Medical Devices; Ophthalmic Devices; Classification of the Intranasal Electrostimulation Device for Dry Eye Symptoms, 52973-52975 [2018-22785]
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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.
52973
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—THERMAL VESTIBULAR STIMULATOR FOR HEADACHE RISKS AND MITIGATION MEASURES
Identified risks
Mitigation measures
Adverse tissue reaction .............................
Thermal injury ............................................
Biocompatibility evaluation, Cleaning validation, and Labeling.
Labeling, Non-clinical performance testing, Thermal safety testing, Technical specifications, and
Software verification, validation, and hazard analysis.
Labeling, Non-clinical performance testing, and Thermal safety testing.
Labeling, Non-clinical performance testing, and Software verification, validation, and hazard analysis.
Labeling, Non-clinical performance testing, and Software verification, validation, and hazard analysis.
Ear tenderness and/or pruritus ..................
Nausea and/or dizziness ...........................
Tinnitus ......................................................
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)).
amozie on DSK3GDR082PROD with RULES
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
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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:
(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
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 882.5893 to subpart F to read
as follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
■
21 CFR Part 886
§ 882.5893 Thermal vestibular stimulator
for headache.
[Docket No. FDA–2018–N–3634]
(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:
Medical Devices; Ophthalmic Devices;
Classification of the Intranasal
Electrostimulation Device for Dry Eye
Symptoms
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AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
SUMMARY:
E:\FR\FM\19OCR1.SGM
19OCR1
52974
Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Rules and Regulations
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:
amozie on DSK3GDR082PROD with RULES
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—INTRANASAL ELECTROSTIMULATION DEVICE FOR DRY EYE SYMPTOMS 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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Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Rules and Regulations
52975
TABLE 1—INTRANASAL ELECTROSTIMULATION DEVICE FOR DRY EYE SYMPTOMS RISKS AND MITIGATION MEASURES—
Continued
Identified risks
Mitigation measures
Adverse tissue reaction ............................................................................
Infection ....................................................................................................
Electrical shock or burn ............................................................................
Biocompatibility evaluation and Labeling.
Labeling.
Electrical, thermal, and mechanical safety testing; Software verification,
validation, and hazard analysis; and Labeling.
Electromagnetic compatibility (EMC) testing; Software verification, validation, and hazard analysis; and Labeling.
Clinical performance testing; Non-clinical performance testing; Electrical, thermal, and mechanical safety testing; and Labeling.
Clinical performance testing, Training, and Labeling.
Interference with other devices ................................................................
Pain, headache, or discomfort .................................................................
Failure to mitigate dry eye symptoms ......................................................
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)).
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.
III. Analysis of Environmental Impact
PART 886—OPHTHALMIC DEVICES
amozie on DSK3GDR082PROD with RULES
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.
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:
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:
■
IV. Paperwork Reduction Act of 1995
§ 886.5310 Intranasal electrostimulation
device for dry eye symptoms.
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,
(a) Identification. An intranasal
electrostimulation device for dry eye
symptoms is a prescription nonimplantable, 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,
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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
E:\FR\FM\19OCR1.SGM
19OCR1
]]>Agencies
[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)]
[Rules and Regulations]
[Pages 52973-52975]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22785]
-----------------------------------------------------------------------
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
[[Page 52974]]
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,
[email protected].
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--Intranasal Electrostimulation Device for Dry Eye Symptoms Risks
and Mitigation Measures
------------------------------------------------------------------------
Identified risks Mitigation measures
------------------------------------------------------------------------
Tissue damage due to overstimulation/ Non-clinical performance
understimulation or mechanical injury testing; Software
(ex: tips too long), device breakage. verification, validation, and
hazard analysis; Electrical,
thermal, and mechanical safety
testing; and Labeling.
[[Page 52975]]
Adverse tissue reaction................ Biocompatibility evaluation and
Labeling.
Infection.............................. Labeling.
Electrical shock or burn............... Electrical, thermal, and
mechanical safety testing;
Software verification,
validation, and hazard
analysis; and Labeling.
Interference with other devices........ Electromagnetic compatibility
(EMC) testing; Software
verification, validation, and
hazard analysis; and Labeling.
Pain, headache, or discomfort.......... Clinical performance testing;
Non-clinical performance
testing; Electrical, 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
0
1. The authority citation for part 886 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
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2. Add Sec. 886.5310 to subpart F to read as follows:
Sec. 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
