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FDA Releases Proposed Rule On UDI System, Ushering in ‘Modern Post-Market Surveillance System’

This article was originally published in The Silver Sheet

Executive Summary

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.

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