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.

To register with the U.S. Food and Drug Administration (FDA), the specific requirements and processes will vary depending on the type of business and the products or services you provide. Here is a general overview of the FDA registration process:

1. Determine Applicability: Identify whether your business or product falls under FDA regulation. The FDA oversees a wide range of products, including food, drugs (including prescription and over-the-counter medications), medical devices, dietary supplements, cosmetics, and more.

2. Obtain a DUNS Number: If your business is not already registered with the FDA, you will need to obtain a Unique number. This unique identifier and is required for certain FDA registrations.

3. Determine the Appropriate FDA Registration: Depending on your business and the products you deal with, you may need to register with specific FDA programs. For example:

   a. Food Facilities: If you are involved in food manufacturing, processing, packaging, or storing, you may need to register as a food facility with the FDA.

   b. Drug Establishments: If you manufacture, distribute, or package drugs (including over-the-counter medications), you may need to register as a drug establishment.

   c. Medical Devices: Manufacturers, distributors, and importers of medical devices are generally required to register their establishments and list their devices with the FDA.

   d. Dietary Supplements: If you manufacture or distribute dietary supplements, you may need to register with the FDA as a dietary supplement facility.

4. Complete the FDA Registration: Once you have determined the appropriate registration category, you will need to complete the registration process. This typically involves submitting an online application through the FDA’s registration portal, providing the necessary information about your business, products, and manufacturing processes.

5. Pay the Registration Fee: Depending on the specific FDA program and type of registration, there may be a fee associated with the registration process. Ensure you review the FDA’s fee schedule and make the necessary payment.

6. FDA Inspection (if applicable): Certain businesses may be subject to FDA inspections to verify compliance with regulatory requirements. This is more common for food facilities, drug establishments, and medical device manufacturers.

It’s important to note that the FDA registration process can be complex, and requirements can change over time. It is recommended to consult specialist and relevant guidance documents specific to your industry to ensure compliance with the most up-to-date regulations. Additionally, you may consider engaging with legal or regulatory experts familiar with FDA requirements to assist you with the registration process.