Efficacy Supplement |
$365,657 |
$91,414 |
|
30-Day Notice |
$5,851 |
$2,926 |
|
Annual Fee for Periodic |
$12,798 |
$3,200 |
† For small businesses with an approved SBD.
‡ Note: 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.
Small businesses with an approved SBD with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first PMA, PDP, PMR, or BLA.
Annual Establishment Registration Fee: $5,546
There are no waivers or reductions for small establishments, businesses, or groups – all establishments must pay the establishment registration fee.
FDA网站相关链接：
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa
FDA2021财年小企业资格申请程序指南:
FY 2021 Medical Device User Fee Small Business Qualification and Certification Guidance.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-user-fee-small-business-qualification-and-certification
IRC将从2020年10月开始按照该费率为所有客人进行2021年度认证和受理新认证申请。
IRC编译整理
www.FDAChina.com
