Medical Devices

MDUFA III Fees

The Fees for Fiscal Year 2014 (October 1, 2013 through September 30, 2014) are as follows:

FY14 User Fees (in U.S. Dollars)

application typestandard feesmall business fee
510(k)$5,170$2,585
513(g)$3,490$1,745
PMA, PDP, PMR, BLA$258,520$64,630
panel-track supplement$193,890$48,473
180-day supplement$38,778$9,695
real-time supplement$18,096$4,524
BLA efficacy supplement$258,520$64,630
PMA annual report$9,048$2,262
30-day notice$4,136$2,068

† 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: $3,313

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

Page Last Updated: 06/26/2014
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