FDA unveils final mobile medical app guidance

Tools

The U.S. Food and Drug Administration today has issued its long-awaited final guidance for the regulation of mobile medical applications. FDA will focus oversight on apps:

  • To be used as accessories to regulate 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).

"Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly," Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement. "The FDA's tailored policy protects patients while encouraging innovation."

"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," Shuren added. "Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products."

Read FierceMobileHealthcare Editor Greg Slabodkin's full coverage.