Notice2023-00422
Photobiomodulation Devices-Premarket Notification Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
January 12, 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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Photobiomodulation (PBM) Devices--Premarket Notification [510(k)] Submissions." This draft guidance provides recommendations on premarket submissions for photobiomodulation devices, which are used in applications such as aesthetics, dermatology, and other general indications. This draft guidance is not final nor is it for implementation at this time.
Full Text
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<title>Federal Register, Volume 88 Issue 8 (Thursday, January 12, 2023)</title>
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[Federal Register Volume 88, Number 8 (Thursday, January 12, 2023)]
[Notices]
[Pages 2102-2103]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-00422]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-3116]
Photobiomodulation Devices--Premarket Notification 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Draft Guidance for Industry and Food and Drug Administration Staff;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the availability of the draft guidance entitled ``Photobiomodulation
(PBM) Devices--Premarket Notification [510(k)] Submissions.'' This
draft guidance provides recommendations on premarket submissions for
photobiomodulation devices, which are used in applications such as
aesthetics, dermatology, and other general indications. This draft
guidance is not final nor is it for implementation at this time.
DATES: Submit either electronic or written comments on the draft
guidance by March 13, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-3116 for ``Photobiomodulation (PBM) Devices--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 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
``Photobiomodulation (PBM) Devices--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: Jessica Mavadia-Shukla, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 4643, Silver Spring, MD 20993-0002,
301-348-1596.
SUPPLEMENTARY INFORMATION:
I. Background
PBM devices, also known as low level light therapy devices, are
intended for use in applications such as aesthetics, dermatology, and
other general indications. A PBM device is designed to deliver a non-
heating dose of light energy into the body to provide clinical benefit
to the patient. This draft guidance document provides FDA's
recommendations on non-clinical testing, clinical studies, and labeling
to support premarket submissions for PBM devices. The recommendations
reflect current review practices and are intended to promote
consistency and facilitate efficient review of these submissions.
[[Page 2103]]
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
``Photobiomodulation (PBM) Devices--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 <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> and at https://w<a href="http://ww.fda.gov/regulatory-information/search-fda-guidance-documents">ww.fda.gov/regulatory-information/search-fda-guidance-documents</a>. Persons unable to
download an electronic copy of ``Photobiomodulation (PBM) Devices--
Premarket Notification [510(k)] Submissions'' may send an email request
to <a href="/cdn-cgi/l/email-protection#357671677d1872405c51545b5650755351541b5d5d461b525a43"><span class="__cf_email__" data-cfemail="125156405a3f55677b76737c7177527476733c7a7a613c757d64">[email protected]</span></a> to receive an electronic copy of the
document. Please use the document number 16030 and complete title to
identify the guidance you are requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no 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 and guidance have been
approved by OMB as listed in the following table:
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OMB control
21 CFR part; guidance Topic No.
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807, subpart E................. Premarket notification. 0910-0120
812............................ Investigational Device 0910-0078
Exemption.
``Requests for Feedback and Q-submissions.......... 0910-0756
Meetings for Medical Device
Submissions: The Q-Submission
Program''.
800, 801, and 809.............. Medical Device Labeling 0910-0485
Regulations.
50, 56......................... Protection of Human 0910-0130
Subjects: Informed
Consent; Institutional
Review Boards.
820............................ Quality Systems 0910-0073
Regulations.
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Dated: January 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00422 Filed 1-11-23; 8:45 am]
BILLING CODE 4164-01-P
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