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.

 

[madball911]

Does anyone know what to do if the original manufacturing company no longer exists? I'm trying to get back devices that were manufactured by my old company, and sat in Customs in China for 7 years (so technically never left the US?), but I don't have the device listing number.

 

[ChrisM]

Why are you trying to get them back? Techically and legally, who do they currently belong to?

 

[Ed Panek]

Why are you trying to get them back? Techically and legally, who do they currently belong to?

Yes. After 7 years I would be amazed the products were not written off on some accounting audit. 7 years without contact seems like a long time

Also, is the device still permitted under its original clearance? If the OEM no longer exists I imagine the registration FDA requires each year has expired. If the original manufacturer is gone, expect that you may become the legal manufacturer the moment you try to take responsibility.

I would contact a customs broker with experience with FDA regulated products. They would possibly know this very odd edge case.

 

[madball911]

Technically and legally, the owner of these specific devices is the party in China that I sold them to 7 years ago, even though they never got them out of Customs. They are now the shipper for this "return".

As for the technology/510(k) of the device, that was sold to a competitor a few years back, who did not keep up the registration, as their intent was not to make the device, but rather help my company go out of business.

The devices have depreciated to zero for anyone involved.

I've been working with two different brokers so far, and they appear to know less than I do. The best response I've gotten is that I have to pay 45% of the original sales price to get them back, but even for that privilege, I need to provide a listing number.

 

[ChrisM]

This begins to sound like a nightmare, I think I'd try to distance myself as far as possible from the product and let the legal owner sort it all out unless there is a very good reason that you want them back. I fear that the only "winners" will be the legal profession with their fees for action and advice.......