[Federal Register Volume 82, Number 247 (Wednesday, December 27, 2017)]
[Rules and Regulations]
[Pages 61168-61169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27854]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2017-N-6531]


Medical Devices; Neurological Devices; Classification of the 
External Vagal Nerve Stimulator for Headache

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the external vagal nerve stimulator for headache 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 external vagal nerve stimulator for headache's 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 December 27, 2017. The classification 
was applicable on April 14, 2017.

FOR FURTHER INFORMATION CONTACT: William Heetderks, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 2682, Silver Spring, MD 20993-0002, 240-
402-5360, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the external vagal nerve 
stimulator for headache 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 established the first procedure for De Novo classification 
(Pub. L. 105-115). Section 607 of the Food and Drug Administration 
Safety and Innovation Act modified the De Novo application process by 
adding a second procedure (Pub. L. 112-144). 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 in order 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 16, 2015, electroCore, LLC, submitted a request for De 
Novo classification of the gammaCore Non-invasive Vagus Nerve 
Stimulator. 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.

[[Page 61169]]

    Therefore, on April 14, 2017, 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 882.5892. We have named 
the generic type of device external vagal nerve stimulator for 
headache, and it is identified as a prescription device used to apply 
an electrical current to a patient's vagus nerve through electrodes 
placed on the skin 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--External Vagal Nerve Stimulator for Headache Risks and
                           Mitigation Measures
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            Identified risks                   Mitigation measures
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Adverse tissue reaction resulting from   Biocompatibility evaluation and
 patient contacting components.           Labeling.
Electrical shock injury from device      Electrical safety, thermal, and
 failure.                                 mechanical testing; Software
                                          verification, validation, and
                                          hazard analysis; and Labeling.
Incorrect stimulation resulting from     Electromagnetic compatibility
 interference from other electrical       testing.
 devices.
Stimulation side effects such as the     Labeling.
 following.
     Seizure
     Cardiac side effects
     Worsening of headache.
Ineffective therapeutic response due to  Non-clinical performance
 device failure.                          testing; Software
                                          verification, validation, and
                                          hazard analysis; and Labeling.
User error.............................  Labeling.
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    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, external vagal nerve 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

    The Agency has 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. 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 
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, Neurological devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
882 is amended as follows:

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for part 882 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. Add Sec.  882.5892 to subpart F to read as follows:


Sec.  882.5892  External vagal nerve stimulator for headache.

    (a) Identification. An external vagal nerve stimulator for headache 
is a prescription device used to apply an electrical current to a 
patient's vagus nerve through electrodes placed on the skin for the 
treatment of headache.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The technical parameters of the device, including waveform, 
output modes, maximum output voltage and current (with 500, 2,000, and 
10,000 ohm loads), pulse duration, frequency, net charge ([mu]C) per 
pulse, maximum phase charge at 500 ohms, maximum current density (mA/
cm\2\, r.m.s.), maximum average current (mA), maximum average power 
density (W/cm\2\), and the type of impedance monitoring system shall be 
fully characterized through non-clinical performance testing.
    (2) Software verification, validation, and hazard analysis shall be 
performed.
    (3) Biocompatibility evaluation of the patient-contacting 
components of the device shall be performed.
    (4) The device shall be tested for electrical, thermal, and 
mechanical safety, and for electromagnetic compatibility (EMC).
    (5) The labeling must include:
    (i) Instructions for proper use of the device, including placement 
of the device on the patient; and
    (ii) Instructions on care and cleaning of the device.

    Dated: December 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27854 Filed 12-26-17; 8:45 am]
 BILLING CODE 4164-01-P