When importers or customs brokers submit an entry to U.S. Customs and Border Protection (CBP), the Harmonized Tariff Schedule (HTS) code indicates whether or not the entry should be transmitted to FDA. For those products that are FDA-regulated, submission of specific information is required. You can help expedite FDA’s review of your imported product(s) by initially providing accurate and complete information and by responding quickly to requests from FDA for additional documents or information.
The following links provide information on mandatory and optional data elements:
- FDA Supplemental Guide for the Automated Commercial Environment/International Trade Data System (ACE/ITDS)
- Industry Quick Reference to the FDA ACE Supplemental Guide
- See Appendix A: Entity Glossary of the Industry Quick Reference Guide for a description of the Entity Types
Providing the information for the optional data fields to FDA can help expedite the review of your entry.
FDA uses the entry number to identify and track your shipment. Each customs broker has a designated 3-digit filer code that will consist of letters and/or numbers. Every entry number submitted by a customs broker will start with their designated 3-digit filer code and will contain an additional 8 digits after the filer code. (i.e. xxx-xxxxxxx-x).
Promptly submitting entry documents when requested by FDA can help to expedite a shipment. FDA entry reviewers may use entry documents to gather additional information or compare the information/data transmitted against the product invoice or other import entry documents to determine if the information/data transmitted to FDA is accurate.
Use the FEI Portal to look up a FDA Establishment Identifier (FEI) based on a firm name and address or validate an address of an FEI.
Importers or entry filers are encouraged to upload entry documents in ITACS so that entry reviewers may reference them when electronically reviewing your entry. Visit the Documents Required Status page for more information on what documents might be requested by FDA.
For food and feed products, Prior Notice information must be electronically transmitted to FDA.
For more information on Affirmation of Compliance visit the Affirmation of Compliance Codes page.