• FDA Issues Draft Guidance on Mobile Medical Applications
  • August 9, 2011 | Authors: Scott D. Danzis; Ellen J. Flannery; Christopher H. Pruitt
  • Law Firm: Covington & Burling LLP - Washington Office
  • On July 21, 2011, the Food and Drug Administration (FDA) issued a draft guidance document addressing how it intends to regulate certain software applications intended for use on mobile platforms—termed “mobile medical apps”—as medical devices. According to the draft guidance, a mobile medical app is a mobile software application that meets the definition of “device” in the Food, Drug, and Cosmetic Act (FDCA) and is either (1) “used as an accessory to a regulated medical device,” or (2) “transforms a mobile platform into a regulated medical device.” If an app qualifies as a mobile medical app, the regulatory requirements of the FDCA apply to the device. For other apps that qualify as devices under the FDCA, but do not meet the mobile medical app definition, FDA intends to apply enforcement discretion.