RE: FDA documentation experience?

["Dan Goldstein" <DGoldstein -at- riverainmedical -dot- com>]

The FDA Quality System Regulation for medical devices, 21 CFR 820,
covers all devices "intended for human use" -- both diagnosis and
treatment. There are additional regulations for (among other things) in
vitro diagnostic devices, but the FDA documentation story begins with
the Quality System Regulation.

> -----Original Message-----
> From: Gene Kim-Eng
> Sent: Friday, September 05, 2008 9:36 PM
> To: ; techwr-l -at- lists -dot- techwr-l -dot- com
> Subject: Re: FDA documentation experience?
> 
> What kind of equipment? Is it laboratory/diagnostic, 
> or treatment? The requirements for the two categories 
> are very different.
> 

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