52973 Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Rules and Regulations 
is codifying the classification of the 
device by adding 21 CFR 882.5893. We have named the generic type of device thermal vestibular stimulator for headache, and it is identified as a prescription device used to stimulate the vestibular system by applying thermal waveforms through earpieces placed in a patient’s ear canal for the treatment of headache. FDA has identified the following risks 
to health associated specifically with this type of device and the measures required to mitigate these risks in table 1. 
TABLE 1—T HERMAL VESTIBULAR STIMULATOR FOR HEADACHE RISKS AND MITIGATION MEASURES  
Identified risks Mitigation measures 
Adverse tissue reaction ............................. Biocompatibility evaluation, Cleaning validation, and Labeling. 
Thermal injury ............................................ Labeling, Non-clinical performance testing, Thermal safety testing, Technical specifications, and 
Software verification, validation, and hazard analysis. 
Ear tenderness and/or pruritus .................. Labeling, Non-clinical performance testing, and Thermal safety testing. 
Nausea and/or dizziness ........................... Labeling, Non-clinical performance testing, and Software verification, validation, and hazard anal-
ysis. 
Tinnitus ...................................................... Labeling, Non-clinical performance testing, and Software verification, validation, and hazard anal-
ysis. 
FDA has determined that special 
controls, in combination with the 
general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act. 
At the time of classification, thermal 
vestibular stimulators for headache are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met (referring to 21 U.S.C. 352(f)(1)). 
III. Analysis of Environmental Impact 
We have determined under 21 CFR 
25.34(b) that this action is of a type that 
does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. 
IV. Paperwork Reduction Act of 1995 
This final order establishes special 
controls that refer to previously 
approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the 
Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in the guidance document ‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’ have been approved under OMB control number 0910–0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910–0231; the collections of information in 21 CFR part 820, regarding quality system regulations, have been approved under OMB control number 0910–0073; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910–0120; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910–0485. 
List of Subjects in 21 CFR Part 882 
Medical devices. 
Therefore, under the Federal Food, 
Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, part 882 is amended as follows: 
PART 882—NEUROLOGICAL DEVICES 
■1. The authority citation for part 882 
continues to read as follows: 
Authority: 21 U.S.C. 351, 360, 360c, 360e, 
360j, 360l, 371. 
■2. Add § 882.5893 to subpart F to read 
as follows: 
§ 882.5893 Thermal vestibular stimulator 
for headache. 
(a) Identification. The thermal 
vestibular stimulator for headache is a 
prescription device used to stimulate the vestibular system by applying thermal waveforms through earpieces placed in a patient’s ear canal for the treatment of headache. 
(b) Classification. Class II (special 
controls). The special controls for this device are: (1) The patient-contacting 
components of the device must be demonstrated to be biocompatible. 
(2) Performance testing must validate 
electromagnetic compatibility and electrical, mechanical, and thermal safety. 
(3) The technical parameters of the 
device, including waveform outputs and temperature limits, must be identified. 
(4) Cleaning validation of earpieces 
must be conducted. 
(5) Software verification, validation, 
and hazard analysis must be performed. 
(6) Labeling must include the 
following: 
(i) Information on how the device 
operates and the typical sensations experienced during treatment; 
(ii) A detailed summary of the 
device’s technical parameters; and 
(iii) Instructions for maintenance and 
cleaning of the device. 
Dated: October 16, 2018. 
Leslie Kux, 
Associate Commissioner for Policy. 
[FR Doc. 2018–22842 Filed 10–18–18; 8:45 am] 
BILLING CODE 4164–01–P 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Part 886 
[Docket No. FDA–2018–N–3634] 
Medical Devices; Ophthalmic Devices; 
Classification of the Intranasal Electrostimulation Device for Dry Eye Symptoms 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Final order. 
SUMMARY : The Food and Drug 
Administration (FDA or we) is 
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classifying the intranasal 
electrostimulation device for dry eye symptoms into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the intranasal electrostimulation device for dry eye symptoms’ classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens. 
DATES : This order is effective October 
19, 2018. The classification was applicable on May 17, 2018. 
FOR FURTHER INFORMATION CONTACT : 
Elvin Ng, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2431, Silver Spring, MD, 20993–0002, 240–402–4662, Elvin.Ng@fda.hhs.gov. 
SUPPLEMENTARY INFORMATION : 
I. Background 
Upon request, FDA has classified the 
intranasal electrostimulation device for dry eye symptoms as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients’ access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment. 
The automatic assignment of class III 
occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as ‘‘postamendments devices’’ because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA may take a variety of actions in 
appropriate circumstances to classify or 
reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807). 
FDA may also classify a device 
through ‘‘De Novo’’ classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105–115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112–144) modified the De Novo application process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification. 
Under the first procedure, the person 
submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2). 
