FDA current fee schedule, reviewed for 2026, in USD.
21 fee lines100% exact amountscurrency USDFX rates 2026-09-24reviewed 2026-08-25
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Annual Establishment Registration FY2026; FY2027 fee of $13,785 takes effect October 1, 2026 | $11,423 | $11,423 | Annual per facility | Verified |
| 510(k) Review - Standard FY2026; Class II typically | $26,067 | $26,067 | Per submission | Verified |
| 510(k) Review - Small Business FY2026; FDA-qualified small businesses | $6,517 | $6,517 | Per submission | Verified |
| 513(g) Request - Standard FY2026 | $7,820 | $7,820 | Per request | Verified |
| 513(g) Request - Small Business FY2026; FDA-qualified small businesses | $3,910 | $3,910 | Per request | Verified |
| PMA/PDP/PMR/BLA - Standard FY2026 | $579,272 | $579,272 | Per submission | Verified |
| PMA/PDP/PMR/BLA - Small Business FY2026; FDA-qualified small businesses | $144,818 | $144,818 | Per submission | Verified |
| De Novo Review - Standard FY2026 | $173,782 | $173,782 | Per submission | Verified |
| De Novo Review - Small Business FY2026; FDA-qualified small businesses | $43,446 | $43,446 | Per submission | Verified |
| Panel-track Supplement - Standard FY2026 | $463,418 | $463,418 | Per supplement | Verified |
| Panel-track Supplement - Small Business FY2026; FDA-qualified small businesses | $115,855 | $115,855 | Per supplement | Verified |
| 180-Day Supplement - Standard FY2026 | $86,891 | $86,891 | Per supplement | Verified |
| 180-Day Supplement - Small Business FY2026; FDA-qualified small businesses | $21,723 | $21,723 | Per supplement | Verified |
| Real-Time Supplement - Standard FY2026 | $40,549 | $40,549 | Per supplement | Verified |
| Real-Time Supplement - Small Business FY2026; FDA-qualified small businesses | $10,137 | $10,137 | Per supplement | Verified |
| BLA Efficacy Supplement - Standard FY2026 | $579,272 | $579,272 | Per supplement | Verified |
| BLA Efficacy Supplement - Small Business FY2026; FDA-qualified small businesses | $144,818 | $144,818 | Per supplement | Verified |
| 30-Day Notice - Standard FY2026 | $9,268 | $9,268 | Per notice | Verified |
| 30-Day Notice - Small Business FY2026; FDA-qualified small businesses | $4,634 | $4,634 | Per notice | Verified |
| Class III Periodic Reporting - Standard FY2026; PMAs, PDPs, and PMRs | $20,275 | $20,275 | Annual | Verified |
| Class III Periodic Reporting - Small Business FY2026; PMAs, PDPs, and PMRs; FDA-qualified small businesses | $5,069 | $5,069 | Annual | Verified |
Government fees only — service and testing costs are separate- FY2026 amounts remain payable through 30 September 2026.
- FDA has published FY2027 amounts effective 1 October 2026; they are not presented as current before their effective date.
- Establishment registration is facility-level; submission fees are application-level.
- 510(k)s reviewed by an FDA-accredited third-party reviewer incur no FDA user fee.
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Exact amounts verified against the FDA fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:usa:annual-establishment-registration