FY2027 MDF facility user fee is: $47,891 (monograph drug facility)
FY2027 CMO facility user fee is: $31,927 (contract manufacturing organization)
Please review this chart to ensure understanding of the fee liable periods.
| FY2026 | FY2027 | FY2028 | FY2029 | FY2030 | |
| Fee Liable Period | Jan 1, 2025 – Dec 31, 2025 |
Jan 1, 2026 – Sept 30, 2026 |
Oct 1, 2026 – Sept 30, 2027 |
Oct 1, 2027 – Sept 30, 2028 |
Oct 1, 2028 – Sept 30, 2029 |
| Fee due on | June 1, 2026 | 50% Oct 1, 2026 / 50% Feb 1, 2027 |
Oct 1, 2027 | Oct 2, 2028 | Oct 1, 2029 |
Not liable if: OTC monograph drug activities ceased prior to
| Jan 1, 2025 |
Jan 1, 2026 |
Oct 1, 2026 |
Oct 1, 2027 |
Oct 1, 2028 |
|
To ensure a user fee is not assessed to your facility, all NDC listings must have submitted an end marketing date, and the facility must be de-registered prior to the date noted in the above chart.
Additional changes brought by OMUFA II (2026 – 2030)
The agency is increasing visibility of the OMUFA arrears list by highlighting it in FDA communications, updating the OMUFA website, and reaching out to external stakeholders. The arrears list and facilities paid list will be published on the OMUFA website. The lists will identify if a facility is foreign or domestic.
Companies are reminded that OTC monograph drugs manufactured at a facility identified on the arrears list are considered misbranded. Additionally, the FDA will be assessing accrued interest, which begins to accumulate 1 day after the invoice due date, on invoices that are not settled by the payment date.
Letters are being issued to companies that have not paid their FY2026 OMUFA user fee invoices advising of these penalties.
The below websites have full information on the OMUFA facility user fee program. You can also reach out to EAS with any specific questions you might have.
- Over-The-Counter Monograph Drug User Fee Program (OMUFA)
- Federal Register Vol 91, No. 145 Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027
- OTC Monograph Drug User Fee Amendments (OMUFA): Understanding FY 2026 User Fees and Registration recorded webinar
Generic Drug User Fee Amendments (GDUFA) 2027 user fees were published in the Federal Register Vol. 91, No. 145 published 30 July 2026. User fees are due 1 October 2026.
| User Fee Type | FY 2027 | |
| ANDA | $ 375,684 | |
| DMF | $ 109,899 | |
| Program | Large Size | $ 1,927,291 |
| Medium Size | $ 770,916 | |
| Small Size | $ 192,729 | |
| Facility | Domestic API | $ 39,680 |
| Foreign API | $ 54,680 | |
| Domestic FDF | $ 230,033 | |
| Foreign FDF | $ 245,033 | |
| Domestic CMO | $ 55.208 | |
| Foreign CMO | $ 70,208 | |
Medical Device User Fee Amendments (MDUFA) 2027 user fees were published in the 30 July 2026 Federal Register Vol. 91, No. 145. User fees are due prior to submitting your medical device establishment registration renewal, between 1 October and 31 December 2026.
Annual Establishment Registration Fee: $13,785
Application Fees:
| Application Type | Standard Fee | Small Business Fee |
| 510(k) | $ 28,653 | $ 7,163 |
| 513(g) | $ 8,596 | $ 4,298 |
| PMA, PDP, PMR, BLA | $ 636,732 | $ 159,183 |
| De Novo Classification Request | $ 191,020 | $ 47,755 |
| Panel-track Supplement | $ 509,386 | $ 127,347 |
| 180-Day Supplement | $ 95,510 | $ 23,878 |
| Real-Time Supplement | $ 44,571 | $ 11,143 |
| BLA Efficacy Supplement | $ 636,732 | $ 159,183 |
| 30-Day Notice | $ 10,188 | $ 5,094 |
Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs):
Standard: $22,286 Small Business Fee: $5,572
Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program applications opened 1 August 2026 for FY2027.
| Fee Category | Fee Rates for FY 2026 | |
| Application | ||
| Requiring clinical data | $ 4,600,753 | |
| Not requiring clinical data | $ 2,300,376 | |
| Program | $ 416,857 | |
FDA is announcing this Data Request for the submission of data from the public to help inform whether the pH cycling test model should be included as a testing procedure for fluoride dentifrice drug products under Over-the-Counter (OTC) Monograph M021.
