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UUser Fees for FY 2027
Annual Establishment Registration Fee: $13,785
Most establishments must pay the establishment registration fee. For more information, see Who Must Register, List and Pay the Fee. For payment timing, see When to Register and List.
For FY 2027, the FDA may grant a waiver of the annual establishment registration fee (excluding the initial registration) to certain small businesses qualified through the Small Business Determination (SBD) Program who demonstrate that paying the fee represents financial hardship as determined by the FDA. For more information, visit Reduced Medical Device User Fees: Small Business Determination (SBD) Program..
Application Fees:
Application Type |
Standard Fee |
Small Business Fee† |
|---|---|---|
510(k)‡ |
$28,653 |
$7,163 |
513(g) |
$8,596 |
$4,298 |
PMA, PDP, PMR, BLA |
$636,732 |
$159,183 |
De Novo Classification Request |
$191,020 |
$47,755 |
Panel-track Supplement |
$509,386 |
$127,347 |
180-Day Supplement |
$95,510 |
$23,878 |
Real-Time Supplement |
$44,571 |
$11,143 |
BLA Efficacy Supplement |
$636,732 |
$159,183 |
30-Day Notice |
$10,188 |
$5,094 |
Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) |
$22,286 |
$5,572 |
† Small Business Fee: For businesses qualified by the Center for Devices and Radiological Health (CDRH) as a small business. For information about qualification, visit Reduced Medical Device User Fees: Small Business Determination (SBD) Program.
‡ 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.
