Fees - FDA Services

FDA

User & Service Fees

We make it affordable and easy for companies in over 100 countries, seven days a week, twenty four hours daily, unlike our competitors.

For your information, there is no U.S. Agent Service separate fee, here. Great, right?

You may want to use the 24/7 Live Chat option, for faster responses, in your language.

T: +1 855 389 7344

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FDA REGISTRATION FEES

What You Should Know

There are two types of fees here, indeed:

Service Fees paid to ITB HOLDINGS LLC.

User Fees paid to the United States Department of the Treasury.

Obviously, not all FDA registrations require the payment of a User Fee, like Food Facilities.

FDA SERVICE FEES

Although your U.S. company does not need a U.S. Agent, your Canadian, Mexican, Brazilian, Australian, Indian, Chinese, South Korean, Japanese, Russian, Italian, Greek, Portuguese, French, Belgian, Dutch, German, Swiss, Swedish, British, Irish Facility or Establishment, is always required to appoint one as part of the registration process.

Hence, expect the following Service Fees, each time you request the assistance of ITB HOLDINGS LLC, because professional providers charge a fee, anywhere around the world. No surprise, there, in fact. See below.

MOSTLY REQUESTED FDA SERVICE FEES

Essentially, they include the following, unless otherwise indicated:

Food Facility

$180.00

Dietary Supplements Facility

$180.00

Food Canning Establishment (FCE)

$350.00

OTC Drug Establishment

$350.00

Prescription Drug Establishment

$350.00

Medical Devices Establishment

$350.00

Cosmetics Establishment

$350.00

OTC Cosmetics Establishment

$350.00

Label Review

$99.00

Foreign Supplier Verification Program (FSVP) Importer

$350.00

Prior Notice

$25.00.

FEES LIST

Days

Hours

Minutes

Seconds

ENJOY MORE PAYMENT OPTIONS, HERE

While Debit / Credit Card, Bancontact, Giropay, iDEAL, Sofort, Apple Pay, Google Pay, SEPA Direct Debit, Stripe, Payments in multiple currencies are popular, PayPal invoices are also available, when requested.

FOOD FACILITY & ESTABLISHMENT

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U.S. AGENT

LIMITED OFFER

FDA ESTABLISHMENT
REGISTRATION

MEDICAL DEVICES

$350.00 | SERVICE FEE

Facemasks
Surgical Masks
N95 Respirators
Gowns, Face Shields, Gloves, Goggles
Other medical devices

PAY HERE

LIMITED OFFER

FDA ESTABLISHMENT
REGISTRATION

OVER-THE-COUNTER (OTC) DRUGS

$350.00 | SERVICE FEE

Alcohol Hand Sanitizers
Alcohol Wipes
Sunscreens
Antidandruff shampoo, Toothpaste containing fluoride, Antiperspirant deodorant, Cold and cough products, Skin Protectant, Sleep Aid, Topical Analgesic, and Weight Control

PAY HERE

FDA REGISTRATION requests must include:

Full company name
Complete physical address
First and last name of CEO or Manager
Email and telephone of CEO or Manager
Product details
Company DUNS Number

Thus, getting a Data Universal Numbering System, DUNS or D-U-N-S Number from Dun & Bradstreet Inc is free in 30 days or for a fee in 15 days (in the U.S).

Specifically, all domestic and foreign companies must have a DUNS Number. Therefore, requesting one now or as soon as possible, is indeed in your company’s best interest.

FDA automatically performs a DUNS check during the registration process. So, make sure your company’s name and physical address match D&B’s records.

FDA USER FEES

Medical Devices

Personal Protective Equipment (PPE)s (gowns, gloves, face shields, goggles, facemasks and respirators) are Medical Devices. Therefore, an FDA User Fee of $9,280 is required for the annual Establishment Registration (Fiscal Year 2025).

Furthermore, some medical devices are subject to Premarket Notification 510(k), with Standard Fee of $24,335, and Small Business Fee of $6,084 (Fiscal Year 2025).

Over-the-Counter (OTC) Drugs

Over-The-Counter Monograph Drug User Fees (OMUFA) (FY 2024)

▪ Monograph Drug Facility (MDF) Facility Fee: $34,166.

▪ Contract Manufacturing Organization (CMO) Facility Fee: $22,777.

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.

Below is a list of fees covering Annual Establishment Registration and or filing of an Application:

Accredited Third-Party Certification Program User Fees
Animal Drug User Fee Act (ADUFA)
Animal Generic Drug User Fee Act (AGDUFA)
Biosimilar User Fee Amendments
Color Additive Certification Fees
Export Certificate Fees
Freedom of Information Act Fees (FOIA)
Generic Drug User Fee Amendments
Human Drug Compounding Outsourcing Facility Fees
Mammography Facility Fees (MQSA)
Medical Device User Fee Amendments (MDUFA)
Over-The-Counter Monograph User Fee Program (OMUFA)
Prescription Drug User Fee Amendments
Voluntary Qualified Importer Program User Fees.

Lastly, these User Fees tend to increase yearly, but not ITB HOLDINGS LLC’s Service Fees.

PAYMENT OPTIONS FOR USER FEES

The preferred payment methods are

electronic check (Automated Clearing House – ACH also known as eCheck)
credit or debit card (Discover, VISA, MasterCard, American Express).

Payment by credit card is available for balances less than $25,000.

PAYMENT OF USER FEES

You must first create an account. Click here

U.S. Department of Treasury
TREAS NYC
33 Liberty St
New York, NY 10045
Account Number: 75060099
Routing number: 021030004
SWIFT: FRNYUS33
Beneficiary:
FDA
8455 Colesville Rd, 14th Floor
Silver Spring, MD 20993-0002
FDA’s Tax Identification Number: 53-0196965.

User Fees are due October 1st of each applicable Fiscal Year (FY).

The fee amounts are published in the Federal Register, the official journal of the federal government of the United States that contains government agency rules, proposed rules, and public notices.

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