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.

    Delta-8 THC is one of over 100 cannabinoids produced in the Cannabis sativa L. plant, but is not found naturally in significant amounts. Concentrated amounts of delta-8 tetrahydrocannabinol (delta-8 THC) are typically manufactured from hemp-derived cannabidiol (CBD) and have psychoactive and intoxicating effects. Products containing delta-8-THC are available in varying forms, including but not limited to candy, cookies, breakfast cereal, chocolate, gummies, vape cartridges (carts), dabs, shatter, smokable hemp sprayed with delta-8-THC extract, distillate, tinctures, and infused beverages. The FDA has received reports of adverse events experienced by patients who have consumed these products.

    FDA issued an Emergency Use Authorization (EUA) for the first COVID19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection.

    The Dietary Supplement Health and Education Act of 1994 (DSHEA) requires manufacturers and distributors who wish to market a dietary supplement containing a New Dietary Ingredient (NDI) to notify the FDA before marketing, unless a legal exception applies.

    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)