Re: FDA (b)anality

Subject: Re: FDA (b)anality
From: Bill Swallow <techcommdood -at- gmail -dot- com>
To: salt -dot- morton -at- gmail -dot- com
Date: Mon, 9 Jan 2012 13:51:26 -0500

Isn't it your regulatory affairs guy's job to decide these things so
your company is compliant with the industry and the laws surrounding
it? If the FDA insists you use the statement, then you likely need to
use it as-provided. Any changes would need to be approved by the FDA
else they could find your company at fault.

On Mon, Jan 9, 2012 at 12:04 PM, Chris Morton <salt -dot- morton -at- gmail -dot- com> wrote:
> 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?

Bill Swallow

Twitter: @techcommdood

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FDA (b)anality: From: Chris Morton

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