Complaint File Establishment

[margadia]

Hi All. I have a registration question I was hoping one of you fine people could help me clear up. Before I arrived at my current job (Initial Importer/Distributor), we had listed 2 devices of which we were listed as the Complaint File Establishment for. One device we don't even import or distribute anymore and the other we are about to discontinue selling due to low sales. My question is, as an Initial Importer, are we even required to be listed as a Complaint File Establishment for these products? We will be replacing both with similar devices, but we are not a spec developer, have never had any input on design or specs, we aren't a manufacturer, we simply purchase these devices from a manufacturer in Europe, import them to US and sell them domestically. All devices hold 510ks. We do install these devices and service them, when required. My understanding is that we do not need to list any of these devices and as such, not list ourselves as a Complaint File Establishment as the Initial Importer, but I'm looking for clarification and confirmation. Any and all feedback is as always, much appreciated. Thank you!

 

[indubioush]

If you are not the Complaint File Establishment, who is? If there are devices still existing with users and your company would manage those complaints, you cannot remove the listing simply because you no longer import more of those same devices.