Re: FDA (b)anality

Subject: Re: FDA (b)anality
From: Gene Kim-Eng <techwr -at- genek -dot- com>
To: salt -dot- morton -at- gmail -dot- com
Date: Mon, 9 Jan 2012 09:18:34 -0800

Your software cannot be used without loading it onto a computer or whatever
other instrument it's designed to be used on. Once loaded, the software
becomes part of a "device."

As with most regulatory warnings, your validation will be evaluated by
someone who is using a checklist. If that checklist calls for the device
warning, your reworded software warning will be marked as noncompliant.

I would do what the regs guy says. Common sense has little to do with
regulatory approvals.

Gene Kim-Eng

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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FDA (b)anality: From: Chris Morton

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