UDI Perspectives and Timetables Explained by FDA Senior Advisor in Recent Articleby sterling1 on Mar 11, 2010 • 7:45 am No Comments
This is an important update to the Food and Drug Administration’s (FDA) timelines for UDI (Unique Device Identification) implementation deadlines. It comes by way of a recently published article entitled, “The FDA’s Take on Unique Device Identification,” authored by Jay Crowley who is senior advisor for patient safety for the Food and Drug Administration’s Center for Devices and Radiological Health.
In addition to outlining the FDA’s opinion of the three most important benefits of UDI, Mr. Crowley’s piece says the following about UDI timetables from the FDA: We are hoping to publish the proposed UDI system regulations sometime in 2010, and a period of public comment would follow before we could determine a final ruling. We know we can’t just spring this on device manufacturers. We would like to stagger implementation based on the device’s premarket risk classification – class III being the riskiest. We think that UDI implementation for these could be required one year following the publishing of the final rule. Then, we envision Class II devices three years after publication of the final rule and class I devices would be rolled out within about five years.
Like us and the many companies we serve in healthcare, are you doing the math too? Could a class III UDI mandate for implementation comes as early as 2011-2012? That could be a tight squeeze, wouldn’t you agree? But if you’re worried about getting ready to be where you’ll need to be, we can help. In the meantime, to read the full text of Mr. Crowley’s article, use this link.
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