FDA UDI (Unique Identification) amendment on 19 Nov 2012 - Date of 'final rule'?

X

X.Liu

#1
FDA published UDI amendament on 19 Nov 2012.

There is a table of effective date of UDI requirement. It mentioned 'after publication of a final rule'. Does anyone can give an idea/estimation that when would be the date of 'final rule'. I am working on implantable device, to which the implementation of UDI is quite a challenge. Knowing when we should put the UDI on device would help a lot on planning of change.
 
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L

lfrost

#3
Because there are many times a "proposed" rule will stay as a draft for many years with the FDA, the date the final rule is published is very hard to "pin" down. There is a comment period which for this current proposed rule which ends December 19, 2012. After the FDA has made the necessary adjustments to the rule based on the comments received, the FDA will publish the final rule. When that happens then the table that you mention, that phases in the UDI rule, goes into effect. That means that it is a graduated phase in with class III devices that will be affected first. That means that the class III device that you are working on will need to have the UDI labeling one year after the final rule is published.

Hope this helps.
 
R

red66climb

#4
The UDI Guidance is not on the list of the FDA's priorities "A-list" or "B-list" for guidance documents to be released in 2013: http://bit.ly/FY2013Guidance. To get a better sense of the progress, I think the IMDRF working group that is meeting on this topic might be more helpful. They even have a draft Gantt chart: http://bit.ly/UDIRoadway. I suspect it will be finalized in 2014 in parallel with the Europeans release of the EU Regulations that also require UDI implementation.
 
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