发布日期：2024-08-02
近日FDA在其官网上公布了2025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。
2025财年的企业年费为$9,280，较2024财年$7,653上涨21.25%。
510（k）的审评费$24,335，较2024财年$21,760上涨11.83%。
510（k）的小企业审评费$6,084，较2024财年$5,440上涨11.84%。
User Fees for FY 2025
Annual Establishment Registration Fee: $9,280
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 |
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
