FDA’s UDI Draft Rule Details Device Marking, Database Submission Mandates

 
• By Shawn M. Schmitt

The long-anticipated proposal maps out a unique device identifier system that FDA says will be crucial to the future of post-market safety surveillance, recall management and safety alerts. The effort also will help reduce medical errors and bring an array of other benefits, stakeholders say.

Makers of high-risk medical devices would be required to include on product packaging a unique identifying code linked to a new FDA-run database by about May 2014 under a regulation proposed by FDA July 3.

The mandate will extend to class II, moderate-risk devices two years later, and to some low-risk class I devices two...

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