Senators have added language to FDA user fee legislation that would require HHS to issue a final rule establishing a unique device identifier system for medical devices by the end of 2012, Health Data Management reports.
Sens. Tom Harkin (D-Iowa) and Michael Enzi (R.-Wyo.) introduced the FDA Safety and Innovation Act, which has not yet been assigned a number. The bill would reauthorize FDA's user fee programs (Goedert, Health Data Management, 4/19).
Background on UDI System
There currently is no uniform labeling system for medical devices, making it difficult to track down problematic equipment used by hospitals and patients.
In 2007, Congress voted to support FDA's plan to create a UDI system for medical devices. Such a system would allow FDA officials to electronically track medical tools and promptly recall any devices that could jeopardize patient safety.
In July 2011, FDA sent its proposal to Office of Management and Budget for review, but OMB has yet to release a proposed rule based on FDA's plan.
In February, Sens. Charles Grassley (R-Iowa), Herb Kohl (D-Wis.) and Richard Blumenthal (D-Conn.), sent a letter urging OMB to release the delayed rule (iHealthBeat, 3/16).
Language Added to FDA User Fee Legislation
The language added to the FDA user fee legislation calls for HHS to implement a UDI system "as soon as practical."
Under a UDI system, each medical device's unique identifier -- which could include its lot or serial number -- would be used to track the device through its distribution and use.
The Senate Health, Education, Labor & Pensions Committee will hold hearings to discuss the FDA user fee legislation on April 25 (Health Data Management, 4/19).