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 |