---

The Food and Drug Administration (FDA) is announcing a virtual public workshop entitled "Animal Studies for Orthopedic Products". The purpose of the workshop is to share best practices regarding premarket animal studies* for orthopedic products in CDRH, and hold an open public discussion on the topic with interested stakeholders. These stakeholders include members of the orthopedic community, manufacturers, regulatory affairs professionals, clinicians, patients and the general public.

• Date and Time
• Agenda
• Registration
• Comments
• Contact

---

DATE and TIME

This meeting will be held on June 2, 2022, from 8:30 a.m. to 1:00 p.m. (ET) by webcast only.

WEBCAST

Archived webcast:
https://fda.yorkcast.com/webcast/Play/532488c061cb497cb931555d226548e81d

PRELIMINARY AGENDA

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

Time	Subject	Name of Speaker
8:30 AM - 8:40 AM	Welcome & Opening Remarks	CAPT Raquel Peat, PhD, MPH Director, OHT6: Office of Orthopedic Devices,  Office of Product Evaluation and Quality, CDRH
Mistress of Ceremony- Kira Moore, DVM, FDA, CDRH
Session 1: Animal Models for Orthopedics Moderators: Sara Thompson, DVM, FDA, CDRH
8:40 AM - 8:50 AM	Orthopedic Comparative Anatomy	Lisa Fortier, DVM, PhD, DACVS James Law Professor of Surgery Cornell University
8:50 AM - 9:05 AM	Considerations for Animal Study Design	James Cook, DVM, PhD, OTSC William & Kathryn Allen Distinguished Professor University of Missouri
9:05 AM - 9:30 AM	Orthopedic Specific Models:  1. Extremities 2. Spine	Extremities- Natalie Miller, VMD, PhD FDA, CDRH, OHT2B: : Division of Circulatory Support, Structural and Vascular Prostheses ------ Spine- Donita Bylski-Austrow, PhD Professor Emeritus, Dept of Orthopaedics University of Cincinnati
9:30 AM - 9:40 AM	Assessments & Endpoints in Animal Studies	Jeremiah Easley, DVM  Associate Professor, Dept of Clinical Sciences Colorado State University
9:40 AM - 10:00 AM	Clinical Translation	Matthew Allen, MA VetMB PhD FORS MRCVS Professor of Small Animal Surgery University of Cambridge
10:00 AM - 10:30 AM	Presenter Discussion
10:30 AM- 10:40 AM	Break
Session 2:  Regulatory Considerations for Orthopedics Moderator: Laura Rose, PhD, FDA, CDRH
10:40 AM - 11:00 AM	Standards & FDA Guidance in Animal Models	Aric Kaiser, MS FDA, CDRH, OHT6: Division of Restorative, Repair and Trauma Devices
11:00 AM - 11:20 AM	Good Laboratory Practices	Annabelle Crusan, DVM, MS FDA, CDRH, OHT2B: Division of Circulatory Support,  Structural and Vascular Prostheses
11:20 AM - 11:40 AM	Best Practices for Premarket Animal Studies	Sara Thompson, DVM FDA, CDRH, OHT6: Division of Restorative,  Repair and Trauma Devices
11:40 AM - 11:55 AM	Reporting Considerations for Animal Studies	Liza Fisher, DVM FDA, CDRH, OHT6: Division of Spine Devices
11:55 AM - 12:10 PM	The Role of Animal Data in Marketing Submissions**	Pooja Panigrahi, PhD 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 FDA, CDRH, OHT6C: Director, Division of Restorative,  Repair and Trauma Devices

REGISTRATION

Online Registration is closed: If you wish to attend this workshop, you must register by 4:00 p.m. on May 31, 2022. 

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, 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, 301-796-5661, [email protected].

COMMENTS

Please submit your comments regarding the workshop to https://www.regulations.gov/, Docket No. FDA-2022-N-0719 by July 5, 2022.

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 Docket and accessible at http://www.regulations.gov.

CONTACT

For questions regarding workshop content, please contact:

LCDR Randoshia Miller
Program Coordinator
Office of Health Technology 6
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Food and Drug Administration
301-796-6838
[email protected]

*We encourage sponsors to consult with us if they wish to use a non-animal testing method they believe is suitable, adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency to an animal test method.

**When considering the number of animals and the amount of data that can support the safety and performance of a medical device, FDA recommends balancing the ethical principles of reduction/replacement/refinement as well as regulatory least burdensome principles, with the goal of using the minimum number of animals necessary to generate valid scientific data to demonstrate reasonable safety and performance.