Do components of a system require UDIs?

Cthames

Involved In Discussions
#1
Hello all,

Let's say a company is producing an x-ray system. This device is comprised of the actual x-ray machine, the x-ray detector, the detector holders, the software that images upload to, and the high-voltage generator. In the 510(k) submission, these are all listed as components of the x-ray system. None of these components are capable of acting as a medical device without being used in conjunction with all of the other components.

Does each component listed on the 510(k) need its own UDI, or is a system UDI sufficient?

I have been assuming if the company plans to sell any components individually, such as the detectors or detector holders, that these items would need UDIs prior to being sold and distributed to customers. Is this a correct assumption?

I apologize if I have not provided enough details and would be happy to provide more if necessary.

Thanks for the help!
 
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blackholequasar

The Cheerful Diabetic
#2
That is an interesting question! Where I worked before, an implant was placed into the spine. It had several parts that comprised it, and bone matrix that was used to fuse the implant. But the UDI was for the final device only.

These components were not very complex, though, so I'm not sure if that scope would change with something more complex like an x-ray system. And I used to work for a pretty big company that made x-ray systems, but they did NOT do medical device so I am afraid I can't apply the knowledge I have across the two haha

My assumption would be for final device only as the components cannot work independently as a medical device.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#3
We manufacture a small wearable patch. We have Unique UDI for the packaging; specifically, the quantity in each package. For example, if we sold patches in 1, 5, and 10 patch boxed quantities we would need 3 UDI total.
 

blackholequasar

The Cheerful Diabetic
#4
We manufacture a small wearable patch. We have Unique UDI for the packaging; specifically, the quantity in each package. For example, if we sold patches in 1, 5, and 10 patch boxed quantities we would need 3 UDI total.
You know, I actually noticed something similar to this today with my new Dexcom! The outer packaging has a unique UDI on it that identifies the three completed devices inside the box. Each transmitter injector has its own UDI (which is great for tracking because I have had some failures I needed to report to Dexcom and return for new product)
 

yodon

Staff member
Super Moderator
#5
Let me start out with "I'm not sure!" :) Seriously, every time I think I understand UDIs, I get another curveball.

Here's what I think I know:
  • I think you're correct in that anything that can be sold separately would need a UDI.
  • Every packaging level except a shipping package needs a UDI.
  • Software needs a UDI.
I would urge you to get that confirmed with somebody. If someone can correct me (or confirm what I wrote), I'd appreciate it!
 
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