July 26, 2016

FDA issues draft UDI guidance

By: Judy Mathias
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Editor's Note

The Food and Drug Administration (FDA) on July 26 issued a draft Unique Device Identification (UDI) guideline that requires most medical device labels and packages to bear a UDI in easily readable plain-text and automatic identification and data capture technology forms.

UDIs must be issued under a system operating by FDA-accredited issuing agencies. Comments on the draft guideline will be accepted for 60 days.

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