FDA Recommends Use of ITACS

Trade Update • OCTOBER 28, 2021

The U.S. Food and Drug Administration is encouraging importers and others who deal in FDA-regulated goods to use its Import Trade Auxiliary Communication System (ITACS) for checking current entry status and to receive Notices of Action electronically.

What is ITACS?

Released in August 2011, ITACS provides the import trade community with four functions:

• the ability to check the status of FDA-regulated entries and lines;
• the ability to submit entry documentation electronically;
• the ability to electronically submit the location of goods’ availability for those lines targeted for FDA exam; and
• the ability to check the estimated laboratory analysis completion date for sampled lines.

ITACS basic functionality may be accessed via the web at https://itacs.fda.gov. No login accounts are necessary. All that is needed is a valid Customs entry number that has been successfully transmitted to FDA

ITACS Account Management

This level of 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, which are currently delivered via hard copy.

ITACS Account Management functionality may be used by Filers, Importers of Record, and Consignees with an approved ITACS account.

Getting an ITACS Account

ITACS accounts are limited to one individual per firm at the corporate level, who is then responsible for creating and managing ITACS accounts for other users within their firm. For those who have not already created an account, a new one can be requested via the FDA Unified Registration and Listing System (FURLS) by following the step-by-step instructions provided here.

Note: The approval of an account request may take 2-3 business days, or longer if additional information is needed.

Benefits of ITACS

According to the FDA, the use of ITACS offers several benefits to importers including:

• More detailed FDA entry/line statuses than what is currently transmitted to filers via CBP systems reducing the need for phone calls inquiring about entry status;
• Elimination of the need to email or fax entry documentation and goods availability to FDA;
• No problem with lost documents;
• No need to maintain paper copies of FDA Notices; and
• Faster receipt of requests for specific information via email or ITACS.

It should also be noted that review of documents submitted to FDA via ITACS is prioritized over those submitted via other means.

More Information

Additional information on ITACS can be found on FDA’s ITACS for Industry webpage or by contacting ITACS support via email.