Document ID: FDA-2022-N-0589-0044
Agency: fda
Document Type: Notice
Title: General and Plastic Surgery Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Posted Date: 2022-10-06T04:00Z

[Federal Register Volume 87, Number 193 (Thursday, October 6, 2022)]
[Notices]
[Pages 60691-60693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21746]

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

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.

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

[[Page 60692]]

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 October 26, 2022, from 9 
a.m. Eastern Time to 6:15 p.m. Eastern Time and October 27, 2022, from 
9 a.m. Eastern Time to 3 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. Please note that late, untimely 
filed comments will not be considered. The docket will close on 
November 28, 2022. The https://www.regulations.gov electronic filing 
system will accept comments until 11:59 p.m. Eastern Time at the end of 
November 28, 2022. Comments received by mail/hand delivery/courier (for 
written/paper submissions) will be considered timely if they are 
received on or before that date.
    Comments received on or before October 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 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: The meeting presentations will be heard, viewed, captioned, 
and recorded through an online teleconferencing platform. On day 1, 
October 26, 2022, in the morning, the committee will discuss and make 
recommendations on the classification proposal for tissue expanders and 
accessories, which are currently unclassified preamendments devices, to 
be class III (general controls and premarket approval) and class II 
(general and special controls), and mammary sizers, which are currently

[[Page 60693]]

unclassified preamendments devices, to be class II (general and special 
controls). In the afternoon on the first day, the committee will 
discuss and make recommendations on the classification proposals for 
wound dressings with animal-derived materials, absorbable synthetic 
wound dressings, and hemostatic wound dressings with or without 
thrombin, which are all currently unclassified preamendments devices, 
to be class II (general and special controls).
    On day 2, October 27, 2022, the committee will discuss and make 
recommendations on the classification proposals for nail prostheses, 
which are currently unclassified preamendments devices, to be class I 
(general controls); and ultrasonic surgical instruments, single-use 
reprocessed ultrasonic surgical instruments, and neurosurgical 
ultrasonic instruments, which are all currently unclassified 
preamendments devices, to be class II (general and special controls).
    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 at 
the time of the advisory committee meeting, and the background material 
will be posted on FDA's website after the meeting. Background material 
is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the advisory committee meeting link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
All electronic and written submissions to the Docket (see ADDRESSES) on 
or before October 11, 2022, will be provided to the committee. Oral 
presentations from the public will be scheduled on October 26, 2022, 
between approximately 9:30 a.m. and 10 a.m. Eastern Time, and 2 p.m. 
and 2:30 p.m. Eastern Time, and on October 27, 2022, between 
approximately 9:30 a.m. and 10 a.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 September 30, 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 October 3, 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 Ann Marie Williams, at [email protected] or 301-
796-5966 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: September 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21746 Filed 10-5-22; 8:45 am]
BILLING CODE 4164-01-P