Below are the Fees for
Fiscal Year 2020 (October 1, 2019 through September 30, 2020):
|Application Type||Standard Fee||Small Business Fee†|
|PMA, PDP, PMR, BLA||$340,995||$85,249|
|De Novo Classification Request||$102,299||$25,575|
|BLA Efficacy Supplement||$340,995||$85,249|
Annual Fee for Periodic|
Reporting on a Class III device
(PMAs, PDPs, and PMRs)
† 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: $5,236. There are no waivers or reductions for small establishments, businesses, or groups – all establishments must pay the establishment registration fee.