390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
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:

  • Black Friday & Cyber Monday Deals
  • you pay only for the services you want or need
  • at costs you would appreciate
  • there are no long-term commitments

See countdown below, for FDA Registration deadlines. However, be smart about it.

Why not switch U.S. Agent, today?

E: info@m.itbhdg.com

E: info@itbhdg.com

Days
Hours
Minutes
Seconds
LIMITED OFFER
FDA FOOD FACILITY
REGISTRATION
$99.00 | SERVICE FEE
SAVE TIME & MONEY: FOOD FACILITY NEW 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 REGISTRATION FEES

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.

FDA SERVICE FEES
  • ITB HOLDINGS LLC, like many other U.S. Agents, charges a variety of fees for its services, upon request.
  • Click on link above for Biennial Registration Renewal of 2020.

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

for the following

  • SUPPLEMENT FACILITY
  • FOOD CANNING ESTABLISHMENT (FCE)
  • MEDICAL DEVICE ESTABLISHMENT
  • DRUG ESTABLISHMENT
  • COSMETIC ESTABLISHMENT

Complete list of fees is available here. Or simply contact us.

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 starting October 1, 2020.

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.

REGISTRATION TRENDS
Hand Sanitizers
0%
Alcohol Wipes
0%
Face Masks
0%
N95 Respirators
0%
REGISTRATION
FDA ESTABLISHMENT REGISTRATION
$350
ANNUAL
Establishment Registration
Hand Sanitizer Listing
Alcohol Wipes Listing
REGISTRATION
FDA ESTABLISHMENT REGISTRATION
$350
ANNUAL
Establishment Registration
Face Masks
N95 Respirators
CONTACT ITB HOLDINGS LLC