Published FDA-UDI Ruling

Published FDA-UDI Ruling

FDA Rule for Unique Device Identification System

The Food and Drug Administration (FDA) issued a final rule on October 24, 2013 to establish an identification system for medical devices.

Here is a brief summary of the rule:

  • The label and packaging of medical devices must include a Unique Device Identifier (UDI).
  • The labeler must submit product information concerning devices to FDA’s Global Unique Device Identification Database (GUDID).
  • Each UDI must be provided in a plain-text version and in a form that uses Automatic Identification and Data Capture (AIDC) technology.
  • The UDI will be required to be directly marked on the device itself if the device is intended to be used more than once and requires reprocessing before each use.

See: UDI Rule RIN 0910–AG31

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