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If you really thought the official wording could place the patient in
jeopardy, you would contact FDA and explain your reasoning to them. In
the unlikely event that you were right, they would tell you to use the
wording that your users understand best. But they wouldn't tell you to
use two inconsistent notices as a solution; no good technical editor
From: Paul Goble
Sent: Thursday, January 12, 2012 2:07 PM
Subject: Re: FDA (b)anality
Would it be acceptable to include the official notice in a
less-prominent place, then in a more prominent place include a notice
which would actually be meaningful to the reader?
I haven't yet worked on FDA-regulated medical devices, so I'm curious.
It probably isn't critical in this case, but I can imagine circumstances
where using only the official wording could in fact place the user or
patient in jeopardy.
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