[Federal Register Volume 88, Number 4 (Friday, January 6, 2023)]
[Rules and Regulations]
[Pages 981-983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00007]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

[Docket No. FDA-2022-N-3131]


Medical Devices; Physical Medicine Devices; Classification of the 
Electroencephalography-Driven Upper Extremity Powered Exerciser

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
classifying the electroencephalography (EEG)-driven upper extremity 
powered exerciser 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 electroencephalography 
(EEG)-driven upper extremity powered exerciser'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.

DATES: This order is effective January 6, 2023. The classification was 
applicable on April 23, 2021.

FOR FURTHER INFORMATION CONTACT: Heather Dean, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4214, Silver Spring, MD, 20993-0002, 240-402-9874, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the electroencephalography (EEG)-
driven upper extremity powered exerciser 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 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 (see 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 device by means of 
the procedures for premarket notification under section 510(k) of the 
FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    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 (Pub. L. 105-115) established the first procedure for De 
Novo

[[Page 982]]

classification. Section 607 of the Food and Drug Administration Safety 
and Innovation Act (Pub. L. 112-144) modified the De Novo application 
process by adding a second procedure. 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 placed 
within class III, the De Novo classification is considered to be the 
initial classification of the device.
    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 section 513(f)(2)(B)(i) of the FD&C 
Act). As a result, other device sponsors do not have to submit a De 
Novo request or premarket approval application to market a 
substantially equivalent device (see section 513(i) of the FD&C Act, 
defining ``substantial equivalence''). Instead, sponsors can use the 
less-burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On July 23, 2020, FDA received Neurolutions, Inc.'s request for De 
Novo classification of the Neurolutions IpsiHand Upper Extremity 
Rehabilitation 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 April 23, 2021, FDA issued an order to the requester 
classifying the device into class II. In this final order, FDA is 
codifying the classification of the device by adding 21 CFR 
890.5420.\1\ We have named the generic type of device 
electroencephalography (EEG)-driven upper extremity powered exerciser, 
and it is identified as a non-invasive prescription device intended for 
rehabilitation by driving movement or exercise of an impaired upper 
extremity in response to the detection of purpose oriented electrical 
activity produced by the patient's brain.
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    \1\ FDA notes that the ``ACTION'' caption for this final order 
is styled as ``Final amendment; final order,'' rather than ``Final 
order.'' Beginning in December 2019, this editorial change was made 
to indicate that the document ``amends'' the Code of Federal 
Regulations. The change was made in accordance with the Office of 
Federal Register's (OFR) interpretations of the Federal Register Act 
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and 
parts 21 and 22), and the Document Drafting Handbook.
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    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--Electroencephalography (EEG)-Driven Upper Extremity Powered
                 Exerciser Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
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Device provides ineffective treatment,   Clinical performance testing,
 leading to worsening condition.          Software verification,
                                          validation, and hazard
                                          analysis, and Wireless
                                          compatibility testing.
Unintended motion leading to injury....  Software verification,
                                          validation, and hazard
                                          analysis.
Thermal injury including burns and       Electromagnetic compatibility
 shock.                                   testing, Electrical safety
                                          testing, Battery safety
                                          testing, and Labeling.
Adverse tissue reaction................  Biocompatibility evaluation,
                                          and Labeling.
Cross contamination, leading to          Reprocessing validation, and
 infection or adverse tissue reaction.    Labeling.
Pain or discomfort including:            Labeling, and Clinical
                                          performance testing.
     Headache..................
     Fatigue...................
     Skin redness..............
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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. 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, the electroencephalography (EEG)-
driven upper extremity powered exerciser is 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.

[[Page 983]]

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. 3501-3521). The collections 
of information in 21 CFR part 860, subpart D, regarding De Novo 
classification have been approved under OMB control number 0910-0844; 
the collections of information in 21 CFR 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; the collections of information in 
21 CFR part 820, regarding quality system regulation, have been 
approved under OMB control number 0910-0073; 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 890

    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 
890 is amended as follows:

PART 890--PHYSICAL MEDICINE DEVICES

0
1. The authority citation for part 890 continues to read as follows:

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


0
2. Add Sec.  890.5420 to subpart F to read as follows:


Sec.  890.5420  Electroencephalography (EEG)-driven upper extremity 
powered exerciser.

    (a) Identification. An EEG-driven upper extremity powered exerciser 
is a non-invasive prescription device intended for rehabilitation by 
driving movement or exercise of an impaired upper extremity in response 
to the detection of purpose oriented electrical activity produced by 
the patient's brain.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use. Testing must 
capture any adverse events observed during clinical use and must 
demonstrate that the EEG signal can be translated into intended motion.
    (2) Software verification, validation, and hazard analysis must be 
performed.
    (3) Performance data must demonstrate the electromagnetic 
compatibility, electrical safety, battery safety, and wireless 
compatibility of the device.
    (4) The device components that contact the patient must be 
demonstrated to be biocompatible.
    (5) Performance data must validate the reprocessing instructions 
for the reusable components of the device.
    (6) Labeling must include:
    (i) Instructions on fitting the device to the patient;
    (ii) Information on how the device operates and the typical 
sensations experienced during treatment; and
    (iii) Reprocessing instructions.

    Dated: January 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00007 Filed 1-5-23; 8:45 am]
BILLING CODE 4164-01-P