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  5. Virtual Public Workshop - Orthopedic Cartilage Repair Products - 11/12/2021 - 11/12/2021
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Workshop

Event Title
Virtual Public Workshop - Orthopedic Cartilage Repair Products
November 12, 2021


Date:
November 12, 2021
Time:
8:30 AM - 3:00 PM ET

The Food and Drug Administration (FDA) is announcing a virtual public workshop entitled “Orthopedic Cartilage Repair Products.” This workshop is intended to enhance public understanding of FDA’s efforts to address unmet needs of cartilage repair products related to the regulation of orthopedic devices under 21 CFR Part 888. The purpose of the workshop is to provide stakeholders, including members of the orthopedic community, manufacturers, regulatory affairs professionals, clinicians, patients and the general public, a forum to share information about data and studies to support marketing submissions for cartilage repair products.

Background

This public workshop seeks to share knowledge pertaining to FDA’s regulation of cartilage repair products. The goal is to provide an overview and description of cartilage diseases and degenerative disorders, emerging technologies for cartilage repair, and recommendations for data to support the safety and effectiveness of these products. The main objective of this public workshop is to expand public understanding of cartilage repair products and performance data related to their regulation. The public workshop is not intended to communicate any new policies, processes or interpretations regarding cartilage repair products marketing authorizations. The topics for discussion include cartilage physiology, animal models of cartilage disease and repair, emerging technologies, clinical trial design and endpoints, imaging,  rehabilitation, and safety. Presenters will discuss potential strategies to address challenges in these areas to promote orthopedic product stakeholders develop cartilage repair products to meet this unmet need.

DATE and TIME 

This meeting will be held November 12, 2021, from 8:30 a.m. to 3:00 p.m. ET by webcast only.

WEBCAST WORKSHOP LINK

The virtual public workshop will be a live webcast and the link will be provided in your confirmation email if you registered.  The link for archived webcast will be posted to this webpage for viewing after the public workshop.  

PRELIMINARY AGENDA

This agenda is preliminary and subject to change. More information will be made available as presenters are confirmed.

TIME TOPIC PRESENTER
8:30-8:45 a.m. Welcome and Opening Remarks CAPT Raquel Peat, PhD, MPH, FDA

Master of Ceremony: TBD

Session 1:  Overview of cartilage diseases and unmet clinical need
Moderator(s):
8:45-9:15 a.m. Overview of cartilage diseases TBD
9:15-9:30 a.m. Chondrocytes and cartilage TBD
9:30-9:45 a.m. Chronic and degenerative cartilage injury TBD
9:45-10:00 a.m. Unmet need for cartilage repair products TBD
10:00-10:15 a.m. Group Discussion TBD
10:15-10:30 a.m.

Break

Session 2:  Non-clinical assessment of cartilage repair devices
Moderator(s):
10:30-10:45 a.m. Animal models for cartilage disease and repair  TBD
10:45-11:00 a.m. Imaging techniques for cartilage TBD
11:00-11:30 a.m. Emerging technologies TBD
11:30-12:00 p.m. Group Discussion TBD
12:00-1:00 p.m.

Lunch Break

Session 2:  Clinical performance and marketing
Moderator(s):
1:00-1:15 p.m. Clinical trial design TBD
1:15-1:30 p.m. Clinical endpoints TBD
1:30-1:45 p.m. Safety issues TBD
1:45-2:00 p.m. Marketing and total product life cycle TBD
2:00-2:30 p.m. Group Discussion TBD
2:30-3:00 p.m. Closing Remarks Laurence Coyne, PhD, FDA

REGISTRATION

If you wish to attend this workshop, you must register by 4:00 p.m. on November 10, 2021.

There is no fee to register for the workshop.  Registration will be on a first-come, first-served basis.

No dashes or spaces in phone numbers please.
 

Registrants will receive confirmation when requests for participation have been accepted, if applicable.  

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Peggy Roney, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, Peggy.Roney@fda.hhs.gov by October 28, 2021

COMMENTS

Please submit your comments regarding the workshop to https://www.regulations.gov, Docket No. FDA-2021-N-0697 by December 13, 2021. 

Please refer to the Instructions for submitting comments to the docket to ensure that your feedback is received.  

The resulting discussions from the workshop and comments received in the docket will be taken into consideration.

Please be advised that as soon as a transcript is available, it will be posted in the Dockets and accessible at http://www.regulations.gov.

CONTACT

For questions regarding workshop content please contact:

LCDR Randoshia Miller
Regulatory Health Project Manager
Office of Health Technology 6
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Food and Drug Administration 
301-796-6938
OHT6-Feedback@fda.hhs.gov
CDRHpublicmeetings@fda.hhs.gov

REFERENCES

Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage (issued December 2011)

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