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Subject:Re: FDA (b)anality From:mattgras -at- comcast -dot- net To:salt morton <salt -dot- morton -at- gmail -dot- com> Date:Mon, 9 Jan 2012 17:21:22 +0000 (UTC)
Seems a good time to find something else to wrangle over. Why invite a tussle? I'd leave the regulatory language as is.
matt
----- Original Message -----
From: "Chris Morton" <salt -dot- morton -at- gmail -dot- com>
To: techwr-l -at- lists -dot- techwr-l -dot- com
Sent: Monday, January 9, 2012 9:04:00 AM
Subject: FDA (b)anality
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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