FDA UDI with Multiple Packaging Configurations

Mark Meer

Trusted Information Resource
#1
Hi Everyone,

Really frustrated with the FDA's UDI help desk (they take weeks to send you a copy-and-pasted response, and then close the ticket before you can reply), so was hoping someone here could offer some wisdom....

Here's the situation:
We have a device (510(k) approved), that has multiple packaging configurations (e.g. left/right, small/medium/large, and a "kit" that has all sizes).

The FDA UDI help desk informs me that each configuration must have its own device identifier (DI).

Here's the problem:
  • There is only one 510(k) associated with the device.
  • Only one device listing can be created in the FDA FURLS database for a given 510(k), and this listing requires a DI be specified.
  • The GUDID system requires a device listing (registered through FURLS DRLM) be specified for each entry.

Hence, for a given 510(k) number, it seems that it is impossible to create multiple DIs, such that the information in the FURLS DRLM device listing and GUDID align.

I could go ahead and register DIs for each packaging configuration through the GUDID and cite the same device listing, but these DIs would not correspond to the DI entered in the FURLS device listing.

Anyone have any experience registering multiple package configurations through the GUDID help me out with how this is done?
MM
 
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Mark Meer

Trusted Information Resource
#3
Re: Help: UDI with Multiple Packaging Configurations

I am 99.7% positive that you can create multiple DIs using the same 510(k) number.
If you are referring to their GUDID system, you are correct.
...but the FURLS device listing manager, on the other hand, can only create ONE device listing per 510(k), and there is a SINGLE field for a DI when creating the listing.

The issue I'm expressing here is the disconnect. The UDI Help Desk is telling me to create multiple DIs, but the FURLS DRLM can only accommodate one.

I don't know if this is separate offices/departments not communicating or what...but so far my efforts to get a straight answer from the FDA have been nothing but aggravating! :frust:
 

missjenny

Involved In Discussions
#4
Sorry for misunderstanding your post.

However, from what I understand, isn't the device identifier section optional at this point when you are doing your device listing? Also, if you so desired, couldn't you just simply add a proprietary name to the existing one and change the device identifier that way? I have not tried it so if it is not possible, I apologize.
 
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