This listing of FAQs is beingness provided to assist medical device establishments with understanding the new requirements and their responsibilities for registration and listing that became effective October 1, 2012.

  • Changes to Device Registration and List
  • Updating Existing Registration and List Information
  • Proprietary (Make) Names
  • Medical Device Excise Taxation
  • Foreign Establishments, Exporters, Importers, and Contract Manufacturers and Sterilizers
  • FURLS Account Types and Buying Responsibilities

Changes to Device Registration and Listing

1. What changes to device registration and list requirements became effective on October 1, 2012?

The changes are:

  • All proprietary names under which a device is marketed must be reported, at a minimum, when a device is start listed and during the almanac update of registration and listing information.
  • 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 case, convenience kit, prefilled drug delivery device, etc.) must be selected from the listing displayed in the FDA Unified Registration and Listing Organization (FURLS).
  • 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 programmer.
  • Initial importers must identify the manufacturers of the devices they are importing.
  • Strange establishments that are exporting devices or offering devices for export to the Usa must identify all known U.South. importers of their devices.
  • A device must exist listed by the manufacturer, specification developer, single-use device reprocessor, remanufacturer, or repacker/relabeler before a strange exporter, contract manufacturer, or contract sterilizer tin can listing information technology.
  • Establishments that only handle complaints and previously registered every bit manufacturers or specification developers should modify their establishment type to "Complaint File Establishment."
  • Establishments located in foreign trade zones must now register and listing, every bit well every bit identify themselves as being located in a foreign trade zone.
  • All establishments that are required to register must now pay the almanac registration user fee as required by Food and Drug Assistants Prophylactic and Innovation Act (FDASIA).

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Updating Existing Registration and Listing Data

2. How do I update data for the owner/operator or official correspondent?

Information for the possessor operator and official correspondent is created and updated in the Account Management module of FURLS, accessed from the carte du jour on the left side of the screen subsequently logging into FDA Industry Systems at https://www.access.fda.gov/oaa/. The information yous enter here for your account profile is automatically transferred to your Device Registration and Listing Module (DRLM) records as the owner operator information. You tin can find step-past-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 Data.

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Proprietary (Brand) Names

3. Practise I have to add all of the proprietary names of my device? How many proprietary names can I add to my list?

Yeah, the account holder should include all electric current proprietary names (or brand names) under which each device is marketed in the U.s.a.. At that place is no limit to the number of proprietary names that can be added. The names tin can now exist uploaded from a spreadsheet that is formatted as a Microsoft™ Excel (.xls only) file or entered manually via FURLS/DRLM. Manufacturers of export-but devices should include all current proprietary names (or make names) under which each device is marketed outside the The states, including private-label names.

four. We currently have our in-house make and we private-characterization for a number of companies in the U.S. Do we need to include the proprietary names for each private-label device?

Aye, your device listings should include all of the current proprietary names that are used to market the devices you make in the U.S.

v. Do we have to include all proprietary names that our listed device has ever been marketed nether?

No, yous need only provide the names that the device is currently marketed under in the United States. Manufacturers of export but devices need just provide the names that the device is currently marketed under exterior the United States.

6. We exercise not have any proprietary names for our device, can we simply fill in that field with the device blazon (e.thousand., a scalpel)? What culling information volition 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 "diverse" are non acceptable entries as your device's proprietary names.

7. Should I include model numbers as function of the proprietary name?

Model numbers may be included every bit the proprietary name or part of the proprietary proper name.

viii. Nosotros brand different devices at different establishments that are listed nether the aforementioned 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 non demand to identify the names on an institution-past-establishment footing.

nine. 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 business relationship. After logging into FURLS, click on the button titled "Device Registration and Listing" and go along to the main menu. There are two options for viewing your listings in the DRLM main bill of fare.

a) To view the listings in FURLS itself, click on the link titled View Your Registration and Listing Information and select the selection for viewing your device listings. To view a list, click on the radio push side by side to the listing number and so 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 equally a downloadable Microsoft™ Excel spreadsheet, click on the link titled Download Your List Data and click the "DOWNLOAD LISTINGS" push 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 relieve 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 take incorrect proprietary names, please have note of the listing numbers and and so return to the main menu.

