FDA U.S. AGENT
ITB HOLDINGS LLC AS U.S. AGENT

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

Our consultants serve both domestic and international clients.

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.

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

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.

CHAT WITH US IN YOUR OWN LANGUAGE
The location of your company does not determine our fees. That’s refreshing!

Just you know, we do speak more than 5 languages.

FDA REGISTRATIONS TRENDS
English
0%
French
0%
Spanish
0%
German
0%
Dutch
0%
FRENCH
FRANÇAIS
ENREGISTREMENT FDA
SPANISH
ESPAÑOL
REGISTRO FDA
DUTCH
NEDERLANDS
FDA REGISTRATIE
GERMAN
DEUTSCH
REGISTRO FDA
EXTENDED OFFICE HOURS

Monday – Sunday

3:00 AM – 6:00 PM

Eastern Standard Time

Get a faster response to your questions and concerns.

Usually same day or less than 30 minutes if you provide full company name, physical address and telephone number.

T: +44 800 610 1577

MOSTLY REQUESTED FDA REGISTRATIONS
Food Facility Registration
0%
Dietary Supplements Facility
0%
Cosmetic Establishment (OTC)
0%
Drug Establishment
0%
Medical Device Establishment
0%
Food Canning Establishment
0%
LIMITED OFFER
FOOD FACILITY REGISTRATION
Available for Biennial Renewal of 2020 or New Registration.
$99.00 | ANNUAL SERVICE FEE
PERSONAL PROTECTIVE EQUIPMENT
(PPE)

The global personal protective equipment (PPE) market is expected to reach nearly $13.2 billion by 2027.

Is your company manufacturing, exporting, importing, distributing the following products, instead?

  • Facemasks
  • N95 Respirators and Surgical Masks
  • Face shields, isolation gowns, goggles, gloves

The FDA Registration of your establishment is required, and ITB HOLDINGS LLC can assist.

$350.00 | ANNUAL SERVICE FEE
HAND SANITIZERS

Global Hand sanitizer market valuation to reach $17.2 billion by 2026.

The growth is primarily attributed to rising prevalence of COVID-19, supportive regulatory scenario which promote the use of the product, and increasing awareness pertaining to personal hygiene.

Are you ready to meet the supply challenge?

Your first step is the registration of your company as OTC Drug Establishment with the U.S. Food and Drug Administration.

ITB HOLDINGS LLC offers assistance to domestic and foreign firms.

$350.00 | ANNUAL SERVICE FEE