FDA releases final guidance for Unique Device Identifier (UDI)

Posted on February 1, 2014 · Posted in FDA Regulatory Updates

FDA Releases Final Guidance for Unique Device IdentifierDirect from the Federal Register: 

“The Food and Drug Administration (FDA) is issuing a final rule to establish a system to adequately identify devices through distribution and use. This rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement. The labeler must submit product information concerning devices to FDA’s Global Unique Device Identification Database (GUDID), unless subject to an exception or alternative. The system established by this rule requires the label and device package of each medical device to include a UDI and requires that each UDI 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 intended to be reprocessed before each use.”

Compliance dates for UDI requirements listed here.

You can read the final guidance here.

Sample label image: courtesy of www.FDA.gov. Main photo from Flickr.