Medical Devices; Neurological Devices, Classification of the Vibratory Counter-Stimulation Device, 13553-13554 [2017-04939]
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Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Rules and Regulations
reference source shall have sequence
generated independently of the
manufacturer with respect to technology
and analysis. Percent agreement and
percent disagreement with the reference
sequences must be described for all
regions queried by the instrument.
(C) If applicable, data describing
endogenous or exogenous substances
that may interfere with the instrument
system.
(D) If applicable, data demonstrating
the ability of the system to consistently
generate an accurate result for a given
sample across different indexing primer
combinations.
(ix) The upper and lower limit of
input nucleic acid that will achieve the
claimed accuracy and reproducibility.
Data supporting such claims must also
be summarized.
Dated: March 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–04941 Filed 3–13–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 882
[Docket No. FDA–2017–N–1123]
Medical Devices; Neurological
Devices, Classification of the Vibratory
Counter-Stimulation Device
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA) is classifying the
vibratory counter-stimulation device
into class II (special controls). The
special controls that will apply to the
device are identified in this order and
will be part of the codified language for
the vibratory counter-stimulation
device’s classification. The Agency is
classifying the device into class II
(special controls) in order to provide a
reasonable assurance of safety and
effectiveness of the device.
DATES: This order is effective March 14,
2017. The classification was applicable
on December 18, 2013.
FOR FURTHER INFORMATION CONTACT:
Michael Hoffmann, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2640, Silver Spring,
MD 20993–0002, 301–796–6476,
michael.hoffmann@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
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I. Background
In accordance with section 513(f)(1) of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C.
360c(f)(1)), devices that were not in
commercial distribution before May 28,
1976 (the date of enactment of the
Medical Device Amendments of 1976),
generally referred to as postamendments
devices, are classified automatically by
statute into class III without any FDA
rulemaking process. These devices
remain in class III and require
premarket approval unless and until the
device is classified or reclassified into
class I or II, or FDA issues an order
finding the device to be substantially
equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate
device that does not require premarket
approval. The Agency determines
whether new devices are substantially
equivalent to predicate devices by
means of premarket notification
procedures in section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part
807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act,
also known as De Novo classification, as
amended by section 607 of the Food and
Drug Administration Safety and
Innovation Act (Pub. L. 112–144),
provides two procedures by which a
person may request FDA to classify a
device under the criteria set forth in
section 513(a)(1). Under the first
procedure, the person submits a
premarket notification under section
510(k) of the FD&C Act for a device that
has not previously been classified and,
within 30 days of receiving an order
classifying the device into class III
under section 513(f)(1) of the FD&C Act,
the person requests a classification
under section 513(f)(2). Under the
second procedure, rather than first
submitting a premarket notification
under section 510(k) of the FD&C Act
and then a request for classification
under the first procedure, the person
determines that there is no legally
marketed device upon which to base a
determination of substantial
equivalence and requests a classification
under section 513(f)(2) of the FD&C Act.
If the person submits a request to
classify the device under this second
procedure, FDA may decline to
undertake the classification request if
FDA identifies a legally marketed device
that could provide a reasonable basis for
review of substantial equivalence with
the device or if FDA determines that the
device submitted is not of ‘‘lowmoderate risk’’ or that general controls
would be inadequate to control the risks
and special controls to mitigate the risks
cannot be developed.
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Fmt 4700
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13553
In response to a request to classify a
device under either procedure provided
by section 513(f)(2) of the FD&C Act,
FDA shall classify the device by written
order within 120 days. This
classification will be the initial
classification of the device. In
accordance with section 513(f)(1) of the
FD&C Act, FDA issued an order on June
14, 2011, classifying the Symphony
Device into class III, because it was not
substantially equivalent to a device that
was introduced or delivered for
introduction into interstate commerce
for commercial distribution before May
28, 1976, or a device which was
subsequently reclassified into class I or
class II.
On July 13, 2011, Sensory Medical,
Inc. submitted a request for
classification of the Symphony Device
under section 513(f)(2) of the FD&C Act.
