RE: Manual fail...

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

Bee's hypothesis (or something like it) is more likely. Nothing in FDA's
regulations for medical devices would guide a manufacturer toward a
specific manual length. If J&J's initial requirement had been something
like, "the product shall have a 40-page manual," the PMA review for the
stent would have lit up a few red lights at the agency.

> -----Original Message-----
> From: beelia
> Sent: Sunday, January 10, 2010 4:27 PM
> To: Fred Ridder
> Cc: techwr-l -at- lists -dot- techwr-l -dot- com
> Subject: Re: Manual fail...
> 
> I have a different theory (for the second example). The 
> writer may have been using a tool like inDesign and was told 
> that the result would be printed locally, double-sided and 
> saddlestitched. He or she probably didn't know how to revise 
> the 2-up or 4-up format to get all the pages to print 
> consecutively with the correct numbered page on the other 
> side, and as a short (sloppy) cut, put in all those blank 
> pages to provide the correct number of folded-over pages.
> 
> Just a theory, not an excuse.
> 
> Cheers
> 
> Bee
> 
> 2010/1/10 Fred Ridder
> 
> >
> > I suspect that it is significant that these manuals are both for 
> > medical (i.e. highly regulated) products, and that in both 
> cases the 
> > total page count is exactly 40. I'm hypothesizing that at 
> some point 
> > in the product's regulatory history it was established that the 
> > product shall have a 40-page manual, and that is what the 
> company is 
> > delivering. Our healthcare dollars hard at work...
> >


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