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ninacborges
I know that 21 CFR 809.10 states there needs to be a lot number in the immediate container of an IVD medical device. Does anybody know whether or not there needs to be a lot number or expiration date on the secondary packaging. The CFR code does no explicitly state it does for secondary packaging but there is a clause in 809.10 that says
"The label for IVD's must state the following information, except in cases where it is not applicable. In addition, all information must appear on the outside container or wrapper, or be easily legible through the outside container or wrapper.
Lot or control number traceable to the production history"
I am trying to minimize the burden of labeling reconcilitation during dispatch. Any guidance is helpful. Thanks
"The label for IVD's must state the following information, except in cases where it is not applicable. In addition, all information must appear on the outside container or wrapper, or be easily legible through the outside container or wrapper.
Lot or control number traceable to the production history"
I am trying to minimize the burden of labeling reconcilitation during dispatch. Any guidance is helpful. Thanks