[Federal Register Volume 89, Number 172 (Thursday, September 5, 2024)]
[Rules and Regulations]
[Pages 72322-72323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19882]
[[Page 72322]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 886
[Docket No. FDA-2024-N-3970]
Medical Devices; Ophthalmic Devices; Classification of the
Hydrophilic Re-Coating Solution
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the hydrophilic re-coating solution 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 hydrophilic re-coating solution'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 September 5, 2024. The classification
was applicable on September 24, 2020.
FOR FURTHER INFORMATION CONTACT: Elissa Wong, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1246, Silver Spring, MD 20993-0002, 240-402-0204,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the hydrophilic re-coating
solution as class II (special controls), which we have determined will
provide a reasonable assurance of safety and effectiveness.
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 (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 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 on 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
510(k) process, when necessary, to market their device.
II. De Novo Classification
On January 15, 2020, FDA received Tangible Science, Inc.'s request
for De Novo classification of the Tangible Boost. 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 September 24, 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
886.5919.\1\ We have named the generic type of device hydrophilic re-
coating solution, and it is identified as a home use device intended to
restore the hydrophilic coating of rigid gas permeable (RGP) contact
lenses using reactive coating components.
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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.
[[Page 72323]]
Table 1--Hydrophilic Re-Coating Solution Risks and Mitigation Measures
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Identified risks Mitigation measures
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Adverse events leading to eye Clinical performance testing, Human
irritation (redness, factors evaluation, and Labeling.
burning, stinging,
discomfort, pain),
infection, keratitis,
corneal ulcer, loss of
visual acuity, or allergic
reaction.
Adverse tissue reaction...... Biocompatibility evaluation, Lens
solution compatibility testing, Coating
effectiveness testing, and Labeling.
Infection.................... Sterility testing and validation,
Disinfection solution compatibility
testing, Shelf life testing, and
Labeling.
Use error/improper device use Clinical performance testing, Human
leading to eye irritation factors evaluation, Coating performance
(redness, burning, stinging, testing, and Labeling.
discomfort, pain),
infection, keratitis,
corneal ulcer, loss of
visual acuity.
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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.
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 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 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 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. 886.5919 to subpart F to read as follows:
Sec. 886.5919 Hydrophilic re-coating solution.
(a) Identification. A hydrophilic re-coating solution is a home use
device intended to restore the hydrophilic coating of rigid gas
permeable (RGP) contact lenses using reactive coating components.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Clinical performance testing must evaluate device safety as
assessed by adverse events, slit lamp findings, and maintenance of
visual acuity.
(2) The patient contacting components of the device and packaging
components must be demonstrated to be biocompatible.
(3) Performance testing must demonstrate the sterility of the
device.
(4) Use-related risk analysis must be performed to determine if a
self-selection study and human factors validation study must be
conducted to demonstrate that users can correctly use the device based
solely on reading the directions for use.
(5) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the identified shelf life.
(6) Performance testing must demonstrate compatibility with each
lens and solution labeled for use with the device.
(7) Performance testing must demonstrate the ability of the device
to restore the coating of compatible lenses.
(8) Labeling must include the following:
(i) Instructions on how to correctly use the device, including
instructions to use fresh components for each use;
(ii) Descriptions of compatible contact lenses;
(iii) Descriptions of compatible care solutions;
(iv) A warning that if patients are not sure of their lens
material, they should contact their health care provider prior to use;
and
(v) A precaution against use with lenses that have not been
demonstrated to be compatible with the device.
Dated: August 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19882 Filed 9-4-24; 8:45 am]
BILLING CODE 4164-01-P