- November 12, 2021
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.
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.
This meeting will be held November 12, 2021, from 8:30 a.m. to 3:00 p.m. ET by webcast only.
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.
This agenda is preliminary and subject to change. More information will be made available as presenters are confirmed.
|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
|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|
|Session 2: Non-clinical assessment of cartilage repair devices
|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|
|Session 2: Clinical performance and marketing
|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|
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.
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
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.
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
Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage (issued December 2011)