AAOS and FDA Prioritize Collaboration to Promote Medical Device Safety and Innovation

AAOS has a long history of fostering collaboration with the U.S. FDA on orthopaedic medical products, focusing on advancing medical device innovation and safety by working closely with the FDA’s Office of Orthopedic Devices in the Center for Devices and Radiological Health (CDRH). The underlying value of responsibly advancing high-quality care underpins and helps guide both organizations. AAOS and the FDA both seek to further strengthen this working relationship by encouraging AAOS members who are considering submitting live educational events for the 2025 AAOS Annual Meeting programming (i.e., symposia and Instructional Course Lectures [ICLs]) to contact representatives from the FDA to discuss their topics and request FDA contributors when a federal regulatory perspective may add to the quality of the content.

Including FDA input can enhance understanding of regulatory effects on practices. However, it may not be immediately clear how to pursue the opportunity. Capt. Raquel Peat, PhD, MPH, USPHS, is the director of the Office of Health Technology 6 (OHT6): Office of Orthopedic Devices within CDRH, which regulates all orthopaedic medical devices. The Office of Orthopedic Devices serves as the primary source for scientific and medical expertise regarding safety and effectiveness of orthopaedic medical devices throughout the product lifecycle. Along with CDRH leadership, Capt. Peat welcomes an open dialogue with any ICL, symposium, or scientific organizer who believes that an FDA speaker or collaborator might enhance their programs and submissions. The window for submitting 2025 ICLs and symposia opens in April, so now is the time to determine whether FDA input could further help members understand how regulation affects their practices.

Current FDA involvement
More than 30 staff members and leaders from CDRH attended the AAOS 2024 Annual Meeting in San Francisco to participate in scheduled educational events and further their own knowledge of the ever-evolving orthopaedic landscape, signaling a clear desire to be present for the important conversations affecting the profession. Likewise, AAOS leadership has consistently signaled support for these collaborative initiatives that discuss important topics, such as the recent second annual AAOS/FDA Town Hall, focusing on the use of diverse real-world evidence for product development.

Attendees of this event were treated to presentations discussing the importance of capturing data from diverse and underrepresented populations in the United States through orthopaedic registries and clinical studies and the importance of representation. Attendees also gained insights into the mission and function of CDRH and OHT6. Discussion leaders for the AAOS/FDA Town Hall included:

• Kevin J. Bozic, MD, MBA, FAAOS, FACS, FAOA, AAOS then-president
• David Jevsevar, MD, MBA, FAAOS, chair of the AAOS Research and Quality Council
• James Huddleston III, MD, FAAOS, chair of the AAOS American Joint Replacement Registry Steering Committee
• Anthony E. Johnson, MD, FAAOS, FACS, FAOA, LTC, MC, USA (Ret.), chair of the AAOS Diversity Advisory Board
• William Maisel, MD, MPH, FDA director of the CDRH Office of Product Evaluation and Quality
• Capt. Peat, representing the CDRH OHT6: Office of Orthopedic Devices, Office of Product Evaluation and Quality
• Industry representative Daryll C. Dykes, PhD, MD, JD, vice president of Global Medical Affairs at J&J Medtech/DePuy Synthes, nominated by the Orthopaedic Surgical Manufacturers Association
• Patient representative Staff Sergeant Kisha Makerney
• Moderator S. Raymond Golish, MD, PhD, FAAOS

In addition to the AAOS/FDA Town Hall and Engagement Theater sessions held during past Annual Meetings, the FDA and AAOS have collaborated to ensure that orthopaedic surgeons remain well-represented in discussions regarding rulemaking that may affect the profession. The AAOS Committee on Devices, Biologics, and Technology (DBT) has also collaborated with the FDA to develop resources to raise awareness of federal guidance and compliance resources with webinars and publications. Additionally, the DBT has worked to make federal guidance easier to interpret with resources for orthopaedic surgeons such as the Biologics Dashboard and the Device Recall Dashboard.

To inquire about inviting an FDA speaker to discuss orthopaedic regulatory science at an upcoming event, please contact Christopher Harner, MD, FAAOS, FAOA, clinical deputy office director of OHT6: Office of Orthopedic Devices, via email at christopher.harner@fda.hhs.gov.

Members interested in submitting a proposal for a symposium or ICL to take place during Annual Meeting 2025 are invited to submit an application at aaos.org/callforabstracts. Applications open on April 1 and close May 1.

Ryan Pezold, MA, MBA, is director of clinical quality and value at AAOS.

FDA volunteers to provide speakers to enhance 2025 ICL and symposia submissions

To inquire about inviting an FDA speaker to discuss orthopaedic regulatory science for an Instructional Course Lecture (ICL) or symposium at an upcoming event, please contact Christopher Harner, MD, FAAOS, FAOA, clinical deputy office director of OHT6: Office of Orthopedic Devices, at christopher.harner@fda.hhs.gov.