Labeling and UDI requirements for medical device kits

C

celticfrosting

Starting to get Involved
#1
#1
Hello, I’m trying to understand the UDI and labeling procedures when building medical device kits and the requirements necessary. I’ve been looking into something called “convenience kits.” The instruments are reusable class I pieces.

The items will be packaged together in a kit, steel carrying tray enclosure. The instruments (not the tray) will be cleaned and sterilized by the end user before use on a patient. The instruments in the kit are not interchangeable and will remain together before and after use. This would not classify as a convenience kit I’m assuming?

Can it still be packaged with a UDI Device Identifier to encompass it as a complete medical device?

Does the package label need to list all the contents inside the kit or can I give it a simple device name?
 
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S

Sulamistan

Moved On
#2
#2
According to CFR 801, the convenience kit is defined as follows,

Convenience kit means two or more different medical devices packaged together for the convenience of the user.

It would not be classified as a convenience kit if it is replaced, substituted, repackaged, sterilized, or otherwise processed or modified before the devices are used by an end user fulfills these purposes. I guess that rules out your 'kit' as convenience kit.

If it is not a convenience kit then I guess you would need to follow UDI rule for each of the components.

FDA published guidance on convenience kit might help.

Unique Device Identification:Convenience Kits
 
C

celticfrosting

Starting to get Involved
#3
#3
I did get a response from the FDA Help Desk - "There does need to be a DI for the whole assembly of case and instruments because this is a kit (even if not a convenience kit) and kits (collections of medical devices) are, in and of themselves, medical devices."

With that said it can still be packaged together with a single DI to encompass it entirely – it would be a single medical device. Do the instruments inside require separate UDIs on them as well? The instruments are all class I.

If the kit was registered on the GUDID database, and for one particular instance not all the pieces were contained in it or certain items were swapped with different ones - it would not classify as said kit? I would have to make a new kit variant?

Is it possible to create a kit that is always interchangeable regarding the pieces inside, but have the same kit name and UDI when used?
 
R

RL-WANG

Registered
#5
#5
Hi guys! I found a complete guideline for Unique Device Identification system (UDI system) Application Guide from IMDRF group.
Go to IMDRF webpage www imdrf org and look for IMDRF Documents.
 
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