CSMS Message: 16-000991

Title:Food and Drug Administration Final Rule
Date:2016-12-05
To:abi,acep,edi,newace,partner
Links:previous, original, next

The Food and Drug Administration (FDA) published a Final Rule in the Federal Register regarding requirements for the submission of information to the Automated Commercial Environment (ACE) on November 29, 2016.

It is now mandated that select data elements be submitted into ACE at the time of entry for FDA-regulated articles to include foods, human and animal drugs, medical devices, biological products, human cells, tissues, and cellular and tissue-based products (HCT/Ps), radiation-emitting electronic products, cosmetics, and tobacco products.

The full Final Rule may be found on the Federal Register at the link below:
https://www.federalregister.gov/documents/2016/11/29/2016-28582/submission-of-food-and-drug-administration-import-data-in-the-automated-commercial-environment