Document ID: FDA-2021-N-0896-0001
Agency: fda
Document Type: Rule
Title: Medical Devices; Neurological Devices; Classification of the Traumatic Brain Injury Eye Movement Assessment Aid
Posted Date: 2021-12-16T05:00Z

[Federal Register Volume 86, Number 239 (Thursday, December 16, 2021)]
[Rules and Regulations]
[Pages 71383-71385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27227]

[[Page 71383]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2021-N-0896]

Medical Devices; Neurological Devices; Classification of the 
Traumatic Brain Injury Eye Movement Assessment Aid

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the traumatic brain injury eye movement assessment aid 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 traumatic brain injury eye movement assessment aid'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 December 16, 2021. The classification 
was applicable on December 28, 2018.

FOR FURTHER INFORMATION CONTACT: Patrick Antkowiak, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 4254, Silver Spring, MD 20993-0002, 240-
402-3705, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the traumatic brain injury eye 
movement assessment aid 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, 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 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 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 December 22, 2017, FDA received Oculogica, Inc.'s request for De 
Novo classification of the EyeBOX[supreg]. 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 section 513(a)(1)(B) of the FD&C Act). 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 December 28, 2018, 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 
882.1455.\1\ We have named the generic type of device traumatic brain 
injury eye movement assessment aid, and it is identified as a 
prescription device that uses a patient's tracked eye movements to 
provide an interpretation of the functional condition of the patient's 
brain. This device is an assessment aid that is not intended for 
standalone detection or diagnostic purposes.
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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

[[Page 71384]]

required to mitigate these risks in table 1.

  Table 1--Traumatic Brain Injury Eye Movement Assessment Aid Risks and
                           Mitigation Measures
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            Identified risks                   Mitigation measures
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Incorrect or misinterpreted results,
 including:
     False positive: Brain       Clinical performance testing;
     injury when in fact none is
     present.
     False negative: No brain    Software verification,
     injury when in fact brain injury     validation, and hazard
     is present.                          analysis; and
                                         Labeling.
Interference with other devices........  Electromagnetic compatibility
                                          (EMC) testing; and
                                         Software verification,
                                          validation, and hazard
                                          analysis.
Electrical shock or burn...............  Electrical safety testing; and
                                         Software verification,
                                          validation, and hazard
                                          analysis.
Adverse tissue reaction................  Biocompatibility evaluation.
Eye hazard or injury...................  Light hazard assessment.
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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, traumatic brain injury eye movement 
assessment aids 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

    While this final order contains no collection of information, it 
establishes special controls that refer to previously approved FDA 
collections of information found in other FDA regulations and guidance. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this order. The previously approved collections of 
information are subject to review by OMB under the PRA. 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 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 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.  882.1455 to subpart B to read as follows:

Sec.  882.1455  Traumatic brain injury eye movement assessment aid.

    (a) Identification. A traumatic brain injury eye movement 
assessment aid is a prescription device that uses a patient's tracked 
eye movements to provide an interpretation of the functional condition 
of the patient's brain. This device is an assessment aid that is not 
intended for standalone detection or diagnostic purposes.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance data under anticipated conditions of use 
must evaluate tracked eye movement in supporting the indications for 
use and include the following:
    (i) Evaluation of sensitivity, specificity, positive predictive 
value, and negative predictive value using a reference method of 
diagnosis;
    (ii) Evaluation of device test-retest reliability; and
    (iii) A description of the development of the reference method of 
diagnosis, which may include a normative database, to include the 
following:
    (A) A discussion of how the clinical work-up was completed to 
establish the reference method of diagnosis, including the 
establishment of inclusion and exclusion criteria; and
    (B) If using a normative database, a description of how the 
``normal'' population was established, and the statistical methods and 
model assumptions used.
    (2) Software verification, validation, and hazard analysis must be 
performed. Software documentation must include a description of the 
algorithms used to generate device output.
    (3) Performance testing must demonstrate the electrical safety and 
electromagnetic compatibility (EMC) of the device.
    (4) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (5) A light hazard assessment must be performed for all eye-
tracking and visual display light sources.
    (6) Labeling must include:
    (i) A summary of clinical performance testing conducted with the 
device, including sensitivity, specificity, positive predictive value, 
negative predictive value, and test-retest reliability;

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    (ii) A description of any normative database that includes the 
following:
    (A) The clinical definition used to establish a ``normal'' 
population and the specific selection criteria;
    (B) The format for reporting normal values;
    (C) Examples of screen displays and reports generated to provide 
the user results and normative data;
    (D) Statistical methods and model assumptions; and
    (E) Any adjustments for age and gender.
    (iii) A warning that the device should only be used by trained 
healthcare professionals;
    (iv) A warning that the device does not identify the presence or 
absence of traumatic brain injury or other clinical diagnoses;
    (v) A warning that the device is not a standalone diagnostic; and
    (vi) Any instructions to convey to patients regarding the 
administration of the test and collection of test data.

    Dated: December 9, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27227 Filed 12-15-21; 8:45 am]
BILLING CODE 4164-01-P