GUDID/UDI Packaging and Labeling Questions

[missjenny]

Hello,

I would be forever grateful if you could offer any suggestions regarding below:

1. We manufacture and market glucose meters (Class II) in the US. Can the device label and immediate package (only has one meter in it) label have different PI's? I am asking because usually meter labels only carry serial numbers and the immediate package (carton/box) labels only carry LOT numbers. It is my understanding that whatever is on the label currently should be on the UDI label. We would like to not change our entire traceability/labeling process because of this. However, it seems that the GUDID does not allow for a separate PI flagging for package DIs. Thus, I would have to flag both the serial number and the LOT number and this may confuse some consumers. Anybody have any ideas?

2. From time to time, due to the quantity ordered not matching the packaging configuration, the number of test strip boxes in a case pack may vary (e.g. 10 full+2 empty boxes rather than 12 full). Would this qualify as a shipping container exception?

Hopefully my questions are clear enough. And for what it's worth, I have asked these questions to the FDA Help Desk and have been waiting to hear back from them since forever.

 

[Stijloor]

A Quick Bump!

Can someone help with this question? Thank you very much!

 

[QA-Man]

1. Sure, you can have different PI's on different packaging levels. The UDI Rule does not include any additional requirement to place any of the five elements that would be considered a PI on the label. However if one or more of the five PIs defined under 21 CFR 801.3 are included on a device label, the UDI must include each of the PIs that appears on the label (21 CFR 801.40(b)). It is not unusual to have individual units with serial numbers that are part of a lot/batch. When uploading to GUDID, your going to indicate the PI's of the primary DI.

2. If it is not a shipping container, then no (only you know if it is). If it is not a shipping container, the best way is to make 2 packaging configurations (one for a 10 pack, the other for 12), each with its own DI.

 

[ciclozan]

Hello,

Can someone provide me with an example SOP/template regarding the UDI implementation? Anything would help...Did you update your Complaint Procedure, MDR, Post Market Surveillance, Labeling, etc., to incorporate the UDI portion?

Thank you in advance.

 

[QA-Man]

I attached our initial plan.

We started with a basic overview of our processes and the UDI requirements in 21CFR820. As the plan developed (we are on revision 10) we went document by document to review the applicability.

 

[ciclozan]

Thank you so much for your answer! That is a great start!

 

[Highground]

I attached our initial plan.

We started with a basic overview of our processes and the UDI requirements in 21CFR820. As the plan developed (we are on revision 10) we went document by document to review the applicability.

This has helped me as well. I'm new with Labeling. Have to look at EU and US and have sound knowledge of their systems.