In the November 29, 2016, Federal Register, FDA issued a final rule/regulation to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment ("ACE") or any other electronic data interchange ("EDI") system authorized by the U.S. Customs and Border Protection Agency ("CBP"), in order for the filing to be processed by CBP and to help FDA in determining admissibility of that product. ACE is a commercial trade processing system operated by CBP that is designed to implement the International Trade Data System, automate import and export processing, enhance border security, and foster U.S. economic security through lawful international trade and policy. As of July 23, 2016, ACE became the sole EDI system authorized by CBP for entry of FDA-regulated articles into the United States. FDA also updated certain sections of FDA regulations related to imports. This rule aims to facilitate effective and efficient admissibility review by the Agency and protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being imported or offered for import that may be associated with a greater public health risk. The rule is effective December 29, 2016.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.