[Federal Register Volume 88, Number 143 (Thursday, July 27, 2023)]
[Notices]
[Pages 48472-48473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15879]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0986]


Hydrogen Peroxide-Based Contact Lens Care Products: Consumer 
Labeling Recommendations--Premarket Notification (510(k)) Submissions; 
Guidance for Industry and Food and Drug Administration Staff; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Hydrogen Peroxide-Based 
Contact Lens Care Products: Consumer Labeling Recommendations--
Premarket Notification (510(k)) Submissions.'' FDA is issuing this 
guidance to provide labeling recommendations for Hydrogen Peroxide-
Based Contact Lens Care Products (HPCPs) submitted in premarket 
notification (510(k)) submissions. The labeling recommendations in this 
guidance are intended to promote the safe and effective use of HPCPs 
and help consumers receive and understand information regarding the 
benefits and risks associated with the use of the device.

DATES: The announcement of the guidance is published in the Federal 
Register on July 27, 2023.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2022-D-0986 for ``Hydrogen Peroxide-Based Contact Lens Care 
Products: Consumer Labeling Recommendations--Premarket Notification 
(510(k)) Submissions.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    An electronic copy of the guidance document is available for 
download

[[Page 48473]]

from the internet. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling 
Recommendations--Premarket Notification (510(k)) Submissions'' to the 
Office of Policy, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Angelo Green, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1306, Silver Spring, MD 20993-0002, 301-796-6860.

SUPPLEMENTARY INFORMATION:

I. Background

    The safety and effectiveness of HPCPs when used as directed has 
been well established in the last few decades; however, FDA had become 
aware of an increase in the number of adverse event reports related to 
the misuse of these products. These reports led FDA to convene a 
meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory 
Committee and the Risk Communication Advisory Committee on March 17, 
2017, to discuss additional measures to mitigate the potential risk for 
misuse of these devices. The meeting covered a range of important 
issues, including appropriate labeling and packaging of these products 
and the importance of clearly communicating these concerns to the 
consumer public, which were incorporated into this guidance. This 
guidance is intended to provide recommendations concerning the content 
and format of labeling for HPCPs. FDA believes that the labeling 
recommendations in this guidance may help manufacturers develop 
labeling with information about specific risks and directions for use 
of the HPCPs in conjunction with a user's prescribed contact lenses.
    A notice of availability of the draft guidance appeared in the 
Federal Register of August 17, 2022 (87 FR 50629). FDA considered the 
comments received and revised the guidance as appropriate in response 
to the comments, including clarifying examples and language included in 
the guidance recommendations.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Hydrogen Peroxide-Based Contact Lens Care 
Products: Consumer Labeling Recommendations--Premarket Notification 
(510(k)) Submissions.'' It does not establish any rights for any person 
and is not binding on FDA or the public. You can use an alternative 
approach if it satisfies the requirements of the applicable statutes 
and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to 
download an electronic copy of ``Hydrogen Peroxide-Based Contact Lens 
Care Products: Consumer Labeling Recommendations--Premarket 
Notification (510(k)) Submissions'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number GUI00018041 and complete title to 
identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it 
does refer to previously approved FDA collections of information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the following FDA regulations have been approved by 
OMB as listed in the following table:

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                                                            OMB control
            21 CFR part                     Topic               No.
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807, subpart E....................  Premarket                  0910-0120
                                     notification.
800, 801, 809, and 830............  Medical Device             0910-0485
                                     Labeling
                                     Regulations; Unique
                                     Device
                                     Identification.
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    Dated: July 19, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15879 Filed 7-26-23; 8:45 am]
BILLING CODE 4164-01-P