Document ID: FDA-2022-N-0104-0001
Agency: fda
Document Type: Rule
Title: Medical Devices; Ophthalmic Devices; Classification of the Electromechanical Tear Stimulator
Posted Date: 2022-02-18T05:00Z

[Federal Register Volume 87, Number 34 (Friday, February 18, 2022)]
[Rules and Regulations]
[Pages 9242-9244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03540]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 886

[Docket No. FDA-2022-N-0104]

Medical Devices; Ophthalmic Devices; Classification of the 
Electromechanical Tear Stimulator

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 electromechanical tear stimulator 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 
electromechanical tear stimulator'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 February 18, 2022 . The classification 
was applicable on May 1, 2020.

FOR FURTHER INFORMATION CONTACT: Leonid Livshitz, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1234, Silver Spring, MD 20993-0002, 301-
796-6975, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the electromechanical tear 
stimulator 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 (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 
application 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 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 May 15, 2019, FDA received Olympic Ophthalmics, Inc.'s request 
for De Novo classification of the iTEAR100 Neurostimulator. 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

[[Page 9243]]

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 May 01, 2020, 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 
886.5305.\1\ We have named the generic type of device electromechanical 
tear stimulator, and it is identified as a non-implantable device 
intended to increase tear production via mechanical stimulation.
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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 required to 
mitigate these risks in table 1.

Table 1--Electromechanical Tear Stimulator Risks and Mitigation Measures
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           Identified risks                   Mitigation measures
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Tissue damage due to over stimulation/ Clinical performance testing; Non-
 under stimulation or mechanical        clinical performance testing;
 injury, device breakage.               Software verification,
                                        validation, and hazard analysis;
                                        and Labeling.
Adverse tissue reaction..............  Biocompatibility evaluation, and
                                        Labeling.
Electrical shock or burn.............  Electrical, thermal, and
                                        mechanical safety testing;
                                        Software verification,
                                        validation, and hazard analysis;
                                        and Labeling.
Interference with other devices......  Electromagnetic compatibility
                                        (EMC) testing; Software
                                        verification, validation, and
                                        hazard analysis; and Labeling.
Pain, headache, or discomfort........  Clinical performance testing, and
                                        Non-clinical performance
                                        testing.
Insufficient tear production.........  Clinical performance testing.
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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. In order 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.

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 21 CFR 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 system regulation, have been 
approved under OMB control number 0910-0073; and the collections of 
information in 21 CFR parts 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.  886.5305 to subpart F to read as follows:

Sec.  886.5305  Electromechanical tear stimulator.

    (a) Identification. An electromechanical tear stimulator is a non-
implantable device intended to increase tear production via mechanical 
stimulation.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing under anticipated conditions of 
use must evaluate tear production and all adverse events, including 
tissue damage, pain, headache, and discomfort.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following must be conducted:
    (i) An assessment of mechanical output specifications, including 
vibration amplitude and frequency, pressure and force, and acoustic 
(noise level) properties;
    (ii) Mechanical safety testing to validate safeguards related to 
the pressure aspects of the device; and
    (iii) Use life testing.
    (3) Performance data must demonstrate the electrical safety, 
thermal safety, and electromagnetic compatibility (EMC) of all 
electrical components of the device.
    (4) All patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (5) Software verification, validation, and hazard analysis must be 
performed.

[[Page 9244]]

    (6) Physician and patient labeling must include:
    (i) A detailed summary of the device's technical parameters;
    (ii) Instructions for use, including an explanation of all user-
interface components and information regarding proper device placement;
    (iii) Information related to electromagnetic compatibility 
classification;
    (iv) Instructions on how to clean and maintain the device;
    (v) A summary of the clinical performance testing conducted with 
the device;
    (vi) Language to direct end users to contact the device 
manufacturer and MedWatch if they experience any adverse events with 
this device; and
    (vii) Information on how the device operates and the typical 
sensations experienced during treatment.

    Dated: February 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03540 Filed 2-17-22; 8:45 am]
BILLING CODE 4164-01-P