By Stewart Eisenhart, Emergo Group
Medical device market regulators in the US have launched a new website to provide public access to their Global Unique Device Identification Database (GUDID) designed to store device labelers’ information about their products.
The website, AccessGUDID, has gone live in beta version and the Food and Drug Administration is requesting feedback on functionality and contents from users including healthcare providers, patients and researchers. Availability of UDI content on the site reflects the FDA’s phased implementation of UDI requirements; currently, only data for Class III and high-risk devices can be found on the site, as these devices were the first to have to comply with UDI rules.
Additional device types and classifications will be added to GUDID through 2020, according to the FDA’s implementation timeline. The FDA had set itself a goal of Spring 2015 for launching AccessGUDID, so the agency appears to have met that deadline.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.