
Center for Devices and Radiological Health director Dr. Jeffrey Shuren introduces proposed updates to the Food & Drug Administration’s 510(k) device approval process and discusses the changes with members of the media.
Dr. Shuren was joined by Christy Foreman, acting director of CDRH’s office of device evaluation, and Maggie Dietrich, special assistant to Dr. Shuren. The call with FDA officials took place at 12:00 P.M. August 3, 2010.
Listen to an mp3 recording of Dr. Shuren’s remarks by clicking here or downloading the full podcast (55 MB).