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.
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.