|Orthopaedic Device Forum Meets in Washington, DC |
On September 25, 2017, the Orthopaedic Device Forum met in Washington, DC to discuss regulatory matters of significance to orthopaedics. Established in 1996, the mission of the Orthopaedic Device Forum is to foster an environment of open communication among the scientific community, government, and related industry on orthopaedic issues of mutual interest.
The Orthopaedic Device Forum includes representatives of the scientific and clinical orthopaedic community, the Food and Drug Administration (FDA) and other governmental agencies, and representatives of the industry related to musculoskeletal health and diseases. The Forum works to improve communication, provide educational seminars, respond to guidance documents, and develop consensus standards that provide the FDA with a streamlined template for device reviews. This results in fewer returned applications and a shorter timeline to the marketplace.
At the September meeting, representatives discussed the recent Medical Device User Fee Amendments (MDUFA) legislation, which helps the FDA increase the efficiency of regulatory processes with a goal of reducing the time it takes to bring safe and effective medical devices to the U.S. market. They also discussed implementation of the 21st Century Cures Act, enacted into law on December 13, 2016 after a bipartisan, multi-year effort. The Cures Act primarily affects activities of the Department of Health and Human Services (HHS) and its agencies, including the FDA. Finally, the group considered efforts related to stem cell therapies and their use in regenerative medicine. In particular, FDA Commissioner Dr. Scott Gottlieb has stated that there are “a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products.” The Forum will continue to look at these and other related issues. For more information on the Forum, read this October 2017 AAOS Now article: https://www.aaos.org/AAOSNow/2017/Oct/Research/research02/.