Medical Devices; General and Plastic Surgery Devices; Classification of the Light Based Energy Source Device for Topical Application, 52968-52970 [2018-22786]
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52968
Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Rules and Regulations
List of Subjects in 21 CFR Part 878
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, part 878 is amended
as follows:
PART 878—GENERAL AND PLASTIC
SURGERY DEVICES
1. The authority citation for part 878
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 878.4165 to subpart E to read
as follows:
■
§ 878.4165 Wound autofluorescence
imaging device.
(a) Identification. A wound
autofluorescence imaging device is a
tool to view autofluorescence images
from skin wounds that are exposed to an
excitation light. The device is not
intended to provide quantitative or
diagnostic information.
(b) Classification. Class I (general
controls). The device is exempt from the
premarket notification procedures in
subpart E of part 807 of this chapter,
subject to the limitations in § 878.9.
Dated: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–22837 Filed 10–18–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA–2018–N–3598]
Medical Devices; General and Plastic
Surgery Devices; Classification of the
Light Based Energy Source Device for
Topical Application
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the light based energy source
device for topical application 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 light
based energy source device for topical
application’s classification. We are
taking this action because we have
determined that classifying the device
amozie on DSK3GDR082PROD with RULES
SUMMARY:
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16:11 Oct 18, 2018
Jkt 247001
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 October 18, 2012.
FOR FURTHER INFORMATION CONTACT: Neil
Ogden, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G414, Silver Spring,
MD, 20993–0002, 301–796–6397,
Neil.Ogden@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the
light based energy source device for
topical application 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
PO 00000
Frm 00026
Fmt 4700
Sfmt 4700
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 (PMA) 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
For this device, FDA issued an order
on June 10, 2009, finding the ViruLite
Cold Sore Machine not substantially
equivalent to a predicate not subject to
PMA. Thus, the device remained in
class III in accordance with section
513(f)(1) of the FD&C Act when we
issued the order.
On June 30, 2009, Pacer Therapeutics,
Ltd. submitted a request for De Novo
classification of the ViruLite Cold Sore
Machine. FDA reviewed the request in
E:\FR\FM\19OCR1.SGM
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Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Rules and Regulations
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 October 18, 2012, 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 878.4860. We
52969
have named the generic type of device
light based energy source device for
topical application, and it is identified
as a device that emits light energy at
near infrared spectrum and is applied
externally to the surface of herpes
simplex labialis lesions on or around
the lips.
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—LIGHT BASED ENERGY SOURCE DEVICE FOR TOPICAL APPLICATION RISKS AND MITIGATION MEASURES
Identified risks
Mitigation measures
Redness and discomfort ...........................................................................
Burns and blisters .....................................................................................
Adverse tissue reaction ............................................................................
Infection/transmissibility ............................................................................
Electrical shock .........................................................................................
Electromagnetic incompatibility ................................................................
User error .................................................................................................
Ocular injury .............................................................................................
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.
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
number 0910–0844; the collections of
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Clinical performance testing, Usability testing, and Labeling.
Clinical performance testing, Usability testing, and Labeling.
Biocompatibility evaluation.
Labeling, Cleaning and disinfection validation, and Usability testing.
Electrical safety testing and Labeling.
Electromagnetic compatibility testing and Labeling.
Usability testing and Labeling.
Labeling and Non-clinical performance testing for ocular safety.
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 878
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 878 is
amended as follows:
PART 878—GENERAL AND PLASTIC
SURGERY DEVICES
1. The authority citation for part 878
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 878.4860 to subpart E to read
as follows:
■
§ 878.4860 Light based energy source
device for topical application.
(a) Identification. The device emits
light energy at near infrared spectrum
and is applied externally to the surface
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Frm 00027
Fmt 4700
Sfmt 4700
of herpes simplex labialis lesions on or
around the lips.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) The technical parameters of the
device, including wavelength, treatment
time, treatment area, energy density,
spot size, and power, must be
characterized.
(2) The cleaning and disinfection
instructions for the device must be
validated.
(3) The device must be demonstrated
to be biocompatible.
(4) Performance testing must validate
electromagnetic compatibility (EMC),
ocular safety, and electrical safety of the
device.
(5) Labeling must direct end-users to
contact the device manufacturer and
MedWatch if they experience any
adverse events when using this device.
(6) Labeling must include specific
information pertinent to use of the
device by the intended patient
population and the treatment regimen.
(7) Simulated use testing must
include information from a usability,
label comprehension and self-selection
study to demonstrate that the device can
be used by the intended patient
population without any assistance.
(8) Clinical data must show adequate
reduction in time to healing and assess
risks of redness, discomfort, burns, and
blisters.
