[Federal Register Volume 88, Number 13 (Friday, January 20, 2023)]
[Rules and Regulations]
[Pages 3636-3638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01049]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 886
[Docket No. FDA-2022-N-3256]
Medical Devices; Ophthalmic Devices; Classification of the
Intense Pulsed Light Device for Managing Dry Eye
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 intense pulsed light device for managing dry eye 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 intense pulsed light device for managing dry
eye'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 20, 2023. The classification was
applicable on February 23, 2021.
FOR FURTHER INFORMATION CONTACT: Arkady Kaplan, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1568, Silver Spring, MD 20993-0002, 301-796-6365,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the intense pulsed light device
for managing dry eye 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 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
[[Page 3637]]
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 April 20, 2020, FDA received Lumenis's request for De Novo
classification of the Lumenis Stellar M22. 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 February 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
886.5201.\1\ We have named the generic type of device intense pulsed
light device for managing dry eye, and it is identified as a
prescription device intended for use in the application of intense
pulsed light therapy to the skin. The device is used in patients with
dry eye disease due to meibomian gland dysfunction, also known as
evaporative dry eye or lipid deficiency dry eye.
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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 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--Intense Pulsed Light Device for Managing Dry Eye Risks and
Mitigation Measures
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Identified risks Mitigation measures
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Tissue damage due to overheating....... Thermal safety assessment,
Software verification,
validation, and hazard
analysis, and Labeling.
Tissue damage or loss of vision due to Clinical performance testing,
light radiation. and Labeling.
Adverse tissue reaction................ Biocompatibility evaluation.
Electrical shock or burn............... Thermal safety assessment,
Electrical safety testing,
Software verification,
validation, and hazard
analysis, and Labeling.
Interference with other devices........ Electromagnetic compatibility
testing; Software
verification, validation, and
hazard analysis; and Labeling.
Pain or discomfort..................... Clinical performance testing,
and Labeling.
Failure to mitigate dry eye signs and/ Clinical performance testing,
or symptoms. and Labeling.
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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, intense pulsed light device for
managing dry eye is/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
(referring to 21 U.S.C. 352(f)(1)).
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
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 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 886
Medical devices, Ophthalmic goods and services.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner
[[Page 3638]]
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. 886.5201 to subpart F to read as follows:
Sec. 886.5201 Intense pulsed light device for managing dry eye.
(a) Identification. An intense pulsed light device for managing dry
eye is a prescription device intended for use in the application of
intense pulsed light therapy to the skin. The device is used in
patients with dry eye disease due to meibomian gland dysfunction, also
known as evaporative dry eye or lipid deficiency dry eye.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Clinical performance testing must evaluate adverse events and
improvement of dry eye signs and symptoms under anticipated conditions
of use.
(2) Thermal safety assessment in a worst-case scenario must be
performed to validate temperature safeguards.
(3) Performance testing must demonstrate electrical safety and
electromagnetic compatibility (EMC) of the device in the intended use
environment.
(4) Software verification, validation, and hazard analysis must be
performed.
(5) The patient-contacting components of the device must be
demonstrated to be biocompatible.
(6) Physician and patient labeling must include:
(i) Device technical parameters;
(ii) A summary of the clinical performance testing conducted with
the device;
(iii) A description of the intended treatment area location;
(iv) Warnings and instructions regarding the use of safety-
protective eyewear for patient and device operator;
(v) A description of intense pulse light (IPL) radiation hazards
and protection for patient and operator;
(vi) Instructions for use, including an explanation of all user
interface components; and
(vii) Instructions on how to clean and maintain the device and its
components.
Dated: January 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01049 Filed 1-19-23; 8:45 am]
BILLING CODE 4164-01-P