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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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