Renewing your USFDA registration involves several steps. Our USFDA team will help you through the process:

1. Prepare the required information:

Our USFDA team ensures you have the necessary details about your facility and products. This includes:

• Facility name and address
• Owner or operator name
• Contact information
• Type of facility
• Products handled (e.g., drugs, medical devices, food, cosmetics)

2. Access the FDA’s FURLS System:

The FDA uses the FDA Unified Registration and Listing System (FURLS) for registration and listing. Our USFDA experts log in to your account on the FURLS website.

3. Annual Renewal Requirement:

USFDA registrations must be renewed between October 1 and December 31 each year. Make sure to renew within this period to avoid any penalties or suspension of your registration. Our experts provide One year free support

4. Log In to Your Account:

• Our specialists from the USFDA access your accounts using the necessary credentials.

5. Renew Your Registration:

• Once logged in, the specialist will select the required option to renew your registration.
• By reviewing and updating the information, they will ensure all details are current and accurate.

6. Pay the Required Fees:

• For 1 year, a one-time renewal cost US$ 3499. Fees can vary based on the type of facility and products.

7. Submit Your Renewal:

• After payment, after reviewing and confirming all the information, the expert submits your renewal application.

8. Confirmation:

• Once the team informs you that the renewal is processed, you will receive a confirmation.

9. Maintain Records:

• Our USFDA expert ensure to keep records of your registration, renewal, and any communications with the FDA on a confidential basis.

For any further information, feel free to contact us at support@regpro.us

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.