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U.S. Department of Health and Human Services

Medical Devices

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FDA Device Establishment Registration and Listing Update - April 2009

This newsletter features information about the different types of accounts in the FDA Unified Registration and Listing System (FURLS). A FURLS account is needed to submit certain types of information over the Internet to FDA. Once you are logged on to FURLS with your User ID and Password, you will be able to access the Device Registration and Listing Module (DRLM) part of FURLS. DRLM is the part of the FURLS system where you can submit device establishment registration and listing information.

What types of accounts are there?

There are two kinds of accounts. Each account contains the name, phone, and email and physical address for the contact person.

  • The owner/operator (O/O) account can be thought of as the primary account, as it can make any changes in DRLM.
  • The official correspondent (OC) account is created by the owner/operator, and is responsible for the annual registration and device listing for the establishment(s) they have been assigned to by the O/O.

What is an O/O account responsible for?

  • Creating and updating all of the OC accounts, including their own account(s) and keeping them up-to-date (the O/O is the ONLY one that can do so)
  • Assigning an OC to registered establishments (by creating subaccounts), and making changes to them when appropriate
  • Acting as the official correspondent if the O/O does not create a separate OC account
  • Making additions, updates, and deactivating ALL registrations and listings having that same O/O, if an O/O account has multiple establishments

What is an OC account responsible for?

  • Knowing who their O/O account holder is, as the O/O is the only one who can make changes to their OC information (name, address, telephone, email, etc.)
  • Receiving and reviewing routine correspondence, usually by email, from the FDA
  • Completing the annual registration and device listing process
  • Creating new registrations and listings under the existing O/O number
  • Making changes, updates, and cancellations ONLY to registrations and listings that have been assigned to them by the OC
  • Updating US agent information

How do I tell what kind of account I am logged in with?

When you first log into FURLS with your account ID and password, look on the left hand side of the screen. If you see a button that says Edit Account Profile, you are logged in as the O/O. If you do not see that button, you are logged in as the OC.

What happens if I don't remember the password to my account?

The quickest way to get a new password is to use the “Forgot Your Password” function on the DRLM log in page. The “forgot your password” function will only work if you have previously created a secret question and answer and your email address for your account is up-to-date in our records (FURLS). Please click on the “Edit Account Profile” function once you are able to log in to make sure this information is up to date as it will make the password reset process much quicker and easier for you.

You can always contact us by email at reglist@cdrh.fda.gov for assistance with getting your password reset. Please provide us with your account ID (if known) or your registration number and owner operator number.

What if I still have questions or need help?

If you have any questions about your account or about device registration and listing, please contact us at reglist@cdrh.fda.gov. Copies of this newsletter can be found on our website by going to the Registration & Listing Website and selecting the Documents link.

Theresa McDonald
Chief, Regulatory Policy and Systems Branch
Division of Risk Management Operations
Office of Compliance
Center for Devices and Radiological Health