For Industry

FY 2019 MDUFA User Fees

The Fees for Fiscal Year 2019 (October 1, 2018 through September 30, 2019) are as follows:

FY 2019 User Fees (in U.S. Dollars)

Application TypeStandard FeeSmall Business Fee
510(k)$10,953$2,738
513(g)$4,349$2,175
De Novo classification$96,644$24,161
PMA, PDP, PMR, BLA$322,147$80,537
panel-track supplement$241,610$60,403
180-day supplement$48,322$12,081
real-time supplement$22,550$5,638
BLA efficacy supplement$322,147$80,537
Annual Report$11,275$2,819
30-day notice$5,154$2,577

† For small businesses with an approved SBD.

‡ Note: 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.

Small businesses with an approved SBD with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first PMA, PDP, PMR, or BLA.

Annual Establishment Registration Fee: $4,884

There are no waivers or reductions for small establishments, businesses, or groups – all establishments must pay the establishment registration fee. 

Page Last Updated: 08/01/2018
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