Comprehensive up-to-date news coverage by Chemron FDA Korea.
User Fees for FY 2024
Annual Establishment Registration
Fee: $7,653
All
establishments must pay the establishment registration fee.
There
are no waivers or reductions for small establishments, businesses, or groups in
FY 2024.
Other fees for Fiscal Year 2024 (October 1, 2023, through September 30, 2024) are:
|
Application
Type |
Standard
Fee |
Small
Business Fee† |
|
510(k)‡ |
$21,760 |
$5,440 |
|
513(g) |
$6,528 |
$3,264 |
|
PMA, PDP, PMR, BLA |
$483,560 |
$120,890 |
|
De
Novo Classification Request |
$145,068 |
$36,267 |
|
Panel-track Supplement |
$386,848 |
$96,712 |
|
180-Day
Supplement |
$72,534 |
$18,134 |
|
Real-Time Supplement |
$33,849 |
$8,462 |
|
BLA
Efficacy Supplement |
$483,560 |
$120,890 |
|
30-Day Notice |
$7,737 |
$3,869 |
|
Annual
Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs) |
$16,925 |
$4,231 |
† 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.
