Preliminary Rule on UDI May Be Out Early 2010

Devicemakers may see a proposed rule on a unique device identification (UDI) system by early next year, but required compliance would still be a few years away, Jay Crowley, senior adviser for patient safety with the FDA’s Center for Devices and Radiological Health (CDRH) said following a panel discussion on UDI at the 2009 AdvaMed Medtech Conference last month.

“We hope to have a proposed rule out by the spring and a final ruling the following year,” Crowley said.

Once a rule is released, the agency will likely implement it in phases, with Class III devices expected to be labeled about 18 months after the rule is posted. Class I and II devices would have to comply within two to three years, he added.
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