Scott A. Colburn is the Director of the Standards and Conformity Assessment Program at the Food and Drug Administration’s Center for Devices and Radiological Health. In this role, Scott is responsible for the Center’s standards recognition and related development activities in 600+ national and international consensus standards committees. In addition, Scott oversees the program’s new Accreditation Scheme for Conformity Assessment (ASCA) Pilot program and the Center’s efforts to optimize standards for regulatory use within the International Medical Device Regulators Forum.
Scott has served in numerous roles in the area of premarket review and voluntary consensus standards development and implementation for medical devices. He is a member of many national and international standards organizations and serves on several policy and leadership committees.