To obtain a USFDA FEI (Facility Establishment Identifier) number, a facility needs to register with the FDA. The process varies slightly depending on the type of facility (e.g., drug, medical device, food, biologics). Here are the general steps to acquire an FEI number through our USFDA experts.

1. Determine the Type of Registration

Different types of facilities need to follow different registration procedures. Our USFDA agent will identify whether your facility is involved in drugs, medical devices, food, biologics, or other FDA-regulated products.

2. Account creation with FDA Industry Systems (FIS)

Our USFDA agent will be doing the registration process and create an account with the FDA Industry Systems.

3. Register Your Facility

Our USFDA professionals will register your facility when they have set up the account:

For Drug Establishments, Medical Device Establishments, Food Facilities, Biologics our team follow the instruction parameterized by FDA

4. Receive Your FEI Number

After completing the registration process, our USFDA expert will assign an FEI number to your facility. This number is unique to your establishment and will be used in all interactions with the FDA.

If you encounter any issues or need specific guidance, you can contact us – support@regpro.us

or seek assistance from regulatory consultants who specialize in FDA registrations.