Medical Devices

MDUFA III Fees

The Fees for Fiscal Year 2015 (October 1, 2014 through September 30, 2015) are as follows:

FY15 User Fees (in U.S. Dollars)

application typestandard feesmall business fee
510(k)$5,018$2,509
513(g)$3,387$1,694
PMA, PDP, PMR, BLA$250,895$62,724
panel-track supplement$188,171$47,043
180-day supplement$37,634$9,409
real-time supplement$17,563$4,391
BLA efficacy supplement$250,895$62,724
PMA annual report$8,781$2,195
30-day notice$4,014$2,007

† 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: $3,646

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

Page Last Updated: 09/30/2014
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