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Subject:Re: FDA (b)anality From:William Gaffga <will -dot- gaffga -at- gmail -dot- com> To:techwr-l -at- lists -dot- techwr-l -dot- com Date:Mon, 9 Jan 2012 09:17:55 -0800
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
Sure, to you, me, and every other tech comm'r, we know it is wrong. We're a
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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