In accordance with section 513(f)(2) of
the FD&C Act, FDA reviewed the
request in order to classify the device
under the criteria for classification set
forth in section 513(a)(1). FDA classifies
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
to provide reasonable assurance of the
safety and effectiveness of the device for
its intended use. After review of the
information submitted in the request,
FDA determined that the device can be
classified into class II with the
establishment of special controls. FDA
believes these special controls, in
addition to general controls, will
provide reasonable assurance of the
safety and effectiveness of the device.
Therefore, on December 18, 2013,
FDA issued an order to the requestor
classifying the device into class II. FDA
is codifying the classification of the
device by adding 21 CFR 882.5895.
Following the effective date of this
final classification order, any firm
submitting a premarket notification
(510(k)) for a vibratory counterstimulation device will need to comply
with the special controls named in this
final order. A De Novo classification
decreases regulatory burdens. When
FDA classifies a device type as class I
or II via the De Novo pathway, other
manufacturers do not have to submit a
De Novo request or PMA in order to
market the same type of device, unless
the device has a new intended use or
technological characteristics that raise
different questions of safety or
effectiveness. Instead, manufacturers
can use the less burdensome pathway of
510(k), when necessary, to market their
device, and the device that was the
subject of the original De Novo
E:\FR\FM\14MRR1.SGM
14MRR1
13554
Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Rules and Regulations
classification can serve as a predicate
device for additional 510(k)s from other
manufacturers.
The device is assigned the generic
name vibratory counter-stimulation
device, and it is identified as a
prescription device that provides
electrically powered mechanical
vibration to improve the quality of sleep
in patients with primary Restless Legs
Syndrome.
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—VIBRATORY COUNTER-STIMULATION DEVICE RISKS AND MITIGATION MEASURES
Identified risks
Mitigation measure
Pain, discomfort, worsening of Restless Legs Syndrome symptoms .............................................
Electrical shock ................................................................................................................................
Burns ...............................................................................................................................................
Adverse skin reactions ....................................................................................................................
Interference with other medical devices ..........................................................................................
Non-clinical testing, Software testing, Labeling.
Electrical safety testing, Labeling.
Electrical and thermal safety testing, Labeling.
Biocompatibility assessment, Labeling.
Electromagnetic compatibility testing, Labeling.
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.
intended under anticipated conditions
of use.
(5) Labeling must include:
(i) Specific information pertinent to
use of the device by the intended
patient population and the treatment
regimen;
(ii) Warning to only use the device on
normal, intact, clean, healthy skin;
(iii) Warning to not use the device if
the user has leg skin disorders, such as
eczema, psoriasis, cellulitis, non-healing
wounds;
(iv) Warning to discontinue use if
Restless Leg Syndrome symptoms
worsen; and
(v) Instructions for end users to
contact the device manufacturer and
MedWatch in case they experience any
adverse events when using this device.
FDA believes that special controls, in
combination with the general controls,
address these risks to health and
provide reasonable assurance of the
safety and effectiveness.
Vibratory counter-stimulation devices
are not safe for use except under the
supervision of a practitioner licensed by
law to direct the use of the device. As
such, the device is a prescription device
and must satisfy prescription labeling
requirements (see 21 CFR 801.109,
Prescription devices).
Section 510(m) of the FD&C Act
provides that FDA may exempt a class
II device from the premarket notification
requirements under section 510(k), if
FDA determines that premarket
notification is not necessary to provide
reasonable assurance of the safety and
effectiveness of the device. For this type
of device, FDA has determined that the
device is not exempt from the premarket
notification requirements of the FD&C
Act. Persons who intend to market this
type of device must submit a premarket
notification (510(k)), prior to marketing
the device, which contains information
on the vibratory counter-stimulation
device they intend to market.
II. 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.
rmajette on DSK30RV082PROD with RULES
III. 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
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Jkt 241001
List of Subjects in 21 CFR Part 882
Medical devices, Neurological
devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 882 is
amended as follows:
PART 882—NEUROLOGICAL DEVICES
1. The authority citation for part 882
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 882.5895 to subpart F to read
as follows:
■
Dated: March 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–04939 Filed 3–13–17; 8:45 am]
BILLING CODE 4164–01–P
§ 882.5895
device.
