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# FDA Sets New Import Data Requirements
- URL: https://www.fdaweb.com/fda-sets-new-import-data-requirements/
- Published: 2016-11-30T12:00:00.000Z
- Updated: 2026-09-14T21:51:36.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5137458

FDA published 11/29 in the *Federal Register* a [final rule](https://www.federalregister.gov/documents/2016/11/29/2016-28582/submission-of-food-and-drug-administration-import-data-in-the-automated-commercial-environment?ref=fdaweb.com) specifying import data that must be submitted through the agency’s Automated Commercial Environment (ACE) when an FDA-regulated product is offered for import into the U.S. Writing in an *FDA Voice* blog [post](http://blogs.fda.gov/fdavoice/index.php/2016/11/trade-alert-fda-issues-new-import-data-requirements/?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery), agency deputy commissioner for global regulatory operations and policy **Howard Sklamberg** says the ACE data requirements take effect 12/29.

“The trade community helped us pilot ACE, which is operated by U.S. Customs and Border Protection (CBP), from 8/2015 to 5/2016,” he writes. “In 7/2016, ACE became the sole CBP-authorized system for electronic submissions of entries that contain FDA-regulated products.”

According to Sklamberg, as a result of the more streamlined import process for FDA-regulated products provided by ACE, the rule is expected to lead to an efficient use of agency and importer resources, and more effective enforcement of laws and regulations enforced by FDA.

The post discusses some of the measures FDA has taken to help filers working to properly submit the required data. It notes that ACE replaces the Automated Commercial System, an older electronic submission system. It also provides an efficient single window for importers, Sklamberg says. Before its development, he says, importers of products regulated by multiple government agencies could in some cases be required to submit information more than once.