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...
To view the full article, register now.
Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.