Can previously packaged/labled devices be date extended?

M

MedDevMike

#1
My Quality Representative claims it is against the law (though he can not site the regulation) to rework previously packaged and labeled product with a date extension derived from a new stability study but all new product can be labeled with the extended date. This does not make sense to me. :confused:
 
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T

tracyw - 2011

#3
People overlabel all the time. This is normal practice to update based on new data, which you now have available. The FDA regulation for Expiration Date Labeling doesn't specify extensions, but it certainly doesn't forbid it:
Good luck!
 
#4
People overlabel all the time. This is normal practice to update based on new data, which you now have available. The FDA regulation for Expiration Date Labeling doesn't specify extensions, but it certainly doesn't forbid it:
Good luck!
Hello Tracy.:bigwave:

I'm not sure this is about over-labelling. Although I agree, to over-label is acceptable with the FDA. I thought it was about repackaging. Not that it matters.

The real issue though is about extending the shelf life using stability studies for justification. I don't see any problem with that and if there is evidence against it, it would be interesting to see, but I doubt it.

I am guessing as well, that the OP knows the answer and that is why he's questioning his Quality rep. Too many Quality reps give opinion based advice rather than facts.

Now I'm probably going to get it! :lmao:
 
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