FDA announces Medical Device & Generic Drug Fees

by t_king

Medical Device

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 TypeStandard FeeSmall Business Fee
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