Medical Devices; Ophthalmic Devices; Classification of the Tear Electrostimulation Device, 60114-60116 [2017-27280]
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60114
Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Rules and Regulations
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.
(i) Reliability testing of device
deployment and retrieval under relevant
use conditions must be conducted.
(ii) Testing of the maximum force
applied to the fetal head in an anatomic
model must be conducted.
(iii) Testing of uniform application of
the elevator mechanism on the fetal
head must be conducted.
(5) Labeling must include the
following:
(i) Contraindication for use in the
presence of active genital infection;
(ii) Specific instructions regarding the
proper placement and use of the device;
and
(iii) A shelf life.
Dated: December 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–27277 Filed 12–18–17; 8:45 am]
BILLING CODE 4164–01–P
List of Subjects in 21 CFR Part 884
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 884 is
amended as follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PART 884—OBSTETRICAL AND
GYNECOLOGICAL DEVICES
Medical Devices; Ophthalmic Devices;
Classification of the Tear
Electrostimulation Device
1. The authority citation for part 884
continues to read as follows:
AGENCY:
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
ACTION:
2. Add § 884.4350 to subpart E to read
as follows:
SUMMARY:
■
sradovich on DSK3GMQ082PROD with RULES
Fetal head elevator.
(a) Identification. A fetal head
elevator is a prescription device
consisting of a mechanism that elevates
the fetal head to facilitate delivery
during a Caesarean section.
(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 data must
demonstrate the sterility of patientcontacting components of the device.
(3) Performance data must support the
shelf life of the device by demonstrating
continued sterility, package integrity,
and device functionality over the
identified shelf life.
(4) Non-clinical performance data
must demonstrate that the device
performs as intended under anticipated
conditions of use. The following
performance characteristics must be
tested:
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21 CFR Part 886
[Docket No. FDA–2017–N–6597]
Food and Drug Administration,
HHS.
■
§ 884.4350
Food and Drug Administration
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the tear electrostimulation
device 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 tear electrostimulation device’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
19, 2017. The classification was
applicable on April 24, 2017.
FOR FURTHER INFORMATION CONTACT:
Scott Steffen, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2574, Silver Spring,
MD 20993–0002, 240–402–8795,
Scott.Steffen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
Upon request, FDA has classified the
tear electrostimulation device 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 and part 807 (21
U.S.C. 360(k) and 21 CFR part 807,
respectively).
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).
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Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Rules and Regulations
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 July 7, 2016, Oculeve, Inc.,
submitted a request for De Novo
classification of the 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 generals controls,
provide reasonable assurance of the
60115
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 April 24, 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 886.5300. We
have named the generic type of device
tear electrostimulation device, and it is
identified as a non-implantable,
electrostimulation device intended to
increase tear production.
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—TEAR ELECTROSTIMULATION DEVICE RISKS AND MITIGATION MEASURES
Identified risks
Mitigation measures
Tissue damage due to over-stimulation/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.
Non-clinical performance testing; Electrical, thermal, and mechanical
safety testing; and Labeling.
Biocompatibility, 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.
Pain, headache, or discomfort .................................................................
Adverse tissue reaction ............................................................................
Infection ....................................................................................................
Electrical shock or burn ............................................................................
Interference with other devices ................................................................
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. In order 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.
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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
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18:11 Dec 18, 2017
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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,
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Fmt 4700
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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
is revised to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
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60116
Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Rules and Regulations
2. Add § 886.5300 to subpart F to read
as follows:
■
§ 886.5300
Tear electrostimulation device.
(a) Identification. A tear
electrostimulation device is a nonimplantable, electrostimulation device
intended to increase tear production.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) 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.
(2) Patient-contacting components of
the device must be demonstrated to be
biocompatible.
(3) Performance testing must
demonstrate the electrical, thermal, and
mechanical safety along with
electromagnetic compatibility (EMC) of
the device in the intended use
environment.
(4) Software verification, validation,
and hazard analysis must be performed.
(5) 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; and
(v) Instructions on how to clean the
device.
Dated: December 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–27280 Filed 12–18–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
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[Docket No. USCG–2017–1026]
Drawbridge Operation Regulation;
Newark Bay, Newark, NJ
Coast Guard, DHS.
Notice of deviation from
drawbridge regulations.
AGENCY:
ACTION:
The Coast Guard has issued a
temporary deviation from the operating
SUMMARY:
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16:00 Dec 18, 2017
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schedule that governs the Lehigh Valley
Railroad Bridge across the Newark Bay,
mile 4.3, at Newark, New Jersey. The
deviation is necessary to test a change
to the drawbridge operation schedule to
determine whether a permanent change
to the schedule is needed. This
deviation allows the Lehigh Valley RR
Bridge to operate under an alternate
schedule for ninety (90) days to alleviate
high volume of rail service across the
Lehigh Valley RR Bridge and to better
accommodate vessel traffic.
DATES: This deviation is effective from
12:01 a.m. on January 1, 2018 to 11:59
p.m. on March 31, 2018.
Comments and related material must
reach by the Coast Guard on or before
March 31, 2018.
ADDRESSES: You may submit comments
identified by docket number USCG–
2017–1026 using Federal eRulemaking
Portal at https://www.regulations.gov.
See the ‘‘Public Participation and
Request for Comments’’ portion of the
SUPPLEMENTARY INFORMATION section
below for instructions on submitting
comments.
signal if at least one hour advance
notice is given.
