The US FDA Establishment Identifier (FEI) number

The FDA Establishment Identifier (FEI) number is a unique identifier assigned by the U.S. Food and Drug Administration (FDA) to regulated establishments. This number is used to track and identify establishments that manufacture, process, pack, or hold FDA-regulated products. Here’s an overview of the process to register for an FEI number:

1. Determine if FEI Registration is Required: FEI registration is typically required for establishments involved in manufacturing, processing, packing, or holding FDA-regulated products such as drugs, medical devices, biologics, or certain food products. Check whether your establishment falls under FDA regulation and requires an FEI number.

2. Obtain a DUNS Number (if applicable): Before applying for an FEI number, you may need to obtain a Data Universal Numbering System (DUNS) number, particularly if you are not already registered with the FDA. The DUNS number is provided by Dun & Bradstreet and is often required for FDA registrations.

3. Submit a Facility Establishment Registration: To obtain an FEI number, you need to complete and submit the FDA’s Facility Establishment Registration form. This can be done electronically through the FDA’s Unified Registration and Listing System (FURLS).

4. Provide Required Information: When filling out the registration form, you will need to provide various details about your establishment, including:

   – Business name, address, and contact information.

   – Type of establishment and activities conducted.

   – Details of the FDA-regulated products manufactured, processed, packed, or held at the facility.

   – Details of the products’ categories, such as drugs, devices, or food products.

   – Manufacturing processes and quality control measures.

5. Pay the Registration Fee: Depending on the type of establishment and the FDA-regulated products involved, there may be a fee associated with the registration process. Review the FDA’s fee schedule to determine the applicable fees and make the necessary payment.

6. Obtain the FEI Number: Once the registration process is complete and the FDA has reviewed and approved your submission, you will receive an FEI number assigned to your establishment. This number should be used for future communications or submissions to the FDA.

It’s important to note that the FEI registration process may have additional requirements and specific procedures depending on the type of establishment and the FDA-regulated products involved. To ensure compliance with the latest FDA regulations and guidance, it is advisable to refer to the FDA’s official website (www.fda.gov) and consult relevant resources or seek professional assistance as needed.