April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement – 04/20/2023

April 20, 2023
9:00 AM
– 6:00 PM

Section OF Wellness AND HUMAN Products and services

Foods and Drug Administration 

[Docket No. FDA-2023-N-0008] 

Orthopaedic and Rehabilitation Equipment Panel of the Clinical Units Advisory Committee See of Conference

Agency:  Food and Drug Administration, HHS.

Motion:  Notice.

SUMMARY:  The Meals and Drug Administration (Fda) announces a forthcoming general public advisory committee conference of the Orthopaedic and Rehabilitation Units Panel of the Healthcare Units Advisory Committee.  The general purpose of the committee is to provide information and recommendations to the Agency on FDA’s regulatory challenges.  The assembly will be open up to the community.  

DATES:  The assembly will get position virtually on April 20, 2023, from 9 a.m. to 6 p.m. Eastern Time. 

ADDRESSES:  Please be aware that because of to the impression of this COVID-19 pandemic, all meeting individuals will be signing up for this advisory committee conference by way of an on line teleconferencing platform.  Answers to normally requested inquiries, together with data relating to particular accommodations thanks to a disability, may well be accessed at:  https://www.fda.gov/advisory-committees/about-advisory-committees/frequent-issues-and-responses-about-food and drug administration-advisory-committee-meetings.

FOR Even more Facts Get hold of:  Akinola Awojope, Centre for Gadgets and Radiological Well being, Food and Drug Administration, 10903 New Hampshire Ave., Bldg., 66, Rm. 5214, Silver Spring, MD 20993-0002, [email protected], 301-636-0512, or Food and drug administration Advisory Committee Information and facts Line, 1-800-741-8138 (301-443-0572 in the Washington, DC spot).  A recognize in the Federal Sign-up about final-moment modifications that impact a beforehand introduced advisory committee assembly can not generally be released swiftly plenty of to provide timely notice.  Therefore, you must always verify the Agency’s web-site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the acceptable advisory committee conference connection, or simply call the advisory committee info line to find out about doable modifications prior to the assembly.


Agenda:  The conference displays will be heard, considered, captioned, and recorded by an on line teleconferencing platform.  On April 20, 2023, the committee will discuss, make suggestions, and vote on scientific data related to the De Novo request for the NUsurface Meniscus Implant sponsored by Lively Implants, Inc.  The machine is a polymeric disc-formed product implanted in the medial compartment of the knee to distribute load involving the distal femur and proximal tibia and is intended to make improvements to ache and purpose in the medial compartment of a knee in which the medial meniscus has been resected.

Food and drug administration intends to make qualifications product offered to the general public no afterwards than 2 company days just before the conference.  If Fda is not able to post the history product on its web site prior to the conference, the track record content will be created publicly accessible on FDA’s web site at the time of the advisory committee meeting, and the track record material will be posted on FDA’s web-site immediately after the conference.  Background substance and the hyperlink to the on-line teleconference conference place will be obtainable at https://www.food and drug administration.gov/AdvisoryCommittees/Calendar/default.htm.  Scroll down and select the suitable advisory committee conference backlink.  The meeting will include things like slide displays with audio components to allow for the presentation of components in a manner that most intently resembles an in-individual advisory committee conference.

Method:  Interested individuals may perhaps current facts, data, or sights, orally or in composing, on difficulties pending before the committee.  Written submissions may perhaps be manufactured to the make contact with individual on or right before April 4, 2023.  Oral displays from the community will be scheduled on April 20, 2023, in between around 1 p.m. and 2 p.m. Jap Time.  Those persons intrigued in earning official oral displays must notify the get hold of man or woman (see FOR More Info Make contact with).  The notification really should incorporate a temporary assertion of the standard mother nature of the evidence or arguments they would like to existing, the names and addresses of proposed participants, and an indicator of the approximate time requested to make their presentation on or right before March 27, 2023.  Time allotted for each presentation may be constrained.  If the quantity of registrants requesting to converse is larger than can be fairly accommodated in the course of the scheduled open public listening to session, Food and drug administration may conduct a lottery to figure out the speakers for the scheduled open general public hearing session.  The speak to individual will notify interested people concerning their ask for to converse by March 28, 2023. 

For push inquiries, you should get hold of the Business of Media Affairs at mailto:[email protected] or 301-796-4540.

Food and drug administration welcomes the attendance of the general public at its advisory committee meetings and will make just about every energy to accommodate people with disabilities.  If you call for accommodations owing to a incapacity, remember to contact Artair.Mallett@food and drug administration.hhs.gov or 301-796-9638 at minimum 7 days in advance of the meeting.

Fda is committed to the orderly carry out of its advisory committee conferences.  Please stop by our web page at https://www.food and drug administration.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for techniques on general public conduct through advisory committee conferences.

Notice of this conference is offered beneath the Federal Advisory Committee Act (5 U.S.C. app. 2).

Dated:  March 1, 2023.

Lauren K. Roth,

Associate Commissioner for Coverage

A detect in the Federal Sign up about final moment modifications that effect a beforehand introduced advisory committee meeting simply cannot constantly be published immediately plenty of to supply timely notice. As a result, you need to constantly examine the agency’s website or phone the committee’s Designated Federal Officer (see Get hold of Details) to find out about feasible modifications right before coming to the meeting.

Individuals attending FDA’s advisory committee meetings are encouraged that the company is not dependable for providing entry to electrical stores. Fda welcomes the attendance of the community at its advisory committee meetings and will make just about every hard work to accommodate individuals with disabilities. If you demand accommodations because of to a incapacity, please get hold of the committee’s Selected Federal Officer (see Make contact with Information) at minimum 7 days in advance of the meeting.

Responses to normally requested thoughts which includes information relating to unique accommodations because of to a disability may well be accessed at: Prevalent Questions and Responses about Fda Advisory Committee Meetings.

Fda is dedicated to the orderly carry out of its advisory committee conferences. You should visit our Net web-site at Community Carry out Through Fda Advisory Committee Conferences for techniques on public carry out for the duration of advisory committee conferences.

Recognize of this meeting is given less than the Federal Advisory Committee Act (5 U.S.C. application.2).