FDA (b)anality

Subject: FDA (b)anality
From: Chris Morton <salt -dot- morton -at- gmail -dot- com>
To: techwr-l -at- lists -dot- techwr-l -dot- com
Date: Mon, 9 Jan 2012 09:04:00 -0800

My company has a software solution that is subject to FDA
approval/scrutiny. That entity insists that we use the following cautionary
statement in our user manual:

CAUTION: Federal law restricts this device to the sale by, or on the order
of, a physician.

Because the software is not a device, I modified the statement to read:

CAUTION: Federal law restricts this product to the sale by, or on the order
of, a physician.

Now our regulatory affairs guy has a pickle up his _____ and is hassling me
over the change. I believe that no one can, or will, bother us about this
minor modification.

What are your thoughts about this?

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