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  • 1.  UDI: remanufactured units

    Posted 18-May-2016 16:58

    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!

    ------------------------------
    Rene' Hardee
    Regulatory Affairs Specialist III
    Sun Nuclear Corporation
    Melbourne FL
    United States
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  • 2.  RE: UDI: remanufactured units

    Posted 18-May-2016 17:13
    Rene,

    To stimulate our thinking process, I am twisting your description. 

    You submit "DI" info to the GUDID and you manage UDI info (DI and PI) in house.
     
    Based on your description, why do you develop concerns when PI is "variable"?  

    Your PI info with "RM" constitutes a PI, which is supposed to be variable, dynamic not static.    

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



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  • 3.  RE: UDI: remanufactured units

    Posted 18-May-2016 18:16

    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.

    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States



  • 4.  RE: UDI: remanufactured units

    Posted 20-May-2016 09:37

    Thanks for the replies gentlemen.  The question still remains, if a device gets refurbished, does it get a NEW UDI (via a change to the PI information), or maintain the same UDI as before?  It is essentially the same device, so I would think the UDI would stay the same throughout its lifetime.

    As an update to my company's current situation: After a few meetings with the service and sales departments, we have come up with a solution to introduce an add-on label showing the device as refurbished, leaving the original label, and UDI in-tact. 

    I hope this is in line with FDA expectations!

    ------------------------------
    Rene' Hardee
    Regulatory Affairs Specialist III
    Sun Nuclear Corporation
    Melbourne FL
    United States



  • 5.  RE: UDI: remanufactured units

    Posted 20-May-2016 10:54

    I didn’t find anything in the rule or guidance documents, so I’ll offer an opinion.

    I would consider refurbishing as a type of servicing described in 820.200. Neither corrective maintenance nor preventive maintenance would change either the DI or any PIs on the device, so I would like to think refurbishing would not either.

    As part of the servicing records, you must record the UDI. In addition, you must analyze the servicing records. Changing the UDI has the potential to make the analysis more difficult and possibly miss some useful information. My recommendation is to leave the UDI unchanged and document your decision in the servicing procedures.

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    Dan O'Leary
    Swanzey NH
    United States