OT:RR:CTF:VSP H345243 ACH
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/
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
2
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 duty-
free 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/
3
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 individuals not substantially disabled; (iii)
therapeutic and diagnostic articles; or, (iv) medicine or drugs.” U.S. Note 4(b), Subchapter
XVII, Chapter 98, HTSUS. Thus, classification under subheading 9817.00.96, HTSUS, depends
on whether the article is “specially designed or adapted for the use or benefit of the blind or
physically and mentally handicapped persons,” and whether it falls within any of the enumerated
exclusions under U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS.
The term “blind or other physically or mentally handicapped persons” includes “any
person suffering from a permanent or chronic physical or mental impairment which substantially
limits one or more major life activities, such as caring for one’s self, performing manual tasks,
walking, seeing, hearing, speaking, breathing, learning, or working.” U.S. Note 4(a), Subchapter
XVII, Chapter 98, HTSUS. While the HTSUS does not establish a clear definition of
“substantial limitation,” in Sigvaris, 227 F. Supp 3d at 1335, the CIT explained that “[t]he
inclusion of the word ‘substantially’ denotes that the limitation must be ‘considerable in amount’
or ‘to a large degree.’”
To determine whether the intermittent catheters are “specially designed” for the use or
benefit of a class of persons to an extent greater than for others, CBP must examine the following
five factors adopted by the CAFC in Sigvaris, 899 F.3d at 1314-15: (1) physical properties of the
article itself (e.g., whether the article is easily distinguishable in design, form and use from
articles useful to non-handicapped persons); (2) presence of any characteristics that create a
substantial probability of use by the chronically handicapped, so that the article is easily
distinguishable from articles useful to the general public and any use thereof by the general
public is so improbable that it would be fugitive; (3) importation by manufacturers or distributors
recognized or proven to be involved in this class or kind of articles for the handicapped; (4) sale
in specialty stores that serve handicapped individuals; and (5) indication at the time of
importation that the article is for the handicapped. See also T.D. 92-77 (26 Cust. B. 240 (1992)).
As to whether those who use catheters are handicapped, in HQ 085175, dated October 20,
1989, Customs stated, “we see no absolute correlation between being incontinent and being
mentally or physically handicapped. It is quite possible to be incontinent and healthy in every
other way. Incontinence in and of itself is not a physical handicap…” However, as stated in HQ
H328390, dated January 25, 2024, Customs determined in multiple other rulings that a person
suffering from chronic incontinence is physically handicapped. See HQ 960056, dated January
30, 1997, which cites to two rulings that held certain products to be specially designed for the
4
handicapped within subheading 9817.00.96, HTSUS; HQ 085691, dated April 18, 1990, (which
considered washable, breathable diapers used by men and women in hospitals); and HQ 557529,
dated March 8, 1994 (which considered an institutional adult diaper designed to manage serious,
chronic incontinence problems).
CBP is satisfied that incontinence necessitating the use of catheterization constitutes an
impairment which substantially limits one or more major life activities. Though CBP previously
stated that there is no absolute correlation between incontinence and disability, it has since issued
multiple rulings holding that incontinence may be considered a handicap. Further, incontinence
is not the primary disability affecting many people who use intermittent catheters. The materials
provided by ConvaTec show that these devices are often used by those with multiple sclerosis,
spina bifida, spinal cord injuries, and other disabilities. Therefore, we are satisfied that these
intermittent catheters are used by physically or mentally handicapped persons.
There is evidence that the intermittent catheters at issue are specially designed for use by
the physically handicapped. Regarding the first two Sigvaris factors, it is highly unlikely that
members of the public would use these intermittent catheters unless one of the aforementioned
disabilities listed in the description so required. Further, the catheters enable those with physical
disabilities to void with ease, whether the user self-catheterizes, or with the assistance of a
personal care assistant/health professional, because these catheters have specialized grips and
handling features designed specifically for users with limited manual dexterity and pre-lubricated
and compact designs to accommodate mobility limitations.
For the third through fifth factors, ConvaTec Group’s website states, “Convatec is a
global medical products and technologies group focused on solutions for the management of
chronic conditions.”5 ConvaTec sells two types of intermittent catheters—Cure Medical and
GentleCath. The Cure Medical website includes lists of catheters “by condition,” including
multiple sclerosis, pelvic organ prolapse, prostate cancer, spina bifida, spinal cord injury, and
transverse myelitis.”6 The website includes pictures of many people in wheelchairs and
testimonials from disabled individuals. Further, the GentleCath “get started” pamphlets provided
by ConvaTec also show pictures of men and women in wheelchairs, which indicates that they are
the intended audience.
Therefore, CBP holds that these intermittent catheters are specially designed for the use
or benefit of handicapped persons. However, Subheading 9817.00.96, HTSUS, excludes articles
for acute or transient disability, even if those articles are specially designed for the use or benefit
of handicapped persons.
In HQ 556532, dated June 18, 1992, Customs held that canes were predominantly used
by permanently or chronically handicapped individuals, even though individuals with acute
disabilities such as sprained ankles could use them. On the other hand, Customs stated that
crutches were predominantly used by individuals with acute or transient disabilities, even though
they may be used by individuals with chronic or permanent disabilities. Therefore, CBP must
5
https://www.convatecgroup.com/
6
https://curemedical.com/
5
determine whether these intermittent catheters are used predominantly by individuals with acute
or transient disabilities or by individuals with chronic or permanent disabilities.
