This post was written by Erin Janssen. On July 19, 2011 the FDA released a draft guidance document regarding the use and oversight of mobile medical applications.  FDA is seeking input on its proposed oversight approach for certain mobile applications specific to medicine or health care called mobile medical applications (“apps”) that are designed for use on smartphones and other mobile computing devices. This approach encourages the development of new apps, focuses only on a select group of applications and will not regulate the sale or general consumer use of smartphones or tablets. The agency’s draft guidance defines a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices to be regulated. This subset includes mobile medical apps that are used as an accessory to medical device already regulated by the FDA (e.g., an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet) or transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices (e.g., an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack). A notice regarding the draft guidance was published in the Federal Register on July 21, 2011; comments on the guidance are due October 19, 2011.