On July 30, 2026, FDA published eleven Federal Register notices establishing Fiscal Year (FY) 2027 user fee rates across its major regulatory programs. The updates cover prescription drugs, generic drugs, biosimilars, over-the-counter monograph drugs, medical devices, animal drugs, outsourcing facilities, and several Food Safety Modernization Act (FSMA) programs.
Most FY 2027 fees take effect October 1, 2026, and remain in effect through September 30, 2027. Two exceptions apply:
- OMUFA facility fees are payable in two installments on October 1, 2026, and February 1, 2027.
- The Voluntary Qualified Importer Program (VQIP) participation fee takes effect August 1, 2026, to support benefits beginning October 1.
Many FY 2027 rates increased due to FDA’s annual inflation adjustment and program workload changes, while a few programs saw modest reductions because of required operating reserve adjustments.
FY 2027 Fee Schedule
| Program | Fee Category | FY 2027 Rate | Effective |
|---|---|---|---|
| PDUFA – Prescription Drug | Application requiring clinical data | $4,600,753 | 10/1/26-9/30/27 |
| Application not requiring clinical data | $2,300,376 | 10/1/26-9/30/27 | |
| Prescription drug program fee | $416,857 | 10/1/26-9/30/27 | |
| GDUFA – Generic Drug | ANDA | $375,684 | 10/1/26-9/30/27 |
| Drug Master File | $109,899 | 10/1/26-9/30/27 | |
| API facility (domestic / foreign) | $39,680 / $54,680 | 10/1/26-9/30/27 | |
| FDF facility (domestic / foreign) | $230,033 / $245,033 | 10/1/26-9/30/27 | |
| CMO facility (domestic / foreign) | $55,208 / $70,208 | 10/1/26-9/30/27 | |
| Applicant program fee (large / medium / small) | $1,927,291 / $770,916 / $192,729 | 10/1/26-9/30/27 | |
| BsUFA – Biosimilar | Initial / annual BPD fee | $10,000 | 10/1/26-9/30/27 |
| Reactivation fee | $20,000 | 10/1/26-9/30/27 | |
| Application (clinical data required / not required) | $1,124,936 / $562,468 | 10/1/26-9/30/27 | |
| Program fee | $195,887 | 10/1/26-9/30/27 | |
| OMUFA – OTC Monograph Drug | MDF facility fee | $47,891 | 10/1/26-9/30/27 |
| CMO facility fee | $31,927 | 10/1/26-9/30/27 | |
| Tier 1 / Tier 2 OMOR fee | $614,608 / $122,921 | 10/1/26-9/30/27 | |
| MDUFA – Medical Device | PMA/PDP/BLA (standard / small business) | $636,732 / $159,183 | 10/1/26-9/30/27 |
| 510(k) notification (standard / small business) | $28,653 / $7,163 | 10/1/26-9/30/27 | |
| De Novo request (standard / small business) | $191,020 / $47,755 | 10/1/26-9/30/27 | |
| Annual establishment registration | $13,785 | 10/1/26-9/30/27 | |
| ADUFA – Animal Drug | Animal drug application | $621,692 | 10/1/26-9/30/27 |
| Supplemental application | $310,846 | 10/1/26-9/30/27 | |
| Annual product fee | $12,294 | 10/1/26-9/30/27 | |
| Annual establishment fee | $215,520 | 10/1/26-9/30/27 | |
| Annual sponsor fee | $145,476 | 10/1/26-9/30/27 | |
| AGDUFA – Animal Generic Drug | Abbreviated application | $132,614 | 10/1/26-9/30/27 |
| Abbreviated application (512(d)(4)) | $66,307 | 10/1/26-9/30/27 | |
| JINAD file fee | $50,000 | 10/1/26-9/30/27 | |
| Annual product fee | $15,670 | 10/1/26-9/30/27 | |
| Annual sponsor fee (100% / 75% / 50%) | $264,009 / $198,007 / $132,005 | 10/1/26-9/30/27 | |
| Outsourcing Facility | Small business establishment fee | $7,142 | 10/1/26-9/30/27 |
| Non-small business establishment fee | $22,074 | 10/1/26-9/30/27 | |
| Reinspection fee | $21,427 | 10/1/26-9/30/27 | |
| FSMA Reinspection, Recall & Importer Reinspection | Domestic travel | $354/hr | 10/1/26-9/30/27 |
| Foreign travel | $414/hr | 10/1/26-9/30/27 | |
| FSMA Third-Party Certification | Initial accreditation application | $56,272 | 10/1/26-9/30/27 |
| Annual accreditation fee | $2,612 | 10/1/26-9/30/27 | |
| Annual certification body fee | $3,266 | 10/1/26-9/30/27 | |
| Direct accreditation application | $56,272 | 10/1/26-9/30/27 | |
| Renewal application | $34,311 | 10/1/26-9/30/27 | |
| FSMA VQIP | Annual importer participation fee | $9,994 | 8/1/26-9/30/27 |
Rates shown are standard fees unless otherwise noted. Small business, waiver, and reduced-fee provisions may apply under each program.
What to Do Before October 1
- Confirm which FY 2027 fee schedule applies to any application, facility registration, or program fee due on or after October 1, 2026.
- Budget for OMUFA facility fees, which must be paid in two installments on October 1, 2026, and February 1, 2027.
- VQIP participants should note the annual fee is due before October 1 to maintain FY 2027 program benefits and is non-refundable.
- Medical device establishments should renew small business qualification, if applicable, before September 30, 2026, to receive reduced MDUFA fees.
- Companies participating in FDA’s accredited third-party certification program should budget for the updated application, annual, and renewal fees.
ASK Alba™
Questions about how the FY 2027 FDA user fee changes affect your submissions, facility registrations, or import operations? Contact Alba, our trade compliance team is here to help.
References
• Prescription Drug User Fee Rates for Fiscal Year 2027 (91 FR 48160)
• Generic Drug User Fee Rates for Fiscal Year 2027 (91 FR 48154)
• Biosimilar User Fee Rates for Fiscal Year 2027 (91 FR 48166)
• Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027 (91 FR 48121)
• Medical Device User Fee Rates for Fiscal Year 2027 (91 FR 48134)
• Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2027 (91 FR 48128)
• Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2027 (91 FR 48149)
• Outsourcing Facility Fee Rates for Fiscal Year 2027
• FSMA Third-Party Certification Program User Fee Rate for Fiscal Year 2027 (91 FR 48145)
• FSMA Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2027 (91 FR 48125)
Related
CBP separately announced its own FY 2027 inflation adjustment to customs COBRA user fees (merchandise processing fees, vessel/truck/rail/aircraft arrival fees, broker permit fees) — see “CBP Announces FY 2027 COBRA User Fee Adjustments.”
