FDA requirements (was Pray for Me)

Subject: FDA requirements (was Pray for Me)
From: rickk -at- slmd -dot- com
To: techwr-l -at- lists -dot- raycomm -dot- com
Date: Tue, 25 Jul 2000 10:04:57 -0700

All of you participants in the "Pray for Me" thread, including the original
poster, have been laboring under an erroneous assumption.

As a long-time tech writer for a medical devices company, I am familiar
with FDA requirments.
They do NOT require online help or online documentation, context-sensitive
or otherwise. The hardcopy manual that the original poster already has is
enough to "satisfy the FDA."
The original poster probably misunderstood why she was being asked to

>I have a new assignment: "Do a context-sensitive HTMLHelp system for
>Product X [an automated medical device used in hospital operating rooms].
>The 400-page user manual needs to be in HTML, too. We need a working
>prototype of both, complete enough to satisfy the FDA, for the next
>build on Thursday afternoon."

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