Companies (also called establishments) 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.
At the time of the registration, the owner or operator should obtain an FDA Establishment Identification (FEI) Number or Firm Establishment Identifier Number, because it 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.
Keep in mind that the FEI is usually assigned subsequent to or following the registration, and expect several business days or longer.
Finally, 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.
Products regulated by the Food and Drug Administration (FDA), are subject to review by the agency when they are offered for entry into the U.S. The FDA electronically reviews all FDA-regulated entries submitted through the U.S. Customs and Border Protection (CBP).
The FDA reminds the import-export community to utilize helpful tools, available at no cost to users, so complete and accurate information can be submitted to the agency, in order to facilitate efficient processing of import entries.
It allows the look-up and verification of any 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 must sign up for an account, to access the FEI Portal and log in by visiting the link below (“Search Now”):
You can perform up to 50 searches in an hour. Once you reach the limit, please wait an hour, then log back in to continue searching.
When there is a result returned from the search, it will display the firm’s FEI, name, physical address, and mailing address. However, not all FEIs are searchable within this portal. FEIs may be associated with information not considered releasable.
If an FEI is not returned from the search engine, several other resources might be used:
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.
The U.S. FDA oversees the safety of more than $2.1 trillion worth of products produced in the United States and abroad.
● 20,000 prescription drug products approved for marketing.
● 1,600 approved animal drug products.
● 6,500 different medical device products.