(For a Single Device) In the DRLM chief card, click on the link titled Change, Cancel, or Reactivate Listings. Click on the radio push button next to the device listing that needs to be edited and then click on the "CHANGE LISTING" button. On the next folio, ensure that the correct facility is indicated and continue. The adjacent page allows you to betoken the establishment activity for the device and the proprietary names. Enter the proprietary names in the second (thinner) box and so click on the "Add Proprietary Name" push. If the proprietary proper name is confidential, make sure to click on the confidentiality box prior to clicking on the "Add together Proprietary Name" button. To remove any wrong proprietary names, select the name from the list in the top box and then click on the "Remove" button.

If you accept a big list of proprietary names to add together to the device you are currently editing, FURLS has the option of using a Microsoft™ Excel spreadsheet for uploading them all at 1 time. Click on the spreadsheet download link to get a sample spreadsheet. Enter one proprietary proper noun per line of the spreadsheet and indicate whether or not the proper name is confidential. Afterward all proprietary names accept been entered, salve the spreadsheet to your computer. Click on the "Browse" button to identify the location of the spreadsheet and then click on the "Upload" push.

When your list of proprietary names is correct, click the continue push button. On the next page, complete the certification statement and and so submit. You volition at present 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 i time. In the DRLM main carte, click on the link titled Add/Supercede Proprietary Names or Importers to Listings. On the side by side page, click on the link titled Add/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 proper name per line and betoken whether or not the proper noun is confidential. After all proprietary names have been entered, save the spreadsheet to your reckoner. Click on the "Browse" push button to identify the location of the spreadsheet. Click on the appropriate radio push button to betoken whether the uploaded proprietary names will exist added to the existing names or will exist 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 right click on the "Submit" button. You volition now encounter a confirmation of the changes made to your device listings.

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Medical Device Excise Tax

10. Is the Medical Device Excise Tax part of the Annual Registration User Fees?

No, the Medical Device Excise Revenue enhancement is non office of the Annual Registration User Fee; is not related to whatsoever of the changes to registration and list requirements; and is not enforced, nerveless, or implemented past FDA. Delight visit the Internal Acquirement Service website for more information on this tax.

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Strange Establishments, Exporters, Importers, and Contract Manufacturers and Sterilizers

xi. Tin can an individual stand for a foreign establishment every bit its U.S. amanuensis and its official correspondent?

Yes, but as the U.S. amanuensis, the individual must reside or have a place of business concern in the U.s.a.. 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. At present that a strange institution is required to provide the names of all known importers of its devices, must it continue to update this information in FURLS whenever information technology changes?

Yes. A foreign establishment must provide this information during initial registration, almanac registration, and at the fourth dimension of any changes.

thirteen. As an importer, I am at present required to provide the manufacturer information for devices I volition be importing. Must I update this data 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 data 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 keep. Why tin can I not list this device?

The device must be listed by a manufacturer, remanufacturer, single-employ device reprocessor, specification programmer, or repacker/relabeler earlier you can list the device. Yous should check with your customer, manufacturer, or specification developer to brand sure they have listed the device, or yous tin can search for the listing in the Establishment Registration & Device Listing database.

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FURLS Account Types and Ownership Responsibilities

15. What are the unlike types of accounts in the FDA Unified Registration and Listing Organization (FURLS) that are used to admission the Device Registration and Listing Module (DRLM)?

In that location are 2 kinds of accounts. Each business relationship contains the name, phone, and email and physical accost for the contact person.

  • The owner/operator (O/O) business relationship can be thought of as the primary business relationship, as it tin can make any changes in DRLM.
  • The official correspondent (OC) account is created by the possessor/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 Merely 1 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 split up 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 business relationship responsible for?

  • Knowing who their O/O account holder is, as the O/O is the only one who tin make changes to their OC information (name, address, phone, email, etc.)
  • Receiving and reviewing routine correspondence, usually past 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 But to registrations and listings that have been assigned to them past the OO
  • Updating United states amanuensis information

eighteen. How practise I tell what kind of business relationship I am logged in with?

When you showtime log into FURLS with your business relationship ID and password, expect on the left hand side of the screen. If you lot see a push button that says Edit Account Contour, you are logged in as the O/O. If yous do not see that button, you are logged in every bit the OC.

19. How often practice I need to alter my countersign in FURLS?

Passwords for both the Owner Operator (O/O) and Official Contributor (OC) expire every 90 days and the system will prompt you to create a new password.

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Additional Information

  • Medical Device Establishment Registration: Device Facility User Fee (DFUF) - Often Asked Questions (FAQs)