[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.
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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) 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