Device user fees were first established in 2002 by the Medical Device User Fee and Modernization Act (MDUFMA). User fees were renewed in 2007, with the Medical Device User Fee Amendments (MDUFA II) to the FDA Amendments Act (FDAAA), in 2012 with the Medical Device User Fee Amendments (MDUFA III) to the FDA Safety and Innovation Act (FDASIA), and in 2017 with the Medical Device User Fee Amendments (MDUFA IV) to the FDA Reauthorization Act (FDARA). MDUFA IV will be in place from Oct. 1, 2017 until Sept. 30, 2022.
Under the user fee system, medical device companies pay fees to the FDA when they register their establishments and list their devices with the agency, whenever they submit an application or a notification to market a new medical device in the U.S. and for certain other types of submissions. These fees help the FDA increase the efficiency of regulatory processes with a goal of reducing the time it takes to bring safe and effective medical devices to the U.S. market.
FY 2021 MDUFA User Fees
The Fees for Fiscal Year 2021 (October 1, 2020 through September 30, 2021) are as follows:
|Application Type||Standard Fee||Small Business Fee†|
|PMA, PDP, PMR, BLA||$365,657||$91,414|
|De Novo Classification Request||$109,697||$27,424|
|BLA Efficacy Supplement||$365,657||$91,414|
|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: $5,546.
There are no waivers or reductions for small establishments, businesses, or groups – all establishments must pay the establishment registration fee.
- Medical Device User Fee Small Business Qualification and Certification: Guidance for Industry, Food and Drug Administreation Staff and Foreign Governments
- Medical Device User Fee Amendments 2017 (MDUFA IV)
- Medical Device User Fee Amendments 2012 (MDUFA III)
- Medical Device User Fee Amendments 2007 (MDUFA II)
- Medical Device User Fee and Modernization Act 2002 (MDUFMA)