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Two articles on bmj.com look at high risk devices for rare conditions, and how the US Food and Drug Administration regulates them.
Joining us to discuss the problems are Rita Redberg, professor of medicine at the University of California San Francisco, and Aaron Kesselheim, assistant professor of medicine at the Harvard School of Public health.
Read the articles
Presumed safe no more: lessons from the Wingspan saga on regulation of devices
Assessment of US pathway for approving medical devices for rare conditions http://www.bmj.com/content/348/bmj.g217