390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | USA
+1 855-510-2240
FDA Fees
FDA REGISTRATION SERVICE FEES

There is no reason to pay more for less, because ITB HOLDINGS LLC’s fees are the lowest for FDA Registration of your Facility or Establishment.

Because PPEs (gowns, gloves, face shields, goggles, facemasks and respirators) are Medical Devices, 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, starting October 1, 2020).

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.

LOWEST FDA FEES

■ No hidden costs
■ No forced options
■ Only what you need or want
■ Reduced fee for multiple services
■ Reduced fee for multiple companies
U.S. Agent Service included
■ Same Day Service for extra fee

Click on link below for Biennial Registration Renewal of 2020.

Some registrations require additional Government fees.
You will be informed as expected.

DOMESTIC FACILITY
FDA REGISTRATION
$99.00
FOREIGN FACILITY
FDA REGISTRATION
$99.00
U.S. AGENT
SERVICE
FOOD FACILITY
FREE
FDA REGISTRATION
$99.00
FOOD LABEL
REVIEW OR DESIGN
$99.00
FDA PRIOR NOTICE
STANDARD FEE
$25.00
FOOD CANNING
FDA REGISTRATION
$350.00
MEDICAL DEVICE
FDA REGISTRATION
$350.00
DRUGS
FDA REGISTRATION
$350.00
OTC COSMETICS
FDA REGISTRATION
$350.00
Voluntary Cosmetic Registration Program (VCRP)
$99.00
Foreign Supplier Verification Program (FSVP)
$150.00

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 will be required to have a DUNS Number by September 30, 2020. 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

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 | October 1 – December 31, 2020

Government Fees

$5,236.00 | Medical Device Establishment Registration (FY 2020)
$5,546.00 | Medical Device Establishment Registration (FY 2021, starting on October 1, 2020)

The preferred payment methods are

  • online using 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.