M
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.
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.