The U.S. Food and Drug Administration (FDA) is one of 47 partner government agencies participating in the Automated Commercial Environment/International Trade Data System (ACE/ITDS) in collaboration with the U.S. Customs and Border Protection (CBP). 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.
This project was 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.
The specifications and requirements for filing the FDA message set as per the FDA ACE Final Rule, Submission of Food and Drug Administration Import Data in the Automated Commercial Environment, is located in the FDA Supplemental Guide for the Automated Commercial Environment.
New entry filers can request a production call to walk through and verify an entry submitted via ACE in real time. FDA encourages entry filers to include their software vendors in the production calls as it assists in troubleshooting errors within a filer’s software, as well as enhancing the filer’s understanding of their software. If you need additional information or clarification to correct CBP (bucket one) or FDA (bucket two) rejects, refer to the PGA Error Messages and/or PGA Status Notification Codes, respectively, provided under Additional Resources Section.
For questions about data requirements, rejects and the Supplemental Guide, FDA ACE Support can be reached from 8 a.m. to 8 p.m. ET, Monday-Friday (excluding federal holidays) at ACE_Support@fda.hhs.gov
Submit general import operations questions to FDAImportsInquiry@fda.hhs.gov
- FDA ACE External Outreach Presentation
- FDA ACE External Outreach Presentation-Animal Drugs & Devices
- FDA ACE External Outreach Presentation-Biologics
- FDA ACE External Outreach Presentation-Cosmetics
- FDA ACE External Outreach Presentation-Drugs
- FDA ACE External Outreach Presentation-Human & Animal Food
- FDA ACE External Outreach Presentation- Medical Devices
- FDA ACE External Outreach Presentation- Radiation Emitting Products
- FDA ACE External Outreach Presentation-Tobacco