[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Rules and Regulations]
[Pages 50080-50082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

[[Page 50081]]

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, 301-796-6500, 
[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.

[[Page 50082]]

 
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.
------------------------------------------------------------------------

    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