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You have more imagination than I do. Short of sharpening the edges of the
CDs and throwing them as ninja weapons or scattering them on a wet floor to
act as substitutes for banana peels, I can't think of any way you could put
anyone in jeopardy from software without first installing it into a
"device."
Gene Kim-Eng
On Thu, Jan 12, 2012 at 11:06 AM, Paul GobleI 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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