FDA Medical Device FY2025 User’s Fee (Oct. 1, 2024~Sept. 30, 2025)
FDA FY2025 年度註冊規費: US$9,280
其他的年度規費如下: (2024年10月1日起至2025年9月30日止)
|
Application Type |
Standard Fee |
SBD 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 |
註1： F DA於每年10月1日前會公佈下一年度申請費用。
註2：小型企業(SBD)：適用於經FDA CDRH 核可為小型企業之公司。
註3：510(k) 費用: 除透過FDA 認可的第三方審核單位向FDA 提交510(k)無需繳交申請規費，其他所有類型的510(k) ( Traditional, Abbreviated, Special) 均需繳納。
詳細內容請參見: Medical Device User Fee Amendments (MDUFA) https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa
