Re: Documentation Feedback Form

Subject: Re: Documentation Feedback Form
From: "Gene Kim-Eng" <techwr -at- genek -dot- com>
To: <techwr-l -at- lists -dot- techwr-l -dot- com>
Date: Fri, 14 Sep 2007 12:33:47 -0700

I would say yes. 21 CFR 820.198 classifies any information
that might identify a "defect" in the product or any issue that
requires corrective action in the product (which includes its
documentation) or in the product's design, manufacturing
or quality processes as a "complaint." Even if feedback
doesn't constitute a complaint, you'll need to keep records to
document how you determined whether feedback did or did
not meet the criteria.

Gene Kim-Eng

----- Original Message -----
From: "Milan Davidovic" <milan -dot- lists -at- gmail -dot- com>
> Does anyone here suppose that, for FDA purposes, feedback elicited by
> such a form could be regarded as "complaints" and therefore subject to
> FDA regulations on complaint handling?


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Documentation Feedback Form: From: Zen C
Re: Documentation Feedback Form: From: Milan Davidovic

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