FDA Seeking Comments on Use of Identifier System for Medical Devices: Identifier System Could Be Important Tool for Patient Safety
MedSun: Newsletter #7, September 2006

In an August 9, 2006, news release, the FDA announced a 90-day public comment period for collecting information on the feasibility, utility, benefits, and costs of developing and implementing a unique device identifier (UDI) system for medical devices. The development of complex medical devices has grown rapidly, and it is important for FDA to identify new hazards and to work with industry and device users to manage risks appropriately.

In meetings with FDA over the past year, stakeholders broadly supported the development of a UDI system as a means of improving patient safety. Stakeholders recognize that such a system could likely provide better management of purchasing, distribution, and use of medical devices. Two reports commissioned by FDA from outside experts also identified potential advantages of a UDI system. FDA continues to work with Federal partners to understand issues associated with use of a UDI system. A public meeting is planned in the fall, and FDA will use the public comments to help the agency determine the next steps.

According to Daniel Schultz, M.D., Director of FDA’s Center for Devices and Radiological Health, “A unique device identifier system could have broad applications in reducing medical errors, facilitating device recalls, improving medical device adverse event reporting, and encouraging cost effectiveness by improving delivery and supply chain efficiency.”

Additional Information:

For this FDA news release, go to

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