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

 

REGISTRATION SERVICE & USER 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.

  • 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

CHECK MORE PAYMENT OPTIONS, HERE

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

ENJOY LIVE SUPPORT CHAT, 24/7

Why wait 30 minutes or longer, when you can get answers in 10 seconds?

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 $7,653 for Fiscal Year (FY) 2024.

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

  • 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
Days
Hours
Minutes
Seconds
LIMITED
OFFER

FOOD
FACILITY
REGISTRATION

$99.00

ANNUAL SERVICE FEE

Company Registration U.S. Agent Service.

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 | Italy | Spain | Greece | Portugal | Brazil | Mexico | Canada | United States.

INNOVATIONS

Trending medical technologies in 2023 have great potential to enhance healthcare and research, improve patient experiences, and increase staffing efficiency.

Contract research organizations (CROs) provide broad to niche clinical trial management services for biotechnology, pharmaceutical, and medical device manufacturers.

▪ Three-dimensional (3D) printing in healthcare.

▪ Wearable devices that can track steps taken, heartbeats, blood oxygen levels and sleep patterns.

▪ Augmented Reality (AR) and Virtual Reality (VR) for physician training.

▪ Nanomedicine.

▪ Telemedicine.

▪ Securing healthcare data with Artificial Intelligence (AI).

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

We can assist with the process.

FDA REGISTRATION TRENDS
Food
0%
Supplements
0%
OTC Drugs
0%
Medical Devices
0%
FDA FEE
FDA ESTABLISHMENT REGISTRATION
$350
ANNUAL
FDA Establishment Registration
Hand Sanitizers and Alcohol Wipes Listing
OTC Cosmetics Listing
Sunscreens Listing
OTC Drugs
Nighttime Sleep Aid Drug Products
FDA FEE
FDA ESTABLISHMENT REGISTRATION
$350
ANNUAL
FDA Establishment Registration
Face Masks, Surgical Masks
N95 Respirators
Dental Devices
Radiology Devices
Orthopedic Devices
Medical Apps

FDA User Fees are additional and required.

CONTACT
ITB HOLDINGS LLC