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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 - March 2009

We know that many of you experienced problems during the Medical Device Registration and Listing registration period for Fiscal Year 2009 (October 1, 2008 through December 31, 2008). In an effort to minimize such issues in the future, we will be sending a monthly email that will provide tips on how to more easily access your data in the electronic system and to inform you of any upcoming changes or deadlines.

We use email as the primary method for communicating with firms on registration and listing issues. You have been identified as the holder of an Owner Operator account. The Owner Operator is the ONLY account that can update email addresses. You are responsible for ensuring that the Owner Operator and Official Correspondent email addresses are correct. It order to receive information from us in a timely manner, it is critical that these addresses be correct. The Owner/Operator account ID for each establishment is at the end of this email.

Instructions on how to update the email address in your account (which includes both the Owner/Operator account and the Official Correspondent account) are listed below and are also posted on our website. Some email systems may mistakenly consider messages from FDA as spam. In order to prevent this, please be sure to add the email addresses device.reg@fda.hhs.gov and access@fda.gov to your spam filter as well as any addresses ending in fda.gov, hhs.gov, or cdrh.fda.gov.

In the future we will be sending this newsletter to both you and your Official Correspondent. We will include more information about the different types of accounts in a future issue. Please look for our monthly update either in your email account or on our website.

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

To update your email address for the establishment:

  1. Go to the Electronic Registration and Listing system log on page (FDA Industry Systems) at: https://www.access.fda.gov/oaa/
  2. Log in with the Owner/Operator Account ID and password. If you do not know your password, please contact us at reglist@cdrh.fda.gov
  3. On the left hand side of the screen, choose Edit Account Profile. If you do not see the choice Edit Account Profile, then you are not logged in as the owner operator of the account and instead are logged in as the official correspondent. Only the owner operator can make a change in the account profile, including the email address. Additional information on the difference between an owner operator account and the official correspondent account can be found online.
  4. You may be asked to choose which account (owner operator or official correspondent) that you wish to modify. Choose the account and click on Continue. If you do not have a separate official correspondent account for your firm, you will be taken directly to the edit screen.
  5. Make any changes to your information and click on Continue at the bottom of the page. All of your account information, including the changes you made will then be shown on the screen. At the bottom of the screen, click on the Submit button and your account will be updated. You may then log out of the system by clicking on the log out link near the top of the screen.

Note: if you log into the electronic system using the Official Correspondent account for this establishment, you cannot change your email address. Instead you must use the owner operator account to update the email address.