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Your Location：Home >The US FDA announces the annual medical registration fee for 2021, which will increase to US$5546
Release Time：2020-11-13 Browse：2943 times
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.
