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  • 1.  OEM Product Labeling

    This message was posted by a user wishing to remain anonymous
    Posted 11-Jun-2019 14:44
    This message was posted by a user wishing to remain anonymous

    Hello All,

    I am in uncharted territory and would love some feedback on the following conundrum. There is an OUS company who holds a 510(k) for a device that my company in the US is redesigning. The redesign is only to the external shell to align with our corporate "look". There is no change to the specs, functionality, or indications for use of the originally cleared device. The OUS company is sending the core component with proprietary technology to us, and we are building the first 30 Pilot systems in our US location. After the Pilot run, we will transfer our redesign to the OUS company, where they will manufacture our company-branded systems and send back to us to distribute to our US customers. (We are only distributing domestically for the time being.)

    I believe that my company is considered the contract manufacturer for the first 30 units built in the US. Can anyone confirm? What is our role once we transfer manufacturing back to the OUS company? Will we be considered the distributor or private labeler of the OUS-built systems? I don't think that we are considered the legal manufacturer, because we do not own the technology or 510(k) clearance.

    The project leader (who is not in Regulatory) suggests that we label the units built here: "Manufactured for <OUS company> by <my company>". When we switch to OUS manufacturing, the label will read: "Manufactured for <my company> by <OUS company>. Is that correct?

    Last but not least, what about the UDI label? My assumption is that the OUS company's DI should be on the UDI label, regardless of where the device is manufactured, because they are the legal manufacturer. Is that assumption accurate? 

    Thank you for any guidance you can provide!!!


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