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FY 2018 MDUFA User Fees

2017/09/29

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The Fees for Fiscal Year 2018 (October 1, 2017 through September 30, 2018) are as follows:

FY 18 User Fees (in U.S. Dollars)

Application TypeStandard FeeSmall Business Fee?
510(k)?$10,566$2,642
513(g)$4,195$2,098
De Novo classification$93,229$23,307
PMA, PDP, PMR, BLA$310,764$77,691
panel-track supplement$233,073$58,268
180-day supplement$46,615$11,654
real-time supplement$21,753$5,438
BLA efficacy supplement$310,764$77,691
PMA annual report$10,877$2,719
30-day notice$4,972$2,486

? 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: $4,624

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