Sens. Herb Kohl (D-Wis.), Chuck Grassley (R-Iowa) and Richard Blumenthal (D-Conn.) are calling for the release of the Office of Management and Budget's rule on the unique device identifier.
The OMB missed the deadline to release the rule in October, leading Kohl, Grassley and Blumenthal to express concern about delay in a Feb. 9 letter (PDF) to the OMB acting Director Jeffrey Zients.
The unique device identifier, which is a tracking system for medical devices, will be used to enhance the Food and Drug Administration's post-market surveillance of devices by collecting data and allowing the FDA and manufacturers to track faulty devices.
“Due to our strong desire for a robust post-market environment, we are very concerned with the delayed implementation of the UDI,” the lawmakers wrote in the letter.
The FDA submitted the proposed rule in July. The OMB was expected to review and release the rule within 90 days, according to the letter.
A Government Accountability Office report released in June found that the implementation of the UDI system has been slowed by a number of factors including questions about establishing different labeling requirements for devices and whether hospitals have installed the automated inventory systems needed to support the system.
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