One of our location in US manufactures an accessory that is bulk packed and sends to the customer. The customer in turn packages individually in the saleable pack, labels and does commercial distribution.
The customer wants us to have a Device Listing for the above mentioned product but our stand has been that we are sending "Components" to them (since its bulk pack) and they manufacture a finished devices since final packing and labeling is another step in manufacturing.
But the customer feels that since we already mold a finished accessory, we must have FDA establishment and get the device listed. Is our stand on the interpretation of the "component" is correct ?
The customer wants us to have a Device Listing for the above mentioned product but our stand has been that we are sending "Components" to them (since its bulk pack) and they manufacture a finished devices since final packing and labeling is another step in manufacturing.
But the customer feels that since we already mold a finished accessory, we must have FDA establishment and get the device listed. Is our stand on the interpretation of the "component" is correct ?