TechWhirl (TECHWR-L) is a resource for technical writing and technical communications professionals of all experience levels and in all industries to share their experiences and acquire information.
For two decades, technical communicators have turned to TechWhirl to ask and answer questions about the always-changing world of technical communications, such as tools, skills, career paths, methodologies, and emerging industries. The TechWhirl Archives and magazine, created for, by and about technical writers, offer a wealth of knowledge to everyone with an interest in any aspect of technical communications.
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
equivalents).
-----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?
This message contains confidential information intended only for the use of the addressee(s). If you are not the addressee, or the person responsible for delivering it to the addressee, you are hereby notified that reading, disseminating, distributing, copying, electronic storing or the taking of any action in reliance on the contents of this message is strictly prohibited. If you have received this message by mistake, please notify us, by replying to the sender, and delete the original message immediately thereafter. Thank you.
Create and publish documentation through multiple channels with Doc-To-Help.
Choose your authoring formats and get any output you may need. Try
Doc-To-Help, now with MS SharePoint integration, free for 30-days. http://www.doctohelp.com
---
You are currently subscribed to TECHWR-L as archive -at- web -dot- techwr-l -dot- com -dot-
