FDA U.S. AGENT
FDA REGISTRATION RENEWAL OF 2020
  • Annual Registration Renewal for Medical Devices and Drugs Establishments
  • Biennial Registration Renewal for Food Facilities. Click on link below, and enjoy current offer

See countdown for deadlines. However, be smart about it. Why not switch U.S. Agent, today?

Don’t lose your FDA Registration Number or FDA Establishment Identifier (FEI) Number. Save now on New FDA Registration.

E: info@fda.itbhdg.com

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ITB HOLDINGS LLC AS U.S. AGENT

Our consultants serve both domestic and international clients.

Although your U.S. company does not need a U.S. Agent, 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, is required to appoint one as part of the registration process.

What a U.S. Agent is not?

  • Commercial Agent
  • Customs Broker
  • Initial Importer
  • Importer of Record
  • FSVP Importer

FDA will not complete a registration, or provide a registration number, until ITB HOLDINGS LLC confirms it has agreed to serve as the U.S. Agent for a foreign facility or establishment.

 

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 or below for Food Facility 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, foreign companies mostly in Canada, Mexico, Brazil, Australia, India, South Korea, China, Japan, Russia, Portugal, Spain, France, Belgium, Netherlands, Switzerland, Germany, Sweden, United Kingdom, and Ireland, we believe it is fair to keep our fees low:
$99.00 – $350.00

for the following facilities or establishments

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

Or simply contact us.

SAVE TIME & MONEY

Food Facility Registration or Biennial Registration Renewal of 2020 Service Fee is only $99.00 for domestic or foreign companies, and U.S. Agent Service is included.

Why pay more in the middle of a pandemic? Simply select a payment option, click below, to get started.

We expect you to provide the DUNS Number of your Food Facility.

 

 


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.

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

Current User Fee for Medical Device Establishment Registration is $5,546.00 until September 30, 2021.

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