The U.S. Food and Drug Administration (FDA) requires various types of registrations, depending on the nature of your business. Here are some common types of FDA registrations:

1. Food Facility Registration: If you manufacture, process, pack, or store food for consumption in the U.S., you need to register your facility with the FDA.
2. Medical Device Establishment Registration: Any establishment involved in the production and distribution of medical devices intended for use in the U.S. must register with the FDA.
3. Drug Establishment Registration: Manufacturers, repackers, and relabelers of drugs must register their establishments with the FDA.
4. Biologics Establishment Registration: Facilities involved in the manufacture of biological products must register with the FDA.
5. Cosmetic Registration: While not mandatory, the FDA encourages cosmetic companies to participate in the Voluntary Cosmetic Registration Program (VCRP).
6. Tobacco Product Establishment Registration: Domestic establishments engaged in manufacturing, preparing, compounding, or processing tobacco products must register with the FDA.

Steps to Register with the FDA

1. Determine the Type of Registration Required: Identify which type of registration applies to your business. Apply online with xproamerica.com
2. Create an FDA Industry Systems (FIS) Account: Our team will register for an account on the FDA’s Unified Registration and Listing System (FURLS).
3. Submit Registration Information: Our support team will login into your FIS account and submit the required information for your specific type of registration.
4. Pay Applicable Fees: Some registrations, like those for drug and medical device establishments, require payment of user fees.
5. Maintain and Update Registration: Our team will ensure your registration is renewed as required (usually annually) and update any changes to your business information.

If you have a specific type of product or facility in mind, contact us on support@xproamerica.com