I have just been made aware that one of my customers (actually my distributor) in the US jurisdiction is removing the device serial number label which is applied at the manufacturing site and is the sole traceability to the Device History Record and applying their own serial number label. I'm not sure if the distributor is maintaining a log of the corresponding serial numbers for traceability purposes.

My question is what regulations or laws (if any) are being violated here? As a device manufacturer, what is my duty now that I am aware that this is occurring?

Please help!

:thanx:

I have just been made aware that one of my customers (actually my distributor) in the US jurisdiction is removing the device serial number label which is applied at the manufacturing site and is the sole traceability to the Device History Record and applying their own serial number label. I'm not sure if the distributor is maintaining a log of the corresponding serial numbers for traceability purposes.

My question is what regulations or laws (if any) are being violated here? As a device manufacturer, what is my duty now that I am aware that this is occurring?

Please help!

:thanx:If he is relabeling, he must register and list the device (http://www.fda.gov/cdrh/registration/whomust.html).

Al, thanks for your help on this. I guess I have some issues to sort out!

Al, thanks for your help on this. I guess I have some issues to sort out!Good Luck! If you need additional help on this, you can post it in this thread. Let us know how it goes.