FDA's UDI Marching Orders: Don't Wait For The Regulation

Article preview from "The Gray Sheet" - December 6, 2010

The hoped-for regulation on FDA's unique device identification framework will not come out until the first part of 2011, but companies should start taking steps to implement UDI now, an agency official says.

FDA's UDI Marching Orders: Don't Wait For The Regulation

Article preview from "The Gray Sheet" - December 6, 2010

The hoped-for regulation on FDA's unique device identification framework will not come out until the first part of 2011, but companies should start taking steps to implement UDI now, an agency official says.

"Don't wait for the regulation," Jay Crowley, senior advisor for patient safety at FDA's device center and head of the UDI initiative, said last week.

FDA had hoped to issue the UDI rule – about three years in the making – by this December, but it appears "that is not going to happen," Crowley said Dec. 1 at the Clarion Group's UDI Conference in Baltimore, Md. (See " UDI By December? FDA Confident On Year-End Release Of Proposed Rule " – "The Gray Sheet" Nov. 1, 2010


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