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:
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
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