FY 2021 MDUFA User Fees
US FDA Medical Device Class 2021 Registration Annual Fee
The Fees for Fiscal Year 2021 (October 1, 2020 through September 30, 2021) are as follows:
The FDA issued a charge for medical devices in fiscal 2021 (applicable to 2020.10.01-2021.09.30)
| Application Type | Standard Fee | Small Business Fee |
| 510(k) | $12,432 | $3,108 |
| 513(g) | $4,936 | $2,468 |
| PMA, PDP, PMR, BLA | $365,657 | $91,414 |
| De Novo Classification Request | $109,697 | $27,424 |
| Panel-track Supplement | $274,243 | $68,561 |
| 180-Day Supplement | $54,849 | $13,712 |
| Real-Time Supplement | $25,596 | $6,399 |
| BLA Efficacy Supplement | $365,657 | $91,414 |
| 30-Day Notice | $5,851 | $2,926 |
Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) | $12,798 | $3,200 |
Note: All types of 510(k) (traditional, abbreviated and special) require annual fees. However, there is no annual fee for 510(k) reports submitted to the FDA on behalf of third-party examiners recognized by the FDA.
Small businesses as long as they have an approved SBD with total revenue or sales of $30 million or less are eligible for fee waivers on their first PMA, PDP, PMR, or BLA.
Annual registration fee: $5,546.
For small institutions, businesses or groups, there are no exemptions or reductions-all institutions must pay the establishment registration fee.
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