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U.S. Department of Health and Human Services

Medical Devices

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To: Firms Without an Assigned Establishment Registration Number - Steps to Complete Annual Registration and Listing for FY2010 (10/09)

The period for renewing the FDA Device Establishment Registration for FY10 runs from October 1, 2009 through December 31, 2009. Firms are required during this period to pay the annual establishment registration fee (if applicable), review their registration and listing information in the electronic system (FURLS), and make any updates.

Your establishment has been identified as one that has not yet been assigned an establishment registration number by FDA. Because of that status, you must follow special steps in FURLS when renewing your FY09 establishment registration.

1. Determine if you are required to pay the establishment registration fee. (See Who Must Register, List, and Pay the Fee). There is no change in who must pay the fee for FY10. If you are not required to pay the fee, skip to step 3.

2. If you are required to pay the fee, follow the instructions online to obtain a Payment Identification Number (PIN) and Payment Confirmation Number (PCN). Once you have obtained both numbers, proceed to step 3

3. Log on to FDA Industry Page (FURLS) at https://www.access.fda.gov/oaa/ with the Account ID and password that you used last year to access your FURLS account.

4. Select the DRLM button (Device Registration and Listing Module).

5. Select Change Registration Information for a Facility.

6. Select the Facility and Click on Update Selected Registration.

7. Review your registration information. (Make any changes if needed by clicking the EDIT button). After any edits or if you do not need to make any edits, check the certification statement box and click submit.

8. If you are required to pay the establishment registration fee, you will be presented with a screen to enter your PIN and PCN. Enter those numbers and click submit.

9. You will receive a confirmation screen. Once you receive the confirmation screen, FDA will consider you registered for FY2010.

10. If you have any changes to your listings, return to the main menu and select Change, Cancel or Reactivate Listings to update your listing information.

Note: FURLS will not show at first a change in the expiration date of your registration when you complete the above steps.

If you have any questions about this process, you may email us at reglist@cdrh.fda.gov.