topic Re: Assistance requested for FDA GUDID attributes in Ask A Question for FDA GUDID

Assistance requested for FDA GUDID attributes

MinhLamAroa — Sun, 01 Dec 2024 21:35:04 GMT

Hi 1WS Community,

I have successfully synchronized our item information with the FDA GUDID. Most attributes have been synchronized and it looks great, however, there are a few attributes that I am struggling with as it doesn't appear in the GUDID.

The following GUDID attributes are not being populated although I've populated them in Item Management. Does anyone know how to get these attributes to appear within the GUDID?

Customer Contact Phone

Customer Contact Email

Device labeled as "Not made with natural rubber latex"

The GUI attribute for "device labeled as "Not made with natural rubber latex" is referred to as 'Package Marks Free From' but I cannot find this attribute within Item Management.

Any help would be appreciated as I want to make sure our information in GUDID is accurate.

Kind regards,

Minh

Re: Assistance requested for FDA GUDID attributes

alien — Mon, 02 Dec 2024 14:32:37 GMT

Hello @MinhLamAroa and thank you for utilizing our customer community.

According to the FDA GUDID Mapping Guide, you can add the Customer Contact Phone/email under the Communication Channel Information. You would need to add 2 options for the Communication Channel.

The other attribute you mentioned Device labeled as "Not made with natural rubber latex is mapped as the Does Trade Item Contain Latex? in our system.

Do you have any other attributes you wish to know about?

If you have any further questions please let me know. Thank you and have a great day.

Re: Assistance requested for FDA GUDID attributes

MinhLamAroa — Mon, 02 Dec 2024 20:28:49 GMT

Hi @alien,

Thank you for responding to my questions. I've already populated both options under Communication Channel. 1. Email and 2. Telephone. These attributes are still not appearing within GUDID although I've populated them in Item Management.

According to the FDA Mapping Guide, the attribute you suggested "Does Trade Item Contain Latex" populates the Data Element "Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)." I have already populated this in Item Management and the correct attribute has been marked in GUDID.

My issue is with the other GUDID attribute for 'Device labeled as "not made with natural rubber latex" which is linked to the "Package Marks Free From" GUI Attribute and I cannot locate this anywhere in Item Management.

Can you please look into these issues? I have not been able to resolve any of them.

Kind regards,

Minh

Re: Assistance requested for FDA GUDID attributes

ana_neamtu — Tue, 03 Dec 2024 13:20:50 GMT

Hello, @MinhLamAroa,

It’s good chatting with you again.

Just wanted to let you know that we are looking into your questions. We have generated a help ticket with the Service Desk and the team will follow up with you as soon as possible.

Thank you

Re: Assistance requested for FDA GUDID attributes

MinhLamAroa — Mon, 20 Jan 2025 21:18:09 GMT

Hi @ana_neamtu,

May I ask if there has been any solution to my queries above? I received an email stating that this ticket has been escalated but I have not received any response.

Can you please advise if these issues have been resolved?

Cheers.

Re: Assistance requested for FDA GUDID attributes

Val — Wed, 22 Jan 2025 13:59:41 GMT

Hello @MinhLamAroa, thanks for continuing the use of the community.

O can see my colleagues replied in ticket CXTECH-70396 on December 20th at 9:34 AM EST. If the email was not received or deleted, we can send it again if needed. As no reply was received to the email and after our 2 follow-up emails, the ticket was closed. Thank you.

Re: Assistance requested for FDA GUDID attributes

MinhLamAroa — Sun, 09 Mar 2025 21:53:14 GMT

Dear Val,

Thank you for responding to my question. I looked back into my emails and found the response provided in ticket CXTECH-70396. Unfortunately, none of solutions worked as I've followed the instructions but it's still not appearing in the FDA GUDID.

In the response I received, it states "We are in the process of updating our documentation for this as well as including IM attribute Claim Marked On Package in the FDA GUDID Item Playlist." Can I ask if this has been completed?

I also haven't received any updates regarding the Customer Contact attributes - I was told that this would be investigated but heard no update since.

Kind regards,

Minh

Re: Assistance requested for FDA GUDID attributes

Val — Mon, 10 Mar 2025 13:53:33 GMT

Hello @MinhLamAroa and thank you for continuing the use of the community.

I will be reopening the referenced ticket for you so that we may assist further and provide you with more information. Thanks.

Re: Assistance requested for FDA GUDID attributes

MinhLamAroa — Tue, 18 Mar 2025 00:35:22 GMT

Hi @Val

Thank you very much. I have sent an email in the same thread of the referenced ticket. I hope to receive a response soon for these issues.

Kind regards,

Minh

Re: Assistance requested for FDA GUDID attributes

Val — Tue, 18 Mar 2025 13:45:44 GMT

Hello @MinhLamAroa, thank you very much for the update and for following up for this. I have in turn forwarded your request to my colleagues from the correct team so that they are aware of your new email and assist you as needed. Thank you and we hope this will be sorted out very shortly.