Not Sure If Software Is A Device? It's All About 'Intended Use,' FDA Says

'INTENDED USE' IS THE KEY to determining if software is a medical device, FDA software compliance expert John Murray says. Firms often "say, 'I have a product, it has a 10 GB hard drive, it has a fiber-optic hotlink that connects me to the moon.' But what good is that? The perfect engineering description does not help me decide if it's a medical device." Meanwhile, a CDRH working group is trying to determine when and how electronic health record systems should be regulated