Re: FDA (b)anality

Subject: Re: 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 09:42:41 -0800

Thanks to all for your input. I've revised my manual and am about to put in
a change order to document control.

> Chris

On Mon, Jan 9, 2012 at 9:17 AM, William Gaffga <will -dot- gaffga -at- gmail -dot- com>wrote:

> Other than Brian's comment being hilarious ...
>
> If the FDA wants it, go with it. To me it is not worth the neural cycles
> fighting over one word in a statement nobody is going to read, especially
> when it is simply semantics. Move on to other, bigger, more important
> things.
>
> Sure, to you, me, and every other tech comm'r, we know it is wrong. We're a
> weird breed.
>
> --
> William Gaffga
> www.wilyguy.net/portfolio/
> http://www.linkedin.com/in/willgaffga
> H: 805-492-0192
> M: 805-405-6602
> S: willgaffga
>
>
> On Mon, Jan 9, 2012 at 9:04 AM, 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?
> > ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
> >
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References:
FDA (b)anality: From: Chris Morton
Re: FDA (b)anality: From: William Gaffga

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