IVD Lot Numbers and Expiration Dates - 21 CFR 809.10



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


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The answer is...it depends.

If the lot number and expiration date are legible through the outer package (i.e. if the out package is clear plastic), the expiration and lot number are not required to be on the outer package.

If the outer package is not transparent, the lot number and expiration date are required to be present according to the CFR.

Something that might be helpful to you is to think of a practical reason as to why the lot number and expiration would be required to be on a non-transparent outer container. Personally, I think of a recall situation in which a customer has purchased the product and must identify the product via lot number and expiration date. If this is not printed on a non-transparent outer package and only on the internal container label, how is that customer going to identify the recalled product?


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Is this the same for non IVD medical devices? can you please reference which section of the CFR?


21 CFR 801 governs medical device labeling and the requirements are not as prescriptive compared to labeling for IVDs; labeling for medical devices will also depend on the type of device (e.g. a box of bandaids will not have the individual lot number on the bandaid wrapper, but only on the outer packaging), patient use vs. professional use, etc. Nonetheless, I would suggest reviewing guidance and ISO standards:

IMDRF http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-190321-pl-md-ivd.pdf
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices

Also, don't forget about UDI - 21 CFR 830.
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