By Carol Ko , DOTmed Staff Writer
Late last month, the FDA finalized a new tracking system that requires medical device manufacturers to put a unique identifying number on all products. With the implementation of this system, the U.S. Food and Drug Administration hopes to improve on the shortcomings of its current reporting process for malfunctioning devices.
Most notably the agency took some heat from critics in 2007, when defibrillator wires made by Medtronic were fracturing in patients. Doctors raised the alarm early on, but it took many months for the FDA to react and recall the product.
The UDI system will have a far-reaching impact on the medical device industry, and manufacturers are understandably apprehensive about the challenges ahead.
To get an expert’s reaction to the final rule, DOTmed News consulted Dr. John Smith, partner at international law firm Hogan Lovells, which counsels medical device clients throughout the premarket regulatory process.
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Published Thursday, October 03, 2013 DOTmed News.