发布时间：2021年8月2日
更新日期：2021-08-02
FDA公布2022财年收费案
来源：FDA
FDA于美国当地时间2021年8月2日联邦公报发布了FDA 2022财年(2021年10月1日 – 2022年9月30日)的FDA各项服务的收费案。
FDA2022财年费率比2021财年收费微涨，FDA公司年度认证费用由2020财年的USD5,546提升到2022财年的USD5,672； FDA510K审核费标准费率由原来的USD12,432提高到USD12,745(小企业费率同步提高)。
Important Information on Medical Device User Fees for Fiscal Year 2021
(适用于FDA 2022财年：2021年10月1日至2022年9月30日)
主要费率：
|
项目 |
2021财年(2020.10.01-2021.09.30) |
2022财年(2021.10.01-2022.09.30) |
|
医疗器械公司年度认证费 |
USD5,546个制造商(无减免) |
USD5,672个制造商(无减免) |
|
FDA510(K)审核费(每个510K申请) |
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) |
USD12,745 (标准收费) USD 3,186 (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 2022 MDUFA User Fees
The Fees for Fiscal Year 2022 (October 1, 2021 through September 30, 2022) are as follows:
|
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 |
|
Premarket Report |
$374,858 |
$93,714 |
|
30-Day Notice |
$5,998 |
$2,999 |
|
Annual Fee for
Periodic |
$13,120 |
$3,280 |
|
Annual establishment registration fee |
$5,672 |
$5,672 |
FDA网站相关链接：
https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa?utm_medium=email&utm_source=govdelivery
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa
FDA2022财年小企业资格申请程序指南:
FY 2022 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?utm_medium=email&utm_source=govdelivery
IRC将从2021年10月开始按照该费率为所有客人进行2022年度认证和受理新认证申请。
IRC编译整理
www.FDAChina.com
