U.S. flag An official website of the United States government
  1. Home
  2. For Industry
  3. Import Program – Food and Drug Administration (FDA)
  4. Entry Process
  5. Import Systems
  6. Automated Commercial Environment/International Trade Data System (ACE/ITDS)
  1. Import Systems

Automated Commercial Environment/International Trade Data System (ACE/ITDS)

In collaboration with the U.S. Customs and Border Protection (CBP) and 46 partner government agencies, the Food and Drug Administration has been working to modernize business processes through the implementation of the Automated Commercial Environment/International Trade Data System (ACE/ITDS).

ACE/ITDS is a single access point whereby industry can electronically submit all data required by various government agencies involved in international trade. ACE replaced the Automated Commercial System in 2016.

In preparation for the roll out of the ACE/ITDS Single Window Program, the FDA and CBP, together with the trade community, performed a pilot to test and evaluate electronic filings through ACE/ITDS. This pilot assisted users in transitioning to ACE filings prior to the mandatory date. CBP issued a Federal Register Notice on Modification of the National Customs Automation Program Test Concerning the Submission of Certain Data Required by FDA using the PGA Message Set, to begin the FDA pilot, in August 2015. The initial commodities selected for the FDA pilot were: drugs, medical devices, and biologics; at the ports of Philadelphia, Baltimore, and Otay Mesa.

For information about upcoming ACE webinars, please visit CBP's ACE webpage

This project is mandated by the Security and Accountability for Every Port Act of 2006 and the Executive Order on Streamlining the Export/Import Process for America’s Businesses, issued February 2014. 

To review the specifications and requirements for filing in ACE as per the final rule, Submission of Food and Drug Administration Import Data in the Automated Commercial Environment, please refer to FDA’s Supplemental Guide for the Automated Commercial Environment/International Trade Data System (ACE/ITDS).

Visit CBP's webpage to review the ACE Cargo Release Status Notification Implementation Guide.

For questions about data requirements and the supplemental guide, the FDA ACE support center can be reached from 8 a.m. to 8 p.m. EST, Monday-Friday (excluding federal holidays) at ACE_Support@fda.hhs.gov


Section 508 Compliance Disclaimer: Please use transcript provided for use along with video if needed.  A closed captioned video will be replacing the current one.  



Back to Top