Notice2023-15879
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
Primary source
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Published
July 27, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 143 (Thursday, July 27, 2023)</title>
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[Federal Register Volume 88, Number 143 (Thursday, July 27, 2023)]
[Notices]
[Pages 48472-48473]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance document is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. 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 <a href="/cdn-cgi/l/email-protection#8bc8cfd9c3a6ccfee2efeae5e8eecbedefeaa5e3e3f8a5ece4fd"><span class="__cf_email__" data-cfemail="bffcfbedf792f8cad6dbded1dcdaffd9dbde91d7d7cc91d8d0c9">[email protected]</span></a> 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
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