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As of June 15, 2016, all electronic entries and summary entries for goods subject to FDA import requirements must be filed in the Automated Commercial Environment (ACE). For your assistance in preparation of this date, the FDA has provided a document titled “Tips for Importing FDA-Regulated Products in ACE”.  This document details the required data elements (including some new requirements) for all FDA products, and lists additional data requirements for specific products such as:

  • Drugs

  • Medical Devices & Radiation-Emitting Products

  • Biologics

  • Food Products

  • Tobacco

  • Animal Drugs & Devices

More Information:

For more information, please contact your Cole account representative or one of our Cole USA offices

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