[Federal Register Volume 84, Number 50 (Thursday, March 14, 2019)]
[Rules and Regulations]
[Pages 9228-9230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04709]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2019-N-0396]


Medical Devices; Neurological Devices; Classification of the 
Transcranial Magnetic Stimulation System for Neurological and 
Psychiatric Disorders and Conditions

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 transcranial magnetic stimulation system for neurological and 
psychiatric disorders and conditions into class II (special controls). 
The

[[Page 9229]]

special controls that apply to the device type are identified in this 
order and will be part of the codified language for the transcranial 
magnetic stimulation system for neurological and psychiatric disorders 
and conditions' 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 March 14, 2019. The classification was 
applicable on August 16, 2018.

FOR FURTHER INFORMATION CONTACT: John Doucet, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1535, Silver Spring, MD 20993-0002, 301-796-6474, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the transcranial magnetic 
stimulation system for neurological and psychiatric disorders and 
conditions 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) (21 U.S.C. 
360(k)) of the FD&C Act and part 807 (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 is required 
to 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 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 510(k) process, when 
necessary, to market their device.

II. De Novo Classification

    On September 29, 2017, Brainsway Ltd. submitted a request for De 
Novo classification of the Brainsway Deep Transcranial Magnetic 
Stimulation System. 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 August 16, 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 882.5802. We have named 
the generic type of device transcranial magnetic stimulation system for 
neurological and psychiatric disorders and conditions, and it is 
identified as a prescription, non-implantable device that uses brief 
duration, rapidly alternating, or pulsed, magnetic fields to induce 
neural activity in the cerebral cortex. It is not intended for applying 
or focusing magnetic fields towards brain areas outside cerebral cortex 
(e.g., cerebellum). A repetitive transcranial magnetic stimulation 
system that is intended to treat major depressive disorder is 
classified in Sec.  882.5805. A transcranial magnetic stimulation 
system for headache is classified in Sec.  882.5808.
    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.

[[Page 9230]]



 Table 1--Transcranial Magnetic Stimulation System for Neurological and
   Psychiatric Disorders and Conditions Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
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Seizure................................  Non-clinical performance
                                          testing, and Labeling.
Thermal injury.........................  Non-clinical performance
                                          testing; Thermal safety
                                          testing; Electrical safety
                                          testing; Software
                                          verification, validation, and
                                          hazard analysis; and Labeling.
Hearing loss...........................  Non-clinical performance
                                          testing, and Labeling.
Scalp discomfort, dizziness, nausea,     Labeling.
 pain in neck or jaw, headache, or
 other adverse effects due to treatment.
Adverse tissue reaction................  Biocompatibility evaluation,
                                          and Labeling.
Electrical shock.......................  Electrical safety testing, and
                                          Labeling.
Device failure due to interference with  Electromagnetic compatibility
 other devices.                           testing, Electrical safety
                                          testing, and Labeling.
------------------------------------------------------------------------

    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) of the FD&C Act.
    At the time of classification, transcranial magnetic stimulation 
systems for neurological and psychiatric disorders and conditions are 
for prescription use only. Prescription devices are exempt from the 
requirement for adequate directions for use for the layperson under 
section 502(f)(1) of the FD&C Act and 21 CFR 801.5, as long as the 
conditions of 21 CFR 801.109 are met (referring to 21 U.S.C. 
352(f)(1)).

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 820, regarding quality system regulation, have been 
approved under OMB control number 0910-0073; 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 part 801, regarding 
labeling, have been approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 882

    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 
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.  882.5802 to subpart F to read as follows:


Sec.  882.5802  Transcranial magnetic stimulation system for 
neurological and psychiatric disorders and conditions.

    (a) Identification. A transcranial magnetic stimulation system for 
neurological and psychiatric disorders and conditions is a 
prescription, non-implantable device that uses brief duration, rapidly 
alternating, or pulsed, magnetic fields to induce neural activity in 
the cerebral cortex. It is not intended for applying or focusing 
magnetic fields towards brain areas outside cerebral cortex (e.g., 
cerebellum). A repetitive transcranial magnetic stimulation system that 
is intended to treat major depressive disorder is classified in Sec.  
882.5805. A transcranial magnetic stimulation system for headache is 
classified in Sec.  882.5808.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Performance testing must demonstrate electromagnetic 
compatibility, electrical safety, and thermal safety.
    (2) Software verification, validation, and hazard analysis must be 
performed.
    (3) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (4) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be tested:
    (i) Magnetic pulse output testing;
    (ii) Magnetic and electrical field testing;
    (iii) Testing of the safety features built into the device; and
    (iv) Testing of the sound levels patients are exposed to during 
device use.
    (5) The physician and patient labeling must include the following:
    (i) The risks and benefits associated with use of the device;
    (ii) Detailed instructions to prevent seizures, to monitor the 
patient for seizure activity during treatment, and to provide seizure 
management care if one were to occur during treatment; and
    (iii) A description of the ear protection to be worn by the patient 
during use of the device, including the type of protection and its 
noise reduction rating.

    Dated: March 8, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04709 Filed 3-13-19; 8:45 am]
BILLING CODE 4164-01-P