Serial Number labelling - Medical Devices

stm55

Involved In Discussions
Hello!
We are looking into adding a serial number to our product labelling. This can help enhance traceability, complaint investigations, etc and eventually lead to additional benefits with regard to inventory management. Our product does not fall into a category where the device itself is required to have a unique serial number.

My question is- what additional considerations are there if we were to just add a unique number to the device itself? Obviously this would be considered labelling, and we would want to prove legibility, adhesion, etc for the life of the product (amongst other things). But are there any hard and fast requirements that says anything along the lines of "if the device is marked with a unique number, that number also must appear on exterior packaging labels"? I haven't really seen anything that would indicate we can't simply add a unique numbering tag to the device itself and stop there? IF we do add a serial number (above and beyond any regulations), must we include anything else on that label (i.e. barcode, human readable portion, etc), or can we just have it count up 000001, 000002, etc?

If anyone has any insight on this and can point me to anything definitive it would be much appreciated! (I've read quite a bit of FDA guidance docs, but the firm requirements seem to be for specific devices-- I don't see any implication that IF you add serial numbers to a device, then you must follow additional regulations, if that makes sense)
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
I would say only if this number impacts in any way the safety or effectiveness of the device. Other than that I dont think anyone or agency is going to ask a question.
 

stm55

Involved In Discussions
Do you already have a UDI (required!) in your labeling? That would seemingly kill all the birds.
yes, however the UDI is not a unique serial number where each individual device (of the same part number) has its own specific one. I am saying what if we were to add an individual serial number to the device itself that is not reflected in the exterior labelling? I can't find anything that indicates a problem with this, but just wanted to confirm!
 

yodon

Leader
Super Moderator
The UDI can certainly incorporate a unique serial number. But I'm not aware of any issues with including extra labeling as long as, as @Ed Panek points out, it doesn't introduce any safety or effectiveness issues.
 
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