FDA current fee schedule, reviewed for 2026, in USD.
21 fee lines100% exact amountscurrency USDFX rates 2026-11-09reviewed 2026-10-19
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Annual Establishment Registration FY2027 (October 1, 2026 – September 30, 2027) | $13,785 | $13,785 | Annual per facility | Verified |
| 510(k) Review - Standard FY2027; Class II typically | $28,653 | $28,653 | Per submission | Verified |
| 510(k) Review - Small Business FY2027; FDA-qualified small businesses | $7,163 | $7,163 | Per submission | Verified |
| 513(g) Request - Standard FY2027 | $8,596 | $8,596 | Per request | Verified |
| 513(g) Request - Small Business FY2027; FDA-qualified small businesses | $4,298 | $4,298 | Per request | Verified |
| PMA/PDP/PMR/BLA - Standard FY2027 | $636,732 | $636,732 | Per submission | Verified |
| PMA/PDP/PMR/BLA - Small Business FY2027; FDA-qualified small businesses | $159,183 | $159,183 | Per submission | Verified |
| De Novo Review - Standard FY2027 | $191,020 | $191,020 | Per submission | Verified |
| De Novo Review - Small Business FY2027; FDA-qualified small businesses | $47,755 | $47,755 | Per submission | Verified |
| Panel-track Supplement - Standard FY2027 | $509,386 | $509,386 | Per supplement | Verified |
| Panel-track Supplement - Small Business FY2027; FDA-qualified small businesses | $127,347 | $127,347 | Per supplement | Verified |
| 180-Day Supplement - Standard FY2027 | $95,510 | $95,510 | Per supplement | Verified |
| 180-Day Supplement - Small Business FY2027; FDA-qualified small businesses | $23,878 | $23,878 | Per supplement | Verified |
| Real-Time Supplement - Standard FY2027 | $44,571 | $44,571 | Per supplement | Verified |
| Real-Time Supplement - Small Business FY2027; FDA-qualified small businesses | $11,143 | $11,143 | Per supplement | Verified |
| BLA Efficacy Supplement - Standard FY2027 | $636,732 | $636,732 | Per supplement | Verified |
| BLA Efficacy Supplement - Small Business FY2027; FDA-qualified small businesses | $159,183 | $159,183 | Per supplement | Verified |
| 30-Day Notice - Standard FY2027 | $10,188 | $10,188 | Per notice | Verified |
| 30-Day Notice - Small Business FY2027; FDA-qualified small businesses | $5,094 | $5,094 | Per notice | Verified |
| Class III Periodic Reporting - Standard FY2027; PMAs, PDPs, and PMRs | $22,286 | $22,286 | Annual | Verified |
| Class III Periodic Reporting - Small Business FY2027; PMAs, PDPs, and PMRs; FDA-qualified small businesses | $5,572 | $5,572 | Annual | Verified |
Government fees only — service and testing costs are separate- FY2027 amounts apply from 1 October 2026 through 30 September 2027 (Federal Register 2026-15335).
- 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.
Keep researching this market
More United States medical device resources
Continue with this market
Exact amounts verified against the FDA fee schedule · full review 2026-10-19 · row IDs are stable — cite as government-fees:usa:annual-establishment-registration