Document ID: FDA-2022-D-1253-0001
Agency: fda
Document Type: Notice
Title: Laser-Assisted In Situ Keratomileusis Lasers—Patient Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2022-07-28T04:00Z

[Federal Register Volume 87, Number 144 (Thursday, July 28, 2022)]
[Notices]
[Pages 45334-45335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16166]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-1253]

Laser-Assisted In Situ Keratomileusis Lasers--Patient Labeling 
Recommendations; Draft Guidance for Industry and Food and Drug 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the availability of the draft guidance entitled ``Laser-Assisted In 
Situ Keratomileusis (LASIK) Lasers--Patient Labeling Recommendations.'' 
This draft guidance recommends content and formatting for patient 
labeling information for LASIK devices. FDA is issuing this guidance to 
help ensure that physicians can share and patients can understand 
information on the benefits and risks of these devices. The 
recommendations are being made based on concerns that some patients are 
not receiving and/or understanding information regarding the benefits 
and risks of LASIK devices. This draft guidance is not final nor is it 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DATES: Submit either electronic or written comments on the draft 
guidance by October 26, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-1253 for ``Laser-Assisted In Situ Keratomileusis (LASIK) 
Lasers--Patient Labeling Recommendations.'' 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 
``Laser-Assisted In Situ Keratomileusis (LASIK) Lasers--Patient 
Labeling Recommendations'' 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-

[[Page 45335]]

addressed adhesive label to assist that office in processing your 
request.

FOR FURTHER INFORMATION CONTACT: Bradley Cunningham, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1414, Silver Spring, MD 20993-0002, 301-
796-6484.

SUPPLEMENTARY INFORMATION:

I. Background

    LASIK is currently one of the most commonly performed elective 
procedures in the world, as well as the most popular form of refractive 
surgery that patients choose to correct common vision problems such as 
nearsightedness, farsightedness, and astigmatism.\1\ On April 25, 2008, 
FDA convened its Ophthalmic Devices Panel of the Medical Devices 
Advisory Committee to discuss recommendations for modifications to 
patient labeling of excimer lasers for LASIK as well as other LASIK-
related activities. Since the LASIK Advisory Committee meeting, FDA has 
continued to gather new information pertaining to risks associated with 
LASIK. This draft guidance recommends content and formatting for 
patient labeling information for LASIK devices. FDA is issuing this 
guidance to help ensure that physicians can share and patients can 
understand information on the benefits and risks of these devices. The 
recommendations are being made based on concerns the Agency has 
received regarding patients not receiving and/or understanding key 
information regarding the benefits and risks of LASIK devices. These 
labeling recommendations are intended to enhance, but not replace, the 
physician-patient discussion of the benefits and risks of LASIK devices 
that uniquely pertain to individual patients.
---------------------------------------------------------------------------

    \1\ Vitale, S., Cotch, M.F., Sperduto, R., Ellwein L., ``Costs 
of Refractive Correction of Distance Vision Impairment in the United 
States, 1999-2002,'' Ophthalmology, vol. 113, pp. 2163-2170, 2006.
---------------------------------------------------------------------------

    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 ``Laser-
Assisted In Situ Keratomileusis (LASIK) Lasers--Patient Labeling 
Recommendations.'' 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 ``Laser-Assisted In Situ Keratomileusis 
(LASIK) Lasers--Patient Labeling Recommendations'' may send an email 
request to [email protected] to receive an electronic copy of 
the document. Please use the document number 16053 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:

------------------------------------------------------------------------
                                                            OMB Control
            21 CFR part                     Topic               No.
------------------------------------------------------------------------
814, subparts A through E.........  Premarket approval..       0910-0231
800, 801, and 809.................  Medical Device             0910-0485
                                     Labeling
                                     Regulations.
------------------------------------------------------------------------

    Dated: July 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16166 Filed 7-27-22; 8:45 am]
BILLING CODE 4164-01-P