From a bipartisan duo in the Senate comes a 244-page bill with language calling on the U.S. Department of the Health and Human Services (HHS) to put forth a final unique medical device identifier (UDI) rule sooner rather than later.
Sponsored by Iowa Democrat Tom Harkin and Wyoming Republican Michael Enzi, the FDA's Safety and Innovation Act would amend existing law by, in part, calling for the department to make the rule that will establish the UDI system by no later than Dec. 31.
This is followed by a clause stating, “The Secretary shall implement the unique device identification system under this subsection as soon as practicable.”
The UDI rule would mandate a tag on all medical devices so they can be tracked throughout their lifecycle in the healthcare system, facilitating quicker responses to problem devices, including implantables.
In March, a bipartisan Senate foursome introduced a bill, the Ensuring Safe Medical Devices for Patients Act, likewise calling for a UDI rule by the end of this year while also adding medical devices to the FDA’s Sentinel postmarket surveillance initiative.
Congress approved a UDI system five years ago as part of the FDA Amendments Act of 2007, but the initiative has been slow to gain traction. In February, a bipartisan Senate trio wrote the acting director of the Office of Management and Budget to demand a status report and a plan—a reaction to the office missing an important UDI deadline last October.
The new bill also addresses user-fee programs and other issues involving prescription drugs.
Harkin and Enzi are, respectively, the chairman and ranking member of the Senate’s Health, Education, Labor & Pensions Committee. They have scheduled an executive session to discuss the new legislation April 25.