H352448

HQ H352448 October 13, 2026 OT:RR:CTF:VS H352448 ACH CATEGORY: Classification TARIFF NO.: 9817.00.96 Lydia C. Pardini Polsinelli PC 1401 Eye Street NW Ste 800 Washington, DC 20005 RE: Affirmation of NY N351167; Applicability of Subheading 9817.00.96, HTSUS; NeoMed Enteral Feeding Devices Dear Ms. Pardini: This is in response to your request for reconsideration, on behalf of Avanos Medical, Inc., dated September 2, 2025, of New York Ruling Letter (“NY”) N351167, dated August 4, 2025, regarding the eligibility of NeoMed Enteral Feeding Devices (“Feeding Devices”), including the NeoMed Enteral Feeding Tube (“Tube”), the NeoMed Enteral Feeding Syringe (“Syringe”), and the NeoMed Enteral Extension Set (“Extension Set”) for subheading 9817.00.96, Harmonized Tariff Schedule of the United States (“HTSUS”), treatment. For the reasons set forth below, we affirm NY N351167. Avanos provided the following information in their request for reconsideration: The NeoMed line consists of a feeding tube, syringe, and extension set. All of the components are for feeding-impaired infants with features designed to maintain sterility in sensitive Neonatal Intensive Care Unit (“NICU”) environments. The tube is specifically intended for use in newborns who require continuous feedings via the nasogastric or oral-gastric pathway. This includes specialized, marked tube sections of various lengths and sizes with a specially designed connector. The connectors come in both Enteral-Fit-compatible (“ENFit-compatible”) and non-ENFit-compatible forms. While ENFit- compatible connections offer enhanced safety with features designed to reduce the risk of misconnections, the non-ENFit compatible connections are also designed to interface with the related components in the system. The ENFit-compatible connectors are designed to secure with the syringe. The specialized ENFit-compatible syringe delivers nutrition to the patient’s stomach through the tube. The tube’s “Instructions for Use” indicate that it is designed to last over 30 days, but a replacement tube may be needed if nasogastric or oral-gastric feeding is required beyond 30 days either as a result of co-existing chronic conditions or due to other delays in reaching young infanthood. The syringe is used as a dispenser, a measuring device, and a fluid transfer device for essential fluid nutrition to be delivered to the intended patients, enterally. The ENFit-compatible tips have grooves that allow them to connect to the ENFit connecter on the tube, thus securing the placement of the syringe. The syringes are available in a variety of volumes as small as 0.5 mL, tailored to the small fluid dosing needs of premature newborns. The NeoMed Enteral Syringes are available by physician prescription only and are labeled per FDA requirements to be handled only by licensed healthcare professionals. The extension set elongates the connection between the tube and the syringe. The extension sets are designed to connect to a tube. One end of the tube is placed in the patient, and the other end of the extension set has connectors to allow the syringe to deliver nutrition to the patient through the tube. Regardless of the connector type, the extension sets are designed to work with the compatible syringes and tubes. While the syringe can connect to the tube without the extension set, it is considered an unsafe practice in the NICU. It is stated that connecting a Syringe directly to the feeding tube requires opening the incubator and bringing the caregiver’s hands and equipment in direct contact with the child for prolonged periods of time, which highly increases the risk of contamination. The extension set allows the feeding connection to be made via a porthole. In NY N351167, U.S. Customs and Border Protection (“CBP”) determined that the tube, syringe, and extension set were not eligible for duty free treatment under subheading 9817.00.96, HTSUS, because these enteral feeding devices for a premature baby were not specially designed or adapted for the handicapped. NY N351167, which took into account the information above, is herein incorporated by reference, but additionally the decision noted that the: NeoMed Enteral Feeding Syringe … is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups….for the extremely small fluid dosing needs of premature newborns. The products described above are placed through the nasal or oral route at the Neonatal Intensive Care Unit (“NICU”) bedside by trained neonatal clinical staff and are intended exclusively for neonates who are unable to consume nutrition safely or effectively by mouth. You claim that the premature, low birthweight neonates are substantially limited or impaired in the actual physical act of eating, which is a major life activity. Taking into account information on the March of Dimes’ website (See https://www.marchofdimes.org/find-support/topics/neonatal-intensive-care-unit-nicu/common- conditions-treated-nicu (last visited 7/29/2025), specifically a webpage titled “Common conditions treated in the NICU,” NY N351167 noted the common feeding problems for babies in the NICU, and the use of tube feeding or IV nutrition. Furthermore, referencing another 2 website, NY N351167 noted that “[e]nteral tube feeding is commonly used in preterm infants to provide enteral nutrition…. Among methods of nutrition support for preterm infants, enteral tube feeding via a nasogastric or orogastric tube is commonly used in clinical settings.” See https://www.sciencedirect.com/science/article/abs/pii/S0020748922000177 (last visited 7/29/2025). On March 25, 2026, a meeting was held with representatives from Avanos at our headquarters office to discuss whether the feeding devices were for individuals with acute or transient disabilities. Avanos contends that “feeding impairments that initially required use of NeoMed enteral feeding devices often persist into childhood and adulthood,” and that “feeding impairments beginning at birth and prompting use of NeoMed enteral feeding devices in the NICU continue beyond the hospital into the post-discharge period, even where NeoMed is used as part of a broader continuum of feeding interventions rather than as the only strategy throughout.” Avanos provided the following statistics and information to support their claim: Children born preterm or with low birth weight are at increased risk for feeding difficulties: studies have shown that 40–45% of premature babies experience feeding problems during the first two years of their lives (Gardner & Hagedorn, 1991). Although many infants are able to achieve satisfactory oral feeding by NICU discharge, Koca (2022) reports that problems with feeding for a notable portion of these children may continue at school age. Furthermore, rates of feeding impairment in childhood are also high, with 25% to 40% of typically developing children (who had been premature babies) and 70% to 80% of children with developmental delays or chronic medical needs having feeding problems (Kleinert 2017; Lefton-Greif 2007). Further, these impairments associated with prematurity can persist into adulthood (Lindström 2007). Each of these individuals likely relied on the NeoMed enteral feeding system at some point during their feeding journey. For infants and young children who do not improve, evaluation for G-tube placement may occur. As discussed during our meeting, studies show that gastrostomies often occur when a child is one or two years old. In that sense, the population that ultimately requires G-tube support necessarily includes a preceding phase in which NeoMed-type nasogastric feeding support is required, at a minimum, to bridge the infant to that next stage of care; however, even for children that do not require a G-tube placement, other oral feeding supports may still be required to overcome lingering feeding impairments. These arguments are discussed b