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.
- Switch U.S. AGENT Deals
- 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
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) is required for all other OTC drug products.
User Fees are paid to the U.S. Treasury.
REGISTRATION
- Company Registration
- U.S. Agent Service
Prior Notice, Label Review or Update, Foreign Supplier Verification Programs (FSVP), are available for extra fee.
Is your company manufacturing, exporting, importing or distributing personal protective equipment (PPE) and hand sanitizers, instead?
There are two types of fees here
- SERVICE FEES paid to ITB HOLDINGS LLC
- USER FEES paid to the U.S. Treasury
User Fees are required for the following
- Medical Device Establishment Registration
- $5,546.00 | Medical Device Establishment Registration ( FY 2021)
- $20,322.00 | Over-The-Counter Monograph Drug User Fee Program (OMUFA) ( FY 2021)
When you contact us, have your company’s DUNS NUMBER ready.
REGISTRATION
- Facemasks
- Surgical Masks
- N95 Respirators
- Gowns, Face Shields, Gloves, Goggles
REGISTRATION
- Alcohol Hand Sanitizers
- Alcohol Wipes
- Sunscreens
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.
PayPal, Local European Payments
Debit and Credit cards
Bank Wire Transfer.
An account is required. Contact ITB HOLDINGS LLC, first.
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.
■ Annual
■ Biennial | October 1 – December 31, 2022
$5,546.00 | Medical Device Establishment Registration (FY 2021)
$20,322.00 | Over-The-Counter Monograph Drug User Fee Program (OMUFA) (FY 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.