Regulatory Open Forum

Hello everyone,

Does anyone have any experience with how to handle a product UDI for a "remanufactured" device?  We currently display the Manufacture Date and Serial Number on our product label (which is then required to be a part of the UDI).  When we transition a unit to a remanufactured unit, our current process is to add "RM" to the end of the serial number and record a new Manufacture Date.   But we would keep the same UDI as before, correct?  If so, my concern is that the remanufactured label information is no longer consistent with the information in the UDI.  Is this ok?  

Thanks for any direction you can provide!

Hello everyone,

Does anyone have any experience with how to handle a product UDI for a "remanufactured" device?  We currently display the Manufacture Date and Serial Number on our product label (which is then required to be a part of the UDI).  When we transition a unit to a remanufactured unit, our current process is to add "RM" to the end of the serial number and record a new Manufacture Date.   But we would keep the same UDI as before, correct?  If so, my concern is that the remanufactured label information is no longer consistent with the information in the UDI.  Is this ok?  

Thanks for any direction you can provide!

This is an interesting problem, because it hinges on the definition of remanufacture. From Device Advice on the CDRH website a Remanufacturer must register with that status. The definition says that a Remanufacturer is any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use.

Putting this into the UDI context, a remanufacturer creates a device that is a new version or model and as a result, requires a new primary device identifier. In addition, such a company would be a labeler under the UDI rule. This implies that the labeler would create a new DI Record in GUDID with the new primary DI. The production identifiers in GUDID are attributes, i.e., do the date of manufacture and the serial number appear on the label? This is a Yes/No question.

From your question, however, I infer that your company is not a remanufacturer, but a refurbisher. While this is not a defined term (see below) the generally accepted definition is that a refurbisher returns a device to its original condition. Consequently, the primary DI would not change (this is not a new version or model). In GUDID the same rules for the production identifiers apply, it is a Yes/No question. Refurbishment would not create a new DI record.

When FDA-CDRH issued QSR (circa 1996) they did not define refurbisher, but promised subsequent rule making. They have started the process this year, with a docket and the intention to hold a public meeting. The docket, FDA-2016-N-0436, has the following proposed definitions among others. I recommend you comment to the docket to ensure that FDA-CDRH hears your opinion.

Refurbish: Restore device to a condition of safety and effectiveness that is comparable to when new. This includes reconditioning, repair, installation of certain software/hardware updates that do not change the intended use of the original device, and replacement of worn parts.

Hello everyone,

Does anyone have any experience with how to handle a product UDI for a "remanufactured" device?  We currently display the Manufacture Date and Serial Number on our product label (which is then required to be a part of the UDI).  When we transition a unit to a remanufactured unit, our current process is to add "RM" to the end of the serial number and record a new Manufacture Date.   But we would keep the same UDI as before, correct?  If so, my concern is that the remanufactured label information is no longer consistent with the information in the UDI.  Is this ok?  

Thanks for any direction you can provide!