PMA Device - Lot # change in New ERP Software - What are the FDA Requirements

JB0424

Starting to get Involved
#1
Hi! I am new to supporting PMA devices. My organization is implementing a new ERP system. Due to the differences in systems, the lot # has to change (currently 10 digits, and moving to 8 digits). I am trying to figure out what level of reporting this should be for FDA.

I think this is a 30-day notice, but I am not sure if it could be captured in the Annual Report instead. Also, would I need to submit an additional labeling amendment to the PMA for a change like this?

Any help in understanding how to navigate this type of change is greatly appreciated. Additionally, I would like to understand the logic associated with why a particular submission is appropriate.
 
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