FDA publishes final mobile medical app guidance

The U.S. Food and Drug Administration this morning issued its final guidance for the regulation of mobile medical applications. FDA says it will focus its oversight on mobile medical apps:

  • Intended for use as accessories to regulated medical devices (for instance, apps that enable providers to make specific diagnoses by viewing medical images through picture archiving and communication systems on smartphones or tablets); or
  • That can transform mobile tools like smartphones or tablets into regulated medical devices (for instance, if a smartphone is used as an electrocardiography machine for determining if a patient is having a heart attack).

"We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly," Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health said in a statement. "Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products. Announcement

Read Greg Slabodkin's full coverage here.