Here is my understanding of it, having spent some time trying to learn more:
1. UDI is not the same as part number. UDI is a combination of device identifier and production identifier. Device identifier serves the same function as a part number, but production identifier could be lot#, serial number, expiration date or production date.
2. It depends upon which UDI issuing agency you use. GS1 only allows numeric UDIs. And barcodes have to comply to GS1 standards (e.g. GS1-DataMatrix). HIBCC allows alphanumeric. The barcode has to meet HIBCC standards, but this might be your existing barcode standard. The barcode will still be different, because it has to include both production and device identifier and meet the issuing agencies standards.
3. GMP exempt devices are exempted from UDI. This is not the same as exempt from 510(k). The FDA classification database identifies GMP exempt devices. They tend to be very low risk devices, like ice bags.
1. UDI is not the same as part number. UDI is a combination of device identifier and production identifier. Device identifier serves the same function as a part number, but production identifier could be lot#, serial number, expiration date or production date.
2. It depends upon which UDI issuing agency you use. GS1 only allows numeric UDIs. And barcodes have to comply to GS1 standards (e.g. GS1-DataMatrix). HIBCC allows alphanumeric. The barcode has to meet HIBCC standards, but this might be your existing barcode standard. The barcode will still be different, because it has to include both production and device identifier and meet the issuing agencies standards.
3. GMP exempt devices are exempted from UDI. This is not the same as exempt from 510(k). The FDA classification database identifies GMP exempt devices. They tend to be very low risk devices, like ice bags.