UDI for medical devices at top of the GS1 Connect agenda

The Healthcare Track of GS1 Connect June 12 began with an overview of the State of the Healthcare Industry by Siobhan O’Bara of GS1, and a presentation by Jay Crowley, senior advisor of the U.S. Food and Drug Administration on the newly passed FDA Uniform Device Identifier (UDI) legislation. Crowley has been closely involved with the development of the legislation. It will be effective one year from the final rule publication, which is expected this summer.

This much-anticipated legislation brings with it a number of questions, from both suppliers and distributors, about implementation and compliance, and Crowley presented information on which devices are covered, which devices or combinations of devices are exempted, and how the UDI data can become part of a label.

Crowley also commented on the relationship between the UDI Database and the GDSN, and how GS1 standards can smooth the compliance process. Click here for a copy of Crowley’s slide presentation on UDI.