Cargo Systems Messaging Service

CSMS #49876589 - FDA Recommends Use of ITACS

FDA encourages members of the import community who deal in FDA-regulated articles to utilize the FDA Import Trade Auxiliary Communication System (ITACS) for current entry status and to receive Notices of FDA Action electronically.

The ITACS Account Management functionality enables the electronic distribution of Notices of FDA Action via email and as downloads from within ITACS. It also allows account holders to view the details of specific information requests, versus delivery of hard copy Notices of FDA Action. ITACS Account Management functionality may be used by customs brokers (entry filers), importers of record, and consignees with an approved ITACS account. Note that an ITACS account is not required to import FDA regulated goods. To be granted an ITACS account a firm must have been a party to a previously transmitted, non-disclaimed FDA entry.

ITACS accounts can be requested via the FDA Unified Registration and Listing System (FURLS) at https://www.access.fda.gov/oaa for those who have not already created an account. Please follow the step by step instructions provided in the ITACS Account Management Presentation at https://www.fda.gov/industry/import-systems/itacs to request an account. Please note that approval of an account request may take 2-3 business days, or longer if additional information is needed from the requestor.

ITACS basic functionality can always be accessed at https://itacs.fda.gov. This includes checking statuses, providing requested documentation electronically, and providing location of goods for examination electronically. Note that review of documents submitted to FDA via ITACS is prioritized over review of documents submitted to FDA via other means.

Additional information on ITACS, including questions and answers, can be found on FDA’s ITACS for Industry webpage: https://www.fda.gov/industry/import-systems/itacs.
For further questions regarding ITACS, please contact itacssupport@fda.hhs.gov.