Two weeks ago, the U.S. Food and Drug Administration (FDA) issued its long awaited final guidance for developers of mobile medical applications.
As expected, the guidance outlines the FDA’s tailored approach to mobile apps. But the FDA plans to regulate only the apps posing the greatest potential risks to consumers.
“Some mobile apps carry minimal risks to consumers or patients, but others carry significant risks if they do not operate correctly,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA’s tailored policy protects patients while encouraging innovation.”
In a published report Thursday, journalist Jason Oliva explained to those uncertain of the FDA’s regulatory scope on mHealth apps that the agency intends to “exercise enforcement discretion.”
To date, the agency has cleared approximately 100 mobile medical applications in the last ten years, 40% of which were sanctioned in just the last two years.
While mobile health apps have the potential to transform healthcare by allowing doctors to diagnose patients with potentially life-threatening conditions outside of traditional health care settings, apps that can detail physiological data require greater scrutiny to decrease possibilities of risk for patients and consumers.
“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,” added Dr. Shuren in the FDA’s late September announcement. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”