Scott Colburn, director of the Standards and Conformity Assessment Program at the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), and member of ANSI’s Board of Directors for 2023, recently spoke with AAMI’s Robert Burroughs, chief learning and development officer, on the interface between international standards and national regulators.
Colburn is a convener for the International Organization for Standardization (ISO) Technical Committee (TC) 210, Quality management and corresponding general aspects for medical devices, Joint Working Group 4, and is helping to establish new liaison relationships between ISO, the Global Harmonization Working Party (GHWP), and the International Medical Device Regulators Forum (IMDRF). He discussed how ISO TC 210 members are paying special attention to engaging with regulators to address the national challenges that get in the way of adopting international standards. Colburn expressed that challenges arise when regulators aren’t familiar with the standardization system in their own countries, and that these concerns are being addressed with the IMDRF.
“We […] speak to the importance of regulators participating in the standards development process,” Colburn said. “Regulators are trying to communicate on the global scale to harmonize certain approaches, but we need to influence that effort into the national levels as well, so that when we receive comments [on developing standards] those concerns are taken into account.”
Read more in the AAMI article: Bringing National Perspective to International Standards: A Conversation with Scott Colburn.