OT:RR:CTF:EMAIN H333105 MFT
Center Director, Pharmaceuticals, Health, and Chemicals
Center of Excellence and Expertise
Service Port of New York / Newark
1210 Corbin Street
Elizabeth, NJ 070201
Re: Application for Further Review of Protest No. 4772-23-101801; Classification of a Firefly DE550 Wireless Digital Video Otoscope
Dear Center Director:
The following is our decision regarding the Application for Further Review (AFR) of Protest No. 4772-23-101801, which was filed on June 28, 2023, on behalf of Fresh Pond Ventures, LLC, d/b/a Firefly Global (protestant). The protest pertains to U.S. Customs and Border Protection's (CBP's) classification under the Harmonized Tariff Schedule of the United States (HTSUS) of a certain wireless digital video otoscope. The following decision was based on information submitted with this protest and AFR, information discussed during the conference held between CBP and the protestant on September 27, 2023, as well as the protestant's supplemental arguments submitted on November 2, 2023.
FACTS:
The subject merchandise is a wireless digital video otoscope marketed as the "Firefly DE550." The otoscope is designed for making observations of ear canals using precise images and live videos transmitted wirelessly from the device. It can be used for self-examination, telemedicine, patient education, and electronic medical records.
The otoscope incorporates two magnifying lenses - a native optical lens and a digital lens - with a multi-layer glass assembly. The otoscope supports optical magnification of up to thirty times and digital magnification of up to ninety times. The otoscope has four "ultra-bright" light-emitting diodes (LEDs) with variable brightness control.
The otoscope includes a wireless transmitter and a wireless receiver. The receiver connects to a computer via USB, receives the images that the otoscope captures, and transmits them to the "FireflyPro" image processing software. According to the protestant's submitted product materials, FireflyPro "enables users to capture, store, recall, view, manipulate[,] and measure images and videos in real time."
A built-in 850-milliampere-hour battery powers the otoscope and supports up to three hours of observation. The otoscope comes packaged with an AC battery charger and three specula. The otoscope measures thirteen centimeters long, 3.6 centimeters wide, and four centimeters high.
ISSUE:
Whether the subject wireless digital video otoscope is classified under subheading 9018.19, HTSUS, as "other electro-diagnostic apparatus," or under subheading 9018.90, HTSUS, as "other instruments and appliances."
LAW AND ANALYSIS:
A decision on classification and the rate and amount of duties chargeable is a protestable matter under 19 U.S.C. 1514(a)(2). The subject protest was timely filed on June 28, 2023, within 180 days of liquidation, pursuant to 19 U.S.C. 1514(c)(3). Further review of Protest No. 4772-23-101801 is properly accorded pursuant to 19 C.F.R. 174.24(b), as the protestant has alleged that the decision against which the protest was filed involves questions of law and fact that have not been ruled upon by the Commissioner of CBP or his designee or by the Customs courts, specifically the tariff classification of a wireless digital video otoscope.
Classification under the HTSUS is in accordance with the General Rules of Interpretation (GRIs). GRI 1 provides that the classification of goods will be determined according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRIs 2 through 6 will then be applied in order.
GRI 6 provides that for legal purposes, the classification of goods in the subheadings of a heading shall be determined according to the terms of those subheadings and any related subheading notes and, mutatis mutandis, to the preceding GRIs, on the understanding that only subheadings at the same level are comparable. For purposes of this rule, the relative section, chapter, and subchapter notes also apply, unless the context otherwise requires.
