For Industry

Transmitting Required Information

Overview

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 tables below outline mandatory and optional information that is submitted to FDA. Providing the information for the optional data fields to FDA can help expedite the review of your entry. 

Note:  A “field” refers to a specific location on an electronic form where data is entered or displayed.

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Mandatory FDA data fields for each electronically-transmitted FDA-regulated entry line  

Field NameDefinition/DescriptionInformation Transmitted and Notes
Country of OriginFDA considers the country of origin to be the origin of the FDA-regulated product. CBP considers it to be the country where the product last underwent a "substantial transformation" resulting in an increase in value. Below are a few examples:
  • Peppers are grown in Israel on multiple farms and sent to the Netherlands for packaging.  The country of origin is Israel.
  • Shrimp is caught, peeled, and deveined in Malaysia and exported to Canada.  The Canadian firm incorporates the shrimp into a shrimp dish, such as "Shrimp Quiche." The product is no longer identifiable as shrimp but as "Quiche." The quiche is a product of Canada.
  • ABC Co. in Japan manufactures stereo systems, which contain a CD player manufactured by XYZ Corp. in Korea.

    CBP considers Japan to be the country of origin – based on ABC Co. manufacturing the stereo system. FDA regulates only the CD player and considers the country of origin to be Korea, where the CD player was manufactured.
     

Country
 

You can contact your local FDA office for questions regarding Country of Origin

Product CodeThe seven-character code is a combination of letters and numbers. The code identifies the specific product and must agree with the invoice description of the product. Each FDA line of the entry must have an FDA Product Code.  A matching product description automatically populates when the product code is entered.

Industry, Class, Subclass, Process Indicator Code (PIC), and Group codes.
 

Information on product coding can be found on the FDA Product Codes and Product Code Builder informational page.

Importer Product DescriptionA written description of the actual product. This is usually obtained from the invoice.

A description of the product.
 

To expedite FDA review, the importer’s description of the product should be as detailed as possible.

ManufacturerSite-specific location where the product is manufactured, produced, or grown. The actual manufacturer of the product.Manufacturer name and address
ShipperFirm or individual responsible for shipping product into the United States and that does not act as a manufacturer, repacker, and/or distributor.

Shipper name and address

This can be determined from entry documents.

Affirmation of ComplianceThree-letter codes transmitted to FDA to affirm your product meets a specific FDA regulation. Some affirmations require a qualifier.*Submission of A of C codes is only mandatory in some instances and is not required for all scenarios. Submitting voluntary A of C codes in addition to all mandatory A of C codes may expedite initial screening and review of your entry.

*Qualifiers provide product and manufacturer specific information FDA can use to verify your product is in compliance. For more information visit the Affirmation of Compliance Codes page.

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Optional FDA Data Fields for Electronically-transmitted Lines  

Field NameDefinition/DescriptionInformation Transmitted and Notes
Total QuantityAmount of product included in the line.

Quantity should be broken down from largest to smallest packaging unit and include the unit of measure of the smallest packaging unit.  

(Example:  10 cases, 5 packages per case, 1 pound per package)

Quantity is most often obtained by referring to an invoice or bill of lading associated with the shipment.

Value of GoodsTotal value of the product in U.S. dollars.

The actual value of the product.

Value is most often obtained by referring to an invoice associated with the shipment.

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Additional Information

 

  • 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.
  • 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 more information on Affirmation of Compliance visit the Affirmation of Compliance Codes page.

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Page Last Updated: 10/25/2017
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