A new bill has been introduced into the Senate this week to speed up tracking of medical devices. Although the Unique Device Identification (UDI) mandate was passed in 2007 and the FDA passed a rule on how to implement the mandate, the Office of Management and Budget still has not passed final approval.
Since it’s taking so long to either make a decision or extend the deadline for final approval, the new bill – Ensuring Safe Medical Devices for Patients Act, or S. 2193 – has been introduced to get the UDI process moving again.
The new bill calls for devices to have a unique tracking number and to be included in a post-market surveillance system currently used only for drugs. The post-market surveillance system was put into place four years ago by the FDA to track drugs on the market. The legislation would also require the FDA to issue a final rule on the UDI tracking code.