USFDA Latest Fee Summary Table for Drugs and Devices
Prescription Drug User Fee Amendments
FY 2023 and FY 2024 User Fee Rates
| Fee Category | Fee Rates for FY 2023 | Fee Rates for FY 2024 |
| Application | ||
| Requiring clinical data | $3,242,026 | $4,048,695 |
| Not requiring clinical data | $1,621,013 | $2,024,348 |
| Program | $393,933 | $416,734 |
GDUFA III User Fee Rates for FY 2023 and FY 2024
| User Fee Type | FY 2023 | FY 2024 | |
|---|---|---|---|
| ANDA | $ 240,582 | $ 252,453 | |
| DMF | $ 78,293 | $ 94,682 | |
| Program | Large Size | $ 1,620,556 | $ 1,729,629 |
| Medium Size | $ 648,222 | $ 691,852 | |
| Small Size | $ 162,056 | $ 172,963 | |
| Facility | Domestic API | $ 37,544 | $ 40,464 |
| Foreign API | $ 52,544 | $ 55,464 | |
| Domestic FDF | $ 213,134 | $ 220,427 | |
| Foreign FDF | $ 228,134 | $ 235,427 | |
| Domestic CMO | $ 51,152 | $ 52,902 | |
| Foreign CMO | $ 66,152 | $ 67,902 | |
| Backlog | $ 17,434 | $ 17,434 |
*The one-time backlog fee was set in FY 2013 only. Those who have not paid for the incurred backlog fee
may email CDERCollections@fda.hhs.gov for further assistance.
MDUFA Fee
Annual Establishment Registration Fee: $6,493
All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments,
businesses, or groups in FY 2023.
Other fees for Fiscal Year 2023 (October 1, 2022 through September 30, 2023) are:
| Application Type | Standard Fee | Small Business Fee |
|---|---|---|
| 510(k) | $19,870 | $4,967 |
| 513(g) | $5,961 | $2,980 |
| PMA, PDP, PMR, BLA | $441,547 | $110,387 |
| De Novo Classification Request | $132,464 | $33,116 |
| Panel-track Supplement | $353,238 | $88,309 |
| 180-Day Supplement | $66,232 | $16,558 |
| Real-Time Supplement | $30,908 | $7,727 |
| BLA Efficacy Supplement | $441,547 | $110,387 |
| 30-Day Notice | $7,065 | $3,532 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs) | $15,454 | $3,864 |
Other fees for Fiscal Year 2024 (October 1, 2023, through September 30, 2024) are:
| Application Type | Standard Fee | Small Business Fee |
|---|---|---|
| 510(k) | $21,760 | $5,440 |
| 513(g) | $6,528 | $3,264 |
| PMA, PDP, PMR, BLA | $483,560 | $120,890 |
| De Novo Classification Request | $145,068 | $36,267 |
| Panel-track Supplement | $386,848 | $96,712 |
| 180-Day Supplement | $72,534 | $18,134 |
| Real-Time Supplement | $33,849 | $8,462 |
| BLA Efficacy Supplement | $483,560 | $120,890 |
| 30-Day Notice | $7,737 | $3,869 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) | $16,925 | $4,231 |
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