GUDID listing - Inputting data into the GUDID database

image182

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#1
Hi all.

I have a small question relating to how we go about inputting data into the GUDID database... any comments or thoughts would be appreciated. Especially since the UDI helpdesk takes so long to get a response!

To explain our situation:

We currently have 3 levels of packaging for our device. A single device is placed into a “pouch”. 6 pouches are placed into a “box”. 10 boxes are placed into a “shipper carton”.

According to the regulations we only need to place a UDI on the box. However, we are choosing to also place a UDI on the pouch and shipper carton. FDA confirmed this was acceptable in previous emails.

We have assigned DI as follows:
• pouch (e.g. 1001)
• box (e.g. 2001)
• shipper carton (e.g. 3001)

Most of our products will have a UDI printed on the pouch, box and shipper carton.

However, for one of our devices we can’t print the UDI on the pouch at present. Therefore, in 2016 one of our products will only have a UDI printed on the box and shipper carton. However, at some point in 2017 we will gain the ability to print on the pouch and we will move to printing the UDI on the pouch, box and shipper carton.

Therefore, it is thought that most of our products should be listed on the GUDID database as “format 1”. However, one product will be initially listed as “format 2” before changing to “format 1” at some point in the future.

Format 1
Primary DI = 1001 (Device count = 1)
Packaging DI = 2001 (Device count = 6)
Packaging DI = 3001 (Device count = 10)

Format 2
Primary DI = 2001 (Device count = 6)
Unit of use DI = 1001
Packaging DI = 3001 (Device count = 10)

Question 1:
My concern is that at some point in time we would move from "format 2" to "format 1" for one of our products. Therefore we would need to request changes to the record to change the unit of use DI to a primary DI and also change the primary DI to a packaging DI. I’m not sure if this would be allowed by the FDA. I don’t want to be in a situation where the DI are locked into their roles and cannot be reassigned, or we have to request completely new DI for all packaging levels for this product and re-list it again. Is it possible to reassign the DI once the record is published?

Question 2:
To avoid any potential problems as outlined in Question 1 above, my thought would be that we could adopt “Format 2” for all of our devices. In this situation the primary DI would be the lowest packaging level required to have a UDI as defined in the regulations. However, the unit of use DI is supposed to be virtual and used when the DI is not printed on the labelling. However, in our situation we would have some devices where the unit of use DI is printed and one where it is not printed. Is this situation acceptable? The primary DI is more correct as it matches the regulations, but the unit of use DI is less correct because it is not virtual and a full UDI is being printed.
 
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missjenny

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#3
Hi there,

Are your products for single-use only? Otherwise, you would need UDI on device labels as well. However, since you are using the term unit of use, I am going to assume that they are single-use devices.

With that said, you cannot change the DI roles as the same DI would point to different packaging levels from those already on the market under format 2 and those that will be on the market next year under format 1. This would potentially cause much confusion to customers. Also, the FDA does not allow for reuse of DI under any circumstances.

I think if you were to switch from format 2 to format 1, you would need to do a new set of DIs.

Hopefully I understood you correctly.
 

image182

Involved In Discussions
#4
Hi there,

Are your products for single-use only? Otherwise, you would need UDI on device labels as well. However, since you are using the term unit of use, I am going to assume that they are single-use devices.

With that said, you cannot change the DI roles as the same DI would point to different packaging levels from those already on the market under format 2 and those that will be on the market next year under format 1. This would potentially cause much confusion to customers. Also, the FDA does not allow for reuse of DI under any circumstances.

I think if you were to switch from format 2 to format 1, you would need to do a new set of DIs.

Hopefully I understood you correctly.
Thanks for the response!

21CFR301.30(a)(3) applies to us so we don't need to print a UDI on the pouch.

I've just received a response from the FDA stating that they can "unpublish" a record which will unlock all of the fields and therefore allow us to rearrange the DI used for one of our devices.

However, as you point out above this will also cause problems. I've raised this with the FDA and hopefully they can respond.

Situation 1.
We list all devices as Format 2 on the database.

Most of our devices will have a UDI on the pouch, box and shipper. Therefore the discrepancy here is that the we are printing a UDI on the pouch, but on the database we are stating that the DI is virtual (non printed) "unit of use DI".

Situation 2
We list most of our devices as Format 1. One of our devices will be listed as Format 2 before transferring to Format 1.

Therefore, the discrepancy here is that for one of our devices, when the GUDID record is amended from Format 2 to Format 1, it won't match all of the devices in the field. We will have older devices with a UDI on the box and shipper and new devices with the UDI on the pouch, box and shipper.

I'm still confused as to how to proceed, but hopefully somebody here or the FDA will be explain the best way forwards..
 
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