Rule2021-27227
Medical Devices; Neurological Devices; Classification of the Traumatic Brain Injury Eye Movement Assessment Aid
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 16, 2021
Effective
December 16, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 239 (Thursday, December 16, 2021)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-27227]
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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, <a href="/cdn-cgi/l/email-protection#96c6f7e2e4fff5fdb8d7f8e2fdf9e1fff7fdd6f0f2f7b8fefee5b8f1f9e0"><span class="__cf_email__" data-cfemail="4e1e2f3a3c272d25600f203a252139272f250e282a2f6026263d60292138">[email protected]</span></a>.
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:
<bullet> False positive: Brain Clinical performance testing;
injury when in fact none is
present.
<bullet> 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
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</html>Indexed from Federal Register on December 16, 2021.
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