Today, the announcement of the User Fees for three FDA programs today were published in the Federal Register notice prepublication.  PDUFA, animal and generic drug fees and medical device fees for FY 2021 start October 1, 2020 and are provided below.  We await the GDUFA fee announcement, which we should see in a day or two.

PDUFA Fees for FY 2021

Fee Category Fee Rates for FY 2021

Requiring clinical data


Not requiring clinical data




Medical Device Fees for FY 2021

Application Fee Type Standard Fee (as a percent of the standard fee for a premarket application) FY 2021

Standard Fee

FY 2021

Small Business Fee

Premarket application (a PMA submitted under section 515(c)(1) of the FD&C Act (21 U.S.C. 360e(c)(1)), a PDP

submitted under section 515(f) of the FD&C Act, or a BLA submitted under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262))

Base fee specified in statute $365,657 $91,414
Premarket report (submitted under section 515(c)(2) of the FD&C Act) 100 $365,657 $91,414
Efficacy supplement (to an approved BLA under section 351 of the PHS Act) 100 $365,657 $91,414
Panel-track supplement 75 $274,243 $68,561
De novo classification request 30 $109,697 $27,424
180-day supplement 15 $54,849 $13,712
Real-time supplement 7 $25,596 $6,399
510(k) premarket notification submission 3.40 $12,432 $3,108
30-day notice 1.60 $5,851 $2,926
513(g) request for classification information 1.35 $4,936 $2,468
Annual Fee Type
Annual fee for periodic reporting on a class III device 3.50 $12,798 $3,200
Annual establishment registration fee (to be paid by the establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device, as defined by 21 U.S.C. 379i(14)) Base fee specified in statute $5,546 $5,546

Animal Generic Drug User Fees for FY 2021

Abbreviated Application Fee for Generic New Animal Drug except those subject to the criteria in section 512(d)(4)


Abbreviated Application Fee for Generic New Animal Drug subject to the criteria in section 512(d)(4)


Generic New Animal Drug Product Fee


100% Generic New Animal Drug Sponsor Fee1


75% Generic New Animal Drug Sponsor Fee1


50% Generic New Animal Drug Sponsor Fee1


Animal Drug User Fee Rates for FY 2021

Animal Drug User Fee Category Fee Rate for FY 2021
Animal Drug Application Fees: Animal Drug Application

Supplemental Animal Drug Application for Which Safety or Effectiveness Data are Required or Animal Drug Application Subject to the Criteria Set Forth in Section 512(d)(4) of the FD&C Act




Animal Drug Product Fee $12,230
Animal Drug Establishment Fee1 $166,695
Animal Drug Sponsor Fee2 $142,881

PDUFA user fees decreased for application submission by $67,123 (-.2.3%), primarily because FDA estimated that they would receive more NDAs in the new FY, while the program fees jumped $11,008, (+3.3%) an indication that a number of products likely have been discontinued by innovators.

All medical device fees have increased In FY 2021 across the board by about 6.8% with the exception of the annual facility registration fee, which increased 5.6% from $5,236 to $5596.

Animal generic drug user fees rose with fee increases in the range of about 5%; however, for the sponsor fee a rise of 14.6% was noted for the full sponsor fee; however, as noted in the chart above, that fee is tiered.

Animal drug user fees went up about 23.4% for original applications and supplements, 7.2% for product fees and 4.6% for establishment fees but a decrease for animal drug sponsor fees of -1.6% were noted.

This is certainly an interesting year for adjustments.  Look for the announcements of additional fee categories that will be revised over the next week.