The United States’ Journey to Achieve Accessibility of Medical Devices

Medical devices in the United States were exempt from any accessibility requirements until 2017, when the U.S. Access Board issued its Final Rule on medical device accessibility. This presentation will discuss how the American journey to address medical device accessibility problems proceeded from about 2004 until the final regulation was issued. Lessons learned along the way will be presented, and it is hoped that these lessons will assist other countries that may be pursuing the development of standards or legislation on medical device accessibility. In addition, this paper describes the content of the Final Rule, the aspects of accessibility that are covered, and the specific guidance provided for increasing the accessibility of medical instrumentation.