FDA USER FEES

A business that is qualified and certified as a “small business” is eligible for a substantial reduction

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FDA USER FEES

Is your company manufacturing, exporting, importing or distributing personal protective equipment (PPE), 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.

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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 2023 (October 1, 2022 through September 30, 2023)
Application Standard
510(k)‡ $19,870
513(g) $5,961
PMA, PDP, PMR, BLA $441,547
De Novo Classification
Request
$132,464
Panel-track
Supplement
$353,238
180-Day Supplement $66,232
Real-Time Supplement $30,908
BLA Efficacy Supplement $441,547
30-Day Notice $7,065
Annual Fee for Periodic
Reporting on a Class III device
(PMAs, PDPs, and PMRs)
$15,454
Application Reduced
510(k)‡ $4,967
513(g) $2,980
PMA, PDP, PMR, BLA $110,387
De Novo Classification
Request
$33,116
Panel-track
Supplement
$88,309
180-Day Supplement $16,558
Real-Time Supplement $7,727
BLA Efficacy Supplement $110,387
30-Day Notice $3,532
Annual Fee for Periodic
Reporting on a Class III device
(PMAs, PDPs, and PMRs)
$3,864
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.

Service Fees

Expect to pay these fees when you request the assistance of FDA Consultants. See below:

CONTACT ITB HOLDINGS LLC

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