[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