From the June 18, 2007 issue of "The Gray Sheet"
Language requiring a unique identification system for implantable devices could be added to a House device user fee reauthorization bill scheduled for committee markup this week.
"As we move toward markup, I hope this committee will be able to take sensible and prudent steps to improve patient notification [during product recalls]," Rep. Darlene Hooley, D-Ore. said June 12 at a House Energy and Commerce Health Subcommittee hearing on several draft FDA bills, including user fee reauthorization. "Our first step in that process is to allow the FDA to conclude its work on a unique device identification, or UDI."
FDA has stated its intention to establish a universal UDI coding system and regulations to improve the device recall process and generally make it easier to track individual products.
House members on both sides of the aisle have pushed the agency not to delay on the issue.
Device companies are working with FDA to develop a UDI system, but remain wary of mandates to implement the system for all of its products because of the cost of implementing an automated identification system and a lack of evidence that bar-coding translates to better patient safety.
AdvaMed President Steve Ubl said at the hearing that industry would be troubled if the House passed legislation forcing FDA's hand. "Proposed new UDI and registry requirements are duplicative and an unnecessary and unduly burdensome expansion of the current system without real public health benefit," he said, noting that FDA plans on using authority it already has to develop the UDI system.
Ubl said industry is apprehensive that the House language would not be risk-based and would include unnecessary requirements.
Hooley stressed any legislation should not tie FDA's hands in developing what agency staffers believe is the best system.
The user fee bill is slated for markup in the Health subcommittee June 19 and by the full committee June 21.
- Ingrid Mezo
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