Under the second procedure, rather 
than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act. 
Under either procedure for De Novo 
classification, FDA shall classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was 
automatically placed within class III, the De Novo classification is considered to be the initial classification of the device. 
We believe this De Novo classification 
will enhance patients’ access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining ‘‘substantial equivalence’’). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device. 
II. De Novo Classification 
On October 23, 2017, Allergan 
submitted a request for De Novo 
classification of the TrueTear Intranasal Tear Neurostimulator. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. 
We classify devices into class II if 
general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device. 
Therefore, on May 17, 2018, FDA 
issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 886.5310. We have named the generic type of device intranasal electrostimulation device for dry eye symptoms, and it is identified as a prescription non-implantable, electrostimulation device intended to increase tear production for improvement in dry eye symptoms. 
FDA has identified the following risks 
to health associated specifically with this type of device and the measures required to mitigate these risks in table 1. 
TABLE 1—I NTRANASAL ELECTROSTIMULATION DEVICE FOR DRYEYESYMPTOMS RISKS AND MITIGATION MEASURES  
Identified risks Mitigation measures 
Tissue damage due to overstimulation/understimulation or mechanical 
injury (ex: tips too long), device breakage.Non-clinical performance testing; Software verification, validation, and 
hazard analysis; Electrical, thermal, and mechanical safety testing; 
and Labeling. 
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TABLE 1—I NTRANASAL ELECTROSTIMULATION DEVICE FOR DRYEYESYMPTOMS RISKS AND MITIGATION MEASURES — 
Continued 
Identified risks Mitigation measures 
Adverse tissue reaction ............................................................................ Biocompatibility evaluation and Labeling. 
Infection .................................................................................................... Labeling. 
Electrical shock or burn ............................................................................ Electrical, thermal, and me chanical safety testing; Software verification, 
validation, and hazard analysis; and Labeling. 
Interference with other devices ................................................................ Electromagnetic compatibility (E MC) testing; Software verification, vali-
dation, and hazard analysis; and Labeling. 
Pain, headache, or discomfort ................................................................. Clinical performance testing; Non -clinical performance testing; Elec-
trical, thermal, and mechanical safety testing; and Labeling. 
Failure to mitigate dry eye symptoms ...................................................... Clinical performance testing, Training, and Labeling. 
FDA has determined that special 
controls, in combination with the 
general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k). 
At the time of classification, 
intranasal electrostimulation devices for dry eye symptoms are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met (referring to 21 U.S.C. 352(f)(1)). 
III. Analysis of Environmental Impact 
We have determined under 21 CFR 
25.34(b) that this action is of a type that 
does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. 
IV. Paperwork Reduction Act of 1995 
This final order establishes special 
controls that refer to previously 
approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in the guidance document ‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’ have been approved under OMB control number 0910–0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910–0231; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910–0073; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910–0120; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910–0485. 
List of Subjects in 21 CFR Part 886 
Medical devices, Ophthalmic goods 
and services. 
Therefore, under the Federal Food, 
Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 886 is amended as follows: 
PART 886—OPHTHALMIC DEVICES 
■1. The authority citation for part 886 
continues to read as follows: 
Authority: 21 U.S.C. 351, 360, 360c, 360e, 
360j, 360l, 371. 
■2. Add § 886.5310 to subpart F to read 
as follows: 
§ 886.5310 Intranasal electrostimulation 
device for dry eye symptoms. 
(a) Identification. An intranasal 
electrostimulation device for dry eye 
symptoms is a prescription non- implantable, electrostimulation device intended to increase tear production for improvement in dry eye symptoms. 
(b) Classification. Class II (special 
controls). The special controls for this device are: 
(1) Clinical performance testing must 
evaluate improvement of dry eye symptoms under anticipated conditions of use. 
(2) Non-clinical performance testing 
must assess the following electrical output specifications: waveforms, output modes, maximum output 
voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density. 
(3) Patient-contacting components of 
the device must be demonstrated to be biocompatible. 
(4) Performance testing must 
demonstrate the electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment. 
(5) Software verification, validation, 
and hazard analysis must be performed. 
(6) Training for the proper use of the 
device must be provided. 
(7) Physician and patient labeling 
must include: 
(i) Summaries of electrical stimulation 
parameters; 
(ii) Instructions on how to correctly 
use and maintain the device; 
(iii) Instructions and explanations of 
all user-interface components; 
(iv) Information related to 
electromagnetic compatibility classification; 
(v) Instructions on how to clean the 
device; and 
(vi) Summaries of clinical 
performance testing demonstrating safety and effectiveness. 
Dated: October 15, 2018. 
Leslie Kux, 
Associate Commissioner for Policy. 
[FR Doc. 2018–22785 Filed 10–18–18; 8:45 am] 
BILLING CODE 4164–01–P 
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