[Federal Register Volume 87, Number 103 (Friday, May 27, 2022)]
[Notices]
[Pages 32172-32174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    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 https://www.regulations.gov 
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:
     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

[[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 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-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 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.'' 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 https://www.regulations.gov. 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: 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.

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, 
[email protected], 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 https://www.fda.gov/AdvisoryCommittees/default.htm 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:
     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.
     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.
     Patient characteristics, including lower or higher 
incidence populations, that should be tested before marketing.
     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; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p090012), and (2) Nevisense, a device that 
measures impedance and was approved in 2017 (P150046; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150046).

[[Page 32174]]

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 https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. 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 
[email protected] 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 [email protected] 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 https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm 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