FDA Extends UDI Compliance Dates For Certain Low-Risk Devices

January 12, 2018
FDA Friday (Jan. 12) significantly delayed the date by which class I and unclassified devices must bear a unique device identifier (UDI). While most higher risk devices are already required to bear a UDI, FDA says a number of policy issues have popped up that need to be resolved before lower risk devices also must bear the identifier, which is held up by public health advocates as key to device postmarket surveillance. The UDI rule, finalized by FDA in September...

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