U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Medical Devices
  3. News & Events (Medical Devices)
  4. Workshops & Conferences (Medical Devices)
  5. Virtual Public Workshop – Animal Studies for Orthopedic Products - 06/02/2022
  1. Workshops & Conferences (Medical Devices)

Workshop

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

Date:
June 2, 2022
Time:
8:30 AM - 1:30 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 1:30 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, FDA
8:40 am - 8:50 am Orthopedic Comparative Anatomy Lisa Fortier, DVM, PhD, DACVS
Cornell University
8:50 am - 9:05 am Considerations for Animal Study Design James Cook, DVM, PhD, OTSC
University of Missouri
9:05 am - 9:30 am Orthopedic Specific Models: 
1. Extremities
2. Spine
3. Soft Tissue    		 1. Michael Yaszemski, MD 
Mayo Clinic
2. Donita Bylaski-Austrow, PhD 
University of Cincinnati
3. TBD
9:30 am - 9:40 am Assessments & Endpoints in Animal Studies Jeremiah Easley, DVM
Colorado State University
9:40 am - 10:00 am Clinical Translation Matthew Allen, MA, VetMB, PhD, FORS, MRCVS
University of Cambridge
10:00 am - 10:30 am Presenter Discussion Sara Thompson, DVM, FDA
10:30 am - 10:40 am Break  
10:40 am - 11:00 am Standards & FDA Guidance in Animal Models Aric Kaiser, MS, FDA
11:00 am - 11:20 am Good Laboratory Practices Annabelle Crusan, DVM, MS, FDA
11:20 am - 11:40 am Best Practices for Premarket Animal Studies Sara Thompson, DVM, FDA
11:40 am - 11:55 am Reporting Considerations for Animal Studies Liza Fisher, DVM, FDA
11:55 am - 12:10 pm The Role of Animal Data in Marketing Submissions** Pooja Panigrahi, PhD, FDA
12:10 pm - 1:00 pm Presenter Discussion Laura Rose, PhD, FDA
1:00 pm - 1:10 pm Closing Remarks Laurence Coyne, PhD, FDA

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.

Back to Top