Here, though there is a wide variety of disabilities and conditions necessitating the use of
catheters, the materials given to CBP show that the predominant use of the intermittent catheters
at issue is to help handicapped people perform the everyday task of relieving themselves. Again,
ConvaTec Group’s website states, “Convatec is a global medical products and technologies
group focused on solutions for the management of chronic conditions.” 7 ConvaTec sells two
types of intermittent catheters—Cure Medical and GentleCath. The Cure Medical website
includes lists of catheters “by condition,” including multiple sclerosis, pelvic organ prolapse,
prostate cancer, spina bifida, spinal cord injury, and transverse myelitis.” 8 The website includes
pictures of many people in wheelchairs and testimonials from disabled individuals.
Though urinary catheters are used temporarily, the evidence presented indicates that is
not the predominant use of the intermittent catheters at issue here. ConvaTec is clearly
marketing its products to those who have permanent and chronic conditions. The photographs on
its website and catheter pamphlets feature users in wheelchairs and testimonials from those with
permanent disabilities. Further, ConvaTec provided documentation stating that 85% of
intermittent catheter users have long-term conditions requiring use for more than three years.
Therefore, we believe the predominant use of these catheters is for the treatment of chronic
conditions.
CBP has also looked to the temporary nature of an article itself to determine whether it is
used by individuals with chronic or acute disabilities. In HQ 563008, dated May 20, 2004, aff’d,
HQ 563530, dated September 27, 2006, CBP held that disposable incontinent care products that
were not durable or reusable or designed for long-term use over a long period of time were not
eligible for duty-free treatment under subheading 9817.00.96, HTSUS. In HQ 085094, dated
May 10, 1990, Customs stated that “an individual with acute or transitory incontinence would
not be likely to purchase reusable products, such as those at issue, based on cost alone. Such an
individual could easily meet their need for much less with disposable products.”
However, in HQ H328390, dated January 25, 2024, Customs noted that, in some
instances, non-disposable goods may be less effective. Further, in HQ 562869, dated December
23, 2003, Customs held that disposable insulin pump infusion sets were eligible for duty-free
treatment under subheading 9817.00.96, HTSUS. In HQ H966555, dated September 9, 2003,
Customs affirmed decisions holding that disposable ostomy bags were eligible for duty-free
treatment under subheading 9817.00.96, HTSUS.
Though Customs has shown a preference for goods that are reusable in determining
whether the goods are for permanent or temporary conditions, there is evidence that doctors
recommend intermittent catheters even to those who use catheters consistently over a long period
of time because intermittent catheters cause fewer complications and improve the quality of life
of users. Single-use catheters are also recommended because they are more sanitary. Therefore,
7
Convatecgroup.com
8
https://curemedical.com/
6
the fact that the intermittent catheters are single-use does not necessarily show that their
predominant use is by those with acute or transient disabilities.
Subheading 9817.00.96, HTSUS, also excludes therapeutic and diagnostic articles. In
Richards Medical Co. v. U.S., 13 C.I.T. 519 (1989), “the Court {found} that the term
‘therapeutic’ distinguishes articles, which are used to heal the condition causing a handicap, from
those duty-free articles which are designed to compensate for, or adapt to, the handicapped
condition.”9 The court determined that a prosthetic hip was not a therapeutic article. Further, in
Travenol Lab. V. U.S., 17 C.I.T. 69 (1993), the court determined that, because kidney dialysis
does not restore the kidney function of a person with renal failure, it was not a therapeutic
procedure. Like the prosthetic hip and dialysis articles, the intermittent catheters help manage
but do not cure an underlying condition. Incontinence is an issue while individuals use the
catheter, and still is an issue if users stop using the catheter. Therefore, we believe the catheters
do not treat but simply help users manage the underlying condition causing the incontinence.
HOLDING:
The intermittent catheters at issue are eligible for duty-free treatment under subheading
9817.00.96, HTSUS, as articles specially designed or adapted for the use or benefit of the blind
or other physically or mentally handicapped persons.
Duty rates are provided for your convenience and are subject to change. The text of the
most recent HTSUS and the accompanying duty rates are provided on the internet at
https://hts.usitc.gov.
Please note that 19 C.F.R. § 177.9(b)(1) provides that “[e]ach ruling letter is issued on the
assumption that all of the information furnished in connection with the ruling request and
incorporated in the ruling letter, either directly, by reference, or by implication, is accurate and
complete in every material respect. The application of a ruling letter by a Customs Service field
office to the transaction to which it is purported to relate is subject to the verification of the facts
incorporated in the ruling letter, a comparison of the transaction described therein to the actual
transaction, and the satisfaction of any conditions on which the ruling was based.”
A copy of this ruling letter should be attached to the entry documents filed at the time the
goods are entered. If the documents have been filed without a copy, this ruling should be
brought to the attention of the CBP officer handling the transaction.
Sincerely,
Monika R. Brenner, Chief
Valuation and Special Programs Branch
9
This case defined “therapeutic” under a predecessor heading to subheading 9817.00.96, HTSUS.
7