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FDA Publishes FY 2019 Medical Device and Generic Drug User Fees

The U.S. Food and Drug Administration (FDA) recently published the Fiscal Year (FY) 2019 fee schedules for the Generic Drug User Fee Amendments (GDUFA) and Medical Device User Fee Amendments (MDUFA). FY 2019 rates for both amendments take effect on October 1, 2018. To keep industry updated on these requirements, Registrar Corp outlines upcoming changes to these fees below.

Fees for Drug Facilities
GDUFA requires user fees from certain types of drug facilities. On October 1, 2018, generic drug facilities are required to pay any applicable facility fees to FDA. Additionally, GDUFA requires fees for new Type II Drug Master File (DMF) and Abbreviated New Drug Application (ANDA) submissions to FDA. You will find a table of these fees below.

Notable Changes to GDUFA in FY 2019

  • ANDA Program Fees – In FY 2018, FDA introduced program fees for ANDA holders. These facilities pay a user fee based on the number of approved ANDAs they hold on October 1 of a given year.  The FY 2019 ANDA program fees reflect an approximate 17% increase from the previous year.
  • Type II DMF Submission Fees – In FY 2018, the fee for a single Type II DMF submission to FDA was $47,829. FY 2019 will see an approximate 15% increase to $55,013.

You can view a comparison between the FY 2018 and FY 2019 GDUFA fees below:

FY 2019 GDUFA Fees

Fee Type 2018 2019
Facility Fees Domestic Foreign Domestic Foreign
Active Pharmaceutical Ingredient (API) $45,367 $60,367 $44,226 $59,226
Finished Dosage Form (FDF) $211,087 $226,087 $211,305 $226,305
Contract Manufacturing Organization (CMO) $70,362 $85,362 $70,435 $85,435
ANDA Program Fees – Based upon the number of approved ANDAs held
Large (20 or more ANDAs) $1,590,792 $1,862,167
Medium (6 – 19 ANDAs) $636,317 $744,867
Small (5 or fewer ANDAs) $159,079 $186,217
Application Fees
ANDA $171,823 $178,799
Type II DMF $47,829 $55,013

Fees for Medical Device Establishments
MDUFA requires all FDA-registered establishments to pay a user fee during their annual registration renewal. The FY 2019 establishment registration fee for all establishments is $4,884.  According to the publication of MDUFA fees, FDA does not recognize an establishment as legally registered until this fee is paid.

Additionally, MDUFA requires fees for the submission of certain medical device applications to FDA.  Small businesses, defined by MDUFA as having gross sales or receipts of no more than $100 million during the most recent tax year, may qualify for discounts to application fees. All medical device application fees reflect an approximate 3-4% increase from the previous year.

You can view a comparison between the FY 2018 and FY 2019 MDUFA fees below:

FY 2019 MDUFA Fees

Fee Type 2018 2019
Annual Establishment Registration $4,624 $4,884
Application Fees Standard Small Business Standard Small Business
510(k) $10,566 $2,642 $10,953 $2,738
513(g) $4,195 $2,098 $4,349 $2,175
De Novo Classification $93,229 $23,307 $96,644 $24,161
PMA, PDP, PMR, BLA $310,764 $77,691 $322,147 $80,537
panel-track supplement $233,073 $58,268 $241,610 $60,403
180-day supplement $46,615 $11,654 $48,322 $12,081
real-time supplement $21,753 $5,438 $22,550 $5,638
BLA efficacy supplement $310,764 $77,691 $322,147 $80,537
PMA annual report $10,877 $2,719 $11,275 $2,819

Not sure which fees you may be subject to?  Registrar Corp’s Regulatory Specialists can help determine your applicable fees and facilitate payment with FDA.  Call us at +1-757-224-0177, or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.