FDA Medical Device Accessory Packaging Requirements

GOOD MANUFACTURING PRACTICE (cGMP) US FOOD AND DRUG ADMINISTRATION (FDA)
1

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!

2

Will the “carrying equipment” you make be used by an end user, or just be (in effect) packaging to get your customer’s product to the end user after which it will be discarded or set aside?

In the latter case, it’s a component. In the former case, it’s an accessory.

If your product is an accessory, it probably is appropriate for that product to be labeled on the product itself, not on the polybag, so that the labeling survives the re-packing process conducted by your customer. Then the end user will receive that labeling, which will identify the accessory and any relevant instructions for use and warnings/ contraindications.