87 FR 158 pgs. 50629-50630 - 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Contact Lens Care Products: Consumer Labeling Recommendations—Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

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Type: NOTICEVolume: 87Number: 158Pages: 50629 - 50630

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

FR document: [FR Doc. 2022-17642 Filed 8-16-22; 8:45 am]

Agency: Health and Human Services Department

Sub Agency: Food and Drug Administration

Official PDF Version: PDF Version

Pages: 50629, 50630

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Contact Lens Care Products: Consumer Labeling Recommendations-Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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

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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations-Premarket Notification (510(k)) Submissions." FDA is issuing this draft guidance to provide labeling recommendations for hydrogen peroxide-based contact lens care products (HPCPs) submitted in premarket notification (510(k)) submissions. The labeling recommendations in this draft guidance are intended to promote the safe and effective use of HPCPs and ensure that consumers receive and understand information regarding the benefits and risks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 This draft guidance is not final nor is it for implementation at this time.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Submit either electronic or written comments on the draft guidance by October 17, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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

[top] The safety and effectiveness of HPCPs when used as directed has been well

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 CDRH-Guidance@fda.hhs.gov 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:

21 CFR part	Topic	OMB control No.
807, subpart E	Premarket notification	0910-0120
800, 801, and 809	Medical Device Labeling Regulations	0910-0485

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