The HTSUS headings and subheadings under consideration are as follows:
9018 Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof:
Electro-diagnostic apparatus (including apparatus for functional exploratory examination or for checking physiological parameters); parts and accessories thereof:
9018.19 Other
* * * * *
9018.90 Other instruments and appliances and parts and accessories thereof:
Optical instruments and appliances and parts and accessories thereof
Per GRI 6, supra, the two subheadings under consideration that occur at the same level of indentation are: (1) "Electro-diagnostic apparatus (including apparatus for functional exploratory examination or for checking physiological parameters); parts and accessories thereof" and (2) "Other instruments and appliances and parts and accessories thereof." Since subheading 9018.90, HTSUS, covers instruments and appliances "other" than those previously specified under the heading, the determinative question is whether the subject otoscope constitutes an "other electro-diagnostic apparatus" of subheading 9018.19, HTSUS.[1]
Neither the HTSUS nor the ENs provide a definition for "electro-diagnostic." In the absence of a definition of a term in the HTSUS or ENs, the term's correct meaning is its common and commercial meaning.[2] Common and commercial meaning may be determined by consulting dictionaries, lexicons, scientific authorities, and other reliable sources.[3] In examining subheading 9018.19, HTSUS, we previously consulted dictionary definitions for "diagnostic" and "diagnosis":
The term "diagnostic" is defined in Webster's II New Riverside University Dictionary 372 (1988) as "1. Of, relating to, or used in a diagnosis. 2. Serving to identify a disease." The same term is defined in Dorland's Illustrated Medical Dictionary 458 (28th ed.) as "pertaining to or subserving diagnosis." The term "diagnosis" is defined in Webster's as "1. Med. The act or process of identifying or determining the nature of a disease by way of examination." The term "diagnosis" is defined in Dorland's as the determination of the nature of a case of disease. 2. the art of distinguishing one disease from another."[4]
The full term "electrodiagnosis" appears in Stedman's Medical Dictionary:
282810 electrodiagnosis
(?-lek'tr?-d?'ag-n?'sis)
1. The use of electronic devices for diagnostic purposes.
2. By convention, the studies performed in the EMG [electromyography] laboratory, i.e., nerve conduction studies and needle electrode examination (EMG proper).
SYN: electroneurography[.][5]
The Attorney's Dictionary of Medicine defines "electrodiagnosis" as follows:
The use of electrical instruments as an aid in diagnosis; diagnosis of disease by recording an electrical activity of tissues or organs, as with the electrocardiograph; diagnosis of disease by observing the changes in the electrical irritability of tissues or organs.[6]
Considering these definitions, we gather that the term "electro-diagnostic" (as applied to the merchandise at hand) pertains to the use of electronic devices or electrical instruments for diagnostic purposes, including as an aid in diagnosis.
For two reasons, we find that the subject otoscope meets this definition of "electro-diagnostic." HTSUS. First, the otoscope is undoubtedly an electronic device. An 850-mAh battery delivers electricity to the otoscope. The components of the otoscope use the battery's electricity to capture images and videos, and the wireless transmitter sends signals carrying the images and video feed to a wireless receiver that is plugged into another electronic device. Given this use of electricity, the image capture functionality, and the wireless transmission of data, the subject otoscope is an electronic device.
Second, we find that the subject otoscope is used for diagnostic purposes, including one used for a "functional exploratory examination" under subheading 9018.19, HTSUS. Customs previously considered what constitutes a "functional" exploratory examination in HQ 962858 in the medical context: "Dorland's defines 'functional' as: '1. Of or pertaining to a function. 2. Affecting the function but not the structure.' Dorland's defines 'function' as: '1. The special, normal, or proper physiologic activity of an organ or part . . . .'"[7] There, we concluded that certain endoscopes were "functional" under subheading 9018.19.40, HTSUS, because they "perform[ed] tasks beyond mere observation of the structure [of] organs and cavities," "serve[d] to reveal and record physical activity within the organs and cavities examined, and aid[ed] in diagnosis."[8]
Here, the otoscope is used to examine an organ - the ear. The functioning of the tympanic membrane (i.e., the eardrum) is part of an ear's physiological activity.[9] The functional examination of the tympanic membrane can help a physician identify interference with the normal physiological activity of the ear, such as otitis media (i.e., an infection of the middle ear).[10] Using the subject otoscope to make observations of the ear and identify functional issues constitutes an "act or process of identifying or determining the nature of a disease by way of examination."[11] As such, the subject otoscope is used for diagnostic purposes, including the functional exploratory examination of the human ear. That a physician may use this otoscope's images to educate a patient and provide remote medical care via telemedicine, as well as other clinical applications, further evinces the subject merchandise's suitability for diagnosing diseases.
