CBP and FDA Import Entry Requirements for Medical Devices

1. Key takeaways

Medical devices imported into the United States must satisfy both the requirements of U.S. Customs and Border Protection (CBP) and those of the Food and Drug Administration (FDA) at the same time. The importer or customs broker must submit entry information to CBP through ACE, the Automated Commercial Environment, and that entry information includes the country of origin and the import product code, which is formed by combining the FDA panel code with the FDA product code. The entry information is transmitted electronically to FDA for its review at the same time it is filed with CBP, so both agencies see the shipment through the same electronic channel.

• Entry is filed through ACE, the Automated Commercial Environment, to CBP.
• Entry information includes the country of origin and the import product code, a combination of the FDA panel code and the FDA product code.
• Entry information for FDA-regulated products is also transmitted electronically to FDA for review.
• Radiation-emitting electronic products carry additional obligations: Form FDA 2877 and, where applicable, an accession number.
• Products that do not meet FDA requirements may be detained at entry.

2. Legal basis

The dual-agency structure of device importation rests on the import provisions of the FD&C Act, CBP’s authority under the Tariff Act, and FDA’s published guidance on what entry information must contain. The sources below identify where each element can be verified.

3. Expert insights

Insight 1: The product code in the entry information is a combination code, not a company self-assigned number.

According to FDA’s import page, the entry information must include the import product code, which is a combination of the FDA panel code and the FDA product code. This code comes from the same source as the product code used in device listing, but the customs filing adds the panel code on top of it. A broker who enters only the listing-level product code, or who invents an internal identifier, will file an entry that does not match what FDA expects to see. Because the entry data flows to FDA electronically, code mismatches are visible to the agency at the moment of filing, and they are one of the avoidable causes of entry problems that companies should eliminate before the first shipment.

Insight 2: Radiation-emitting electronic products carry an additional Form FDA 2877 and an accession number.

Under FDA’s import page, importers of radiation-emitting electronic products that are subject to applicable performance standards must report to FDA the declaration of products subject to radiation control standards, Form FDA 2877. They must also provide entry information to FDA through CBP, including the accession number where applicable. The accession number is obtained by the foreign manufacturer after it submits a radiation safety product report, and the importer may submit it on the manufacturer’s behalf. For products in this category, the documentation burden therefore extends beyond the device-specific requirements, and the accession number must exist before the entry is filed rather than after.

Insight 3: Non-conforming goods are detained at the entry stage itself.

Under FDA’s import page, entry information for FDA-regulated products submitted to CBP is transmitted at the same time to FDA for electronic review. Products that do not conform to FDA requirements may be detained at entry. Detention happens in the clearance process, and it has no direct relationship with whether the product has obtained 510(k) clearance. A product with a valid 510(k) can still be detained if the entry data or the accompanying information does not line up with FDA’s records. This is why entry data quality deserves the same attention as the premarket file itself: the detention decision is made on what appears at the border.

Insight 4: The CBP and FDA cooperation rests on a formal legal agreement.

According to FDA’s import page, FDA and CBP have entered into an agreement on cooperative enforcement of section 801 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 381. This agreement explains why two agencies can exercise their respective authorities over the same shipment within a single entry process. For importers, the practical reading is that there is no gap between the two reviews to be exploited: CBP examines the customs side of the entry while FDA examines the product regulatory side, and both reviews are fed by the same entry data filed through ACE.

4. Practical recommendations

The measures below prepare the customs filing so that the entry clears without avoidable friction.

• Before declaring, confirm the complete product code combination of panel code plus product code, and place it on record with the customs broker.
• For radiation-emitting electronic products, obtain the accession number in advance and provide it in the entry information.
• Prepare Form FDA 2877 in advance, for the importer to submit at the time of declaration.
• Build a standard customs documentation package: commercial invoice, packing list, entry information, product code, accession number, and Form FDA 2877.
• Keep the customs data consistent with the registration and listing information, to avoid detention caused by mismatched numbers.

5. Verification checklist

Confirm each item below before the first entry under a new product or a new broker relationship.

• □ The complete product code combination of panel code plus product code has been confirmed.
• □ The customs broker has received the correct entry information template.
• □ If the product is a radiation-emitting electronic product, the accession number has been obtained.
• □ Form FDA 2877 has been prepared.
• □ The customs data has been checked against the registration and listing information for consistency.
• □ It has been confirmed that the customs broker has experience handling FDA-regulated products.

Regulatory information verified as of October 28, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, US Agent and local testing support for the United States market. Our team manages FDA establishment registration and listing, 510(k)/De Novo/PMA submissions, and supports post-market reporting obligations. Business enquiries: info@grzanglobal.com