390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
+1 855-510-2240
FDA REGISTRATION
FEES
LOWEST FDA REGISTRATION FEES

We make it simple and affordable for 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.

When your facility or establishment seeks an FDA Registration and or listing of its products, a payment of a Service Fee and or User Fee, will be required.

  • Weekly Deals
  • You pay only for the services you want or need
  • At costs you would appreciate
  • No long-term commitments

See offers for FDA Registration services. Be smart about it. Why not switch U.S. Agent, today?

All domestic and foreign companies must have a valid DUNS Number.

FDA SERVICE FEES

■ ITB HOLDINGS LLC, like many other U.S. Agents, charges a variety of fees for its services, upon request.

U.S. Agent Service is free when combined with other services.

Because most of our clients are Startups, Small And Midsize Business (SMB), Small and Mid-size Enterprise (SME), companies switching U.S. Agent and foreign companies, we believe it is fair to keep our fees low:
$99.00 – $350.00

Food Facility

$99.00

Dietary Supplements Facility

$99.00

Food Canning Establishment (FCE)

$350.00

OTC Drug Establishment

$350.00

Prescription Drug Establishment

$350.00

Medical Devices Establishment

$350.00

Cosmetics Establishment

$150.00

OTC Cosmetics Establishment

$350.00

Label Review

$99.00

Foreign Supplier Verification Program (FSVP) Importer

$350.00

Prior Notice

$25.00

ENJOY LIVE SUPPORT CHAT, 24/7

T : +1 855 510 2240
T : +1 855 389 7344
T : +44 800 610 1577

Skype : itbholdings

FDA USER FEES

The User Fee programs help the Food and Drug Administration (FDA) fulfill its mission of protecting the public health and accelerating innovation in the industry.

Payment of these fees to the U.S. Treasury is required and expected when the registration of your establishment is initiated.

Therefore, no registration can be completed without a Payment Confirmation Number (PCN) issued by the FDA, first.

U.S. companies making payment of any FDA User Fee must have an Employer Identification Number (EIN). The DUNS Number is used for foreign establishments.

Need help with your payment? Simply contact ITB HOLDINGS LLC for additional information.

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

These fees tend to increase yearly. Current User Fee for Medical Device Establishment Registration is $5,546.00. For Fiscal Year (FY) 2022 starting on October 1, 2021, the fee is $5,672.00.

$20,322.00 | Over-The-Counter Monograph Drug User Fee Program (OMUFA) ( FY 2021) is now required to register an establishment manufacturing, among other products,

  • Sunscreen
  • Antidandruff shampoo
  • Toothpaste containing fluoride
  • Antiperspirant deodorant
  • Cold and cough products
Days
Hours
Minutes
Seconds
LIMITED OFFER
FDA FOOD FACILITY
REGISTRATION
  • Company Registration
  • U.S. Agent Service
$99.00 | ANNUAL SERVICE FEE
SAVE TIME & MONEY: FOOD FACILITY FDA REGISTRATION OR RENEWAL FOR $99.00

Discounts are even available for multiple registrations of food facilities based in China | Japan | South Korea | India | Pakistan | Australia | New Zealand | Russia | Sweden | Norway | Denmark | Germany | Poland | Czech Republic | Switzerland | Netherlands | Belgium | United Kingdom | Ireland | France | Spain | Greece | Portugal | Brazil | Mexico | Canada | United States.

FDA & COVID-19 RELATED PRODUCTS
Your Company Could Help Manage the Pandemic

Are you currently manufacturing, exporting, importing or distributing Hand Sanitizers, Alcohol Wipes, Personal Protective Equipment (PPE)?

The FDA Registration of your Establishment is required, and your products must be listed.

We can assist with the process.

FDA REGISTRATION TRENDS
Hand Sanitizers
0%
Alcohol Wipes
0%
Face Masks
0%
N95 Respirators
0%
FDA FEE
FDA ESTABLISHMENT REGISTRATION
$350
ANNUAL

FDA Establishment Registration

Hand Sanitizer Listing
Alcohol Wipes Listing
FDA FEE
FDA ESTABLISHMENT REGISTRATION
$350
ANNUAL

FDA Establishment Registration

Face Masks, Surgical Masks

N95 Respirators

FDA User Fees are additional and could be required.

Manufacturers of Hand Sanitizers and Alcohol Wipes are exempt, at this time.

But that is expected to change.

CONTACT ITB HOLDINGS LLC