US FDA's Document Dating System

[Mark Meer]

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Today I received an email from the US FDA with a link to a draft guidance: The Least Burdensome Provisions: Concept and Principles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

 

[Marcelo]

It seems it is a leaked draft document. Not even the FDA is hacker-proof

 

[Ajit Basrur]

Yes, I got the document through FDA email notification
.

 

[Ronen E]

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]

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]

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.