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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 - June 2009

The following information is for device firms that are registered in the FDA Unified Registration and Listing System (FURLS). It describes what information you need to know about obtaining a new password. Having a valid password for the purpose of updating or changing your FDA registration or listings is critical.

What passwords are you referring to?
This information pertains only to the password that you would use when registering your device establishment in the FURLS system. Please note: This password is different from the one used in the Device Facility User Fee (payment) website. This information does not apply to the Device Facility User Fee system or to the password that you use in that system. For help with your DFUF password, please contact userfees@fda.gov.

Why would I need to change my password in FURLS?
Passwords for both the Owner Operator (O/O) and Official Correspondent (OC) expire every 90 days and the system will prompt you to create a new password. During the 2009 annual registration cycle, many device firms were unable to log into their account because they did not know their password. Not knowing your password will prevent a firm from being able to complete their annual registration and can result in long delays while the issue is being resolved.

What information do I need to know to access my account?
You should know the following:

  • Your account ID
  • Your password
  • Your secret question
  • The answer to your secret question

If you are an O/O or an OC and do not know your account ID, please contact reglist@cdrh.fda.gov.

How do I create a secret question and answer for an existing account?
Go to: https://www.access.fda.gov/oaa/ and:

  • Login to your account using your ID and password
  • On the main menu, select Edit Account Profile. If there is only an O/O account, your account information will automatically appear
  • If there are also OC accounts, you will need to choose the account to be edited
  • Select one of the secret questions and answer it
  • Click continue
  • Verify the information and click Submit

I know my account and my secret question. How do I get my password reset?
To reset your password go to https://www.access.fda.gov/oaa/ and:

  • Click on the 'Forgot Your Password?' link
  • Enter your Account ID, select your secret question, enter the answer, and click on the Continue button
  • If you answered the question correctly, your password will be reset and sent to the email address that is stored in your O/O or OC account. If you do not receive this email within 24 hours, please contact reglist@cdrh.fda.gov. In your email, please be sure to provide your account ID and your registration number. If your registration number has not yet been assigned, then include your owner operator number.
  • If you did not answer correctly, or you do not know your account ID or the answer to your secret question, contact reglist@cdrh.fda.gov and in the email, include the same information listed above.

Why do I keep getting an 'invalid password' message when I try to choose a password?
You will get this message if the password you are creating for your account does not meet all of the following requirements:

  1. At least 8, but no more than 32 characters
  2. At least one UPPERCASE letter
  3. At least one lowercase letter
  4. At least one special character: (e.g. # or @). Do not use < >& or '.
  5. At least one number

Where can I get assistance if I have any additional questions?
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 the Documents page at the Registration and Listing website.

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