FDA GUDID Implementation Guide

[CommunityJedi22]

Please see the attached details in the FDA Implementation Guide.

[MinhLamAroa]

Hi @CommunityJedi22 , 

I am in need of some assistance with my FDA GUDID Pre-Production testing. I have received a "REVIEW" CIC with this message 'Step 5. At least one valid Product Code is required because kit is not selected and Licensed IVD not provided.' Kit or Combination is not applicable to our devices, so I have left that attribute field blank. Licensed IVD is not applicable either. 

I am not sure why I am receiving this error because I have tried publishing the GTIN with 1 Product Code, and then again with 2 different Product Codes. It seems like 1WS is either not publishing this attribute, or the FDA GUDID is not recognizing this Product Code.

May I please get some assistance?

Thanks,

Minh 

[alien]

Hello @MinhLamAroa and welcome to the customer community. Thanks for reaching out.

According to the FDA GUDID Mapping Guide and if you compare the 2 other items you sent to the FDA the issue is not with the Alternate Item Identification but with the Healthcare Grouped Product Code.

You have it added on 09421906017533 and 09421906017274 but not on 09421904065567.  Please update the item with the necessary information.

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

[MinhLamAroa]

Hi,

Thank you for your prompt response to my query. I will correct the populated fields and try again. 

Cheers,

Minh