Preliminary Rule on UDI May Be Out Early 2010
“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.
The GMP Letter