*The one-time backlog fee was set in FY 2013 only. Those who have not paid for the incurred backlog fee may email CDERCollections@fda.hhs.gov for further assistance.
MDUFA Fee
Annual Establishment Registration Fee: $6,493
All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups in FY 2023.
Other fees for Fiscal Year 2023 (October 1, 2022 through September 30, 2023) are:
Application Type
Standard Fee
Small 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
Other fees for Fiscal Year 2024 (October 1, 2023, through September 30, 2024) are:
Application Type
Standard Fee
Small 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)