CSMS# 18-000300 - FDA Supplemental Guide 2.5.1 Posted to CBP.gov/ACE

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04/23/2018 02:47 PM EDT

Partner Government Agencies

The FDA Supplemental Guide for the PGA Message Set has been updated. In this version (2.5.1), FDA has included clarifications for certain data elements based on feedback from trade, and removed several optional data elements. Please review the change log for specific details. An updated version of the FDA message set samples will be available soon.



In addition, this version refers to a new affirmation of compliance (VQI) that is not yet implemented. Please note that VQI is currently expected to be available in Production in October. A CSMS will be issued later, with the CERT and PROD dates.



The updated document can be found on CBP.gov/ACE or at the link below:

https://www.cbp.gov/document/guidance/fda-supplemental-guide-release-16