A proposed FDA regulation for a Unique Device Identification System is critical to the future of post-market safety surveillance, the agency says. The UDI system aims to reduce medical errors, and provide an array of other benefits for supply chain management. Makers of high-risk class III products will have one year to place UDI codes on devices. The UDI mandate will extend to moderate-risk class II devices two years later and to some low-risk class I devices two years after that.
A Unique Device Identification (UDI) system that FDA says is critical to the future of post-market safety surveillance, Medical Device Reporting (MDR), recall management and safety alerts was unveiled by the agency in a July 3 proposed rule.
The system aims to reduce medical errors, and provide an array of other benefits for supply chain management, CDRH Director...