The U.S. Food and Drug Administration recently said it supports a policy that
would require implantable heart defibrillators to be returned to their manufacturers
to be studied for possible defects after the patient dies. Amid growing debate
over when doctors and patients should be told about malfunctioning implantable
heart devices, FDA Deputy Commissioner for Policy Scott Gottlieb said the agency
has been discussing the value of post-mortem studies with the Heart Rhythm Society,
the professional group representing cardiologists specializing in electrophysiology.