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  1. FDA User Fee Programs

Medical Device User Fee Amendments (MDUFA)

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 to the FDA Amendments Act (MDUFA II), in 2012 with the Medical Device User Fee Amendments to the FDA Safety and Innovation Act (MDUFA III), and in 2017 with the Medical Device User Fee Amendments to the FDA Reauthorization Act (MDUFA IV). 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 2019 User Fees (in U.S. Dollars)

The Fees for Fiscal Year 2019 (October 1, 2018 through September 30, 2019) are as follows:

Application Type Standard Fee Small Business Fee†
510(k)‡ $10,953 $2,738
513(g) $4,349 $2,175
De Novo classification $96,644 $24,161
PMA, PDP, PMR, BLA $322,147 $80,537
panel-track supplement $241,610 $60,403
180-day supplement $48,322 $12,081
real-time supplement $22,550 $5,638
BLA efficacy supplement $322,147 $80,537
Annual Report $11,275 $2,819
30-day notice $5,154 $2,577

† 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: $4,884

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

FY 2020 MDUFA User Fees

The Fees for Fiscal Year 2020 (October 1, 2019 through September 30, 2020) are as follows:

Application Type Standard Fee Small Business Fee†
510(k)‡ $11,594 $2,899
513(g) $4,603 $2,302
PMA, PDP, PMR, BLA $340,995 $85,249
De Novo Classification Request $102,299 $25,575
Panel-track Supplement $255,747 $63,937
180-Day Supplement $51,149 $12,787
Real-Time Supplement $23,870 $5,968
BLA Efficacy Supplement $340,995 $85,249
30-Day Notice $5,456 $2,728
Annual Fee for Periodic
Reporting on a Class III device
(PMAs, PDPs, and PMRs)
$11,935 $2,984

† 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.

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