FDA FY2022 user fee table
The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2022 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities. The table below lists the user fees for each program.Each year, FDA adjusts its user fees based on factors such as inflation and the number of applications or establishments expected to pay the various fees. For FY2022, FDA’s fee for new drug applications (NDAs) and biologics license applications (BLAs) requiring clinical data will surpass $3 million for the first time, up from $$2,875,842 in FY2021.
Medical device user fees will see a more modest increase of about 2.5% across the board. On the other hand, biosimilar developers will get some relief in FY2022, with application fees frozen at the FY2021 level and fees for biological product development (BPD) and reactivation cut nearly in half from the previous year.
| FDA User Fee Table FY2022 | |||
|---|---|---|---|
| Prescription Drug User Fee Act (PDUFA VI) | FY2022 | FY2021 | Change |
| Applications: | |||
| Requiring clinical data | $3,117,218 | $2,875,842 | $241,376 |
| Not requiring clinical data | $1,558,609 | $1,437,921 | $120,688 |
| Program fee | $369,413 | $336,432 | $32,981 |
| Generic Drug User Fee Amendments (GDUFA II) | FY2022 | FY2021 | Change |
| Applications: | |||
| Abbreviated new drug application (ANDA) | $225,712 | $196,868 | $28,844 |
| Drug master file (DMF) | $74,952 | $69,921 | $5,031 |
| Facilities: | |||
| Active pharmaceutical ingredient (API) – Domestic | $42,557 | $41,671 | $886 |
| API – Foreign | $57,557 | $56,671 | $886 |
| Finished dosage form (FDF) – Domestic | $195,012 | $184,022 | $10,990 |
| FDF – Foreign | $210,012 | $199,022 | $10,990 |
| Contract manufacturing organization (CMO) – Domestic | $65,004 | $61,341 | $3,663 |
| CMO – Foreign | $80,004 | $76,341 | $3,663 |
| GDUFA program: | |||
| Large size operation generic drug applicant | $1,536,856 | $1,542,993 | -$6,137 |
| Medium size operation generic drug applicant | $614,742 | $617,197 | -$2,455 |
| Small business operation generic drug applicant | $153,686 | $154,299 | -$613 |
| Biosimilar User Fee Amendments (BSUFA II) | FY2022 | FY2021 | Change |
| Initial biological product development (BPD) | $57,184 | $102,494 | -$45,310 |
| Annual BPD | $57,184 | $102,494 | -$45,310 |
| Reactivation | $114,368 | $204,988 | -$90,620 |
| Applications: | |||
| Requiring clinical data | $1,746,745 | $1,746,745 | $0 |
| Not requiring clinical data | $873,373 | $873,373 | $0 |
| Program | $304,162 | $304,162 | $0 |
| Medical Device User Fee Amendments (MDUFA IV) | FY2022 (small business fee) | F2021 (small business fee) | Change |
| 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 (21 U.S.C. 360e(f), or a BLA submitted under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262)) | $374,858 ($93,714) |
$365,657 ($91,414) |
$9,201 ($2,300) |
| Premarket report (submitted under section 515(c)(2) of the FD&C Act) | $374,858 ($93,714) |
$365,657 ($91,414) |
$9,201 ($2,300) |
| Efficacy supplement (to an approved BLA under section 351 of the PHS Act) | $374,858 ($93,714) |
$365,657 ($91,414) |
$9,201 ($2,300) |
| Panel-track supplement | $281,143 ($70,286) |
$274,243 ($68,561) |
$6,900 ($1,725) |
| De novo classification request | $112,457 ($28,114) |
$109,697 ($27,424) |
$2,760 ($690) |
| 180-day supplement | $56,229 ($14,057) |
$54,849 ($13,712) |
$1,380 ($345) |
| Real-time supplement | $26,240 ($6,560) |
$25,596 ($6,399) |
$644 ($161) |
| 510(k) premarket notification submission | $12,745 ($3,186) |
$12,432 ($3,108) |
$313 ($78) |
| 30-day notice | $5,998 ($2,999) |
$5,851 ($2,926) |
$147 ($73) |
| 513(g) request for classification information | $5,061 ($2,530) |
$4,936 ($2,468) |
$125 ($62) |
| Annual fee type: | |||
| Annual fee for periodic reporting on a Class III device | $13,120 ($3,280) |
$12,798 ($3,200) |
$322 ($80) |
| Annual establishment registration fee | $5,672 ($5,672) |
$5,546 ($5,546) |
$126 ($126) |
| Outsourcing Facility Fees | FY2022 | FY2021 | Change |
| Qualified small business establishment fee | $5,824 | $5,695 | $129 |
| Non-small business establishment fee | $18,999 | $18,837 | $162 |
| Re-inspection fee | $17,472 | $17,085 | $387 |
