FDA Unveils Long-Delayed Device Tracking Rule Proposal

Law360, New York (July 3, 2012, 6:59 PM EDT) -- The U.S. Food and Drug Administration on Tuesday proposed a long-delayed rule creating a unique identifier system for medical devices, which officials said would be a “strong first step” toward a nationwide system for keeping track of devices once they're sold.

The rule is several years overdue. Congress passed a law in 2007, as part of the last FDA user fee authorization, directing the FDA to create a unique device identifier as a way to improve postmarket surveillance and thus patient safety.

In July 2011, after...
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