RE: FDA (b)anality

[<Brian -dot- Henderson -at- mitchell1 -dot- com>]

Aww...that's so cute. Chris thinks the government is benevolent.

Seriously, you KNOW the FDA will notice in two years that the Caution is
wrong, and will fine you massive amounts of money for all the time it
was incorrectly worded. It's the only possible outcome.

-Brian H.

-----Original Message-----
From: techwr-l-bounces+brian -dot- henderson=mitchell1 -dot- com -at- lists -dot- techwr-l -dot- com
[mailto:techwr-l-bounces+brian -dot- henderson=mitchell1 -dot- com -at- lists -dot- techwr-l -dot- co
m] On Behalf Of Chris Morton
Sent: Monday, January 09, 2012 9:04 AM
To: techwr-l -at- lists -dot- techwr-l -dot- com
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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