Data may be submitted electronically to docket number FDA-2026-N-7864 in the Federal eRulemaking Portal at https://www.regulations.gov/. See the Data Request for instructions. Data submissions will be accepted at any time beginning on July 28, 2026 until 11:59 pm Eastern Time at the end of January 25, 2027.
FDA’s Biosimilar User Fee Amendments FY2027 user fees are published on the webpage.
Highlighted Guidance Documents
Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs
The FDA is announcing the availability of a final guidance for industry. This guidance provides recommendations for the design and conduct of studies evaluating the adhesion performance of a transdermal or topical delivery system. The recommendations in this guidance relate to studies submitted in support of an abbreviated new drug application. The guidance replaces the draft guidance (Revision 2) “Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs,” issued on April 13, 2023.
Evaluation of Therapeutic Equivalence
The FDA is announcing the availability of a final guidance for industry titled “Evaluation of Therapeutic Equivalence.” This guidance explains FDA’s thinking on therapeutic equivalence evaluations and therapeutic equivalence codes (TE codes). FDA’s therapeutic equivalence evaluations are listed for multisource prescription drug products approved under the Federal FD&C Act in the active section of the “Approved Drug Products With Therapeutic Equivalence Evaluations” (commonly known as the Orange Book). This guidance finalizes the draft guidance of the same title issued in July 2022.
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
The FDA is announcing the availability of a final guidance for industry titled “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.” This guidance outlines the recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of new drug or biological products regulated by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. This guidance finalizes the draft guidance of the same title issued on September 22, 2023.
DRAFT Determining Whether to Submit an ANDA or a 505(b)(2) Application
Submit Comments by 10/19/2026
DRAFT Container Closure Systems for Human Drugs and Biological Products
Submit Comments by 10/13/2026
DRAFT Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs
Comments may be submitted anytime
DRAFT Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts
Comments may be submitted anytime
All Guidance Documents can be searched on the FDA’s website.
Meetings
Date: September 10, 2026
Time: 8:30 am – 12:40 pm
Date: September 16, 2026
Time: 9:00 a.m. – 2:00 p.m. ET
Public Meeting on the Reauthorization of Generic Drug User Fee Amendments (GDUFA)
Date: September 17, 2026
Time: 9:00 a.m. – 2:00 p.m. ET
Dates: September 23 – 24, 2026
Day1: Wed, Sep 23 8:00 a.m. – 04:30 p.m. ET
Day2: Thu, Sep 24 8:00 a.m. – 04:30 p.m. ET
Location:
Attend In Person or Virtually
In Person: The Universities at Shady Grove
Building II
9630 Gudelsky Drive
Rockville, MD 20850
United States
Communicating Drug Interaction and QTc Information in the U.S. Prescribing Information
Date: September 23, 2026
Time: 1:00 p.m. – 3:00 p.m. ET
Regulatory Science Innovations Catalyzing Medical Device Development
Date: September 25, 2026
Time: 8:30 a.m. – 4:30 p.m. ET
FDA’s Drug Registration and Listing Workshop: Compliance, Regulatory and Submission Updates
Date: Tuesday, September 29, 2026
Time: 8:45 a.m. – 4:00 p.m. ET
Location: Attend In Person or Online
In Person: FDA White Oak Campus
10903 New Hampshire Ave, Building 31
The Great Room
Silver Spring, MD 20903
United States
Date: October 14 – 15, 2026
Day1: Wed, Oct 14 8:00 a.m. – 05:30 p.m. ET
Day2: Thu, Oct 15 8:00 a.m. – 05:30 p.m. ET
Location: Attend In Person or Virtually
In Person: The Universities at Shady Grove
Building II
9630 Gudelsky Drive
Rockville, MD 20850
United States
FDA Websites of Interest
- FDA Announces FY 2027 Animal Drug User Fee Rates for ADUFA and AGDUFA
- Over-the-Counter (OTC) Medical Devices: Considerations for Device Manufacturers
- Assessment of the Use of Patient Experience Data in Regulatory Decision-Making
- FDA Publishes New Product-Specific Guidances to Facilitate Generic Drug Development
- Drug Supply Chain Security Act (DSCSA) Assessment of Small Dispensers
- OTC Monographs@FDA
Posted in Drug and Device Corner, Drugs, Medical Devices.