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  5. Virtual Public Workshop – Animal Studies for Orthopedic Products - 06/02/2022
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Workshop

Event Title
Virtual Public Workshop – Animal Studies for Orthopedic Products
June 2, 2022

Date:
June 2, 2022
Time:
8:30 AM - 1:00 PM ET


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

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

WEBCAST

The virtual public workshop will be a live webcast and the link will be provided in your confirmation email once you have registered. The link for the 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 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

If you wish to attend this workshop, you must register by 4:00 p.m. on May 31, 2022. There is no fee to register for the workshop. Registration will be on a first-come, first-served basis. When registering, you must provide the following information:

  1. First Name
  2. Last Name
  3. Affiliation, Company or Organization
  4. Stakeholder Category (Academia, Clinician, Consultant, Government, Industry, Regulatory and Other)
  5. E-mail address
  6. Telephone number

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 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, Susan.Monahan@fda.hhs.gov.

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
OHT6-Feedback@fda.hhs.gov

*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.

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