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  5. Virtual Public Workshop - Orthopedic Device-Related Infections II Workshop - 12/03/2021
  1. Workshops & Conferences (Medical Devices)

Workshop

Event Title
Virtual Public Workshop - Orthopedic Device-Related Infections II Workshop
December 3, 2021

Date:
December 3, 2021

The Food and Drug Administration (FDA) announced a virtual public workshop entitled "Orthopedic Device-Related Infections II Workshop." This was the second in a series of workshops intended to provide information regarding infections related to orthopedic devices and to seek feedback on current and potential future strategies for protecting and promoting public health in this clinical area. The purpose of this workshop was to catalyze collaboration among the orthopedic community stakeholders, identify regulatory science challenges, discuss innovative strategies to address those challenges.

Background

The workshop provided a forum to facilitate information exchange among academic centers, health care professionals, and device manufacturers interested in developing products and strategies to address infections related to orthopedic devices. The public workshop was not intended to communicate any new policies, processes or interpretations regarding medical device marketing authorizations.

The topics for discussion at this public workshop included 1) current pathways and strategies for marketing orthopedic products that include antimicrobials and what would be needed to improve the availability for patient care of products utilizing such technologies, 2) regulatory considerations regarding non-clinical assessments of orthopedic products that include antimicrobials, 3) aspects of clinical assessments of orthopedic products that include antimicrobials including clinical trial design, the use of alternative clinical data sources such as registries and other real-world data sources, and 4) potential avenues for collaboration between orthopedic surgeons and other healthcare providers, product manufacturers, patients and government agencies and regulators with respect to orthopedic products that include antimicrobials.


DATE and TIME

This meeting was held December 3, 2021, from 8:30 a.m. to 5:00 p.m. ET by webcast only.

WEBCAST WORKSHOP LINK

https://fda.yorkcast.com/webcast/Play/1ec55ffe7dc0423697beaa64d23ce3d21d

Workshop Transcript

AGENDA

Time Title Speaker
8:30 AM–8:45 AM Welcome CAPT Raquel Peat, PhD, MPH, FDA
Director, OHT6: Office of Orthopedic Devices, CDRH
Master of Ceremony - James Bertram, PhD, FDA
Session 1: Marketing Pathways and Strategies for Anti-Infective Combination Products
Moderator: Laurence Coyne, PhD, FDA
 8:45 AM–9:00 AM Regulatory Requirements for Combination Products John Weiner, JD, FDA
Office of Combination Products
9:00 AM–9:15 AM Overview and Jurisdictional Considerations for Device-Drug Combination Products Leigh Hayes, JD, FDA
Office of Combination Products
9:15 AM–9:30 AM Effective Use of the Pre-Submission Program Susannah Gilbert, MS, FDA
Office of Regulatory Programs, CDRH
9:30 AM–9:45 AM Experience with the Breakthrough Devices and Safer Technologies Programs Daniel Ramsey, MS, FDA
Office of Clinical Evidence & Analysis, CDRH
9:45 AM–10:30 AM Presenter Discussion
10:30  AM–10:45 AM Break
Session 2: Regulatory Considerations: Non-Clinical Assessments for Combination Products
Moderator: CDR Kenneth Phillips, PhD, FDA
10:45 AM–11:00 AM In Vitro Test Methodology for Assessing Antimicrobial Effects Ryan Trombetta, PhD, FDA
OHT6: Office of Orthopedic Devices, CDRH
11:00 AM–11:15 AM Non-Clinical Assessments for Combination Products: Industry Perspective Robert Harten, PhD
R&D Biomaterials, DePuy Synthes
11:15 AM–11:30 AM Organization of the Chemistry, Manufacturing, and Controls George Lunn, PhD, FDA
Office of New Drugs, CDER
11:30 AM–11:45 AM Manufacturing Process and Facilities Steven Hertz, MS, MBA, PE, FDA
Office of Pharmaceutical Quality, CDER
11:45 AM–12:00 PM Biocompatibility Antimicrobial Devices Aprajita Garg, PhD, FDA
OHT6: Office of Orthopedic Devices, CDRH
12:00 PM–1:00 PM Lunch Break
1:00 PM–1:15 PM Sterility Assessments Steven Turtil, MS, FDA
OHT6: Office of Orthopedic Devices, CDRH
1:15 PM–1:30 PM Animal Testing Sara Thompson, DVM, FDA
OHT6: Office of Orthopedic Devices, CDRH
1:30 PM–2:15 PM Presenter Discussion
2:15 PM –2:30 PM Break
Session 3: Regulatory Considerations: Clinical Assessments for Combination Products
Moderators: Christopher Harner, MD, FDA & Nitin Goyal, MD, Anderson Orthopaedic Clinic
2:30 PM–2:45 PM Clinical Assessments for Combination Products: Industry Perspective Charisse Sparks, MD
Medical Director, J&J Depuy Synthesis
2:45 PM–3:00 PM Clinical Evidence Considerations for Orthopedic Device-Antimicrobial Drug Combination Products Dmitri Iarikov, MD, FDA
Office of Infectious Diseases, CDER
3:00 PM–3:15 PM Emerging Concepts and Examples Related to Orthopedic Device Technologies Laura Rose, PhD, FDA
OHT6: Office of Orthopedic Devices, CDRH
3:15 PM–3:30 PM Use of Real-World Evidence to Support Regulatory Decision-Making for Anti-Infective Combination Medical Devices Victoria Lilling, MD, FDA
OHT6: Office of Orthopedic Devices, CDRH
3:30 PM–3:45 PM Post- Market Study Designs and Considerations for Anti- Microbial Combination Products Carolina Alvarez-Garriga, MD, FDA
OHT6: Office of Orthopedic Devices, CDRH
3:45 PM–4:45 PM Presenter Discussion
4:45 PM–5:00 PM Closing Remarks Laurence Coyne, PhD, FDA
Director, Division of Restorative, Repair and Trauma Devices, OHT6: Office of Orthopedic Devices, CDRH

REGISTRATION

The Registration is closed. 

COMMENTS

Please submit your comments regarding the workshop to https://www.regulations.gov/, Docket No. FDA-2021-N-1027 by January 3, 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 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
301-796-6838
OHT6-Feedback@fda.hhs.gov
CDRHpublicmeetings@fda.hhs.gov

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