Article preview from "The Gray Sheet"- July 9, 2012
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.
Article preview from "The Gray Sheet"- July 9, 2012
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 years after that. For certain products, including most implantable devices, the unique device identifier (UDI) codes will also need to be etched directly onto devices, not just on the labels, with an additional two-year lag on implementation, according the long-awaited proposed rule 
on mandatory UDIs.
In the proposal, FDA maps out a UDI system that it and others argue will be crucial to the future of post-market safety surveillance, medical device adverse event reporting, recall management and safety alerts. It will help reduce medical errors and will have an array of other benefits for supply chain management and other health care system initiatives, CDRH Director Jeffrey Shuren said during a July 3 press briefing.
The rulemaking is “truly a transformative action for the FDA,” Shuren said. In particular, the UDI system is “the lynchpin for a modern post-market surveillance system for medical devices,” because it will allow regulators and others to actively mine databases and registries for performance data tying specific devices to specific patients, he said.
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