Rule2022-03540
Medical Devices; Ophthalmic Devices; Classification of the Electromechanical Tear Stimulator
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
February 18, 2022
Effective
February 18, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 34 (Friday, February 18, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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, <a href="/cdn-cgi/l/email-protection#90dcf5fffef9f4bedcf9e6e3f8f9e4ead0f6f4f1bef8f8e3bef7ffe6"><span class="__cf_email__" data-cfemail="b8f4ddd7d6d1dc96f4d1cecbd0d1ccc2f8dedcd996d0d0cb96dfd7ce">[email protected]</span></a>.
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
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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.
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(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
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</html>Indexed from Federal Register on February 18, 2022.
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