[Federal Register Volume 79, Number 130 (Tuesday, July 8, 2014)]
[Rules and Regulations]
[Pages 38457-38459]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15876]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2014-M-0850]


Medical Devices; Neurological Devices; Classification of the 
Transcranial Magnetic Stimulator for Headache

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
transcranial magnetic stimulator for headache 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 transcranial magnetic stimulator for headache 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 August 7, 2014. The classification was 
applicable on December 13, 2013.

FOR FURTHER INFORMATION CONTACT: Michael Hoffmann, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1434, 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, 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) 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 will 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device.
    On March 1, 2013, Neuralieve (now eNeura Therapeutics LLC), 
submitted a request for classification of the NEURALIEVE CERENA 
Transcranial Magnetic Stimulator under section 513(f)(2) of the FD&C 
Act. The manufacturer recommended that the device be classified into 
class II (Ref. 1).
    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 de 
novo 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 13, 2013, FDA issued an order to the 
requester classifying the device into class II. FDA is codifying the 
classification of the device by adding Sec.  882.5808.
    Following the effective date of this final classification 
administrative order, any firm submitting a premarket notification 
(510(k)) for a transcranial magnetic stimulator for headache will need 
to comply with the special controls named in the final administrative 
order.
    The device is assigned the generic name transcranial magnetic 
stimulator for headache, and it is identified as a device that delivers 
brief duration, rapidly alternating, or pulsed, magnetic fields that 
are externally directed at spatially discrete regions of the brain to 
induce electrical currents for the treatment of headache.
    FDA has identified the following risks to health associated with 
this type of device and the measures required to mitigate these risks 
in table 1:

    Table 1--Transcranial Magnetic Stimulator for Headache Risks and
                           Mitigation Measures
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            Identified risks                   Mitigation measures
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Failure to identify correct population.  Clinical testing.
                                         Labeling.
Ineffective treatment..................  Clinical testing.
                                         Non-clinical testing.
                                         Software verification,
                                          validation, and hazard
                                          analysis.
                                         Labeling.

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Risk of seizure........................  Clinical testing.
                                         Non-clinical testing.
                                         Labeling.
Scalp discomfort, scalp burn,            Clinical testing.
 dizziness, nausea, or other adverse     Non-clinical testing.
 effects.                                Thermal safety.
                                         Software verification,
                                          validation, and hazard
                                          analysis.
                                         Labeling.
Adverse tissue reaction................  Biocompatibility.
                                         Labeling.
Electrical shock, burn.................  Electrical equipment safety.
                                         Thermal safety.
                                         Labeling.
Interference with other electrical       Electromagnetic compatibility.
 equipment.                              Labeling.
Noise irritation and hearing loss......  Non-clinical testing.
                                         Labeling.
------------------------------------------------------------------------

    FDA believes that the following special controls, in addition to 
the general controls, address these risks to health and provide 
reasonable assurance of safety and effectiveness:
     Appropriate analysis/testing must demonstrate 
electromagnetic compatibility, electrical safety, and thermal safety.
     Appropriate verification, validation, and hazard analysis 
must be performed on the device software and firmware.
     The elements of the device that contact the patient must 
be assessed to be biocompatible.
     Non-clinical testing data must demonstrate that the device 
performs as intended under anticipated conditions of use. This includes 
full characterization of the magnetic pulse output and resulting 
magnetic field map. This also includes characterization of the sound 
level of the device during use.
     Clinical testing must demonstrate that the device is safe 
and effective for treating headache in the indicated patient 
population.
     The physician and patient labeling must include the 
following:
    [cir] A summary of the clinical performance testing, including any 
adverse events and complications;
    [cir] The intended use population in terms of the types of 
headaches appropriate for use with the device;
    [cir] Information on how to report adverse events and device 
malfunctions; and
    [cir] A diagram or picture depicting the proper placement of the 
device on the user.
    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 premarket 
notification is necessary to provide reasonable assurance of the safety 
and effectiveness of the device. Therefore, this device type is not 
exempt from premarket notification requirements. Persons who intend to 
market this type of device must submit to FDA a premarket notification 
prior to marketing the device, which contains information about the 
transcranial magnetic stimulator for headache they intend to market.

II. 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 administrative 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.

IV. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and is available electronically at http://www.regulations.gov.

1. K130556 De Novo Petition for the NEURALIEVE CERENA Transcranial 
Magnetic Stimulator From Neuralieve, dated March 1, 2013.

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 21 CFR part 882 continues to read as 
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.


0
2. Add Sec.  882.5808 to subpart F to read as follows:


Sec.  882.5808  Transcranial magnetic stimulator for headache.

    (a) Identification. A transcranial magnetic stimulator device for 
headache is a device that delivers brief duration, rapidly alternating, 
or pulsed, magnetic fields that are externally directed at spatially 
discrete regions of the brain to induce electrical currents for the 
treatment of headache.

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    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Appropriate analysis/testing must demonstrate electromagnetic 
compatibility, electrical safety, and thermal safety.
    (2) Appropriate verification, validation, and hazard analysis must 
be performed on the device software and firmware.
    (3) The elements of the device that contact the patient must be 
assessed to be biocompatible.
    (4) Non-clinical testing data must demonstrate that the device 
performs as intended under anticipated conditions of use. This includes 
full characterization of the magnetic pulse output and resulting 
magnetic field map. This also includes characterization of the sound 
level of the device during use.
    (5) Clinical testing must demonstrate that the device is safe and 
effective for treating headache in the indicated patient population.
    (6) The physician and patient labeling must include the following:
    (i) A summary of the clinical performance testing, including any 
adverse events and complications.
    (ii) The intended use population in terms of the types of headaches 
appropriate for use with the device.
    (iii) Information on how to report adverse events and device 
malfunctions.
    (iv) A diagram or picture depicting the proper placement of the 
device on the user.

    Dated: July 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15876 Filed 7-7-14; 8:45 am]
BILLING CODE 4164-01-P