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# FDA Posts User Fee Rates for FY 2027
- URL: https://www.fdaweb.com/fda-posts-user-fee-rates-for-fy-2027/
- Published: 2026-07-29T12:00:00.000Z
- Updated: 2026-09-14T13:44:03.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5161538

FDA has published the following user fee rates for medical product programs for fiscal year (FY) 2027:

**Prescription Drug User Fee Rates for FY 2027:**

**\*\*\*** NDA/BLA requiring clinical data: **$4,600,753** (FY 2026 $4,682,003)  
**\*\*\*** NDA/BLA not requiring clinical data: **$2,300,376** (FY 2026 $2,341,002)  
**\*\*\*** Program Fee: **$416,857** (FY 2026 $442,213)

For more information, see notice [here](https://public-inspection.federalregister.gov/2026-15334.pdf?ref=fdaweb.com).  
  
**Biosimilar User Fee Rates for FY 2027:**

\*\*\* Biosimilar Application Requiring Clinical Data: **$1,124,936** (FY 2026 $,1,200,794)  
\*\*\* Biosimilar Application Not Requiring Clinical Data: **$562,468** (FY 2026 $600,397)  
\*\*\* Program Fee $**195,887** (FY 2026 $209,097)

For more information, see notice [here](https://public-inspection.federalregister.gov/2026-15346.pdf?ref=fdaweb.com).

**Generic Drug User Fee Rates for FY 2027:**

- Abbreviated New Drug Application (ANDA): **$375,684** (FY 2026 $358,247)
- Drug Master File (DMF): **$109,899** (FY 2026 $102,584)
- Program Fee -Large size operation: **$1,927,291** (FY 2026 $1,918,377)
- Program Fee - Medium size operation: **$770,916** (FY 2026 $767,351)
- Program Fee- Small business: **$192,729** (FY 2026 $191,838)

For more information, see notice [here](https://public-inspection.federalregister.gov/2026-15343.pdf?ref=fdaweb.com).

**Medical Device User Fee Rates for FY 2027:**

- 510(k): **$28,653** (FY 2026 $26,067)
- PMA: **$636,732** (FY 2026 $579,272)
- De Novo: **$191,020** (FY 2026 $173,782)

For more information, see notice [here](https://public-inspection.federalregister.gov/2026-15335.pdf?ref=fdaweb.com).