Q
qcqueen94
Hi everyone - My company is currently not FDA registered as the vast majority of our products are components sold directly to finished device manufacturers. However, a recent prospective customer has asked us to quote some carrying equipment for one of the medical devices it makes. The print for the equipment says, "This item is a finished device accesory".
The FDA website says you do need to register if you make "accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user". Thes parts would just be polybagged with a simple stick-on part # label and bulk packed. Before shipping their devices to its end users, our customer would have to unbox the unit, remove the polybag to insert the device into the carrying equipment, and then repackage it.
So I'm a little confused on whether we would have to register with the FDA for this type of item. I appreciate any help you can provide. Thank you!
The FDA website says you do need to register if you make "accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user". Thes parts would just be polybagged with a simple stick-on part # label and bulk packed. Before shipping their devices to its end users, our customer would have to unbox the unit, remove the polybag to insert the device into the carrying equipment, and then repackage it.
So I'm a little confused on whether we would have to register with the FDA for this type of item. I appreciate any help you can provide. Thank you!