US FDA's Document Dating System

Mark Meer

Trusted Information Resource
#1
Just an observation up for discussion:

Today I received an email from the US FDA with a link to a draft guidance: The Least Burdensome Provisions: Concept and Principles

The cover page says: "Document issued on December 15, 2017."
Today is December 14th, 2017.

Yes, I realize it's just a draft, and the discrepancy is only off by a day. ...but still...for an agency that's tasked with policing documentation control it seems strange, and it's not the first time I've noticed this.

Just an observation to speculate about...

MM.
 
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Ronen E

Problem Solver
Staff member
Moderator
#4
We’ve had similar discussions in the past. IIRC the printed date is the date the document will be officially published in the FR, and sometimes the FDA circulates the document a short while earlier. No biggy.
 

Ajit Basrur

Staff member
Admin
#5
Yes Ronen

The guidance document issued today (15 December 2017) "Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices" has a release date of 18 December 2017.
 

isolytical

Involved In Discussions
#6
Actually it is the effect of a well thought out policy that most QMSs could/should easily follow. Think about issuing something before it becomes effective so that those needing to take action to implement described change(s) have lead time to implement those changes.
 
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