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ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | USA
+1 855-510-2240
FDA

 

 

AFFORDABLE SERVICES FEES FOR DOMESTIC & FOREIGN COMPANIES

 

 

Click here for more payment options

 

LOW
FDA REGISTRATION
SERVICE FEES

ITB HOLDINGS LLC’s Service 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

Perhaps you noticed yourself that more companies are offering FDA Registration Services. How do you select one, since these professional services are certainly not free?

Using professional service providers to grow your business is not new. Attorneys, accountants, management and marketing consultants have specialized knowledge about niche areas that you couldn’t and shouldn’t hope to duplicate either personally or in the form of an in-house employee. Same applies to FDA Consultants.

Hiring outside consultants will allow you to do things you wouldn’t ordinarily have time for, and don’t want to hire permanent employees for. They can do them faster and more effectively than you ever could. Besides, your skills are needed in helping your business expand.

Beware of comparing one provider with another, on the basis of fees alone.

SERVICE FEES

Service Fees are prepaid to ITB HOLDINGS LLC. There are no monthly invoices, here. You can cover the scope of the services to be rendered, the duration of the agreement and the fees by sending us an email message ou using the 24/7 Live Chat option.

You do not have to worry about fee schedule, whether fees are to be based on an hourly, daily or project rate, and who is responsible for paying expenses, because all our fees are publicly listed.

MORE PAYMENT OPTIONS, HERE

Debit / Credit Card, Bancontact, Giropay, iDEAL, Sofort, Apple Pay, Google Pay, SEPA Direct Debit, Stripe, Payments in multiple currencies.

FDA REGISTERED
Special Offer
GET
15% off
Clear Filters
Canned Food
$350.00
Food Label Review
$99.00
FSVP
$350.00
Item added to cart View Cart Checkout
LIMITED OFFER

FOOD
FACILITY
REGISTRATION

$99.00

ANNUAL SERVICE FEE
  • Company Registration
  • U.S. Agent Service
DOMESTIC FACILITY
FOOD
FDA REGISTRATION
FOREIGN FACILITY
FOOD
FDA REGISTRATION
U.S. AGENT
SERVICE
FOOD FACILITY
SUPPLEMENT FACILITY
FDA REGISTRATION
FOOD LABEL
REVIEW OR UPDATE
FDA PRIOR NOTICE
STANDARD FEE
FDA INNOVATION CHALLENGE

The goal is to provide additional incentives for companies to spur development of medical devices, including digital health and diagnostics that target pain, addiction and diversion, as well as invest in products that can address aspects of the addiction crisis, and advance the development of promising technologies.

REGISTRATION FEES

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, among others:

  • Medical Device Establishment Registration
  • Over-The-Counter Monograph Drug User Fees (OMUFA)

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

LIMITED OFFER
FDA ESTABLISHMENT
REGISTRATION
MEDICAL DEVICES
  • Facemasks
  • Surgical Masks
  • N95 Respirators
  • Gowns, Face Shields, Gloves, Goggles
  • Other medical devices
$350.00 | SERVICE FEE
LIMITED OFFER
FDA ESTABLISHMENT
REGISTRATION
OVER-THE-COUNTER (OTC) DRUGS
  • Alcohol Hand Sanitizers
  • Alcohol Wipes
  • Sunscreens
  • Skin Protectants
  • Pain Relievers
$350.00 | SERVICE FEE
FOOD CANNING
FDA REGISTRATION
MEDICAL DEVICE
FDA REGISTRATION
DRUGS
FDA REGISTRATION
OTC COSMETICS
FDA REGISTRATION
Voluntary Cosmetic Registration Program (VCRP)
Foreign Supplier Verification Program (FSVP)

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.

FDA USER FEES

User Fees are paid to the U.S. Treasury.

Gowns, gloves, face shields, goggles, facemasks and respirators are Medical Devices.  Therefore, an FDA User Fee of $7,653 is required for the annual Establishment Registration (Fiscal Year 2024).

Some devices are subject to Premarket Notification 510(k) – Standard Fee: $21,760. Small Business Fee: $5,440 (Fiscal Year 2024).

Over-The-Counter Monograph Drug User Fees (OMUFA) (FY 2023)

  • Monograph Drug Facility (MDF) Facility Fee: $26,153
  • Contract Manufacturing Organization (CMO) Facility Fee: $17,435

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

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

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.

REGISTRATION RENEWAL

▪ Annual
▪ Biennial | October 1 – December 31, 2024

FDA REGISTERED COMPANY
That should be your goal for your domestic and or foreign establishment.