Registration/Listing; Initial Importer - Private Label w/ Foreign Establishment

[SailandBrew]

We're a US company buying Class II products from a foreign manufacturer who has 510k for their products.

The foreign manufacturer is creating, and managing, labeling where they change only the brand name and add the prerequisite "Manufactured for:" before our name and US address. Their name or address. is not listed anywhere on the labeling.

We have a quality agreement which outlines our responsibilities, which we will import the product for initial distribution and collect/forward complaints to them.

We've Registered as an 'Initial Importer', and List the product with activity 'complaint file establishment'.

They are registered as a manufacture and have listed our private label brand names

Is this correct? Or could you please help with guidance and justifications. I've read over this form and FDA website so many times, but my confidence level is only 80-90% on my justifications for these decisions.

 

[JeantheBigone]

The website can be confusing, that's for sure!

I'm not sure what you mean when you say that the products are listed as "complaint establishment." Are you saying that your establishment is registered both as an "Initial Importer" and as a "Complaint File Establishment?"

If your company is only collecting complaints and forwarding them to the foreign manufacturer as opposed to evaluating them, then yours is not a "Complaint File Establishment" in the sense of 21 CFr 820.198:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.198

 

[SailandBrew]

Thank you JeantheBigone!

We Registered our entity as 'Initial Importer' and for product Listing selected 'Complaint File Establishment' as the activities we perform.

We, our entity, does not own the process of 820.198, but assist the foreign manufacturer by receiving complaints (our contact information is listed on labeling), recording the complaints, and then forwarding them on to the foreign manufacturers RA/QA team.

From FDA 'Who Must Register, List, and Pay The Fee', as an Initial importer it's clear we must Register and Pay the fee, but it has 'Identify Manufacturers per 807.20(a)(5)' under List.

My thought was that be Listing our products and selecting 'Complaint File Establishment' we were identifying the foreign manufacturer and creating the link between our brand name and their 510k/registration.

 

[JeantheBigone]

Hi SailandBrew,

I'm not able to look at the options in FURLS right now (away from the office and don't have the user ID / password) but it sounds as though there is a better choice instead of "complaint file establishment." If your company is not actually performing the activities needed to evaluate complaints as set out in the link, there is a good chance that you will run into problems in the event that your establishment is inspected by FDA.

I'll try to have a look at the other options later when I'm back in my office.

 

[JeantheBigone]

I checked into one of the accounts I manage for a client who imports an exempt device but who otherwise does not perform any activities such as design, sterilization etc. I learned something! I took a screenshot but unfortunately I can't seem to post the image here.

It's too much work to type it all out but what it comes down to is that 9 of the 11 choices can be selected, but two are greyed out,
"Export device to the United States But Perform no Other Operation on Device"
and
"Foreign Private Label Distributor."

My sense of why this is so is that the initial importer is presumed to be involved in those activities, and that aside from registering, FDA has no involvement. In other words, those activities are not of a nature that FDA regulates in the sense that an inspection could turn up a violation. All of the other activities, which could be selected, have potential for an inspection to turn up violation of Federal Law.

So, I'd say to not check anything. That's my story and I'm sticking to it!

 

[SailandBrew]

That is what I was thinking, don't select any, but the form requires at least one is selected. (cant select any of the two grey'd out options)

We have a Quality Agreement with the foreign manufacturer, that they are responsible to create, manage, and control labeling, where we simply issue them a licence to use our trademark and brand name to create labeling for our private label products.

Do you think this would be enough evidence to support our selection of 'relabeler' when we List devices?

Else, I guess I have to reach our to FDA help desk

 

[JeantheBigone]

From the FDA website:

"Relabeler - Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name."

From your description it sounds as though your company is not a relabeler.

If nothing is selected from that list, then it doesn't appear to be possible to "list" a device, but it is possible to register your establishment. The purpose of that is to make sure that whoever takes title of the device once it enters the US is authorized to do so, and customs spot checks goods imported to the US for this.

My recommendation would be to select nothing. Or call the registration and listing helpdesk. Unlike other FDA offices, you can usually get hold of someone who will talk to you on the phone. If you do, please post back what you find out!

 

[SailandBrew]

Okay, so the section where you add the products you import is under facility registration and not under listing. After digging around a bit, and with feedback from FDA, I was able to figure it out

"If you are only the “private label distributor”/wholesale distributor importing ONLY and not conducting further processing on the medical devices, then you do not create listings under your registration. As an initial importer, you would say ‘yes’ to the question asked by the system if you’re an importer of medical devices. The system will eventually prompt you to identify the registered foreign manufacturer and (from the foreign manufacturer’s listing information) the medical device you’re importing.

There’s no other steps to be completed on your registration. Please remember to supply the foreign parties with your registration so they can add you onto their records as an importer."