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FDA USER FEES

 

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

 

 

FDA USER FEES

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.

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MEDICAL DEVICE USER FEES
Annual Establishment Registration Fee: $7,653

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 2024 (October 1, 2023 through September 30, 2024)
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
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.

OVER-THE-COUNTER (OTC) USER FEES

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.

PAYMENT OF FDA USER FEES

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.

SERVICE FEES

Expect to pay Service Fees, when you request the assistance of FDA Consultants, such as ITB HOLDINGS LLC. See below:

CONTACT
ITB HOLDINGS LLC

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