Document ID: FDA-2022-D-0986-0001
Agency: fda
Document Type: Notice
Title: Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2022-08-17T04:00Z

[Federal Register Volume 87, Number 158 (Wednesday, August 17, 2022)]
[Notices]
[Pages 50629-50630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17642]

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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; 
Draft Guidance for Industry and Food and Drug Administration Staff; 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the availability of the draft guidance entitled ``Hydrogen Peroxide-
Based Contact Lens Care Products: Consumer Labeling Recommendations--
Premarket Notification (510(k)) Submissions.'' FDA is issuing this 
draft guidance to provide labeling recommendations for hydrogen 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recommendations in this draft guidance are intended to promote the safe 
and effective use of HPCPs and ensure that consumers receive and 
understand information regarding the benefits and risks associated with 
the use of the device. This draft guidance is not final nor is it for 
implementation at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by October 17, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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 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 draft 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

[[Page 50630]]

established in the last few decades; however, FDA has 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 draft guidance. When 
finalized, 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.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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 draft 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 or 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 18041 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, guidance, and forms 
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, and 809.................  Medical Device             0910-0485
                                     Labeling
                                     Regulations.
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    Dated: August 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17642 Filed 8-16-22; 8:45 am]
BILLING CODE 4164-01-P