FDA Releases Final Guidance on its Unique Device Identification System

July 9, 2021

The FDA has released a long-awaited final guidance on the form and content of its Unique Device Identification (UDI) system, which has been available in draft form for almost five years.

The UDI must be presented in two forms on device labels and packages — easily readable plain-text and a scannable automatic identification and data capture (AIDC) format.

The plain-text format is meant to allow anyone to read and enter the UDI into their data systems, such as for patient records or reports to the FDA without using a scanning device.  

Medical device manufacturers will be required to include UDIs on their device labels and packaging from Sept. 24, 2023.

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