Is your company manufacturing, exporting, importing or distributing personal protective equipment (PPE)?
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.
T: +1 855 389 7344
T: +1 855 510 2240
T: +44 800 610 1577
Skype: itbholdings
E: info@fda.itbhdg.com
There are no waivers or reductions for small establishments or businesses. All establishments must pay the establishment registration fee.
| Application | Standard |
|---|---|
| 510(k)‡ | $12,432 |
| 513(g) | $4,936 |
| PMA, PDP, PMR, BLA | $365,657 |
| De Novo Classification Request |
$109,697 |
| Panel-track Supplement |
$274,243 |
| 180-Day Supplement | $54,849 |
| Real-Time Supplement | $25,596 |
| BLA Efficacy Supplement | $365,657 |
| 30-Day Notice | $5,851 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) |
$12,798 |
| Application | Reduced |
|---|---|
| 510(k)‡ | $3,108 |
| 513(g) | $2,468 |
| PMA, PDP, PMR, BLA | $91,414 |
| De Novo Classification Request |
$27,424 |
| Panel-track Supplement |
$68,561 |
| 180-Day Supplement | $13,712 |
| Real-Time Supplement | $6,399 |
| BLA Efficacy Supplement | $91,414 |
| 30-Day Notice | $2,926 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) |
$3,200 |
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.
Before you get started, you must have the following:
- Employer Identification Number (EIN) for U.S. based companies
- DUNS Number for foreign companies
Then contact ITB HOLDINGS LLC, to help you setup a Payment Account.
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.