Rule2023-00007
Medical Devices; Physical Medicine Devices; Classification of the Electroencephalography-Driven Upper Extremity Powered Exerciser
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Published
January 6, 2023
Effective
January 6, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 4 (Friday, January 6, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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,
<a href="/cdn-cgi/l/email-protection#e2aa8783968a8790cca687838ca2848683cc8a8a91cc858d94"><span class="__cf_email__" data-cfemail="2b634e4a5f434e59056f4e4a456b4d4f4a05434358054c445d">[email protected]</span></a>.
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.
<bullet> Headache..................
<bullet> Fatigue...................
<bullet> 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
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</html>Indexed from Federal Register on January 6, 2023.
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