Feds Rule Most Mobile Medical Apps Don’t Need Regulation, but Some Will
The Food and Drug Administration on Monday issued a series of rules governing which types of medical apps for mobile devices will require government oversight.
In creating the new structure, the FDA said it tried to balance between protecting consumers while not standing in the way of apps that can transform health care by allowing patients to better diagnose and monitor their health.
The agency said that it will exercise discretion in its regulatory powers, choosing to focus on devices that present a clear risk to patients if they malfunction.
There are already apps and add-ons that transform phones and tablets into heart monitors, glucose-level readers and thermometers, with many more on the way.
“Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly. The FDA’s tailored policy protects patients while encouraging innovation,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
The FDA said it will pay particular attention to devices that work in conjunction with or in place of already regulated medical devices.
“We have worked hard to strike the right balance,” said Shuren. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”