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  5. Virtual Public Workshop - Orthopedic Cartilage Repair Products - 11/12/2021 - 11/12/2021
  1. Workshops & Conferences (Medical Devices)

Workshop

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

Date:
November 12, 2021
Time:
8:30 AM - 1:00 PM ET

The Food and Drug Administration (FDA) announced a virtual public workshop entitled “Orthopedic Cartilage Repair Products.” This workshop was 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 was 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 spught to share knowledge pertaining to FDA’s regulation of cartilage repair products. The goal was 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 was to expand public understanding of cartilage repair products and performance data related to their regulation. The public workshop was not intended to communicate any new policies, processes or interpretations regarding cartilage repair products marketing authorizations. The topics for discussion included cartilage physiology, animal models of cartilage disease and repair, emerging technologies, clinical trial design and endpoints, imaging, rehabilitation, and safety. Presenters discussed 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 was held November 12, 2021, from 8:30 AM to 1:00 PM ET by webcast only.

WEBCAST WORKSHOP LINK

https://fda.yorkcast.com/webcast/Play/578ec34c004c44a89d91c9549f4998031d

Workshop Transcript

AGENDA

TIME TOPIC PRESENTER
8:30 AM - 8:40 AM Welcome and Opening Remarks CAPT Raquel Peat, PhD, MPH
Director, OHT6: Office of Orthopedic Devices, 
Office of Product Evaluation and Quality, CDRH
8:40 AM - 8:45 AM Opening Remarks Wilson Bryan, MD 
Director, Office of Tissue and Advanced Therapies, CBER

Master of Ceremony - Aric Kaiser, MS, FDA, CDRH
Session 1: Overview of cartilage diseases and unmet clinical need 
Moderators: Malcolm Moos, MD, PhD, FDA, CBER &  Pooja Panigrahi, PhD, FDA, CDRH
8:45 AM - 9:05 AM Overview of Chondrytes and Cartilage John Terrig Thomas, PhD
Research Biologist
Office of Tissues and Advanced Therapies
9:05 AM - 9:20 AM Knee Arthritis CPT Cody Schlaff, MD
Dept of Orthopedic Surgery
Walter Reed National Military Medical Center
9:20 AM - 9:35 AM Focal Chondral and Osteochondral Defects Seth Lawrence Sherman, MD
Associate Professor
Standford University
9:35 AM - 9:50 AM Unmet need for Cartilage Repair Products Bashir Ahmed Zikria, MD, MSc
Chief of Surgery
Johns Hopkins University
9:50 AM - 10:10 AM Presenter Discussion
10:10 AM - 10:15 AM

Break
Session 2:  Non-Clinical assessment of cartilage repair devices
Moderator(s): Liza Fisher, DVM, PhD, FDA, CDRH & Iwen Wu, PhD, FDA, CBER
10:15 AM - 11:00 AM Animal Models for Cartilage Disease and Repair  James Cook, DVM, PhD, OTSC
William & Kathryn Allen Distinguished Professor
University of Missouri 
&
Anthony Ratcliffe, PhD
President & CEO
Synthasome, Inc.
11:00 AM - 11:40 AM Emerging Technologies Jennifer Elisseeff, PhD
Director, Translational Tissue Center
Johns Hopkins University
11:40 AM - 11:55 AM Cartilage Restoration: Decision-Making and 
What Patient's can Expect		 Brian J. Cole, MD, MBA
Assoc. Chairman & Professor
Rush Medical College
11:55 AM - 12:10 PM Marketing and Total Product Life Cycle Sara Thompson, DVM
FDA, CDRH, OHT6: Division of Restorative, Repair 
and Trauma Devices
12:10 PM -12:50 PM

Presenter Discussion
12:50 PM -1:00 PM Closing Remarks Laurence Coyne, PhD
Director, Division of Restorative, Repair and Trauma Devices, 
OHT6: Office of Orthopedic Devices, 
Office of Product Evaluation and Quality, CDRH

REGISTRATION

The Registration is Closed.

 

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
[email protected]
[email protected]

REFERENCES

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

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