FDA registration fee FY 2021
FDA has published the annual establishment registration fee for FY 2021, which will be effective from October 1, 2020. The FDA registration fee for each medical device establishment is $5,546.
All medical device establishments intended to register/renew their facility are required to pay the establishment registration fee. Waivers or reductions for small establishments, businesses, or groups do not apply to the annual establishment registration fee.
Other Medical Device Regulatory Application Fees For FY 2021.
| Application Type | Standard Fee | Small Business Fee |
|---|---|---|
| 510(k) | $11,594 | $2,899 |
| 513(g) | $4,603 | $2,302 |
| PMA, PDP, PMR, BLA | $340,995 | $85,249 |
| De Novo Classification Request | $102,299 | $25,575 |
| Panel-track Supplement | $255,747 | $63,937 |
| 180-Day Supplement | $51,149 | $12,787 |
| Real-Time Supplement | $23,870 | $5,968 |
| BLA Efficacy Supplement | $340,995 | $85,249 |
| 30-Day Notice | $5,456 | $2,728 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) |
$11,935 | $2,984 |