Shipping Additional Product ("Bundle") with a Class 2 Medical Device

#1
We are introducing a class 2 medical device in the US for sale at the retail level. Our marketing department would like to "bundle" another product with this for sale to specialty markets. The second product would not be a medical product and would be shrink wrapped to the medical device. The medical device packaging would not be altered in any way and they would like to do this at our warehouse facility.

My question is, are there things the FDA would require the warehouse to do outside of what they would normally do for warehouse control because of this?
 
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Stijloor

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#2
We are introducing a class 2 medical device in the US for sale at the retail level. Our marketing department would like to "bundle" another product with this for sale to specialty markets. The second product would not be a medical product and would be shrink wrapped to the medical device. The medical device packaging would not be altered in any way and they would like to do this at our warehouse facility.

My question is, are there things the FDA would require the warehouse to do outside of what they would normally do for warehouse control because of this?
Can someone help?

Thank you!!

Stijloor.
 
M

MIREGMGR

#3
As far as I know, the FDA hasn't established a rule on such product combinations.

The kit rules encompass product combinations where some of the products are non-devices. Normally in a kit there is a common purpose or use-relationship of some sort. In the absence of such a commonality I don't think they'd treat the combination as a kit, but if they did, then there would need to be a device-rules labeling solution for the kit itself, and your facility would need to be appropriately qualified for kit packing and labeling.

The FDA doesn't officially utilize the MDD as a precedent, but there are a few folks there who are thinking in harmonization directions. Your scenario might be seen to be similar to bundling a non-device accessory with a device, which under the MDD is addressed by considering the accessory to be regulated as if it's a device.

My guess is that at least for labeling reasons, you wouldn't want to end up with either of these interpretations.

You might want to call FDA DSMICA and ask them how FDA will view the situation, rather than doing it and running the risk that their take on it might be unfavorable.
 
#4
MIREGMGR,

Thanks for the information. I will give them a call and see what they have to say. I agree, it is better to ask and prepare, then not to ask find out the hard way.
 
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