FDA Device Establishment Registration and Listing Newsletter - June 2012
This newsletter is being sent to remind you of the importance of verifying the proprietary name information on your medical device listings in FURLS.
When you are either completing the annual registration or are submitting new device listing information, you are required to certify that the information submitted is correct. Part of the information that the certification statement refers to is the proprietary names of your listed devices.
Proprietary names are the trade names or brand names that you are using to market your devices in the U.S. Your device listings should include all of the proprietary names that are currently in use. Please note that “multiple” and “various” are not acceptable proprietary names.
To review the proprietary name information of your device listings, please log into your FURLS account. After logging into FURLS, click on the button titled “Device Registration and Listing” and continue to the main menu. In the DRLM main menu, click on the link titled View Your Registration and Listing Information and select the option for viewing your device listings. To view a listing, click on the radio button next to the listing number and then click on the “VIEW SELECTED LISTING” button.
If you find any device listings that are either missing a proprietary name or have incorrect proprietary names, please take note of the listing numbers and then return to the main menu. In the DRLM main menu, click on the link titled Change, Cancel, or Reactivate Listings . Click on the radio button next to the device listing that needs to be edited and then click on the “CHANGE LISTING” button. On the next page, ensure that the correct facility is indicated and continue. The next page allows you to indicate the establishment activity for the device and the proprietary names. Enter the proprietary names in the second (thinner) box and then click on the “Add Proprietary Name” button. If you have a large list of proprietary names, for one device, FURLS has the option of using a Microsoft Excel Spreadsheet for uploading them all at one time. To remove any incorrect proprietary names, select the name from the list in the top box and then click on the “Remove” button. If your list of proprietary names I now correct, click the continue button. On the next page, complete the certification statement and then submit. You will now see a confirmation of the changes made to your device listing.
If you need further help with updating your proprietary names, please send an email to email@example.com for assistance.
Consumer Safety Officer
Regulatory Policy and Systems Branch
Division of Risk Management Operations
Office of Compliance
Center for Devices and Radiological Health