Vessels able to pass through the
bridge in the closed position may do so
at anytime. There are no alternate
routes. The bridge will be able to open
for emergencies.
The Coast Guard contacted the
waterway users regarding this proposed
temporary deviation to test a proposed
change to the Drawbridge Operation
Regulations and no objections were
received. The Coast Guard will also
inform the users of the waterways
through our Local and Broadcast
Notices to Mariners and other
appropriate local media of the change in
operating schedule for the bridge so that
vessel operators may arrange their
transits to minimize any impact caused
by the temporary deviation.
In accordance with 33 CFR 117.35(e),
the drawbridge must return to its regular
operating schedule immediately at the
end of the effective period of this
temporary deviation. This deviation
from the operating regulations is
authorized under 33 CFR 117.35.
If
you have questions on this temporary
deviation, call or email Judy K. LeungYee, Project Officer, First Coast Guard
District; telephone 212–514–4336, email
Judy.K.Leung-Yee@uscg.mil.
SUPPLEMENTARY INFORMATION:
II. Public Participation and Request for
Comments
FOR FURTHER INFORMATION CONTACT:
I. Background, Purpose and Legal Basis
The Lehigh Valley Railroad Bridge
across the Newark Bay, mile 4.3, at
Newark, New Jersey is a lift bridge with
a vertical clearance of 35 feet at mean
high water and 39 feet at mean low
water in the closed position. The
existing drawbridge operating
regulations are listed at 33 CFR 117.5
and 33 CFR 117.735.
The owner of the bridge, Consolidated
Rail Corporation, requested a change to
the Drawbridge Operation Regulations
because the volume of train traffic and
maneuvering of train movements from
the adjacent rail yard across the bridge
cause significant delays to marine
traffic.
The waterway users are seasonal
recreational vessels and commercial
vessels of various sizes.
The Coast Guard is publishing this
temporary deviation to test the proposed
regulation change to determine whether
a permanent change to the schedule is
necessary to better balance the needs of
marine and rail traffic.
Under this deviation, in effect from
12:01 a.m. on January 1, 2018 to 11:59
p.m. on March 31, 2018, the Lehigh
Valley Railroad Bridge will open on
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We view public participation as
essential to effective rulemaking, and
will consider all comments and material
received during the comment period.
Your comment can help shape the
outcome of this rulemaking. If you
submit a comment, please include the
docket number for this rulemaking,
indicating the specific section of this
document to which each comment
applies, and provide reason for each
suggestion or recommendation.
We encourage you to submit
comments through the Federal
eRulemaking Portal at https://
www.regulations.gov, contact the person
in the FOR FURTHER INFORMATION
CONTACT section of this document for
alternate instructions.
We accept anonymous comments. All
comments received will be posted
without change to https://
www.regulations.gov and will include
any person information you have
provided. For more about privacy and
the docket, visit https://
www.regulations.gov/privacynotice.
Documents mentioned in this notice
as being available in this docket and all
public comments, will be in our online
docket at https://www.regulations.gov
and can be viewed by following that
website’s instructions. Additionally, if
you go to the online docket and sign up
for email alerts, you will be notified
when comments are posted or a final
rule is published.
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Agencies
[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)]
[Rules and Regulations]
[Pages 60114-60116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27280]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 886
[Docket No. FDA-2017-N-6597]
Medical Devices; Ophthalmic Devices; Classification of the Tear
Electrostimulation Device
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the tear electrostimulation device 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 tear
electrostimulation device'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 19, 2017. The classification
was applicable on April 24, 2017.
FOR FURTHER INFORMATION CONTACT: Scott Steffen, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2574, Silver Spring, MD 20993-0002, 240-402-8795,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the tear electrostimulation device
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 and
part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
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).
[[Page 60115]]
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 July 7, 2016, Oculeve, Inc., submitted a request for De Novo
classification of the 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 generals 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 April 24, 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 886.5300. We have named
the generic type of device tear electrostimulation device, and it is
identified as a non-implantable, electrostimulation device intended to
increase tear production.
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--Tear Electrostimulation Device Risks and Mitigation Measures
------------------------------------------------------------------------
Identified risks Mitigation measures
------------------------------------------------------------------------
Tissue damage due to over-stimulation/ 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.
Pain, headache, or discomfort.......... Non-clinical performance
testing; Electrical, thermal,
and mechanical safety testing;
and Labeling.
Adverse tissue reaction................ Biocompatibility, 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.
------------------------------------------------------------------------
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. In order 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.
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 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
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1. The authority citation for part 886 is revised to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
[[Page 60116]]
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2. Add Sec. 886.5300 to subpart F to read as follows:
Sec. 886.5300 Tear electrostimulation device.
(a) Identification. A tear electrostimulation device is a non-
implantable, electrostimulation device intended to increase tear
production.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) 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.
(2) Patient-contacting components of the device must be
demonstrated to be biocompatible.
(3) Performance testing must demonstrate the electrical, thermal,
and mechanical safety along with electromagnetic compatibility (EMC) of
the device in the intended use environment.
(4) Software verification, validation, and hazard analysis must be
performed.
(5) 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; and
(v) Instructions on how to clean the device.
Dated: December 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27280 Filed 12-18-17; 8:45 am]
BILLING CODE 4164-01-P