UDI By December? FDA Confident On Year-End Release Of Proposed Rule

Article preview from "The Gray Sheet" - November 1, 2010

FDA expects to lay out a proposed framework for mandatory unique device identification in December, though a final rule is at least a year away, according to Jay Crowley, senior advisor for patient safety at FDA.

UDI By December? FDA Confident On Year-End Release Of Proposed Rule

Article preview from "The Gray Sheet" - November 1, 2010

The FDA staffer, who has been heading up the agency's UDI efforts, gave the latest update on the long-awaited proposed rule, in the works since 2007, at an Oct. 20 session of the AdvaMed annual conference in Washington, D.C.

"We do anticipate that they will actually come out by the end of the year, sometime in the December timeframe," Crowley said at AdvaMed, though the final agency clearance process is out of his control.

The framework, once finally released, won't contain any surprises, since the agency has already presented the gist of the rule, he added.

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