Companies (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States, are required to register annually with the U.S. Food and Drug Administration.
Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA, and list all of their commercially marketed drug products.
Having an FDA Establishment Identifier (FEI) Number and DUNS Number will facilitate the application process and establishment registration.
Section 510 of the Food, Drug, and Cosmetic Act requires that each initial and annual drug establishment registration include a Unique Facility Identifier (UFI).
FDA’s preferred Unique Facility Identifier (UFI) is the DUNS Number, assigned and managed by Dun & Bradstreet Inc, for:
- drug, medical device or cosmetic establishment
- food facility
The Agency recommends that at the time of registration, the owner or operator obtain an FDA Establishment Identification (FEI) Number.
An FDA Establishment Identification (FEI) Number is a unique identifier issued by the FDA to track:
- Inspections of regulated establishments or facilities
- User Fees payments
- Entities within the imports message set, during customs clearance.
Please note that an FEI Number is different from an Employer Identification Number (EIN) also known as a Federal Tax Identification Number used to identify a business entity.
Keep in mind that FEI (FDA Establishment Identifier) is usually assigned subsequent to or following the registration, and expect seven business days or longer.
The Food and Drug Administration (FDA) reminds the import community to utilize helpful tools, available at no cost to users, so complete and accurate information can be submitted to FDA in order to facilitate efficient processing of import entries.
It allows the import community look-up and verify an entity’s FEI.
FEI Portal assists users in identifying:
- FEI numbers associated with a specific address
- Address associated with a FEI number for a firm already in FDA’s firm inventory.
Users can sign up for an account, access the FEI Portal and log in by visiting:
FDA REGISTRATION
You may want to consider the following service, should you be ready to start the registration of your domestic or foreign company:
- Food Facility
- Supplement Facility
- Food Canning Establishment (FCE)
- Medical Device Establishment
- Drug Establishment
- Cosmetic Establishment
