Christine Hintze
Arent Fox LLP
1301 Avenue of the Americas, Floor 42
New York, NY 10019

RE: The country of origin of medical cables

Dear Ms. Hintze:

In your letter dated July 13, 2022, you requested a country of origin ruling on behalf of your client, Authentic Options, LLC.

The merchandise under consideration is identified as the SureLead ECG wire, which is used as a patient cable in an electrocardiography (ECG) machine. The subject cable is constructed of a length of insulated copper conductor affixed at one end with patient-end clips and a specialized monitor connector on the other. The number of patient-end clips, length of wire, and specific monitor connector is dependent upon the needs of the customer.

In use, the patient-end connectors are attached to various points on the patient and the monitor end is connected to the designated display used within the machine. The cable records the electrical signals in the heart of the patient, which is displayed on the monitor.

You state that the manufacturing process of the cable begins in the United States where raw copper wire is drawn, extruded, twisted, and insulated to create the bulk conductor cable. This cable is then tested and sent to China where it is cut to the desired length and prepared for the addition of the connectors. The patient-end clips and monitor-end connectors are then assembled at each end.

The "country of origin" is defined in 19 CFR 134.1(b), in pertinent part, as "the country of manufacture, production, or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the 'country of origin' within the meaning of this part."

For tariff purposes, the courts have held that a substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. United States v. Gibson-Thomsen Co., Inc., 27 CCPA 267, C.A.D. 98 (1940); National Hand Tool Corp. v. United States, 16 CIT 308 (1992), aff'd, 989 F. 2d 1201 (Fed. Cir. 1993); Anheuser Busch Brewing Association v. The United States, 207 U.S. 556 (1908) and Uniroyal Inc. v. United States, 542 F. Supp. 1026 (1982).

Regarding the origin of the subject medical cables, it is the opinion of this office that the cable conductor created in the U.S. imparts the essential functional component of the finished article. Further, this bulk cable is not substantially transformed by the minimal operations performed in China. As such, based upon the fact presented, the country of origin of the SureLead ECG wire is the United States.

Whether an article may be marked with the phrase "Made in the USA" or similar words denoting U.S. origin, is an issue under the authority of the Federal Trade Commission (FTC). We suggest that you contact the FTC Division of Enforcement, 6th and Pennsylvania Avenue, N.W., Washington, D.C. 20508 on the propriety of proposed markings indicating that an article is made in the USA.

This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Luke LePage at [email protected].


Steven A. Mack
National Commodity Specialist Division