Lack of Guidance Has FDA Regulating Health Apps on Case-by-Case Basis

When is a device considered a medical device? That’s a question that’s becoming more difficult to answer as medical technology embraces other types of technology — such as cell phone applications. Medtronic and St. Jude Medical unveiled products last week that use cell phone technology to monitor implantable cardiac devices. So far, there is no guidance in this area, so the FDA is regulating such products on a case-by-case basis. 
Devices & Diagnostics Letter