Global device UDI comes a step closer amid manufacturer compliance concerns
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration’s release in September 2013 of medical device unique identifier (UDI) and associated database guidance will promote patient safety and inject new pace into the move towards globally harmonized rules. That is the view of the FDA. While the device industry broadly agrees, the guidance has prompted certain concerns among medtech trade association AdvaMed and others, including about the ability of the SME-dominated industry to adapt with minimum burden. Ashley Yeo reports.