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FAQs about the New Device Registration and Listing Requirements
Posted Date:2017/8/9 9
Changes to Device Registration and Listing
1. What changes to device registration and listing requirements became effective on October 1, 2012?
The changes are:
o All proprietary names under which a device is marketed must be reported, at a minimum, when a device is first listed and during the annual update of registration and listing information.
o Combination products – products comprising a device and a biological product or a drug – must be identified as a combination product and the type of combination product (for example, convenience kit, prefilled drug delivery device, etc.) must be selected from the list displayed in the FDA Unified Registration and Listing System (FURLS).
o All contract manufacturers and sterilizers of finished devices must register and list regardless of whether they put the device into commercial distribution or return the device to the manufacturer or specification developer.
o Initial importers must identify the manufacturers of the devices they are importing.
o Foreign establishments that are exporting devices or offering devices for export to the United States must identify all known U.S. importers of their devices.
o A device must be listed by the manufacturer, specification developer, single-use device reprocessor, remanufacturer, or repacker/relabeler before a foreign exporter, contract manufacturer, or contract sterilizer can list it.
o Establishments that only handle complaints and previously registered as manufacturers or specification developers should change their establishment type to “Complaint File Establishment.”
o Establishments located in foreign trade zones must now register and list, as well as identify themselves as being located in a foreign trade zone.
o All establishments that are required to register must now pay the annual registration user fee as required by Food and Drug Administration Safety and Innovation Act (FDASIA).
Updating Existing Registration and Listing Information
2. How do I update information for the owner/operator or official correspondent?
Information for the owner operator and official correspondent is created and updated in the Account Management module of FURLS, accessed from the menu on the left side of the screen after logging into FDA Industry Systems at https://www.access.fda.gov/oaa/. The information you enter here for your account profile is automatically transferred to your Device Registration and Listing Module (DRLM) records as the owner operator information. You can find step-by-step directions for how to update your owner/operator and official correspondent information on the FDA website at: Updating Owner/Operator and Official Correspondent Account Information.
Proprietary(Brand) Names
3. Do I have to add all of the proprietary names of my device? How many proprietary names can I add to my listing?
Yes, the account holder should include all current proprietary names (or brand names) under which each device is marketed in the United States. There is no limit to the number of proprietary names that can be added. The names can now be uploaded from a spreadsheet that is formatted as a Microsoft™ Excel (.xls only) file or entered manually via FURLS/DRLM. Manufacturers of export-only devices should include all current proprietary names (or brand names) under which each device is marketed outside the United States, including private-label names.
4. We currently have our in-house brand and we private-label for a number of companies in the U.S. Do we need to include the proprietary names for each private-label device?
Yes, your device listings should include all of the current proprietary names that are used to market the devices you make in the U.S.
5. Do we have to include all proprietary names that our listed device has ever been marketed under?
No, you need only provide the names that the device is currently marketed under in the United States. Manufacturers of export only devices need only provide the names that the device is currently marketed under outside the United States.
6. We do not have any proprietary names for our device, can we just fill in that field with the device type (e.g., a scalpel)? What alternative information will FDA accept in this field?
You may enter the model or catalog number if one exists, the device type or other identifier you apply to the device. The terms "multiple" and "various" are not acceptable entries as your device’s proprietary names.
7. Should I include model numbers as part of the proprietary name?
Model numbers may be included as the proprietary name or part of the proprietary name.
8. We make different devices at different establishments that are listed under the same device product code or submission number. Do we need to identify proprietary names on an establishment-by-establishment basis?
No, the proprietary name need only be identified at the owner/operator level, not the establishment level. You do not need to identify the names on an establishment-by-establishment basis.
9. How do I review the proprietary name information of my current device listings?
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. There are two options for viewing your listings in the DRLM main menu.
a) To view the listings in FURLS itself, 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. Click on the View All link in the proprietary names section to view all proprietary names associated with the device.
b) To view the listings as a downloadable Microsoft™ Excel spreadsheet, click on the link titled Download Your Listing Information and click the “DOWNLOAD LISTINGS” button to download all of your listing information, with the exception of the proprietary or brand names. Click the “DOWNLOAD PROPRIETARY NAMES” to download all of the proprietary names identified for your listings. Both downloads create Microsoft™ Excel spreadsheets that you can save and search locally. The two spreadsheets are cross-referenced by Listing Number.
