[Federal Register Volume 86, Number 229 (Thursday, December 2, 2021)]
[Rules and Regulations]
[Pages 68399-68401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26175]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2021-N-0261]


Medical Devices; Neurological Devices; Classification of the 
Trunk and Limb Electrical Stimulator To Treat Headache

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the trunk and limb electrical stimulator to treat 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 trunk and limb electrical stimulator to treat 
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

[[Page 68400]]

effectiveness of the device. We believe this action will also enhance 
patients' access to beneficial innovative devices.

DATES: This order is effective December 2, 2021. The classification was 
applicable on May 20, 2019.

FOR FURTHER INFORMATION CONTACT: Erin Keegan, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave. Bldg. 66, Rm. 1649, Silver Spring, MD 20993-0002, 240-402-6534, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the trunk and limb electrical 
stimulator to treat 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, 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 is required 
to 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.
    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 November 6, 2018, Theranica Bioelectronics Ltd submitted a 
request for De Novo classification of the Nerivio Migra. 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 20, 2019, 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 882.5899.\1\ We have 
named the generic type of device trunk and limb electrical stimulator 
to treat headache, and it is identified as a device intended to treat 
headache through the application of electrical stimulation anywhere on 
the body of the patient apart from the patient's head or neck through 
electrodes placed on the skin. The stimulation may be provided 
transcutaneously or percutaneously.
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    \1\ FDA notes that the ``ACTION'' caption for this final order 
is styled as ``Final amendment; final order,'' rather than ``Final 
order.'' Beginning in December 2019, this editorial change was made 
to indicate that the document ``amends'' the Code of Federal 
Regulations. The change was made in accordance with the Office of 
Federal Register's (OFR) interpretations of the Federal Register Act 
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and 
parts 21 and 22), and the Document Drafting Handbook.
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    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--Trunk and Limb Electrical Stimulator To Treat Headache Risks
                         and Mitigation Measures
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            Identified risks                   Mitigation measures
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Adverse tissue reaction................  Biocompatibility evaluation.
Electrical, mechanical, or thermal       Non-clinical performance
 hazards that may result in user          testing; Electrical,
 discomfort or injury (e.g., electrical   mechanical, and thermal safety
 shock or burn)..                         testing; Electromagnetic
                                          compatibility (EMC) testing;
                                          Software verification,
                                          validation, and hazard
                                          analysis; and Labeling.
Interference with other devices........  EMC testing, and Labeling.

[[Page 68401]]

 
Software malfunction leading to injury   Software verification,
 or discomfort (e.g., tissue damage due   validation, and hazard
 to over-stimulation).                    analysis.
Hardware malfunction leading to injury   Non-clinical performance
 or discomfort.                           testing, Shelf life testing,
                                          and Labeling.
Use error that may result in user        Labeling.
 discomfort, injury, or delay treatment
 for headaches.
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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).

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 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. 3501-3521). 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 820, regarding quality system regulation, 
have been approved under OMB control number 0910-0073; 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 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.  882.5899 to subpart F to read as follows:


Sec.  882.5899   Trunk and limb electrical stimulator to treat 
headache.

    (a) Identification. A trunk and limb electrical stimulator to treat 
headache is a device intended to treat headache through the application 
of electrical stimulation anywhere on the body of the patient apart 
from the patient's head or neck through electrodes placed on the skin. 
The stimulation may be provided transcutaneously or percutaneously.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. This 
testing must include:
    (i) Characterization of the electrical stimulation, including the 
following: Waveforms; output modes; maximum output voltage and maximum 
output current (at 500[Omega], 2k[Omega], and 10k[Omega] loads); pulse 
duration; frequency; net charge per pulse; and maximum phase charge, 
maximum current density, maximum average current, and maximum average 
power density (at 500[Omega]);
    (ii) Characterization of the impedance monitoring system; and
    (iii) Characterization of the electrode performance including the 
electrical performance, adhesive integrity, shelf-life, reusability, 
and current distribution of the electrode surface area.
    (2) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (3) Performance testing must demonstrate electromagnetic 
compatibility and electrical, mechanical, and thermal safety in the 
intended use environment.
    (4) Software verification, validation, and hazard analysis must be 
performed.
    (5) Labeling must include the following:
    (i) Instructions for use, including the typical sensations 
experienced during treatment;
    (ii) A detailed summary of the electrical stimulation output, and 
the device technical parameters, including any wireless specifications;
    (iii) A shelf life for the electrodes and reuse information; and
    (iv) Instructions on care and cleaning of the device.

    Dated: November 26, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26175 Filed 12-1-21; 8:45 am]
BILLING CODE 4164-01-P