Background

The Food and Drug Administration is encouraging members of the import community who deal in FDA-regulated articles to utilize the agency’s Import Trade Auxiliary Communication System for current entry status and to receive notices of FDA action electronically.

The FDA states that 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. This functionality may be used by customs brokers (entry filers), importers of record, and consignees with an approved ITACS account. To be granted an ITACS account a firm must have been a party to a previously transmitted, non-disclaimed FDA entry.

An ITACS account is not required to import FDA-regulated goods, and 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. The FDA notes that its review of documents submitted via ITACS is prioritized over those submitted via other means.

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