[Federal Register Volume 83, Number 24 (Monday, February 5, 2018)]
[Rules and Regulations]
[Pages 5033-5035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02202]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2018-N-0371]


Medical Devices; Neurological Devices; Classification of the 
Percutaneous Nerve Stimulator for Substance Use Disorders

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the percutaneous nerve stimulator for substance use disorders 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 percutaneous nerve stimulator for substance 
use disorders' 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 February 5, 2018. The classification was 
applicable on November 15, 2017.

FOR FURTHER INFORMATION CONTACT: Eric Franca, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2684, Silver Spring, MD 20993-0002, 301-796-6285, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the percutaneous nerve stimulator 
for substance use disorders 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 to a predicate device that does not require 
premarket approval (see 21 U.S.C. 360c(i)). 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).
    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

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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 March 17, 2017, Innovative Health Solutions, Inc., submitted a 
request for De Novo classification of the NSS-2 BRIDGE. 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 November 15, 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 882.5896. We have named 
the generic type of device percutaneous nerve stimulator for substance 
use disorders, and it is identified as a device that stimulates nerves 
percutaneously to aid in the reduction of withdrawal symptoms 
associated with substance use disorders.
    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--Percutaneous Nerve Stimulator for Substance Use Disorders Risks
                         and Mitigation Measures
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       Identified risks                   Mitigation measures
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Adverse tissue reaction......  Biocompatibility evaluation and Labeling.
Electrical, mechanical, or     Electromagnetic compatibility testing;
 thermal hazards leading to     Electrical, mechanical, and thermal
 user discomfort or injury.     safety testing; Non-clinical performance
                                testing; Software verification,
                                validation, and hazard analysis; and
                                Labeling.
Infection....................  Sterility testing, Shelf life testing,
                                and Labeling.
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    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).

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 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 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 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.  882.5896 to subpart F to read as follows:


Sec.  882.5896  Percutaneous nerve stimulator for substance use 
disorders.

    (a) Identification. A percutaneous nerve stimulator for substance 
use disorders is a device that stimulates nerves percutaneously to aid 
in the reduction of withdrawal symptoms associated with substance use 
disorders.
    (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) Electromagnetic compatibility and electrical, mechanical, and 
thermal safety testing must be performed.
    (3) Electrical performance testing of the device and electrodes 
must be conducted to validate the specified electrical output and 
duration of stimulation of the device.
    (4) Software verification, validation, and hazard analysis must be 
performed.
    (5) Sterility testing of the percutaneous components of the device 
must be performed.
    (6) Shelf life testing must be performed to demonstrate continued

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sterility, package integrity, and device functionality over the 
specified shelf life.
    (7) Labeling must include the following:
    (i) A detailed summary of the device technical parameters;
    (ii) A warning stating that the device is only for use on clean, 
intact skin;
    (iii) Instructions for use, including placement of the device on 
the patient; and
    (iv) A shelf life.

    Dated: January 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02202 Filed 2-2-18; 8:45 am]
 BILLING CODE 4164-01-P