Is your company manufacturing, exporting, importing or distributing personal protective equipment (PPE) and other medical devices, or Over-the-Counter (OTC) drug products?
Then, you will be required to pay a fee directly to the U.S. Treasury before the registration of your establishment can be completed.
Don’t lose your FDA Establishment Identifier (FEI) Number. Save now on New Registration and Listing.
FDA user fees are payments collected by the U.S. Food and Drug Administration (FDA) from companies that produce certain regulated products, primarily drugs, medical devices, generic drugs, and biosimilars. These fees supplement the funding the FDA receives from Congress through annual appropriations.
Here’s a breakdown of how they work and their purpose
The primary goal of user fees is to provide the FDA with additional resources to expedite the review process for new products and conduct related regulatory activities, without compromising the agency’s commitment to public health, safety, and scientific integrity. This helps bring innovative products to market more quickly, benefiting both industry and patients.
Federal law authorizes the FDA to collect these fees. Congress determines the amount and specific uses of the user fees.
Prescription Drug User Fee Act (PDUFA): For human prescription drugs and biological products.
Medical Device User Fee Amendments (MDUFA): For medical devices.
Generic Drug User Fee Amendments (GDUFA): For generic drugs.
Biosimilar User Fee Act (BsUFA): For biosimilar biological products.
There are also user fees for animal drugs, mammography facilities, and over-the-counter monograph drugs.
Many user fee programs involve specific commitments negotiated between the FDA and the regulated industry. These agreements often include performance goals, such as timelines for reviewing applications. These programs typically require reauthorization by Congress every five years.
User fees are collected by the FDA and deposited into an FDA account in the Treasury. By law, these funds can only be spent on the activities specifically allowed by Congress for each user fee program. They are intended to supplement congressional appropriations, not replace them.
User Fees Benefits
User fees have generally been credited with:
● Reducing review times for new medical products.
● Increasing access to new products for patients.
● Providing more predictable timelines for industry.
● Allowing the FDA to hire additional staff and invest in infrastructure to support reviews and oversight.
In essence, FDA user fees are a crucial funding mechanism that helps the agency efficiently and effectively regulate a vast array of products, ensuring their safety and efficacy for public use.
There are no waivers or reductions for small establishments or businesses. All establishments must pay the establishment registration fee.
| Application Type | Standard Fee | Small Business Fee (Reduced) |
|---|---|---|
| 510(k) ‡ | $26,067 | $6,517 |
| 513(g) | $7,820 | $3,910 |
| PMA, PDP, PMR, BLA | $579,272 | $144,818 |
| De Novo Classification Request | $173,782 | $43,446 |
| Panel-track Supplement | $463,418 | $115,855 |
| 180-Day Supplement | $86,891 | $21,723 |
| Real-Time Supplement | $40,549 | $10,137 |
| BLA Efficacy Supplement | $579,272 | $144,818 |
| 30-Day Notice | $9,268 | $4,634 |
| Annual Fee for Periodic Reporting on a Class III Device (PMAs, PDPs, and PMRs) | $20,275 | $5,069 |
A business that is qualified and certified as a “small business” is eligible for a substantial reduction. Application types eligible for reduced small business fee are:
▪ Premarket Notification 510(k).
▪ De Novo request.
▪ Premarket Applications
- Premarket Approval Application (PMA)
- Biologics License Application (BLA)
- Product Development Protocol (PDP).
▪ Premarket Report (PMR).
▪ PMA/BLA Supplements and PMA Annual Reports.
▪ 513(g) request for classification information.
To be eligible for a reduced small business fee, your company must first qualify as a “small business”, which is defined as having gross receipts or sales of no more than $100 million for the most recent tax year.
A Small Business Certification once granted for a fiscal year, runs from October 1 through September 30 of the following year.
Over-The-Counter Monograph Drug User Fees, are now required to register an establishment manufacturing, among other products:
Sunscreen.
Antidandruff shampoo.
Toothpaste containing fluoride.
Antiperspirant deodorant.
Cold and cough products.
Hand sanitizers.
OMUFA User Fees for FY 2025
Monograph Drug Facility (MDF) Facility Fee: $37,556.
Contract Manufacturing Organization (CMO) Facility Fee: $25,037.
Before you get started, you must have the following:
Employer Identification Number (EIN) for U.S. based companies.
DUNS Number for foreign companies.
The Employer Identification Number also known as the Federal Tax Identification Number, is a unique nine-digit number assigned by the U.S. Internal Revenue Service to business entities operating in the United States.
A DUNS number is a nine-digit number, assigned to each business location and issued by Dun & Bradstreet Inc, to companies around the world.
Then contact ITB HOLDINGS LLC, to help you setup a Payment Account, which is required.
Expect to pay Service Fees, when you request the assistance of FDA Consultants, such as ITB HOLDINGS LLC. See below:
