RE: FDA and the ragged right margin

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

It's *possible* to fully comply with FDA regulations without following
an FDA guidance. However, it's often cheaper and easier to comply with
the regulations when you do follow a guidance.

It can also make inspections go more quickly:
"Why did you choose this method?"
"Because that's what the guidance suggested."

> -----Original Message-----
> From: Gene Kim-Eng
> Sent: Friday, March 21, 2008 1:55 PM
> To: techwr-l -at- lists -dot- techwr-l -dot- com
> Subject: Re: FDA and the ragged right margin
> 
> When writing docs for submission to the FDA, the only support 
> needed for their "suggestions" is "because we said so."
> 
> ----- Original Message -----
> From: "Dan Goldstein"
> > We've discussed margins and readability in the past on this 
> > list. I was looking for unrelated information in the FDA 
> > Guidance on Medical Device Patient Labeling (2001), and I 
> > happened upon the following suggestion:
> > "Justify the left-hand margin. Use ragged right margins."
> >
> > They include references about readability, but they don't 
> > specify which reference they used for this suggestion.
> 

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