USFDA Latest Fee Summary Table for Drugs and Devices

September 13, 2023 | Medical Device

Prescription Drug User Fee Amendments

FY 2023 and FY 2024 User Fee Rates

Fee Category	Fee Rates for FY 2023	Fee 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

GDUFA III User Fee Rates for FY 2023 and FY 2024

User Fee Type		FY 2023	FY 2024
ANDA		$ 240,582	$ 252,453
DMF		$ 78,293	$ 94,682
Program	Large Size	$ 1,620,556	$ 1,729,629
	Medium Size	$ 648,222	$ 691,852
	Small Size	$ 162,056	$ 172,963
Facility	Domestic 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 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)	$16,925	$4,231