E:\FR\FM\19OCR1.SGM
19OCR1
52970
Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Rules and Regulations
Dated: October 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–22786 Filed 10–18–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA–2018–N–3595]
Medical Devices; General and Plastic
Surgery Devices; Classification of the
Hemostatic Device for Intraluminal
Gastrointestinal Use
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the hemostatic device for
intraluminal gastrointestinal use 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
hemostatic device for intraluminal
gastrointestinal use’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 October
19, 2018. The classification was
applicable on May 7, 2018.
FOR FURTHER INFORMATION CONTACT:
Maegen Colehour, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G423, Silver Spring,
MD, 20993–0002, 301–796–6436,
Maegen.Colehour@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
amozie on DSK3GDR082PROD with RULES
I. Background
Upon request, FDA has classified the
hemostatic device for intraluminal
gastrointestinal use 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.
VerDate Sep<11>2014
16:11 Oct 18, 2018
Jkt 247001
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 is required to
classify the device by written order
within 120 days. The classification will
be according to the criteria under
PO 00000
Frm 00028
Fmt 4700
Sfmt 4700
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 March 9, 2017, Wilson-Cook
Medical, Inc. submitted a request for De
Novo classification of the Hemospray®
Endoscopic Hemostat. 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 7, 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 878.4456. We
have named the generic type of device
hemostatic device for intraluminal
gastrointestinal use, and it is identified
as a prescription device that is
endoscopically applied to the upper
and/or lower gastrointestinal tract and is
intended to produce hemostasis via
absorption of fluid or by other means.
FDA has identified the following risks
to health associated specifically with
this type of device and the measures
E:\FR\FM\19OCR1.SGM
19OCR1
]]>Agencies
[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)]
[Rules and Regulations]
[Pages 52968-52970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22786]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA-2018-N-3598]
Medical Devices; General and Plastic Surgery Devices;
Classification of the Light Based Energy Source Device for Topical
Application
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the light based energy source device for topical application 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 light based energy source device for topical
application'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 October 19, 2018. The classification was
applicable on October 18, 2012.
FOR FURTHER INFORMATION CONTACT: Neil Ogden, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G414, Silver Spring, MD, 20993-0002, 301-796-6397,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the light based energy source
device for topical application 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 (PMA) 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
For this device, FDA issued an order on June 10, 2009, finding the
ViruLite Cold Sore Machine not substantially equivalent to a predicate
not subject to PMA. Thus, the device remained in class III in
accordance with section 513(f)(1) of the FD&C Act when we issued the
order.
On June 30, 2009, Pacer Therapeutics, Ltd. submitted a request for
De Novo classification of the ViruLite Cold Sore Machine. FDA reviewed
the request in
[[Page 52969]]
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 October 18, 2012, 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 878.4860. We have named
the generic type of device light based energy source device for topical
application, and it is identified as a device that emits light energy
at near infrared spectrum and is applied externally to the surface of
herpes simplex labialis lesions on or around the lips.
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--Light Based Energy Source Device for Topical Application Risks
and Mitigation Measures
------------------------------------------------------------------------
Identified risks Mitigation measures
------------------------------------------------------------------------
Redness and discomfort................. Clinical performance testing,
Usability testing, and
Labeling.
Burns and blisters..................... Clinical performance testing,
Usability testing, and
Labeling.
Adverse tissue reaction................ Biocompatibility evaluation.
Infection/transmissibility............. Labeling, Cleaning and
disinfection validation, and
Usability testing.
Electrical shock....................... Electrical safety testing and
Labeling.
Electromagnetic incompatibility........ Electromagnetic compatibility
testing and Labeling.
User error............................. Usability testing and Labeling.
Ocular injury.......................... Labeling and Non-clinical
performance testing for ocular
safety.
------------------------------------------------------------------------
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.
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 878
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
878 is amended as follows:
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
0
1. The authority citation for part 878 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 878.4860 to subpart E to read as follows:
Sec. 878.4860 Light based energy source device for topical
application.
(a) Identification. The device emits light energy at near infrared
spectrum and is applied externally to the surface of herpes simplex
labialis lesions on or around the lips.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) The technical parameters of the device, including wavelength,
treatment time, treatment area, energy density, spot size, and power,
must be characterized.
(2) The cleaning and disinfection instructions for the device must
be validated.
(3) The device must be demonstrated to be biocompatible.
(4) Performance testing must validate electromagnetic compatibility
(EMC), ocular safety, and electrical safety of the device.
(5) Labeling must direct end-users to contact the device
manufacturer and MedWatch if they experience any adverse events when
using this device.
(6) Labeling must include specific information pertinent to use of
the device by the intended patient population and the treatment
regimen.
(7) Simulated use testing must include information from a
usability, label comprehension and self-selection study to demonstrate
that the device can be used by the intended patient population without
any assistance.
(8) Clinical data must show adequate reduction in time to healing
and assess risks of redness, discomfort, burns, and blisters.
[[Page 52970]]
Dated: October 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22786 Filed 10-18-18; 8:45 am]
BILLING CODE 4164-01-P
