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  1. FDA User Fee Programs

Medical Device User Fee Amendments (MDUFA)

User Fees for FY 2024

Annual Establishment Registration Fee: $7,653

All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups in FY 2024.

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

Small Business Fee: For businesses certified by the Center for Devices and Radiological Health (CDRH) as a small business.

510(k) Fees: All types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer.

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