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Most establishments must pay the establishment registration fee. For more information, see Who Must Register, List and Pay the Fee and When to Register and List.
For FY 2026, 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, see the section on Small Businesses below.
| Application Type | Standard Fee | Small Business Fee† |
|---|---|---|
| 510(k)‡ | $26,067 | $6,517 |
| 513(g) | $7,820 | $3,910 |
| PMA, PDP, PMR, BLA | $579,272 | $144,818 |
| De Novo Classification Request | $173,782 | $43,446 |
| Panel-track Supplement | $463,418 | $115,855 |
| 180-Day Supplement | $86,891 | $21,723 |
| Real-Time Supplement | $40,549 | $10,137 |
| BLA Efficacy Supplement | $579,272 | $144,818 |
| 30-Day Notice | $9,268 | $4,634 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) | $20,275 | $5,069 |
† 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.
