发布日期：2022-10-06
在各种因素影响下美国FDA 2023年度医疗器械官费没能在2022财年结束前如期公布，为不影响每年10月1日至12月31日期间相关企业的年度续费更新，FDA成功游说参议院在9月30日完成投票，并在拜登总统签字后成为法律。
2023年10月5日FDA在其官网上公布了2023财年医疗器械企业年费和各项服务收费标准。
其中大家比较关心的FDA企业注册和器械列名的年费和510(K) 申报费用都有比较大幅的提高。
2023财年的企业年费为$6,493，较2022财年$5,672上涨14.47%。
510（k）的审评费$19,870，较2022财年$12,745上涨55.9%。
详细对比如下。
|
申请类型 |
2023年 |
2022年 |
||
|
标准收费 |
小企业收费 |
标准收费 |
小企业收费 |
|
|
企业注册年费 |
$6,493 |
$6,493 |
$5,672 |
$5,672 |
|
510（K）费用 |
$19,870 |
$4,967 |
$12,745 |
$3,186 |
小企业说明：FDA规定的小企业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，符合条件的企业需要提前1-2个月申请FDA小企业资质认证后才能享受相关优惠。
FDA 2023财年医疗器械各种收费如下：
User Fees for FY2023
Annual Establishment Registration Fee: $6,493
All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups.
Other fees for Fiscal Year 2023 (October 1, 2022 through September 30, 2023) are:
|
Application Type |
Standard Fee |
Small Business Fee† |
|
510(k) |
$19,870 |
$4,967 |
|
513(g) |
$5,961 |
$2,980 |
|
PMA, PDP, PMR, BLA |
$441,547 |
$110,387 |
|
De Novo Classification Request |
$132,464 |
$33,116 |
|
Panel-track Supplement |
$353,238 |
$88,309 |
|
180-Day Supplement |
$66,232 |
$16,558 |
|
Real-Time Supplement |
$30,908 |
$7,727 |
|
BLA Efficacy Supplement |
$441,547 |
$110,387 |
|
30-Day Notice |
$7,065 |
$3,532 |
|
Annual Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs) |
$15,454 |
$3,864 |
† 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.
详情敬请查看FDA官网链接：
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa
