The Premier healthcare alliance and The Pew Charitable Trust urged OMB to finalize the FDA regulations establishing a UDI system
For Immediate Release
In a July 8 letter to Sylvia Mathews Burwell, Director of the Office of Management and Budget (OMB), the Premier healthcare alliance and The Pew Charitable Trusts urged OMB to finalize the U.S. Food and Drug Administration (FDA) regulations establishing a unique device identification (UDI) system. The letter stressed the need for a UDI system, which will assist the FDA in conducting safety surveillance of medical devices, and thus improve patient safety and the quality of care.
Section 614 of the Food and Drug Administration Safety and Innovation Act required the administration to finalize the UDI regulation by June 19, 2013. Prior to this, the FDA has sought to use UDI for well over a decade, and Congress first instructed the development of a medical device identification system in 2007.