Notice2022-11420
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
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Published
May 27, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Full Text
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<title>Federal Register, Volume 87 Issue 103 (Friday, May 27, 2022)</title>
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[Federal Register Volume 87, Number 103 (Friday, May 27, 2022)]
[Notices]
[Pages 32172-32174]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-11420]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0589]
General and Plastic Surgery Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the General and Plastic Surgery
Devices Panel of the Medical Devices Advisory Committee. The general
function of the committee is to provide advice and recommendations to
FDA on regulatory issues. The meeting will be open to the public. FDA
is establishing a docket for public comment on this document.
DATES: The meeting will be held virtually on July 28, 2022, from 9 a.m.
to 5:45 p.m. Eastern Time and July 29, 2022, from 9 a.m. to 4 p.m.
Eastern Time.
ADDRESSES: Please note that due to the impact of the COVID-19 pandemic,
all meeting participants will be joining this advisory committee
meeting via an online teleconferencing platform. Answers to commonly
asked questions, including information regarding special accommodations
due to a disability, may be accessed at: <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm</a>.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2022-N-0589. The docket will close on August
29, 2022. Submit either electronic or written comments on this public
meeting by August 29, 2022. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before August 29, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a>
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of August 29, 2022. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
Comments received on or before July 11, 2022, will be provided to
the committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
You may submit comments 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
[[Page 32173]]
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-N-0589 for ``General and Plastic Surgery Devices Panel of the
Medical Devices Advisory Committee; Notice of Meeting; Establishment of
a Public Docket; Request for Comments.'' Received comments, those filed
in a timely manner (see ADDRESSES), 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.'' FDA 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 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 the 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.
FOR FURTHER INFORMATION CONTACT: Candace Nalls, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993-0002, 301-636-0510,
<a href="/cdn-cgi/l/email-protection#67240609030604024929060b0b1427010306490f0f1449000811"><span class="__cf_email__" data-cfemail="7c3f1d12181d1f1952321d10100f3c1a181d5214140f521b130a">[email protected]</span></a>, or FDA Advisory Committee Information Line,
1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in
the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the FDA's website at <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a> and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before the
meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On July 28, 2022, the committee will discuss the topic of
skin lesion analyzer technology and its application to detecting skin
cancers in various patient care settings. The skin lesion analyzer
devices on which the discussion is focused at this meeting are
algorithm-based devices for adjunctive detection of various skin
lesions, including skin cancers. We will refer to these computer
algorithm-aided devices for adjunctive detection of lesions suspicious
for skin cancers as Skin Lesion Analyzers (SLAs). In recent years, FDA
has seen an increased interest in the development of skin lesion
analyzers that employ artificial intelligence and machine learning.
These devices include a range of technologies and intended user
populations. FDA is interested in the committee members' perspectives
on approaches for evaluating the performance of SLA devices given the
heterogeneity of technologies and indications.
FDA is convening this committee to promote an open public
discussion of, and seek expert opinion on, currently available
scientific and clinical data pertaining to the diagnosing standard also
known as ground truth, performance criteria, and patient population in
future studies assisting medical providers in properly identifying skin
lesions by a computer algorithm-aided device. The committee will be
asked to discuss and provide recommendations regarding:
<bullet> The diagnosing standard, or ground truth, based on factual
data that should be used as a comparison for the performance of
diagnostic devices including, but not limited to, histology, consensus
opinion of a panel of dermatologists, opinion of a single
dermatologist, or other means.
<bullet> Acceptable thresholds for sensitivity and specificity
based on the target diagnosis (melanoma, basal cell carcinoma (BCC),
squamous cell carcinoma (SCC)), or on the intended user (dermatologist,
primary care physician, lay user) if assessed for standalone
performance.
<bullet> Patient characteristics, including lower or higher
incidence populations, that should be tested before marketing.
<bullet> Balance of increased access with risk mitigation measures
that are appropriate when the devices are used by lay people, by
populations with very high or very low incidence of melanoma, by
populations with low incidence, but high mortality associated with
melanoma, or by the target diagnosis/lesion type (melanoma, BCC, SCC)
On July 29, 2022, the committee will discuss the possible
reclassification of approved computer-aided melanoma detection class
III devices: (1) MelaFind, a device that uses multispectral imaging and
was approved in 2012 (P090012; <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p090012">https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p090012</a>), and (2) Nevisense, a device that
measures impedance and was approved in 2017 (P150046; <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150046">https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150046</a>).
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Both Melafind and Nevisense devices are intended for use on cutaneous
lesions suspicious for melanoma when a dermatologist chooses to obtain
additional information when considering biopsy. The committee will
discuss if there is sufficient information to reclassify computer-aided
devices for adjunctive diagnostic information of lesions suspicious for
melanoma from class III to class II, and what special controls may be
appropriate to provide reasonable assurance of safety and effectiveness
for these devices if they are reclassified as class II devices.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website
after the meeting. Background material is available at <a href="https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm">https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm</a>. Scroll down to the
appropriate advisory committee meeting link. The meeting will include
slide presentations with audio components to allow the presentation of
materials in a manner that most closely resembles an in-person advisory
committee meeting.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before July 11, 2022, will be provided to the panel.
Oral presentations from the public will be scheduled on July 28, 2022,
between approximately 1 p.m. and 2 p.m. Eastern Time, and on July 29,
2022, between approximately 1 p.m. and 2 p.m. Eastern Time. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before June
28, 2022. Time allotted for each presentation may be limited. If the
number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by June 29, 2022.
For press inquiries, please contact the Office of Media Affairs at
<a href="/cdn-cgi/l/email-protection#432527222c2e22032527226d2b2b306d242c35"><span class="__cf_email__" data-cfemail="fa9c9e9b95979bba9c9e9bd4929289d49d958c">[email protected]</span></a> or 301-796-4540.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Artair Mallett, at <a href="/cdn-cgi/l/email-protection#1a5b686e7b736834577b76767f6e6e5a7c7e7b34727269347d756c"><span class="__cf_email__" data-cfemail="22635056434b500c6f434e4e475656624446430c4a4a510c454d54">[email protected]</span></a> or 301-796-9638,
at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm</a> for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: May 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-11420 Filed 5-26-22; 8:45 am]
BILLING CODE 4164-01-P
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