FDA SUPPORTS RETURNING ICD TO MAKER FOR STUDY

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.
Reuters