Rule2026-07861
Medical Devices; Ophthalmic Devices; Classification of the Digital Therapy Device for Amblyopia
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
April 22, 2026
Effective
April 22, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is classifying the digital therapy device for amblyopia 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 classification of the digital therapy device for amblyopia. We are taking this action because we have determined that classifying the device into class II 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.
Full Text
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<title>Federal Register, Volume 91 Issue 77 (Wednesday, April 22, 2026)</title>
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[Federal Register Volume 91, Number 77 (Wednesday, April 22, 2026)]
[Rules and Regulations]
[Pages 21383-21385]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-07861]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 882
[Docket No. FDA-2026-N-3928]
Medical Devices; Ophthalmic Devices; Classification of the
Digital Therapy Device for Amblyopia
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
classifying the digital therapy device for amblyopia into class II
(special controls). The special controls that apply to the device type
are identified in this order and will be part
[[Page 21384]]
of the codified language for classification of the digital therapy
device for amblyopia. We are taking this action because we have
determined that classifying the device into class II 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 April 22, 2026. The classification was
applicable on October 20, 2021.
FOR FURTHER INFORMATION CONTACT: Bradley Cunningham, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1414, Silver Spring, MD 20993-0002, 301-
796-6484, <a href="/cdn-cgi/l/email-protection#a8eadac9ccc4cdd186ebddc6c6c1c6cfc0c9c5e8ceccc986c0c0db86cfc7de"><span class="__cf_email__" data-cfemail="9edcecfffaf2fbe7b0ddebf0f0f7f0f9f6fff3def8faffb0f6f6edb0f9f1e8">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA (the Agency or we) has classified the digital
therapy device for amblyopia into class II (special controls), which we
have determined will provide a reasonable assurance of safety and
effectiveness of the device. 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 into, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (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 (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 (see also part 860, subpart D (21 CFR part 860, subpart D)).
Section 207 of the Food and Drug Administration Modernization Act of
1997 (Pub. L. 105-115) established the first procedure for De Novo
classification. Section 607 of the Food and Drug Administration Safety
and Innovation Act (Pub. L. 112-144) modified the De Novo
classification 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 premarket
notification (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.
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 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 March 1, 2021, FDA received Luminopia, Inc.'s request for De
Novo classification of the Luminopia One. 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 of the device, 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 October 20, 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
886.5500.\1\ We have named the generic type of device ``digital therapy
device for amblyopia,'' and it is identified as a device that
incorporates dichoptic presentations on visual displays through
therapeutic algorithms to treat amblyopia or to improve visual acuity
of patients with amblyopia.
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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 risks to health associated with this type of
device and the measures required to mitigate these risks in table 1.
[[Page 21385]]
Table 1--Risks to Health and Mitigation Measures Digital Therapy Device
for Amblyopia
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Identified risks to health Mitigation measures
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Adverse events due to device treatment Clinical performance testing,
(e.g., headache, new or worsening and Labeling.
heterotropia, worsened vision in
either eye, eye strain, eye twitching,
facial redness, increased night
terrors, thermal injury, dizziness,
seizure, nausea, or double vision).
Ineffective treatment leading to Clinical performance testing;
worsening of condition. Software verification,
validation, and hazard
analysis; and Labeling.
Therapeutic effect not sustained Clinical performance testing,
leading to delay of treatment. and Labeling.
Software malfunction leading to delay Software verification,
of treatment. validation, and hazard
analysis; and Labeling.
Improper use of the device including Labeling, and Labeling
Head-Mounted Display or other visual comprehension testing.
display leading to ineffective
treatment or adverse events.
Performance variations among different Clinical performance testing;
brands/models of visual displays Non-clinical performance
leading to ineffective treatment and/ testing; Labeling; and
or adverse events. Software verification,
validation, and hazard
analysis.
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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 of the device. 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 final order.
Under the FD&C Act, submission of a premarket notification under
section 510(k) (21 U.S.C. 360(k)) is required to reasonably assure the
safety and effectiveness of class II devices unless FDA determines that
the device type should be exempt under section 510(m) of the FD&C Act.
At this time FDA has not made this determination for digital therapy
devices for amblyopia. This device is therefore subject to premarket
notification requirements under section 510(k) of the FD&C Act.
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 normally 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 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 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 management 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 886
Medical devices, Ophthalmic goods and services.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
886 is amended as follows:
PART 886--OPHTHALMIC DEVICES
0
1. The authority citation for part 886 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 886.5500 to subpart F to read as follows:
Sec. 886.5500 Digital therapy device for amblyopia.
(a) Identification. A digital therapy device for amblyopia is a
device that incorporates dichoptic presentations on visual displays
through therapeutic algorithms to treat amblyopia or to improve visual
acuity of patients with amblyopia.
(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 with labeled
compatible visual display devices, including evaluation of all adverse
events and device performance to improve measures of visual function.
(2) Software verification, validation, and hazard analysis must be
performed. Documentation must include characterizations of the
technical specifications of the software.
(3) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. All
visual displays intended for use must undergo compatibility testing to
ensure adequate display resolution, luminance, contrast, field of view,
image quality, appropriate optical image distance, and verify their
compatibility with the software and intended user (such as appropriate
interpupillary distance).
(4) Labeling must include the following:
(i) The minimum hardware and operating system requirements that
support the software of the device;
(ii) The models of the visual displays validated to be compatible
with this device;
(iii) The length of treatment and/or retreatment supported by
clinical performance testing; and
(iv) A summary of the clinical performance testing conducted with
the device.
(5) Labeling comprehension testing with intended users must be
performed.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-07861 Filed 4-21-26; 8:45 am]
BILLING CODE 4164-01-P
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