Notice2022-16166
Laser-Assisted In Situ Keratomileusis Lasers-Patient Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
July 28, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Laser-Assisted In Situ Keratomileusis (LASIK) Lasers--Patient Labeling Recommendations." This draft guidance recommends content and formatting for patient labeling information for LASIK devices.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 This draft guidance is not final nor is it for implementation at this time.
Full Text
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<title>Federal Register, Volume 87 Issue 144 (Thursday, July 28, 2022)</title>
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[Federal Register Volume 87, Number 144 (Thursday, July 28, 2022)]
[Notices]
[Pages 45334-45335]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-16166]
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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Recommendations; Draft Guidance for Industry and Food and Drug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.
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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the availability of the draft guidance entitled ``Laser-Assisted In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This draft guidance recommends content and formatting for patient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:
<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-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 <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 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.
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\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.
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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 <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> or <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 ``Laser-Assisted In Situ Keratomileusis
(LASIK) Lasers--Patient Labeling Recommendations'' may send an email
request to <a href="/cdn-cgi/l/email-protection#490a0d1b01640e3c202d28272a2c092f2d286721213a672e263f"><span class="__cf_email__" data-cfemail="a4e7e0f6ec89e3d1cdc0c5cac7c1e4c2c0c58accccd78ac3cbd2">[email protected]</span></a> 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:
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OMB Control
21 CFR part Topic No.
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814, subparts A through E......... Premarket approval.. 0910-0231
800, 801, and 809................. Medical Device 0910-0485
Labeling
Regulations.
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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
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