[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Rules and Regulations]
[Pages 50080-50082]
[FR Doc No: 2017-23516]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2017-N-5934]

Medical Devices; Neurological Devices; Classification of the Non-
Electroencephalogram Physiological Signal Based Seizure Monitoring
System

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 non-electroencephalogram (non-EEG) physiological signal based
seizure monitoring system 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 non-EEG physiological
signal based seizure monitoring system's 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 October 30, 2017. The classification was
applicable on February 16, 2017.

FOR FURTHER INFORMATION CONTACT: Xiaorui Tang, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2609, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the non-EEG physiological signal
based seizure monitoring system 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 (the 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 (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. 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 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 November 10, 2014, Brain Sentinel, Inc., submitted a request for
De Novo classification of the Brain Sentinel Monitoring and Alerting
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 general controls, will provide reasonable assurance of the
safety and effectiveness of the device.
    Therefore, on February 16, 2017, 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 882.1580. We have named
the generic type of device non-EEG physiological signal based seizure
monitoring system, and it is identified as a noninvasive prescription
device that collects physiological signals other than EEG to identify
physiological signals that may be associated with a seizure.
    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--Non-EEG Physiological Signal Based Seizure Monitoring System
                      Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
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Adverse tissue reaction................  Biocompatibility evaluation.
Equipment malfunction leading to injury  Electrical safety, thermal, and
 to users (shock, burn).                  mechanical testing;
                                         Electromagnetic compatibility
                                          testing; and
                                         Labeling.
Interference with or from other          Electromagnetic compatibility
 electrical devices.                      testing.

Incorrect alerts, including:             ...............................
     Missing a seizure--device   Clinical performance testing;
     fails to identify physiological     Non-clinical performance
     signal that is associated with a     testing;
     seizure; or.                        Software verification,
     False alarm--device          validation, and hazard
     mistakenly identifies a              analysis;
     physiological signal as being       Labeling; and
     associated with a seizure.          Training.
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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 the 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, non-EEG physiological signal based
seizure monitoring systems 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 (21 U.S.C.
352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR
801.109 are met.

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. 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.

    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.  882.1580 to subpart B to read as follows:

Sec.  882.1580   Non-electroencephalogram (EEG) physiological signal
based seizure monitoring system.

    (a) Identification. A non-electroencephalogram (non-EEG)
physiological signal based seizure monitoring system is a noninvasive
prescription device that collects physiological signals other than EEG
to identify physiological signals that may be associated with a
seizure.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The technical parameters of the device, hardware and software,
must be fully characterized and include the following information:
    (i) Hardware specifications must be provided. Appropriate
verification, validation, and hazard analysis must be performed.
    (ii) Software, including any proprietary algorithm(s) used by the
device to achieve its intended use, must be described in detail in the
Software Requirements Specification (SRS) and Software Design
Specification (SDS). Appropriate software verification, validation, and
hazard analysis must be performed.
    (2) The patient-contacting components of the device must be
demonstrated to be biocompatible.
    (3) The device must be designed and tested for electrical, thermal,
and mechanical safety and electromagnetic compatibility (EMC).
    (4) Clinical performance testing must demonstrate the ability of
the device to function as an assessment aid for monitoring for seizure-
related activity in the intended population and for the intended use
setting. Performance measurements must include positive percent
agreement and false alarm rate.
    (5) Training must be provided for intended users that includes
information regarding the proper use of the device and factors that may
affect the collection of the physiologic data.
    (6) The labeling must include health care professional labeling and
patient-caregiver labeling. The health care professional and the
patient-caregiver labeling must include the following information:
    (i) A detailed summary of the clinical performance testing,
including any adverse events and complications.
    (ii) Any instructions technicians and clinicians should convey to
patients and caregivers regarding the proper use of the device and
factors that may affect the collection of the physiologic data.
    (iii) Instructions to technicians and clinicians regarding how to
set the device threshold to achieve the intended performance of the
device.

    Dated: October 24, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017-23516 Filed 10-27-17; 8:45 am]
 BILLING CODE 4164-01-P