Regulatory Open Forum

Divya,
This really depends... If your device is Class I in the US, it is not required to have a production identifier (PI), so the device identifier (DI) could be pre-printed on the product packaging. However if your device is Class II or higher, or you have decided to use PI a for the Class I device, then you would need to assign the production control(s) (i.e. lot number, serial number, manufacture date, expiration date) to the product prior to packaging activity. Any changes to the production process requiring a change to the PI would have to be considered accordingly. You will also want to ensure you are verifying the barcode for scan/readabilty quality before the packaging activities begin.

So yes, it is possible but requires coordination and planning.

Thank you for sharing. Is it possible to pre-print the Device Identifier on the package at our carton suppliers rather than printing it after the actual device packaging activity? Thank you.