Vibratory counter-stimulation
(a) Identification. A vibratory counterstimulation device is a prescription
device that provides electrically
powered mechanical vibration to
improve the quality of sleep in patients
with primary Restless Legs Syndrome.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Appropriate analysis/testing must
demonstrate electromagnetic
compatibility (EMC), electrical safety,
and thermal safety.
(2) If the device contains software or
firmware, appropriate verification,
validation, and hazard analysis must be
performed.
(3) The elements of the device that
contact the patient must be assessed to
be biocompatible.
(4) Non-clinical testing data
(including vibration frequency,
amplitude, and acceleration) must
demonstrate that the device performs as
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Fmt 4700
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COURT SERVICES AND OFFENDER
SUPERVISION AGENCY FOR THE
DISTRICT OF COLUMBIA
28 CFR Part 802
RIN 3225–AA12
Revision of Regulations Governing
Freedom of Information Act Requests
Court Services and Offender
Supervision Agency for the District of
Columbia.
ACTION: Interim final rule.
AGENCY:
This interim final rule
updates and clarifies the procedures for
submitting Freedom of Information Act
(FOIA) requests as required under the
FOIA Improvement Act of 2016 (the
2016 Act) which was signed into law by
the President on June 30, 2016. This
rule makes the procedural changes
necessitated by the 2016 Act, including
SUMMARY:
E:\FR\FM\14MRR1.SGM
14MRR1
Agencies
[Federal Register Volume 82, Number 48 (Tuesday, March 14, 2017)]
[Rules and Regulations]
[Pages 13553-13554]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04939]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 882
[Docket No. FDA-2017-N-1123]
Medical Devices; Neurological Devices, Classification of the
Vibratory Counter-Stimulation Device
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is classifying the
vibratory counter-stimulation device into class II (special controls).
The special controls that will apply to the device are identified in
this order and will be part of the codified language for the vibratory
counter-stimulation device's classification. The Agency is classifying
the device into class II (special controls) in order to provide a
reasonable assurance of safety and effectiveness of the device.
DATES: This order is effective March 14, 2017. The classification was
applicable on December 18, 2013.
FOR FURTHER INFORMATION CONTACT: Michael Hoffmann, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2640, Silver Spring, MD 20993-0002, 301-
796-6476, michael.hoffmann@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval unless and until the device
is classified or reclassified into class I or II, or FDA issues an
order finding the device to be substantially equivalent, in accordance
with section 513(i) of the FD&C Act, to a predicate device that does
not require premarket approval. The Agency determines whether new
devices are substantially equivalent to predicate devices by means of
premarket notification procedures in section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act, also known as De Novo
classification, as amended by section 607 of the Food and Drug
Administration Safety and Innovation Act (Pub. L. 112-144), provides
two procedures by which a person may request FDA to classify a device
under the criteria set forth in section 513(a)(1). Under the first
procedure, the person submits a premarket notification under section
510(k) of the FD&C Act for a device that has not previously been
classified and, within 30 days of receiving an order classifying the
device into class III under section 513(f)(1) of the FD&C Act, the
person requests a classification under section 513(f)(2). Under the
second procedure, rather than first submitting a premarket notification
under section 510(k) of the FD&C Act and then a request for
classification under the first procedure, the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence and requests a classification under section
513(f)(2) of the FD&C Act. If the person submits a request to classify
the device under this second procedure, FDA may decline to undertake
the classification request if FDA identifies a legally marketed device
that could provide a reasonable basis for review of substantial
equivalence with the device or if FDA determines that the device
submitted is not of ``low-moderate risk'' or that general controls
would be inadequate to control the risks and special controls to
mitigate the risks cannot be developed.
In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA shall
classify the device by written order within 120 days. This
classification will be the initial classification of the device. In
accordance with section 513(f)(1) of the FD&C Act, FDA issued an order
on June 14, 2011, classifying the Symphony Device into class III,
because it was not substantially equivalent to a device that was
introduced or delivered for introduction into interstate commerce for
commercial distribution before May 28, 1976, or a device which was
subsequently reclassified into class I or class II.
