The country of origin of a glucose monitoring device

N350041 June 23, 2025 OT:RR:NC:N1:105 CATEGORY: Origin Susie Hoeger Abbott Diabetes Care Inc. 100 Abbott Park Road Abbott Park, IL 60064 RE: The country of origin of a glucose monitoring device Dear Ms. Hoeger: In your letter dated June 10, 2025, you requested a country of origin ruling on a glucose monitoring device. Descriptive literature was provided for our review. The item under consideration is described as the Atlas CGM Reader, which is a continuous glucose monitoring device for patients with diabetes mellitus. It is a compact, handheld device used in conjunction with Abbott’s FreeStyle Libre sensor to help people with diabetes monitor their glucose levels. The CGM Reader receives data from a glucose sensor that is applied to the patient’s arm. It analyzes and transforms the data into meaningful glucose readings including directional trend arrows on a pre-defined time interval that provides the patient with a more complete glucose history than traditional blood glucose monitoring. The CGM Reader also provides glucose alarms for the detection of episodes of low glucose (hypoglycemia) and high glucose (hyperglycemia). In regards to the origin of the Reader, all of the research and development, product engineering, hardware design, product software development, and other design investment for the CGM Reader occur in the United States. In total, the CGM Reader is comprised of 228 parts, the majority of which make up the printed circuit board assembly. 41% of the parts by value are from China (including the liquid crystal display, battery, bare PCB, and vibration motor as the most expensive components); 10% from Taiwan (flash memory); 5% from Thailand (transceiver); 4% from Singapore (plastic components); 3% from Japan; 2% from Vietnam; 1% each for Philippines, Korea and Malaysia; and the remaining 32% (primarily capacitors, resistors, inductors, diodes and other electronic components) being dual-sourced from two or more of the above-mentioned countries. The manufacturing of the CGM Reader occurs in six stations. Station 1 - Flash Memory Chip Programming: The first step may occur in either Singapore or Malaysia. This station loads the US-origin CGM Reader software onto the individual flash memory chips and verifies that it was correctly programmed. These flash memory chips are programmed “offline” at dedicated programming stations. The programmed flash memory chips are then sent to the next station for further processing. Station 2 - PCBA Surface Mount Technology (SMT) Process: The SMT process occurs in Malaysia and begins with applying solder paste onto the bare PCB. Programmed flash memory chips from Station 1 and other electronic components, such as resistors, capacitors, and integrated circuits, are then placed onto the solder paste. The solder, which melts and solidifies in a high-temperature reflow oven, creates strong electrical and mechanical bonds between the components and the PCB. These components are connected to the PCB through the solder and to each other through copper traces within the PCB. Station 3 - PCBA Programming and Functional Testing: This programming station also occurs in Malaysia and loads a US-origin CGM Reader application, which is part of the software package, into the flash memory chip on the PCBA and verifies correct programming. This station then performs functionality tests to ensure the PCBA has been properly manufactured and will function as expected after all subcomponents are loaded, inspected, and eventually configured. Station 4 - CGM Reader Assembly: The tested PCBA moves through several secondary assembly stages in Malaysia where components like the LCD, speaker, battery, and buttons are installed. The PCBA subassembly is then placed inside the bottom and top housings, which are bonded together using an ultrasonic welding machine. This mechanical step completes the CGM Reader assembly process. Station 5 - CGM Reader Functionality Final Testing: This station occurs in Malaysia and verifies the functionality of primary Reader hardware such as buttons, LCD display, speaker, vibration motor, and USB port to ensure no issues were introduced during integration and plastic housing welding. The unconfigured readers are then sent to Singapore for final configuration. At this stage, the unit is complete with all of the necessary components however the readers are still incapable of connecting to the patient’s glucose sensor, providing glucose readings, or otherwise functioning as a medical device. Station 6 - CGM Reader Medical Device Configuration: The final step occurs in Singapore. During this step, the electronic reader is configured to receive data from the patient sensor, provide glucose readings, and function as a medical device. A region-specific back label is applied, and the corresponding configuration settings are loaded into the flash memory. Critical device parameters such as glucose-level alarms, unit of measure, and language that enable the CGM Reader to provide accurate blood-glucose values to patients and health care providers are configured during this step. This station also verifies the correct software version is present, clears any error flags from previous processing, and sets the CGM Reader into hibernate mode. Once configured, the CGM Reader interprets encrypted data containing blood glucose values from the sensor patch/puck on the patient’s arm. The glucose values are displayed on the screen in real time and capture history to communicate trend data to patients and healthcare providers. Section 304 of the Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that unless excepted, every article of foreign origin imported into the United States shall be marked in a conspicuous place as legibly, indelibly, and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the United States, the English name of the country of origin of the article. Congressional intent in enacting 19 U.S.C. 1304 was “that the ultimate purchaser should be able to know by an inspection of the marking on the imported goods the country of which the goods is the product. The evident purpose is to mark the goods so that at the time of purchase the ultimate purchaser may, by knowing where the goods were produced, be able to buy or refuse to buy them, if such marking should influence his will.” See United States v. Friedlander & Co., 27 C.C.P.A. 297, 302 (1940). Part 134 of the U.S. Customs and Border Protection (CBP) Regulations (19 CFR 134) implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304. Section 134.1(b), CBP Regulations (19 CFR 134.1(b)), defines “country of origin” 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 the marking laws and regulations. A substantial transformation occurs when, as a result of manufacturing process, a new and different article emerges, having a distinct name, character or use, which is different from that originally possessed by the article or material before being subjected to the manufacturing process. See United States v. Gibson-Thomsen Co., Inc., 27 C.C.P.A. 267 (C.A.D. 98) (1940). Regarding the origin of the Atlas CGM Reader, the assembly of the PCBA in Malaysia by soldering the individual components of various origins onto a bare printed circuit board results in a substantial transformation of those components to produce a PCBA of Malaysian origin. The addition of the remaining components in Malaysia largely completes the production of the finished reader, albeit without the final configurations, and allows it to be used for no other purpose than as a glucose meter. While the final configuration is completed in Singapore, we do not believe that the device is substantially transformed from the product leaving Malaysia. As a result of the forgoing, we find that the Atlas CGM Reader, is considered a product of Malaysia for origin and marking purposes at time of importation into the United States. The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP. This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection 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, please contact National Import Specialist Jason Christie at jason.m.christie@cbp.dhs.gov. Sincerely, (for) Steven A. Mack Director National Commodity Specialist Division