This list of FAQs is being provided to assist medical device establishments1 with understanding the new requirements and responsibilities for registration and listing that will become effective October 1, 2012.
Changes to Device Registration and Listing
1. What are the changes to device registration and listing requirements, effective Oct. 1, 2012?
The changes are:
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.
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).
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.
Initial importers must identify the manufacturers of the devices they are importing.
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.
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.
Establishments that only handle complaints and previously registered as manufacturers or specification developers should change their establishment type to “Complaint File Establishment” as required by 21 CFR 820.198.
Establishments located in foreign trade zones must now register and list, as well as identify themselves as being located in a foreign trade zone.
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 .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. To add, change, or delete an official correspondent other than the owner operator, you can create, update, deactivate, or reactivate a subaccount for that official correspondent. You then choose your official correspondent when you register a facility or update an existing registration for a facility.
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). There is no limit to the number of proprietary names that can be added. The names can now be uploaded from an Excel spreadsheet or entered manually via DRLM.
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 of the brands that we private-label for?
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.
6. We do not have any proprietary names for our device, can we just fill in that field with what the device is (e.g., a scalpel)?
You may enter the model number if one exists or whatever identifier you apply to the device.
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, as appropriate.
8. We make different devices at different establishments that are listed under the same device code or submission number. Do we need to identify proprietary names on an establishment by establishment basis?
The proprietary name need only be identified at the owner operator level, not the establishment level. You will not identify the names on an establishment-by-establishment basis.
9. How long do we have to edit existing device listings and to add all of our proprietary names?
You should update your proprietary names during the annual registration cycle from October to December 2012; however, FDA is not requiring that all proprietary names be added until March 31, 2013.