“We are disappointed that the administration has missed the statutory deadline established by the Food and Drug Administration Safety and Innovation Act to promptly finalize the regulations,” the lawmakers wrote in the Sept. 12 letter. “We are especially concerned with this delay given that the proposed UDI regulations were under OMB review for approximately a full year.”
The Food and Drug Administration submitted the proposed rule to OMB on June 11.
The five hospital systems that make up the Healthcare Transformation Group also submitted a letter to OMB Director Sylvia Mathews Burwell, asking the office to complete the review of the UDI regulations so that hospitals can begin to incorporate the UDI system into electronic health records.
The UDI system, which will require manufacturers to mark the labels and devices themselves with unique identifiers as part of a phased rollout process, is expected to help hospital track medical devices, notably during product recalls, and improve the efficiency of the healthcare supply chain.
“The UDI rule's finalization is the first step to achieving these benefits and must promptly occur in time for the next updates to electronic health-records standards and policies,” the Healthcare Transformation Group said in the Sept. 6 letter.
A handful of organizations, including the Society of Thoracic Surgeons, the Healthcare Supply Chain Association and the Advancing Patient Safety Coalition, in recent months have urged OMB to release the final rule.
Congress first mandated the development of the unique-device identification system in 2007. Legislation passed in 2012 required the release of the final rule within six months of the closing of the comment period for the proposed rule. That deadline passed in June.