Because the subject otoscope meets the definition of an electro-diagnostic apparatus, and given it is used for the functional exploratory examination of the human ear, we hold that it is classifiable under subheading 9018.19, HTSUS. Because the subject otoscope is classifiable under subheading 9018.19, HTSUS, it cannot be classified as an instrument "other" than an electro-diagnostic apparatus; subheading 9018.90, HTSUS, is thus inapplicable.
HOLDING:
By application of GRIs 1 and 6, the subject wireless digital video otoscope is classified under heading 9018, HTSUS, specifically subheading 9018.19.40, HTSUS, which provides for, "Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof: Electro-diagnostic apparatus (including apparatus for functional exploratory examination or for checking physiological parameters); parts and accessories thereof: Other: Apparatus for functional exploratory examination, and parts and accessories thereof." The general column one rate of duty is free.
Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under subheading 9018.19.40, HTSUS, unless specifically excluded, are subject to an additional 25 percent ad valorem rate of duty. At the time of importation, you must report the Chapter 99 subheading, i.e., 9903.88.01, HTSUS, in addition to subheading 9018.19.40, HTSUS, listed above.
The HTSUS is subject to periodic amendment, so you should exercise reasonable care in monitoring the status of goods covered by the Note cited above and the applicable Chapter 99 subheading. For background information regarding the trade remedy initiated pursuant to Section 301 of the Trade Act of 1974, including information on exclusions and their effective dates, you may refer to the relevant parts of the USTR and CBP websites, which are available at https://ustr.gov/issue-areas/enforcement/section-301-investigations/tariff-actions and https://www.cbp.gov/trade/remedies/301-certain-products-china, respectively.
You are instructed to DENY the Protest.
Sixty days from the date of the decision, the Office of Trade, Regulations and Rulings, will make the decision available to CBP personnel, and to the public on the CBP website at www.cbp.gov, by means of the Freedom of Information Act, and other methods of public distribution.
Sincerely,
Yuliya A. Gulis, Director
Commercial and Trade Facilitation Division
-----------------------
[1] There is no dispute that the subject otoscope constitutes an instrument used in medical sciences under heading 9018, HTSUS. Nor is there disagreement that the subject otoscope cannot be classified under the subheadings that precede the "other electro-diagnostic apparatus" provision of subheading 9018.19, HTSUS. Specifically, the subject merchandise is not an "electrocardiograph" (subheading 9018.11, HTSUS); "ultrasonic scanning apparatus" (9018.12, HTSUS); "magnetic resonance imaging apparatus" (subheading 9018.13, HTSUS); or "scintigraphic apparatus" (subheading 9018.14, HTSUS).
[2] See Nippon Kogaku, Inc. v. United States, 69 C.C.P.A. 89, 673 F.2d 380 (1982).
[3] See C.J. Tower & Sons v. United States, 69 C.C.P.A. 128, 673 F.2d 1268 (1982).
[4] Headquarters Ruling Letter (HQ) 961998 (May 7, 1999) (blood pressure monitor).
[5] See electrodiagnosis, Stedman's Medical Dictionary, Westlaw 282810 (database updated Nov. 2014).
[6] See J.E. Schmidt, Attorney's Dictionary of Medicine, Lexis+ (database updated Oct. 2022) (Release No. 56).
[7] HQ 962858 (Jan. 23, 2001) (endoscopes and needle assemblies).
[8] Id.
[9] See generally James O. Pickles, An Introduction to the Physiology of Hearing 11-12, 14 (3d ed. 2013) (explaining the tympanic membrane's role in transferring sound energy to the middle ear apparatus).
[10] See, e.g., Kathryn M. Harmes et al., Otitis Media: Diagnosis and Treatment, 88 Am. Fam. Physician
!0=>GWXcop435, 435-36, 439 (2013) (recommending clinicians to use otoscopy to find signs of inflammation, such as erythema and mild bulging of the tympanic membrane, before diagnosing acute otitis media).
[11] HQ 961998 (May 7, 1999).