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.
There are no waivers or reductions for small establishments or businesses. All establishments must pay the establishment registration fee.
| Application | Standard |
|---|---|
| 510(k)‡ | $21,760 |
| 513(g) | $6,528 |
| PMA, PDP, PMR, BLA | $483,560 |
| De Novo Classification Request |
$145,068 |
| Panel-track Supplement |
$386,848 |
| 180-Day Supplement | $72,534 |
| Real-Time Supplement | $33,849 |
| BLA Efficacy Supplement | $483,560 |
| 30-Day Notice | $7,737 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) |
$16,925 |
| Application | Reduced |
|---|---|
| 510(k)‡ | $5,440 |
| 513(g) | $3,264 |
| PMA, PDP, PMR, BLA | $120,890 |
| De Novo Classification Request |
$36,267 |
| Panel-track Supplement |
$96,712 |
| 180-Day Supplement | $18,134 |
| Real-Time Supplement | $8,462 |
| BLA Efficacy Supplement | $120,890 |
| 30-Day Notice | $3,869 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) |
$4,231 |
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 2023
Monograph Drug Facility (MDF) Facility Fee: $26,153.
Contract Manufacturing Organization (CMO) Facility Fee: $17,435.
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:
