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Agreed and guaranteed :-). There is NO regulatory requirement from FDA
for numbering and bulleting.
From: Ben Davies
Sent: Thursday, October 18, 2012 5:48 PM
To: Becca; tech2wr-l
Subject: RE: Numbering paragraphs
I would question your Quality / Regulatory department to see if numbered
paragraphs are truly a regulatory requirement, or if they are simply
something someone implemented a long time ago as a way to refer to
individual paragraphs easily (but isn't actually a true regulatory
I work for a medical device company. We submit documentation to FDA for
approval all the time. I just finished developing company templates.
We do not use any numbered paragraphs.
Our technical manuals use numbered headings.
Our operator manuals do not use numbered headings.
FDA seems fine with what we are doing...
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