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Devices & Diagnostics Letter
Oct. 1, 2012 | Vol. 39 No. 39
UDI Enforcement May Stall: Address Unwritten Requirements, Experts Urge
FDA enforcement of unique device identifier (UDI) requirements will likely be delayed to allow for ample implementation time, but unwritten mandates in the draft rule with the potential to snarl inspections require prompt attention, compliance experts and former agency officials say.
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