I've got a bit of a nuanced question here.
We are a specification developer for a kitted product. We source components of this kit mainly from China (all 13485 certified), and have them sent to a packager in the U.S. for inspection, kitting, labeling, and then we perform final inspection on the product before it goes out to distributors. The "components" of the kit could be considered finished medical devices (very simple, class I devices) in that they are in their final form except for labeling and are provided bulk, non-sterile to our kitter for final assembly.
A new component (device) was recently stopped at customs and the reason was given that the manufacturer (contract) is not registered with the FDA and the "device" was not listed.
A couple of questions:
1. Could our "kitter" be considered the contract manufacturer considering they are bringing in the components of the kit, performing their own inspections, and doing the final packaging of the device?
2. If not, if we were to leave two components of the "device" unassembled and had our kitter glue these two parts together to produce the final, finished device, would this then eliminate the need for the Chinese firm to register/list and allow the kitter to be the contract manufacturer? Wouldn't this mean the Chinese supplier is supplying components as an OEM only and remove their requirement to list as a contract manufacturer?
This all feels a bit ridiculous considering the simplicity of the "devices" we are talking about here, but we are in a bit of a bind as none of the suppliers of the specific devices are registered with the FDA.
I have already read the kit/convenience kit guidances which did not provide a clear answer.
Thanks in advance for any help!
We are a specification developer for a kitted product. We source components of this kit mainly from China (all 13485 certified), and have them sent to a packager in the U.S. for inspection, kitting, labeling, and then we perform final inspection on the product before it goes out to distributors. The "components" of the kit could be considered finished medical devices (very simple, class I devices) in that they are in their final form except for labeling and are provided bulk, non-sterile to our kitter for final assembly.
A new component (device) was recently stopped at customs and the reason was given that the manufacturer (contract) is not registered with the FDA and the "device" was not listed.
A couple of questions:
1. Could our "kitter" be considered the contract manufacturer considering they are bringing in the components of the kit, performing their own inspections, and doing the final packaging of the device?
2. If not, if we were to leave two components of the "device" unassembled and had our kitter glue these two parts together to produce the final, finished device, would this then eliminate the need for the Chinese firm to register/list and allow the kitter to be the contract manufacturer? Wouldn't this mean the Chinese supplier is supplying components as an OEM only and remove their requirement to list as a contract manufacturer?
This all feels a bit ridiculous considering the simplicity of the "devices" we are talking about here, but we are in a bit of a bind as none of the suppliers of the specific devices are registered with the FDA.
I have already read the kit/convenience kit guidances which did not provide a clear answer.
Thanks in advance for any help!
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