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US FDA FY 2019 MDUFA User Fees

August 6, 2018

On 08/01/2018, the US Food and Drug Administration (FDA) published the user fee amounts it will collect in FY2019 from the manufacturers of medical devices.

Current Law User Fees: +$2.791 Million (Center: +$2.755 million / Field: +$0.036 million)

The Devices Program request includes an increase of $2.8 million for user fees authorized under Food and Drug Administration Reauthorization Act of 2017 (FDARA), which will allow FDA to fulfill its mission of promoting and protecting the public health by ensuring safety and efficacy of medical products and accelerating innovation in the industry.

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

FY 2019 User Fees (in U.S. Dollars)

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.

 

Additional Information About User Fees