LIMITED OFFERS
SWITCH U.S. AGENT DEALS

E: info@fda.itbhdg.com

Days
Hours
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LIMITED OFFER
FDA FOOD FACILITY
REGISTRATION
  • Company Registration
  • U.S. Agent Service
$99.00 | SERVICE FEE

Food Canning Establishment (FCE) Registration requires a separate fee. Contact ITB HOLDINGS LLC, first.

LIMITED OFFER
FDA ESTABLISHMENT
REGISTRATION
MEDICAL DEVICES (PPE)
$350.00 | SERVICE FEE
  • Facemasks
  • Surgical Masks
  • N95 Respirators
  • Gowns, Face Shields, Gloves, Goggles

User Fee is required and extra: $5,546.00 | Medical Device Establishment Registration (FY 2021)

LIMITED OFFER
FDA ESTABLISHMENT
REGISTRATION
OVER-THE-COUNTER (OTC) DRUGS
$350.00 | SERVICE FEE

$20,322.00 | Over-The-Counter Monograph Drug User Fee Program (OMUFA) ( FY 2021). This new fee is additional and required. Manufacturers of hand sanitizers and alcohol wipes are currently exempt.

  • Alcohol Hand Sanitizers
  • Alcohol Wipes
  • Sunscreens
FDA REGISTRATION FEES: WHAT YOU SHOULD KNOW

There are two types of fees here

  • Service Fees paid to ITB HOLDINGS LLC
  • User Fees paid to the U.S. Treasury
FDA USER FEES

User Fees are required for the following

  • Medical Device Establishment Registration
  • Drug Establishment Registration

Personal Protective Equipment (PPE)s (gowns, gloves, face shields, goggles, facemasks and respirators) are Medical Devices.  Therefore, an FDA User Fee of $5,546.00 is required for the annual Establishment Registration (Fiscal Year 2021). Some devices are subject to Premarket Notification 510(k) – Standard Fee: $12,432.00. Small Business Fee: $3,108.00 (Fiscal Year 2021).

In order to register your establishment and list your hand sanitizer, only our annual fee of $350.00 is needed. Hand sanitizers are OTC Drug Products.

$20,322.00 | Over-The-Counter Monograph Drug User Fee Program (OMUFA) ( FY 2021). This new fee does not apply to manufacturers of hand sanitizers, yet.

When you contact us, have your company’s DUNS NUMBER ready.

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

Data Universal Numbering System, DUNS or D-U-N-S from Dun & Bradstreet Inc. Free in 30 days or for a fee in 15 days.

Keep in mind that all domestic and foreign companies must have a DUNS Number. Therefore, requesting one now or as soon as possible, is 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.

PAYMENT METHODS ACCEPTED FOR ITB HOLDINGS LLC’S INVOICES

PayPal, Local European Payments
Debit and Credit cards
Bank Wire Transfer.

PAYMENT OF GOVERNMENT 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.

REGISTRATION RENEWAL

■ Annual
■ Biennial

GOVERNMENT FEES (USER FEES)

$5,546.00Medical Device Establishment Registration (FY 2021, from October 1, 2020 to September 30, 2021)

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.

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