FDA USER FEES
9590
FDA USER FEES

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.

E: info@fda.itbhdg.com

Days
Hours
Minutes
Seconds
Annual Establishment Registration Fee: $5,546.

There are no waivers or reductions for small establishments or businesses. All establishments must pay the establishment registration fee.

Other User Fees for Fiscal Year 2021 (October 1, 2020 through September 30, 2021)
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
Medical Device User Fee Small Business Qualification and Certification

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.

Payment of FDA User Fees

Before you get started, you must have the following:

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.

CONTACT ITB HOLDINGS LLC