US FDA’s UDI rule: devices industry seeks exemption definitions and transition changes
This article was originally published in Clinica
Executive Summary
US medical device manufacturers have followed the medical imaging industry in lodging suggested changes to the US FDA’s proposed rule on UDI (unique device identification). The FDA published its proposals on a system that is designed to improve device traceability throughout the supply chain and into the post-market phase in the Federal Register on 10 July, and began a public consultation (www.clinica.co.uk 2 July 2012) which closed on 7 November.