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USFDA Latest Fee Summary Table for Drugs and Devices

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Fee CategoryFee Rates for FY 2023Fee Rates for FY 2024
Application  
     Requiring clinical data$3,242,026$4,048,695
     Not requiring clinical data$1,621,013$2,024,348
Program$393,933$416,734

 

User Fee Type FY 2023FY 2024
ANDA $ 240,582$ 252,453
DMF $ 78,293$ 94,682
ProgramLarge Size$ 1,620,556$ 1,729,629
 Medium Size$ 648,222$ 691,852
 Small Size$ 162,056$ 172,963
FacilityDomestic API$ 37,544$ 40,464
 Foreign API$ 52,544$ 55,464
 Domestic FDF$ 213,134$ 220,427
 Foreign FDF$ 228,134$ 235,427
 Domestic CMO$ 51,152$ 52,902
 Foreign CMO$ 66,152$ 67,902
Backlog $ 17,434$ 17,434

*The one-time backlog fee was set in FY 2013 only. Those who have not paid for the incurred backlog fee
may email [email protected] for further assistance.

Application TypeStandard FeeSmall Business Fee
510(k)$19,870$4,967
513(g)$5,961$2,980
PMA, PDP, PMR, BLA$441,547$110,387
De Novo Classification Request$132,464$33,116
Panel-track Supplement$353,238$88,309
180-Day Supplement$66,232$16,558
Real-Time Supplement$30,908$7,727
BLA Efficacy Supplement$441,547$110,387
30-Day Notice$7,065$3,532
Annual Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs)$15,454$3,864
Application TypeStandard FeeSmall Business Fee
510(k)$21,760$5,440
513(g)$6,528$3,264 
PMA, PDP, PMR, BLA$483,560$120,890
De Novo Classification Request$145,068$36,267
Panel-track Supplement$386,848$96,712
180-Day Supplement$72,534$18,134
Real-Time Supplement$33,849$8,462
BLA Efficacy Supplement$483,560$120,890
30-Day Notice$7,737$3,869
Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs)$16,925$4,231