UDI - Rechargeable Batteries and Charger

missjenny

Involved In Discussions
#1
Hello,

I am preparing to launch a Class II 510(k) exempt biofeedback device in the US. The product (1 biofeedback device, 2 rechargeable batteries, 1 charger, 1 power cord) will be sold in a metal briefcase.

Now, I am fairly certain that UDI should be applied to the biofeedback device label and also on the metal briefcase. However, do the rechargeable battery and the battery charger also need UDI on them? If so, that means the metal briefcase will be a kit, a medical device itself, therefore it will have a different UDI than the one on the device label, correct?

I would really appreciate your feedback on this issue.

Thank you.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hello,

I am preparing to launch a Class II 510(k) exempt biofeedback device in the US. The product (1 biofeedback device, 2 rechargeable batteries, 1 charger, 1 power cord) will be sold in a metal briefcase.

Now, I am fairly certain that UDI should be applied to the biofeedback device label and also on the metal briefcase. However, do the rechargeable battery and the battery charger also need UDI on them? If so, that means the metal briefcase will be a kit, a medical device itself, therefore it will have a different UDI than the one on the device label, correct?

I would really appreciate your feedback on this issue.

Thank you.
It sounds like the batteries and the charger will be accessories to your biofeedback device (unfortunately there's no clear-cut rule in the USA; vide the recent FDA's guidance about accessories). In that case, unless there's a matching ProCode for them (not likely in my opinion), they'll inherit the biofeedback device's classification and thus be subject to UDI requirements, ie need their own UDIs. That is, unless your 510k covers them as an integral part of the biofeedback device, in which case I think the best practice would be either putting the device+batteries+charger in an immediate package (eg plastic bag) bearing a single device's UDI (no UDI on those 3 elements); or avoiding any packaging layers between the 3 elements and the briefcase and putting that single UDI on the briefcase while the elements, again, don't bear a UDI.

If any UDIs are shown on elements inside the briefcase, the briefcase itself will need a UDI of its own (another layer of packaging which is not a shipping carton).
 

missjenny

Involved In Discussions
#3
It is a 510(k) exempt device only subject to device listing and GMP requirements.

It seems like you are saying:

1) If they are accessories, they are subject to UDI requirements. Now, obviously we do not manufacture the batteries and the chargers ourselves, then do we have to request that the labeling be changed by our suppliers or do we just slap on UDI labels onto the batteries and the charger? This seems a bit excessive.

2) If they are an integral part of the device and not apply UDI to the batteries and chargers, then am I also exempt of listing them on the GUDID as well?

Thank you so much for your helpful response and have a happy Thanksgiving!
 

Ronen E

Problem Solver
Staff member
Moderator
#4
It is a 510(k) exempt device only subject to device listing and GMP requirements.
Oops... I seem to have missed that point...

Actually, it doesn't make too much of a difference. For the 510(k) exemption to apply, you need to identify a device in commercial distribution, under the same classification, with similar characteristics. This means you first need to have a clear definition or scope for your own device (ie, what does it include etc.), which you are able to compare with another given device. So, does your scope (as well as the equivalent device's) include rechargeable batteries and a charger, or not? This should determine how you need to address those items.

It seems like you are saying:

1) If they are accessories, they are subject to UDI requirements. Now, obviously we do not manufacture the batteries and the chargers ourselves, then do we have to request that the labeling be changed by our suppliers or do we just slap on UDI labels onto the batteries and the charger? This seems a bit excessive.
It might look excessive but you must realise that even if you don't make those items in-house, or have them made to your order, you are still their responsible manufacturer (regulatory-wise) as accessories to a medical device, because you're the one who assigns to them their intended purpose as such and you're the one who places them as an integral part inside the immediate packaging of your device (the briefcase). In that they cease to be "just plain batteries and charger" and become something slightly different that potentially entails different responsibilities.

If you have an option to have them labeled to your requirements by the OEM that would seem more streamlined from the regulatory perspective. If not, adding "just UDI labels" should be carefully examined against the applicable regulations (once they are identified).

2) If they are an integral part of the device and not apply UDI to the batteries and chargers, then am I also exempt of listing them on the GUDID as well?
You're not expected to put UDI on device components, nor to register them on GUDID. If you go down this path I suggest not placing a UDI directly on the feedback device, and instead placing the lowest-level UDI in this case on the briefcase. I would also make sure that there is no intermediate packaging (eg plastic bags, extra boxes etc.) between the items and the briefcase. That would help clarify that the entire collection of items inside the briefcase is a single medical device and that the briefcase is the primary retail packaging. Then you could register the briefcase and contents as a single medical device on GUDID.

The above is my current view of this situation. Will it fly? I don't know. I think hardly any of us knows for sure, because UDI is such a new topic and none of us has a lot of field experience with class II devices (having gone past the implementation date - 24.9.16 - only recently).

Cheers,
Ronen.
 

missjenny

Involved In Discussions
#5
Thanks for the detailed/informative input.

Based on our discussion, even if the rechargeable battery pack and charger are considered as accessories, I think the convenience kit exception can be applied as they are intended to be kept together in a briefcase until their use. Do you agree with this? Also, replacement batteries or chargers sent later on could be viewed as components or spare parts as they do not change the function/performance of the finished device.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Thanks for the detailed/informative input.

Based on our discussion, even if the rechargeable battery pack and charger are considered as accessories, I think the convenience kit exception can be applied as they are intended to be kept together in a briefcase until their use. Do you agree with this? Also, replacement batteries or chargers sent later on could be viewed as components or spare parts as they do not change the function/performance of the finished device.
I sent you a private message.

Regards,
Ronen.
 
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