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  1. FDA User Fee Programs

Medical Device User Fee Amendments (MDUFA)

User Fees for FY 2025

Annual Establishment Registration Fee: $9,280

All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups in FY 2025.

Other fees for Fiscal Year 2025 (October 1, 2024, through September 30, 2025) are:

Application Type Standard Fee Small Business Fee
510(k) $24,335 $6,084
513(g) $7,301 $3,650
PMA, PDP, PMR, BLA $540,783 $135,196
De Novo Classification Request $162,235 $40,559
Panel-track Supplement $432,626 $108,157
180-Day Supplement $81,117 $20,279
Real-Time Supplement $37,855 $9,464
BLA Efficacy Supplement $540,783 $135,196
30-Day Notice $8,653 $4,326
Annual Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs) $18,927 $4,732

Small Business Fee: For businesses certified by the Center for Devices and Radiological Health (CDRH) as a small business. For more information, see the section Small Businesses below.

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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