Group Demands FDA Release UDI Regulation Immediately

Tired of waiting for a proposed rule to be released on a unique device identification (UDI) database, an advocacy group is asking the FDA to issue a regulation immediately.

The Advancing Patient Safety Coalition (APSC) sent a letter last month to FDA Commissioner Margaret Hamburg reminding her that it has been three years since Congress passed the FDA Amendments Act, which requires the creation of a UDI system. Now is the time to act, the coalition says.

FDA spokesman Dick Thompson was vague last month about when the proposed rule is likely to be released. “At this point, all we can say is that the rule is still under development,” Thompson said. “It is a high priority within the agency, and we hope to issue it in 2010.”
The GMP Letter