CLA-2-90:OT:RR:NC:N3 135
Dalanee Hester
GDLSK
707 Wilshire Blvd
Los Angeles, CA 90017
RE: The tariff classification of an insulin delivery device from China
Dear Ms. Hester:
In your letter dated June 4, 2025, you requested a tariff classification ruling on behalf of MannKind
Corporation (“MannKind”). Additional information was provided via email on June 12, 2025.
The V-Go wearable insulin delivery device (all-in-one insulin delivery patch) is a fully mechanical,
disposable device designed for diabetic users. It is worn like a patch for 24 hours and provides continuous
subcutaneous insulin infusion over 24 hours at a preset basal rate. The V-Go is designed to mimic the body’s
natural steady release of insulin and provides on-demand insulin at mealtimes to address glucose excursions
that occur after eating. It replaces both basal and mealtime insulin injections and enables diabetics to receive
their required daily insulin without the need for long-acting and mealtime injections. The device includes a
button cover which covers the start button and prevents it from being pushed, an insulin port, a bolus ready
button, a viewing window with an indicator to show a view of the insulin reservoir, a bolus delivery button, a
needle release button, and an adhesive pad and liner on the bottom of the device. You state that MannKind
only markets and sells V-Go to diabetics with a doctor’s prescription. The V-Go is imported without insulin
pre-filled.
In your submission you requested consideration of a secondary classification under 9817.00.96, HTSUS,
which applies to articles and parts and accessories of articles specifically designed or adapted for the use or
benefit of the permanently or chronically physically or mentally handicapped.
Subheading 9817.00.96, HTSUS, covers: “[a]rticles 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: [o]ther.” 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.
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.
In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (Ct. Int’l Trade 2017), aff’d, 899 F.3d 1308
(Fed. Cir. 2018), the U.S. Court of International Trade (CIT) explained that “specially” means “to an extent
greater than in other cases or towards others” and “designed” means something that is “done, performed, or
made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” We
must first evaluate “for whose, if anyone’s, use and benefit is the article specially designed,” and then,
whether “those persons [are] physically handicapped .” Sigvaris, 899 F.3d at 1314.
The Court of Appeals for the Federal Circuit (CAFC) clarified in Sigvaris, 899 F.3d at 1314-15 that to be
“specially designed,” the merchandise “must be intended for the use or benefit of a specific class of persons
to an extent greater than for the use or benefit of others” and adopted the five factors used by U.S. Customs
and Border Protection (CBP):
(1) the physical properties of the article itself (i.e., whether the article is easily distinguishable by
properties of the design, form, and the corresponding use specific to this unique design, from articles
useful to non-handicapped persons); (2) whether any characteristics are present 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) whether articles are imported by manufacturers or
distributors recognized or proven to be involved in this class or kind of articles for the handicapped;
(4) whether the articles are sold in specialty stores which serve handicapped individuals; and, (5)
whether the condition of the articles at the time of importation indicates that these articles are for the
handicapped.
We note that in Headquarters Ruling (HQ) 561020 (dated October 14, 1998), Customs and Border Protection
(CBP) held that people with diabetes suffer from a permanent or physical impairment within the meaning of
U.S. Note 4(a) to Chapter 98 of the HTSUS. Additionally, as discussed in HQ 964169 (dated June 26, 2001),
“people with diabetes are limited in their ability to perform a broad range of jobs because they must be able
to monitor their blood sugar, inject insulin if prescribed, and have work restrictions due to excessive
urination, possible nausea, dizziness and fainting. This interferes with working, a major life activity.
Therefore, persons with diabetes suffer from a permanent or chronic physical impairment which substantially
limits a major life activity and therefore, are considered physically handicapped persons under U.S. Note
4(a).”
In HQ H311614 (dated September 11, 2020), CBP stated that a continuous insulin delivery system for people
with diabetes, similar to the V-GO, was eligible for duty-free treatment under Nairobi Protocol in subheading
9817.00.96, HTSUS. The V-Go is specifically designed to provide precise, 24-hour insulin delivery for
diabetic persons in a home setting. Based on the information provided and the precedents, it is the opinion of
this office that the V-Go is specifically designed for use by the handicapped and qualifies for duty-free
treatment under subheading 9817.00.96, HTSUS.
The tariffs and additional duties cited above are current as of this ruling’s issuance. 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 at https://hts.usitc.gov/.
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 Fei Chen at [email protected].
Sincerely,
(for)
James Forkan
Acting Director
National Commodity Specialist Division