Does a refurbished product required a new UDI?

[simone]

Hello everyone,

Does a refurbished product (medical device) require a new UDI (Unique Device Identification)?
To clarify, I am referring to products that have been returned from customers (after been processed by customer service, QA and cleared from any need for further investigations or other), are in good condition, and can be restored to be 'like new'. The products will be labelled as being refurbished. Of course the products will be tested and inspected as if they were new products with no exceptions (except maybe cosmetic issues).
Do we need to designate a different DI to the refurbished product?
My initial thought was that this is not any different from a repaired product that is returned to the same customer. In which case the catalog number, UDI and serial number do not change. Only this time, the product will be labeled as "refurbished". Does this mean anything in terms of UDI? it is still the same product, model and revision.
I reviewed the FDA Guidelines on UDI but could not come up with a clear answer. I also could not find any guidance on refurbished products, only reprocessing of single use devices which is not the same as what we plan to do. So I would appreciate any advice on the subject.
Thanks
S

 

[LUFAN]

This is a late response, but if you're changing the label to make it clear that the device is no longer new, you will likely want to create a new packaging level and/or model number. That's because your new BOM for the refurbished device is going to call in the refurbished label and a refurbished device, which is materially different than the original device. In terms of specifications, you can't say that your refurbished device conforms to your original device specifications because the labeling is different. In that case, put the new model number (you could add R for refurb at the end of the existing REF number for example) on the label with a new UDI. In the UDI database when you set it up, you can list the packaging configuration that your refurbished DI contains the original DI and have it listed like that. If you device is direct marked, you don't need to change that in this process.

There's no official guidance on this that I am aware of, but inspection becomes difficult if it's unclear what you're inspecting it to. That's the case with two sets of labeling for the same REF number.

 

[lanley liao]

Hi, I agree with Lufan. Although there`s no official guidance on this, you still need to build a control system for it according to your actual condition and requirements of the furbished product quality.

 

[simone]

Thank you @LUFAN and @lanley liao for your answers. We did end up generating new part numbers (same original part number + suffix) + new UDI for the refurbished products.