H345243

HQ H345243 July 23, 2025 OT:RR:CTF:VSP H345243 ACH CATEGORY: Classification TARIFF NO.: 9817.00.96 Mr. Steven B. Zisser Zisser Customs Law Group 9355 Airway Rd. San Diego, CA 91107 RE: Applicability of Subheading 9817.00.96, HTSUS; Intermittent Catheters Dear Mr. Zisser: This is in response to your request, on behalf of ConvaTec, dated January 31, 2025, for a binding ruling regarding the applicability of subheading 9817.00.96, Harmonized Tariff Schedule of the United States (“HTSUS”), to intermittent catheters. Our ruling is set forth below. FACTS: The merchandise addressed in this ruling request are “intermittent catheters,” which are part of ConvaTec’s Continence Care and Critical Care line. ConvaTec’s intermittent catheters are listed under “continence care” on its website. The website states: “{a}t Convatec we create products and services for people with urinary continence issues related to spinal cord injuries, multiple sclerosis, spina bifida and other causes…”1 Only intermittent catheters are at issue in this ruling. Urinary catheters are medical devices designed to help drain urine from the bladder when a person cannot do so naturally. These flexible tubes are inserted into the bladder through the urethra or, in some cases, through a small surgical opening in the abdomen. They are commonly used for patients experiencing urinary retention, following certain surgeries, or during long-term conditions that affect bladder function. Proper bladder emptying is critical, as incomplete emptying can lead to complications such as urinary tract infections, overflow urinary incontinence, and permanent damage to the bladder and kidneys. 1 https://www.convatecgroup.com/our-categories/continence-care/ 2 There are two main types of urinary catheters, each suited to different medical needs: 1) Indwelling Catheters (Foley Catheters) (not at issue in this ruling): These catheters are placed in the bladder through the urethra or stomach wall by a medical professional and are often secured by a small balloon inflated inside the bladder. They remain in place for an extended period until the user does not need them. 2) Intermittent Catheters: These catheters are known as single-use catheters. These catheters are inserted into the urethra, past the sphincter muscle and into the bladder. They are used multiple times throughout the day, and they are removed and discarded immediately after use. Intermittent catheters are designed so catheterization can be performed by the patient themselves. A study published in the Canadian Urological Association Journal found: “Given the benefits of single-use catheters and all the uncertainties with reuse, we believe that repeated use of catheters should not be the preferred method for long-term bladder management.”2 Intermittent catheters enable individuals with permanent and chronic conditions, such as spinal cord injuries, multiple sclerosis, urinary incontinence, and neurogenic bladder, to manage their bladder function independently. Intermittent catheters are available in a variety of designs and configurations tailored to the user’s needs, preferences, and gender. These variations ensure accessibility and ease of use. For example, ConvaTec states that the self-catheterization capability, gender-specific designs, specialized grips and handling features, and pre-lubricated and compact designs enable patients with physical impairments to independently manage this critical bodily function despite limitations in dexterity, mobility, or cognitive function. In some cases, intermittent catheters are prescribed for patients recovering from acute urinary retention, urological surgery, or spinal surgery, as they temporarily may be unable to effectively empty their bladder. ConvaTec states that doctors typically recommend their use for a period of at least three to six months; however, there is always a risk of long-term complications that could necessitate the continued or even permanent use of intermittent self-catheterization. Articles on catheters from both United States and United Kingdom health services provide greater guidance on who typically uses urinary catheters. Urinary catheters are used to drain the bladder. Your health care provider may recommend that you use a catheter if you have: urinary incontinence (leaking urine or being unable to control when you urinate), urinary retention (being unable to empty your bladder when you need to), surgery on the prostate or genitals, other medical conditions such as multiple sclerosis, spinal cord injury, dementia, or other operations.3 2 https://pmc.ncbi.nlm.nih.gov/articles/PMC6363567/#:~:text=multiple%20catheter%20use.- ,Conclusion,children%20doing%20self%2Dcatheterization). 