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FDA Device Labelling/Packaging Information Requirements

fialor

Involved In Discussions
#1
Is anyone able to advise their interpretation of 21 CFR 801.1 part c?
Does the clause require the inclusion or exclusion of the manufacturer's name and address on the labelling if the "manufactured for" or "distributed by" company is not the actual manufacturer.
Thanks for your time.
 
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M

MIREGMGR

#2
Is anyone able to advise their interpretation of 21 CFR 801.1 part c?
Does the clause require the inclusion or exclusion of the manufacturer's name and address on the labelling if the "manufactured for" or "distributed by" company is not the actual manufacturer.
Regarding the second question, neither inclusion nor exclusion of the manufacturer's name and address is required, and both inclusion and exclusion are permitted. See part (a) of the same rule for the minimum requirement: "(...)manufacturer, packer or distributor".

My emphasis above.
 

fialor

Involved In Discussions
#3
Thanks a mil.
That was my interpretation as well.
However I thought I would cover the basis just in case there is an obscure requirement that I missed.
Thanks again.
Fialor
 
M

mr.mike

#4
I'd caution against excluding the manufacturer info.

While the FDA may not explicitly require it, other regions e.g. Canada, Europe, do.

If you ever plan to market outside the US, best to design the labels with the manufacturer information...
 
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