FDA Foreign Exporter Registration and MDL Listing Question

[Shilo]

I have a question regarding FDA registration for foreign exporters and the use of MDL (device listing) numbers.
From my understanding:

• The manufacturer or specification developer must first create the device listing.
• A foreign exporter, when registering, usually selects/uses the existing MDL rather than creating a new one.

My questions are:

1. When registering as a foreign exporter in FURLS, is it always required to reference an existing MDL created by the manufacturer (or other responsible party)?
2. Is there any situation where a foreign exporter is allowed to create a new device listing (new MDL) for the same product?
3. Are there official FDA regulations or guidance documents that clearly describe this requirement? I checked 21 CFR Part 807 and found references to foreign establishments (§807.40), but not a direct statement about foreign exporters creating or reusing listings.

If anyone has practical experience with this process, or can point me to FDA guidance/FAQ links, it would be very helpful.
Thank you in advance!

 

[RA-QA&Cyber]

You’re correct that in FDA’s FURLS/DRLM system, the device listing is generally created by the U.S. manufacturer, specification developer, or initial foreign establishment responsible for the device. A foreign exporter does not typically create a new listing for a product that is already listed rather, they reference the existing number during their registration.

A foreign exporter registering in FURLS must identify the devices they are exporting by referencing an existing listing created by the legal manufacturer/specification developer (or their authorized U.S. agent). The listing number is tied to the product and its regulatory owner, not each exporter. Only if the exporter is also acting as the manufacturer, specification developer, or another establishment type with device listing obligations under, would they need to create their own device listing. But if they are simply exporting a finished device already listed by the manufacturer, they should not create a duplicate listing number.

The real life challenge comes into play when foreign exporters mistakenly create duplicate device listings, it can cause confusion and sometimes delays at import. Best practice is to coordinate with the manufacturer (or their U.S. agent) to ensure you reference the correct listing number already on file.