FDA Seeks Comments on Device ID System

With a public meeting planned for the fall, the FDA is seeking comments on how the use of a unique identifier system for medical devices may reduce medical errors, facilitate device recalls and improve medical device adverse event reporting.

The comments will be used to help the agency determine what next steps to take regarding a unique device identifier (UDI) system.

“Much like the bar code rule for drugs and biological products, unique identifiers for medical devices could have many potential benefits for improving the quality of care for patients,” said Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health.

“A unique device identifier system could have broad applications in … encouraging cost effectiveness by improving delivery and supply chain efficiency.”

FDA Has Specific Questions

During the comment period, the FDA wants to learn about the feasibility, utility, benefits and costs of developing and implementing a UDI system. In addition, the agency wants to hear about various automatic identification technologies, such as bar codes and radiofrequency, which could be used with a UDI system.

A list of typical questions as well as what a UDI could look like are contained in an FDA Aug. 11 Federal Register notice at www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm.

Comments must be received by Nov. 9 and include the docket number 2006N-0292. To submit electronic comments, visit www.fda.gov/dockets/ecomments.

For more information, visit www.fda.gov/cdrh/ocd/udi/index.html.