The FDA plans to issue draft guidance proposing that manufacturers of automated external defibrillators get agency approval. These devices provide early defibrillation to patients suffering from cardiac arrest, a leading cause of death in the United States. The FDA is not questioning the safety or quality of the devices, but believes regulation will ensure that the devices are safe and effective. To read the full article on, click here.  Contact us at 317-899-9341 for help with medical device regulations.