On July 13, 2011, Sensory Medical, Inc. submitted a request for
classification of the Symphony Device under section 513(f)(2) of the
FD&C Act.
In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1). FDA classifies 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 to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. After review of the information submitted in the
request, FDA determined that the device can be classified into class II
with the establishment of special controls. FDA believes these special
controls, in addition to general controls, will provide reasonable
assurance of the safety and effectiveness of the device.
Therefore, on December 18, 2013, FDA issued an order to the
requestor classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 882.5895.
Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for a vibratory
counter-stimulation device will need to comply with the special
controls named in this final order. A De Novo classification decreases
regulatory burdens. When FDA classifies a device type as class I or II
via the De Novo pathway, other manufacturers do not have to submit a De
Novo request or PMA in order to market the same type of device, unless
the device has a new intended use or technological characteristics that
raise different questions of safety or effectiveness. Instead,
manufacturers can use the less burdensome pathway of 510(k), when
necessary, to market their device, and the device that was the subject
of the original De Novo
[[Page 13554]]
classification can serve as a predicate device for additional 510(k)s
from other manufacturers.
The device is assigned the generic name vibratory counter-
stimulation device, and it is identified as a prescription device that
provides electrically powered mechanical vibration to improve the
quality of sleep in patients with primary Restless Legs Syndrome.
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--Vibratory Counter-Stimulation Device Risks and Mitigation
Measures
------------------------------------------------------------------------
Identified risks Mitigation measure
------------------------------------------------------------------------
Pain, discomfort, worsening of Restless Non-clinical testing,
Legs Syndrome symptoms. Software testing,
Labeling.
Electrical shock........................... Electrical safety testing,
Labeling.
Burns...................................... Electrical and thermal
safety testing, Labeling.
Adverse skin reactions..................... Biocompatibility
assessment, Labeling.
Interference with other medical devices.... Electromagnetic
compatibility testing,
Labeling.
------------------------------------------------------------------------
FDA believes that special controls, in combination with the general
controls, address these risks to health and provide reasonable
assurance of the safety and effectiveness.
Vibratory counter-stimulation devices are not safe for use except
under the supervision of a practitioner licensed by law to direct the
use of the device. As such, the device is a prescription device and
must satisfy prescription labeling requirements (see 21 CFR 801.109,
Prescription devices).
Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k), if FDA determines that premarket notification is not necessary
to provide reasonable assurance of the safety and effectiveness of the
device. For this type of device, FDA has determined that the device is
not exempt from the premarket notification requirements of the FD&C
Act. Persons who intend to market this type of device must submit a
premarket notification (510(k)), prior to marketing the device, which
contains information on the vibratory counter-stimulation device they
intend to market.
II. 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.
III. 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
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, Neurological devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
882 is amended as follows:
PART 882--NEUROLOGICAL DEVICES
0
1. The authority citation for part 882 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 882.5895 to subpart F to read as follows:
Sec. 882.5895 Vibratory counter-stimulation device.
(a) Identification. A vibratory counter-stimulation device is a
prescription device that provides electrically powered mechanical
vibration to improve the quality of sleep in patients with primary
Restless Legs Syndrome.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Appropriate analysis/testing must demonstrate electromagnetic
compatibility (EMC), electrical safety, and thermal safety.
(2) If the device contains software or firmware, appropriate
verification, validation, and hazard analysis must be performed.
(3) The elements of the device that contact the patient must be
assessed to be biocompatible.
(4) Non-clinical testing data (including vibration frequency,
amplitude, and acceleration) must demonstrate that the device performs
as intended under anticipated conditions of use.
(5) Labeling must include:
(i) Specific information pertinent to use of the device by the
intended patient population and the treatment regimen;
(ii) Warning to only use the device on normal, intact, clean,
healthy skin;
(iii) Warning to not use the device if the user has leg skin
disorders, such as eczema, psoriasis, cellulitis, non-healing wounds;
(iv) Warning to discontinue use if Restless Leg Syndrome symptoms
worsen; and
(v) Instructions for end users to contact the device manufacturer
and MedWatch in case they experience any adverse events when using this
device.
Dated: March 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-04939 Filed 3-13-17; 8:45 am]
BILLING CODE 4164-01-P