FDA to make 510(k) changes by September

January 27, 2010 by MassDevice staff

The Food & Drug Administration's Center for Devices and Radiological Health outlines an aggressive, four-part plan for 2010 and beyond, including substantial changes to the 510(k) and PMA approval processes and a possible re-organization of the entire agency this year.

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Meet the new boss, who is definitely not the same as the old boss.

The Center for Devices and Radiological Health and new director Jeffrey Shuren are looking to shake things up at the Food & Drug Administration's medical device oversight arm, according to a new set of strategic priorities for 2010 and the following years. The changes include an overhaul of the 510(k) and PMA approval processes, slated to go into effect by September, and a 2013 release date for a unique device identifier system.

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