In 2007, Congress passed a law reauthorizing FDA fees as it does every five years. As is typical in these FDA reauthorization bills, Congress also made changes to FDA policy. One of the 2007 changes was to require the FDA to implement a “unique device identification” or UDI system. It was intended that the UDI system would be better able to track devices and protect patients from significant safety risks.
However, the regulations required to implement the UDI system have not yet been approved, and accordingly, the UDI system has not yet been fully implemented. The regulations have been with the Office of Management and Budget for about a year.
Advancing Patient Safety Coalition Calls for an End to the Waiting
Now, a powerful coalition is calling for Congress to force the government to issue medical device identification regulations by a date certain. The coalition, called the Advancing Patient Safety Coalition, includes groups such as:
- Federation of American Hospitals
- American Medical Association.
The Coalition is requesting that the 2012 reauthorization of FDA fees, which will likely include other FDA policy changes, include a date certain by which UDI regulations will be put into place. The Coalition sent a letter to congressional leaders saying that it believes the regulations would protect patient safety by reducing medical errors and strengthening the ability of the FDA to monitor adverse effects of defective medical products.
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