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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  1. Import Basics

Import Systems

Overview

FDA utilizes electronic import systems to review and validate entry data and information. FDA’s information technology systems help automate and expedite the import review process.  They allow FDA to focus its resources using a risk-based approach. A quick overview of the systems is listed below.

  • Import Trade Auxiliary Communication System (ITACS)
    The FDA’s Import Trade Auxiliary Communication System (ITACS) allows the import trade community to upload entry documentation and any additional information requested by the FDA entry reviewer. You may check on the status of an entry via (ITACS) by using the U.S. Customs and Border Protection (CBP) entry number. Additionally, ITACS allows trade to provide the location of goods for lines selected for examination and to view the expected lab completion date for those lines which have been sampled.  

  • Entry Screening Systems and Tools: Import Entry Review, OASIS, PREDICT
    Two of FDA’s electronic systems, Import Entry Review and Operational and Administrative System for Import Support (OASIS), in combination with a screening tool called Predictive Risk Based Evaluation  for Dynamic Import Compliance Targeting (PREDICT), expedite the import review process by helping FDA reviewers evaluate the declared information. When submitting an import entry to FDA, providing accurate and complete information is critical. Doing so can expedite an admissibility decision, to the benefit of both FDA and the import community. 

  • Automated Commercial Environment/International Trade Data System (ACE/ITDS)
    The Automated Commercial Environment/International Trade Data System (ACE/ITDS) is the new commercial database system of CBP.  CBP has replaced the Automated Commercial System (ACS) with ACE.



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