3 https://medlineplus.gov/ency/article/003981.htm 3 Specific reasons a urinary catheter may be used include: to allow urine to drain if you have an obstruction in the tube that carries urine out of your bladder (urethra). For example: because of scarring or prostate enlargement; to allow you to urinate if you have bladder weakness or nerve damage that affects your ability to pee; to drain your bladder during childbirth if you have an epidural anesthetic; to drain your bladder before, during, or after some types of surgery; to deliver medicine directly into the bladder, such as during chemotherapy for bladder cancer; as a last resort treatment for urinary incontinence when other types of treatment have been unsuccessful. Depending on the type of catheter you have and why it’s being used, the catheter may be removed after a few minutes, hours or days, or it may be needed for the long term.4 ConvaTec provided a physician’s letter stating that 85% of intermittent catheter users have long-term conditions requiring use for more than three years, including multiple sclerosis (28%), spinal cord injuries (18%), diabetes-related bladder dysfunction (8%), diagnosed neurogenic bladder (5%), and other chronic urological conditions (26%). An additional 8% of users have conditions requiring intermediate-term use (1 to 3 years), while only about 7% use these devices for short-term management (less than 1 year), with post-operative recovery representing just 1% of users. ISSUE: Whether the intermittent catheters imported by ConvaTec are eligible for duty-free treatment under subheading 9817.00.96, HTSUS. LAW AND ANALYSIS: 1. The Intermittent Catheters are Eligible for Duty-free Treatment under Subheading 9817.00.96, HTSUS. The Nairobi Protocol to the Agreement on the Importation of Educational, Scientific and Cultural Materials of 1982, Pub. L. No. 97-446, 96 Stat. 2329, 2346 (1983) established the dutyfree treatment for certain articles for the handicapped. Presidential Proclamation 5978 and Section 1121 of the Omnibus Trade and Competitiveness Act of 1988, provided for the implementation of the Nairobi Protocol into subheadings 9817.00.92, 9817.00.94, and 9817.00.96, HTSUS. Subheading 9817.00.96, HTSUS, covers: “Articles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons; parts and accessories (except parts and accessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in the foregoing articles . . . Other.” CBP must evaluate “for whose, if anyone’s, use and benefit is the article specially designed.” Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (C.I.T. 2017), aff’d, 899 F.3d 1308 (Fed. Cir. 2018). In Sigvaris, the CIT explained that: 4 https://www.nhs.uk/conditions/urinary-catheters/ 4 The term “specially” is synonymous with “particularly,” which is defined as “to an extent greater than in other cases or towards others.” Webster’s Third New International Dictionary 1647, 2186 (unabr. 2002). The dictionary definition for “designed” is something that is “done, performed, or made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” Webster’s Third New Internatio

1. The Intermittent Catheters are Eligible for Duty-free Treatment under Subheading
9817.00.96, HTSUS.
The Nairobi Protocol to the Agreement on the Importation of Educational, Scientific and
Cultural Materials of 1982, Pub. L. No. 97-446, 96 Stat. 2329, 2346 (1983) established the dutyfree
treatment for certain articles for the handicapped. Presidential Proclamation 5978 and
Section 1121 of the Omnibus Trade and Competitiveness Act of 1988, provided for the
implementation of the Nairobi Protocol into subheadings 9817.00.92, 9817.00.94, and
9817.00.96, HTSUS.
Subheading 9817.00.96, HTSUS, covers: “Articles specially designed or adapted for the
use or benefit of the blind or other physically or mentally handicapped persons; parts and
accessories (except parts and accessories of braces and artificial limb prosthetics) that are
specially designed or adapted for use in the foregoing articles . . . Other.” CBP must evaluate
“for whose, if anyone’s, use and benefit is the article specially designed.” Sigvaris, Inc. v.
United States, 227 F. Supp 3d 1327, 1336 (C.I.T. 2017), aff’d, 899 F.3d 1308 (Fed. Cir. 2018).
In Sigvaris, the CIT explained that:
4 https://www.nhs.uk/conditions/urinary-catheters/
4
The term “specially” is synonymous with “particularly,” which is defined as “to
an extent greater than in other cases or towards others.” Webster’s Third New
International Dictionary 1647, 2186 (unabr. 2002). The dictionary definition for
“designed” is something that is “done, performed, or made with purpose and
intent often despite an appearance of being accidental, spontaneous, or natural.”
Webster’s Third New International Dictionary 612 (unabr. 2002).
In Sigvaris, the court used the Plaintiff’s own advertising materials to determine whether the
products were specially designed for the use of persons who are physically handicapped.
Subheading 9817.00.96, HTSUS, excludes: “(i) articles for acute or transient disability;
(ii) spectacles, dentures, and cosmetic articles for ind