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US FDA UDI Compliance Question - Class II (Special Controls)

Q

QM Becky

#1
Hi Everyone,
I've got a question regarding UDI compliance in the US. I've not found anything in the FDA's documentation that answers the question... so, hoping one of you lovely people might be able to help.

I have a Class II (Special Controls) product that is NOT lot traced and is not serialized. It is not time sensitive so there is also no expiration date. The only thing I might have is a manufacture date, but really I don't have that either, at least not currently on any labels.

I note in the guidance that any of the 5 items considered PI that are on the labels must be included in the UDI barcode/human readable. What I'm not finding any reference to is what to do if none of the 5 items are on the label. Does the requirement for PI in the UDI still apply?

To further complicate my life, the packaging for these devices is preprinted bags, so a piece of variable data in a barcode will really wreck how I manage this particular product line.

Any thoughts or guidance are very much appreciated.

Kind Regards,
QM B
 
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Mark Meer

Trusted Information Resource
#2
Re: US FDA UDI Compliance Question

Curious: how do you handle product traceability if there are no lot numbers (and, I presume, serial numbers), or production dates maintained?

As far as the pre-printed packaging, you can develop a small label, and attach it to the packaging wherever there's space. If you go with a 2D AIDC (e.g. DataMatrix), you can paste it onto pretty small areas. You need only get an in-house printer that can print these on demand, and then append it as a final step in your existing manufacturing process. This solution would make it viable to put in a production date as the PI...
 
Q

QM Becky

#3
Re: US FDA UDI Compliance Question

Thanks Mark. That is currently my plan, although I was kind of hoping I could find a loophole that would allow me to eliminate the PI portion.

WRT your question about the lot number and traceability... this product, while class II, falls outside the scope of needing a lot number or serial number (blew my mind too when I learned that) and the company that actually owns the product doesn't want to trace them that way. SO, I do have a manufacture date when we assemble it, and I have an internal lot number, but neither are applied to the product when packaged. So, when the UDI guidance indicates that any of the 5 items of PI on the label must be included in the barcode, what do you do when none of them are because they aren't required?
I suppose we we will be applying a small label with just the barcode and human readable portions for these products. The sad part is, it is going to take longer to print and apply the barcodes than the entire rest of the manufacturing process rolled up into one. :)
 

Mark Meer

Trusted Information Resource
#4
Re: US FDA UDI Compliance Question

Have you tried emailing the FDA UDI Help Desk? Takes a couple of weeks at this point to get a response, but they're pretty good at getting back to you eventually.

I suspect though, that their response will be that if the device requires a UDI, then you'll have to have some sort of production identifier. It seems that from what you describe the easiest element to incorporate is just the production date.

I totally agree that this UDI compliance can be (unnecessarily, IMO) burdensome. Most of the costs, however, are in the initial overhead (FDA-accredited agency registration, label development, equipment...).
Once these are in place, however, the actual printing and application of the barcodes should be fast and simple. Most software allows for fields that automatically put in the current date (and update UDI AIDC accordingly), so printing labels can be as simple as just pressing a button on the label printer.
 

Sheemah

Starting to get Involved
#5
Re: US FDA UDI Compliance Question

Does refurbished devices require a new UDI label, even if they are refurbished by the same manufacturer?

Thanks,
Sheemah
 
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