Foreign Medical Device Manufacturer Complaint File Establishment

invitro_spain

Involved In Discussions
Hello,

We are In vitro medical devices foreign manufacturers. When I registered the company and the products list as ASR on the FDA Website I have selected the following options: Manufacturer and complaint file establishment.

I have a doubt with this option, I guess that this option is according to the 21 CFR 820.198 but maybe I missunderstood the concept. I saw that the others appear as Manufaturer only.

Can anybody help me?

Thank you
 
M

MIREGMGR

FDA's presumption is that a Manufacturer is responsible for receiving and evaluating complaints, and reporting as required, unless another effective system is in place. A few Manufacturers direct their customers to interact in regard to complaints and similar problem-reports with a separate customer service company, acting on behalf of the Manufacturer. FDA provides the "Maintains complaint files as required under 21 CFR 820.198" registration category so that such customer service companies can Register as required.
 

Sheila1

Starting to get Involved
I have a question about this. If a contract manufacturer takes on the responsibility to maintain the complaint files (by the terms of the contract), would it need to register both as a contract manufacturer and a maintainer of complaint files?
 
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