Rule2021-26175
Medical Devices; Neurological Devices; Classification of the Trunk and Limb Electrical Stimulator To Treat Headache
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 2, 2021
Effective
December 2, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Full Text
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<title>Federal Register, Volume 86 Issue 229 (Thursday, December 2, 2021)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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,
<a href="/cdn-cgi/l/email-protection#aeebdcc7c080e5cbcbc9cfc0eec8cacf80c6c6dd80c9c1d8"><span class="__cf_email__" data-cfemail="7e3b0c171050351b1b191f103e181a1f5016160d50191108">[email protected]</span></a>.
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
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</html>Indexed from Federal Register on December 2, 2021.
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