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 Type||Standard Fee||Small Business Fee?|
|De Novo classification||$93,229||$23,307|
|PMA, PDP, PMR, BLA||$310,764||$77,691|
|BLA efficacy supplement||$310,764||$77,691|
|PMA annual report||$10,877||$2,719|
? 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.