Making ACE Work for You: Importing FDA Regulated Products Guide

This document, published by the U.S. Food and Drug Administration (FDA) in October 2019, serves as a guide for importers and stakeholders on leveraging the Automated Commercial Environment (ACE) system for the efficient import of FDA-regulated products.

It details how ACE facilitates transactions between trade partners, U.S. Customs and Border Protection (CBP), and various Partner Government Agencies (PGAs), including the FDA. The guide covers the fundamental aspects of ACE, its operational workflow with the PREDICT system for FDA, and current status updates on its implementation.

Key Topics Covered:

Understanding what ACE is and how it functions for FDA
Workflow of ACE and PREDICT for FDA processing
Current status and recent developments within ACE for FDA
Common reasons for CBP and FDA rejections and data errors
Specific guidance for importing Human and Animal Food products
Information needed for submission, including product codes, entities, and affirmations of compliance
Resources and points of contact for further assistance

The document aims to help filers submit accurate and complete data to expedite processing and ensure compliance with FDA regulations.

For more detailed information and resources, consult the official FDA website:

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