FDA USER FEES
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

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Annual Establishment Registration Fee: $5,672.

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 2022 (October 1, 2021 through September 30, 2022)
Application Standard
510(k)‡ $12,745
513(g) $5,061
PMA, PDP, PMR, BLA $374,858
De Novo Classification
Request
$112,457
Panel-track
Supplement
$281,143
180-Day Supplement $56,229
Real-Time Supplement $26,240
BLA Efficacy Supplement $374,858
30-Day Notice $5,998
Annual Fee for Periodic
Reporting on a Class III device
(PMAs, PDPs, and PMRs)
$13,120
Application Reduced
510(k)‡ $3,186
513(g) $2,530
PMA, PDP, PMR, BLA $93,714
De Novo Classification
Request
$28,114
Panel-track
Supplement
$70,286
180-Day Supplement $14,057
Real-Time Supplement $6,560
BLA Efficacy Supplement $93,714
30-Day Notice $2,999
Annual Fee for Periodic
Reporting on a Class III device
(PMAs, PDPs, and PMRs)
$3,280
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