[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]


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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.

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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, [email protected].

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
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              Identified risks                    Mitigation measure
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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