FDA Import Program: How to Comply with Regulatory Requirements?

  • By: Staff Editor
  • Date: August 29, 2017

FDA Import Program: How to Comply with Regulatory Requirements?

U.S. Customs and Border Protection (CBP) and FDA work concurrently during the import entry process and rely on each other’s import requirements to determine the admissibility of a product. The typical import process begins with the CBP service, which collects tariffs that have been placed on imported goods. There are some basic steps that should be considered to start the import process with CBP. Once the import process starts, FDA will be involved as another government agency as it has overlapping jurisdiction over the product.

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FDA Import Program: What is it?

FDA operates its import program under the authority of the Federal Food, Drug, and Cosmetic Act (FDCA), as amended (21 U.S.C. Part 381). If it appears that a product does not meet FDA’s requirements for products that are produced and marketed in the U.S., FDA may refuse entry. There are number of reasons why imported products are detained by FDA. Some of them include:

  • Adulterated Product: An adulteration charge will identify a problem with the product itself. For example:
    • Consists in whole or in part of any filthy, putrid or decomposed substance
    • Prepared or stored in conditions where it may become contaminated and then may be injurious to health
    • The methods and controls used to manufacture the product are not in conformity with GMP requirements
    • Falls below its strength, quality or purity it claims to have
    • Ingredient substitution
  • Misbranded Product: A misbranding charge will identify a problem with an information requirement concerning the product. For example:
    • False or misleading advertising
    • Missing required labeling information
    • Inadequate directions for use
    • Dangerous when used as prescribed
    • Failure to submit required information, such as required reports of adverse events or premarket authorization submissions
    • Unregistered establishment
    • Identification of the manufacturer (Unique Device Identifier)
  • Incorrect or the absence of required information such as registration, product codes and prior notification reports, play a major role in the import business.

FDA’s Required Import Information

FDA requires the submission of information before you can export most products to the U.S. If your import documentation does not include the exact information FDA requests, FDA’s import computer program, PREDICT, is designed to automatically detain your shipment. The required information should include:

  • Establishment registration – a registration number is unique to the physical establishment at its geographic location outside the U.S.
  • Product listing – a textual identification of the generic type of product marketed by the establishment. Product listing information is submitted at the same time that you register. It identifies the products manufactured, produced or exported by the registered establishment.
  • Product Code – an FDA code that applies to the product
  • Qualifier information, when applicable, such as an approved premarket approval number for a device or an approved new drug application number.

The following types of foreign establishments should identify themselves with their registration number:

  • Foreign manufacturer (automatically includes Foreign Exporter)
  • Foreign exporter
  • Contract manufacturer
  • Contract sterilizer
  • Relabelers and repackers
  • Specification developers (design and technology)
  • Remanufacturers
  • Component manufacturers
  • Accessory manufacturers
  • Complaint file entities

The establishment registration process may take several weeks to complete and requires the use of the electronic submission of information. The information and codes used for registration can be difficult to understand, especially when English is a second language. The annual registration renewal process is relatively easy.

If the information submitted during the registration process is not correct, there may be costly consequences in terms of delays or refusals of entries.

FDA provides a guidance document to explain the foreign registration process. For example, the device, drug and food establishment registration guidance, can be found at:

Drug Establishment Registration Guidance

Device Establishment Registration Guidance

Food Establishment Registration

Product Code

Identifying the correct product code has been difficult for importers. FDA provides an Internet site to help identify the correct product code for FDA regulated products, which includes electronic radiation products e.g., wireless device communication. The link takes you to a tutorial on how to identify the correct product code.

The product code should be consistent with the type of product cleared or approved for marketing. For example, a product code for a cardio-vascular catheter is not consistent with an in vitro diagnostic market clearance number.

If a product is detained due to this type of administrative error, you or your broker should resolve it immediately with the import officer who works in the FDA District Office that is responsible for the port of entry.

There are potential long term consequences for this kind of error if it appears that the filer needs remedial training on filing the correct information. FDA and CBP have separate follow-up programs. Eventually, cumulative detentions can create serious problems with the cost of detentions.

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