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.
(For a Single Device) 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 the proprietary name is confidential, make sure to click on the confidentiality box prior to clicking on the “Add Proprietary Name” button. To remove any incorrect proprietary names, select the name from the list in the top box and then click on the “Remove” button.
If you have a large list of proprietary names to add to the device you are currently editing, FURLS has the option of using a Microsoft™ Excel spreadsheet for uploading them all at one time. Click on the spreadsheet download link to get a sample spreadsheet. Enter one proprietary name per line of the spreadsheet and indicate whether or not the name is confidential. After all proprietary names have been entered, save the spreadsheet to your computer. Click on the “Browse” button to identify the location of the spreadsheet and then click on the “Upload” button.
When your list of proprietary names is 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.
(For Multiple Devices) If you have a large list of proprietary names for multiple devices, FURLS has the option of using a Microsoft™ Excel spreadsheet for uploading them all at one time. In the DRLM main menu, click on the link titled Add/Replace Proprietary Names or Importers to Listings. On the next page, click on the link titledAdd/Replace Proprietary Names from Active Listings By File Upload-Multiple Listings. On the next page, you will need to first click on the spreadsheet download link to get a sample spreadsheet. Enter one device listing number and proprietary name per line and indicate whether or not the name is confidential. After all proprietary names have been entered, save the spreadsheet to your computer. Click on the “Browse” button to identify the location of the spreadsheet. Click on the appropriate radio button to indicate whether the uploaded proprietary names will be added to the existing names or will be replacing the existing names. Click on the “Upload” button to proceed to the preview page. Review the listings and proprietary name to be uploaded, if correct click on the “Submit” button. You will now see a confirmation of the changes made to your device listings.
Medical Device Excise Tax
10. Is the Medical Device Excise Tax part of the Annual Registration User Fees?
No, the Medical Device Excise Tax is not part of the Annual Registration User Fee; is not related to any of the changes to registration and listing requirements; and is not enforced, collected, or implemented by FDA. Please visit the Internal Revenue Service website for more information on this tax.
Foreign Establishments, Exporters, Importers, and Contract Manufacturers and Sterilizers
11. Can an individual represent a foreign establishment as its U.S. agent and its official correspondent?
Yes, but as the U.S. agent, the individual must reside or have a place of business in the United States. No post office, lock or mail service drop boxes are allowable. The address must be for a physical location where the U.S. agent can be visited by FDA staff.
12. Now that a foreign establishment is required to provide the names of all known importers of its devices, must it continue to update this information in FURLS whenever it changes?
Yes. A foreign establishment must provide this information during initial registration, annual registration, and at the time of any changes.
13. As an importer, I am now required to provide the manufacturer information for devices I will be importing. Must I update this information in FURLS as new firms are added or I decide to no longer distribute for a particular manufacturer?
FDA recommends that importers keep their manufacturer information current at all times. Failure to keep your information current may lead to your shipments of imported devices undergoing manual import entry review by FDA, which may slow importation of your goods.
14. I am a foreign exporter, contract manufacturer, or contract sterilizer and I am trying to list a non-exempt device and FURLS will not allow me to proceed. Why can I not list this device?
The device must be listed by a manufacturer, remanufacturer, single-use device reprocessor, specification developer, or repacker/relabeler before you can list the device. You should check with your customer, manufacturer, or specification developer to make sure they have listed the device, or you can search for the listing in the Establishment Registration & Device Listing database.
FURLS Account Types and Ownership Responsibilities
15. What are the different types of accounts in the FDA Unified Registration and Listing System (FURLS) that are used to access the Device Registration and Listing Module (DRLM)?
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.
16. 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 and updates to, and deactivating ALL registrations and listings having the same O/O, if an O/O account has multiple establishments
17. 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 OO
· Updating US agent information
18. 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.
19. How often do 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.