The Import for Export (IFE) provision under Section 801(d)(3) of the Federal Food, Drug, and Cosmetic Act allows manufacturers to import medical devices into the US for processing, packaging, or assembly, provided they are not intended for sale or distribution in the US. This route is widely used by global device manufacturers to leverage U.S.-based facilities in their international supply chain. However, to remain compliant, companies must understand the regulatory framework, maintain proper documentation, and coordinate closely with U.S. Customs and Border Protection (CBP). The device must not enter U.S. commercial distribution channels and must be exported after its intended use.

FDA Import for Export (IFE) Provision is a regulatory mechanism that permits the importation of medical devices into the U.S. without FDA market clearance, such as 510(k) or PMA approval, as long as those devices are intended for export only. This route is designed to support global supply chain integration by allowing further processing or integration of non-marketed devices in the U.S., followed by exportation to markets where regulatory approval has already been granted. The IFE process is most commonly used when manufacturers need to import medical device components or finished devices that have not been cleared for U.S. commercial distribution. For example, a manufacturer may import a non-510(k)-cleared part for final assembly at a U.S. contract manufacturing facility, with the finished device destined for foreign markets. This route avoids the need for full FDA approval, saving time and regulatory burden while ensuring global compliance.

Import Documentation Requirements for FDA IFE Medical Devices

To import medical devices under the IFE provision, companies must submit the appropriate CBP entry types, typically Entry Type 51 (Immediate Exportation) or Entry Type 52 (Transportation and Exportation). Each entry must be accompanied by an IFE declaration outlining:

• The processing activities to occur within the U.S.
• The final export destination
• Confirmation that the product will not enter U.S. commercial distribution.

Additional documentation often includes a written export plan, shipment records such as airway bills and commercial invoices, proof of FDA facility registration, and batch or lot tracking logs. All information should be submitted through the Automated Commercial Environment (ACE) system to facilitate FDA review and clearance.

Domestic facilities handling IFE products must retain complete records, including:

• IFE declarations
• Import and export shipping documentation.
• Processing or assembly records
• Batch tracking data.
• Documentation showing origin and final export destination.

These records help ensure compliance and must be made available in case of an FDA inspection or entry review.

Compliance Considerations for Foreign Manufacturers

Foreign medical device manufacturers using the IFE pathway are not required to register their facilities with the FDA, nor must they obtain FDA device clearance. However, many importing countries require export certification, and foreign manufacturers must collaborate with a U.S.-based processor that is registered with the FDA. It is also critical that commercial documentation—such as invoices and packing lists, clearly indicate that the product is “For Export Only.” The IFE declaration must travel with the shipment and must be consistent with all supporting records.

Medical devices that emit radiation, such as X-ray systems, CT scanners, and laser instruments, are subject to additional regulations under the Electronic Product Radiation Control (EPRC) standards found in 21 CFR Parts 1000–1050. These devices must include FDA Form 2877 with each import entry, confirming the device’s radiation compliance status and whether it is for export only. Even though device listing is not required under IFE, radiation-emitting products must be labeled “For Export Only.” Depending on the device, manufacturers may also need to file product reports or obtain accession numbers. These devices are often subject to closer inspection by the FDA and CBP, making complete documentation essential to avoid delays or detentions.

Role of Other U.S. Regulatory Agencies: While the FDA and CBP are the primary authorities overseeing the IFE process, other agencies may be involved based on the nature of the device. For instance, radiation-emitting devices may fall under the jurisdiction of the Environmental Protection Agency (EPA) or the National Institute for Occupational Safety and Health (NIOSH) for additional safety evaluations.

The FDA’s Import for Export provision is a powerful regulatory tool that supports the global medical device industry. It allows manufacturers to process and assemble products in the U.S. without the delays and costs associated with FDA marketing authorization—so long as those devices are not sold within the U.S. market. By registering domestic facilities appropriately, maintaining complete documentation, and complying with CBP and FDA requirements, manufacturers can fully utilize the IFE pathway to streamline international logistics and expand their global footprint.