11/4/2011

Companies seeking medical device approval can make the wrong turn by not communicating with regulators often or soon enough, not having a thorough plan prior to an FDA meeting or failing to have representation, said Tammy Carrea, vice president of quality and regulatory affairs at TransEnterix. Speaking at the medtech11 conference, Carrea suggested five ways to successfully steer medical devices through the FDA, including engaging regulatory staffers early and setting up a timetable and budget ahead of time.

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