CLA-2-90:OT:RR:NC:2:235
Ms. Bonnie Eldridge
Medtronic, Inc.
710 Medtronic Parkway, LS245
Minneapolis, MN 55432
RE: The tariff classification of certain prosthetic and artificial heart valves.
Dear Ms. Eldridge:
In your letter dated August 25, 2014, you requested a tariff classification ruling.
The subject products consist of certain prosthetic and artificial heart valves.
You requested our consideration of three specific models of completed valves, which will be used to replace defective valves in patients.
The three products under review are as follows:
Product Number 310: Mosaic Bio Prosthesis Heart Valve
Product Number ME-TA1:3F Percutaneous Aortic Valve
Product Number 500DM: Open Pivot Mitral Heart Valve
Each of the products are designed to be surgically implanted into the human body. The function is to replace a diseased, malformed or malfunctioning heart valve.
Product number 310 is described as a stented tissue valve obtained from a pig’s heart. It is fitted to a flexible frame that supports the valve tissue.
Product Number ME-TA1 is described as a tissue valve obtained from a horse heart. It is indicated that it does not have a frame, but that it is assembled into a tubular shape and one end is covered with a fabric ring which is used to attach the mechanism to the heart.
Product Number 500DM (Medtronic Open Pivot™ mechanical heart valve). According to literature provided with your request and your company website: “it represents a fundamental change in bileaflet valve design. Other bileaflet valves use cavity pivots, which can provide areas of stasis where potential platelet aggregation can occur”. The valve is not similar to the other two products above, in that it does not use natural tissues but contains a solid pyrolytic carbon orifice surrounded by a mesh.
The applicable subheading for Product Number 310: Mosaic Bio Prosthesis Heart Valve;
Product Number ME-TA1:3F Percutaneous Aortic Valve; and Product Number 500DM: Open Pivot Mitral Heart Valve, will be 9021.39.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Other” artificial parts of the body and parts and accessories thereof.. The rate of duty will be Free.
You also request for consideration of the instant products under the Nairobi Protocol.
Specifically you ask whether the various articles (valves) are "specially designed or adapted" for the handicapped within the meaning of the Nairobi Protocol, and, therefore, eligible for duty-free treatment under subheading 9817.00.96, HTSUSA. The Nairobi Protocol to the Agreement on the Importation of Educational, Scientific, and Cultural Materials Act of 1982, 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, HTSUSA. These tariff provisions specifically state that "[a]rticles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons" are eligible for duty-free treatment. U.S. Note 4(a), subchapter XVII, Chapter 98, HTSUSA, states that, "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(b), subchapter XVII, Chapter 98, HTSUSA, which establishes limits on classification of products in these subheadings, states as follows: (b) Subheadings 9817.00.92, 9817.00.94 and 9817.00.96 do not cover-- (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.
The primary issue is whether the article is specially designed or adapted for the “use or benefit of the handicapped” within the meaning of Nairobi Protocol. Although the legislative history of the Nairobi Protocol discusses the concerns of Congress that the design, modification or adaptation of an article must be significant so as to clearly render the article for use by handicapped individuals, no specific definition of these terms was established by Congress. See, Senate Report (Finance Committee) No. 97-564, September 21, 1982). See also, Headquarters Ruling Letter (HRL) 951004 dated March 3, 1992. Since it is difficult to establish a clear definition of what is “specially designed or adapted," various factors must be utilized on a case-by-case basis to determine whether a given article is "specially designed or adapted" within the meaning of this statute.
It is our opinion that three heart valves described above are considered to be specially designed or adapted for the handicapped, and, therefore, eligible for duty-free treatment under subheading 9817.00.96.
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 World Wide Web at http://www.usitc.gov/tata/hts/.
This ruling is being issued under the provisions of Part 177 of the Customs 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, contact National Import Specialist Paul Hodgkiss at (646) 733-3046 or by email at [email protected].
Sincerely,
Gwenn Klein Kirschner
Director
National Commodity Specialist Division