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


fda registration services

Domestic and foreign companies that are involved in the production and distribution of medical devices or drug products intended for use in the United States, are required to register annually with the U.S. Food and Drug Administration (U.S. FDA). This process is known as establishment registration.

Join thousands of satisfied clients in more than 100 countries. Reach millions more customers willing and able to buy your products.

ITB HOLDINGS LLC assists companies around the world, including manufacturers, exporters, importers of N95 respirators, ventilators, personal protective equipment (PPE), hand sanitizers, and other products covered by the Emergency Use Authorization (EUA) .

Are you exporting or importing conventional food products, dietary supplements, canned food, instead? Simply contact us.

Registration Services

For Domestic and Foreign Companies


■ FDA Establishment or Facility Registration renewal is required.
■ Domestic and foreign companies are required to have a DUNS (Data Universal Numbering System) Number issued by Dun & Bradstreet Inc to all types of business organizations including sole proprietorships, corporations, partnerships, non-profits, and government entities.

    FDA proposed a rule to establish a new category of over-the-counter (OTC) hearing aids. When finalized, hearing aids within this category could to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist.

    FDA issued a Drug Safety Communication for hand sanitizers, warning that symptoms such as headache, nausea, and dizziness can occur after applying alcohol-based hand sanitizers to the skin and inhaling the vapors that linger.

    Manufacturers of dietary supplements cannot claim that their products could be used to diagnose, cure, mitigate, treat, or prevent conditions such as respiratory tract infections, ulcers, heart disease, autoimmune disorders, and epilepsy.

    Exporting Hand Sanitizers or PPEs?
    Contact ITB HOLDINGS LLC, today, to register your company and list your products, with extra savings
    Don’t take a chance assuming that regulations in the United States, Canada, Mexico, Brazil, Australia, India, South Korea, China, Japan, Russia, European Union, are the same or similar.
    Food Facilities
    Medical Devices (PPEs)
    OTC Drugs (Hand Sanitizers)