Document ID: FDA-2023-N-0008-0002
Agency: fda
Document Type: Notice
Title: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Posted Date: 2023-03-07T05:00Z

[Federal Register Volume 88, Number 44 (Tuesday, March 7, 2023)]
[Notices]
[Pages 14168-14169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04561]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0008]

Orthopaedic and Rehabilitation Devices Panel of the Medical 
Devices Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Orthopaedic and Rehabilitation 
Devices Panel of the Medical Devices Advisory Committee. The general 
function of the committee is to provide advice and recommendations to 
the Agency on FDA's regulatory issues. The meeting will be open to the 
public.

DATES: The meeting will take place virtually on April 20, 2023, from 9 
a.m. to 6 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this 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/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings.

FOR FURTHER INFORMATION CONTACT: Akinola Awojope, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993-0002, 
[email protected], 301-636-0512, 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 Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the

[[Page 14169]]

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 April 20, 
2023, the committee will discuss, make recommendations, and vote on 
clinical information related to the De Novo request for the NUsurface 
Meniscus Implant sponsored by Active Implants, Inc. The device is a 
polymeric disc-shaped device implanted in the medial compartment of the 
knee to distribute load between the distal femur and proximal tibia and 
is intended to improve pain and function in the medial compartment of a 
knee in which the medial meniscus has been resected.
    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 
and the link to the online teleconference meeting room will be 
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down and select 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. 
Written submissions may be made to the contact person on or before 
April 4, 2023. Oral presentations from the public will be scheduled on 
April 20, 2023, between approximately 1 p.m. and 2 p.m. Eastern Time. 
Those individuals interested in making formal oral presentations should 
notify the contact person (see FOR FURTHER INFORMATION CONTACT). The 
notification should include 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 March 27, 2023. 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 March 28, 2023.
    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: March 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04561 Filed 3-6-23; 8:45 am]
BILLING CODE 4164-01-P