FDA 510(k) user fees increase by as much as 125%

Small Business qualification is more important than ever!

Establishment Registration Fee increases by more than a third (to $4,624).

In order for a 510(k) submitter to avoid a large increase in the FDA User Fee starting October 1, 2017, it will be very important that a request for Small Business determination (SBD) be submitted well in advance of the 510(k) submission date. A small business is defined as one with gross receipts or sales, including sales of all affiliates, of no more than $100 million for the most recent tax year. Without an SBD, the 510(k) User Fee will be $10,566 for FY 2018, while with an SBD, it will be $2,642. Current (FY 2017) User Fees are $4,690 without and $2,345 with an SBD.

The full list of fees for Fiscal Year 2018 (October 1, 2017 through September 30, 2018) is as follows:

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

Application Type Standard Fee Small 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.