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User Fees for FY 2025
Annual Establishment Registration
Fee: $ 9,280
All
establishments must pay the establishment registration fee. There
are no waivers or reductions for small establishments, businesses, or groups in
FY 2025.
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 |
† Small
Business Fee: For businesses certified by the Center for Devices and
Radiological Health (CDRH) as a small business. For more information, see
the section Small Businesses below.
‡ 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.
