Today, the Federal Register announced the 2022 MDUFA fees (here).  As the FDA notes, “This notice establishes the fee rates for FY 2022, which apply from October 1, 2021 through September 30, 2022, and provides information on how the fees for FY 2022 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.”  While all fees went up from last year (see post here for FY 2021 fees), they did not go up significantly.

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 $374,858 $93,714
Premarket report (submitted under section 515(c)(2) of the FD&C Act) 100 $374,858 $93,714
Efficacy supplement (to an approved BLA under section 351 of the PHS Act 100 $374,858 $93,714
Panel-track supplement 75 $281,143 $70,286
De novo classification request 30 $112,457 $28,114
180-day supplement 15 $56,229 $14,057
Real-time supplement 7 $26,240 $6,560
510(k) premarket notification submission 3.40 $12,745 $3,186
30-day notice 1.60 $5,998 $2,999
513(g) request for classification information 1.35 $5,061 $2,530
Annual Fee Type
Annual fee for periodic reporting on a class III device 3.50 $13,120 $3,280
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 $5,672 $5,672