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Today I received an email from the US FDA with a link to a draft guidance: The Least Burdensome Provisions: Concept and Principles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

Ronen E

Problem Solver
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.
 
#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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