[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.
------------------------------------------------------------------------

    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


