FDA announces Medical Device & Generic Drug Fees
On August 2 the Food & Drug Adminstration (FDA) announced the 2022 Medical Device User Fee Amendments (MDUFA) user fee rates (click here), the 2.5% increase is quite a bit less compared to the 7% hike instituted last year. The fees for a premarket submission received by the FDA during this year will apply from October 1, 2021, through September 30, 2022. All facilities must pay the fee to be considered in good standing with the FDA.
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| Application Type | Standard Fee | Small Business Fee† |
|---|---|---|
| 510(k) | $12,745 | $3,186 |
| 513(g) | $5,061 | $2,530 |
| PMA,PDP,PMR,BLA | $374,858 | $93,714 |
| De Novo Classification Request | $112,457 | $28,114 |
| Panel-track Supplement | $281,143 | $70,286 |
| 180-Day Supplement | $56,229 | $14,057 |
| Real-Time Supplement | $26,240 | $6,560 |
| BLA Efficacy Supplement | $374,858 | $93,714 |
| 30-Day Notice | $5,998 | $2,999 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs) | $13,120 | $3,280 |