RE: FDA (b)anality

Subject: RE: FDA (b)anality
From: "Dan Goldstein" <DGoldstein -at- riveraintech -dot- com>
To: <techwr-l -at- lists -dot- techwr-l -dot- com>
Date: Mon, 9 Jan 2012 12:22:56 -0500

Actually, your regulatory affairs guy is absolutely right. FDA has a
clear definition of a "finished device," and it does include
software-only products.

You might want to read up on this sometime; the regulations are pretty
easy to follow (which is a lot more than I can say for their European

-----Original Message-----
From: Chris Morton
Sent: Monday, January 09, 2012 12:04 PM
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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FDA (b)anality: From: Chris Morton

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