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FDA Plans for UDI in 2015

On December 18, 2014, the U.S. Food and Drug Administration (FDA) sent out an e-mail update regarding the Unique Device Identification (UDI) system.  The update covered information about upcoming compliance dates and FDA’s plans for the system in 2015.

The next two UDI compliance dates are:

  • September 24, 2015 for non-class III implantable, life-supporting, and life-sustaining (I/LS/LS) devices
  • September 24, 2016 for class II devices

As estimated at the 2014 UDI Conference, FDA will begin accepting Global Unique Device Identifier Database (GUDID) account requests from labelers of I/LS/LS devices in January 2015.  The agency will begin accepting requests from class II device labelers later in 2015.

FDA is working with the National Library of Medicine to make the GUDID available for the public to search and download published records.  The database is expected to be open to the public in the spring of 2015. Users will be able to download all published GUDID data at once.

In August and November 2014, FDA granted compliance date extensions for labelers of contact lenses and class III implants due to implementation issues.  The agency continues to work with industry to resolve the issues.  Other UDI issues that FDA plans to focus on in 2015 include:

  • UDI Direct Marketing Requirements
  • Convenience Kits
  • UDI Extensions and Alternatives

The agency also plans to issue an updated Frequently Asked Questions document.

In the update, FDA encouraged device labelers to prepare for UDI and GUDID requirements in advance of their compliance date to account for any potential difficulties.  For assistance with UDI and GUDID requirements, contact Registrar Corp.