FDA Will Regulate Only Some Mobile Health Apps

The Food and Drug Administration (FDA) said last week that it would only regulate some of the growing numbers of mobile health apps, focusing specifically on those that could pose greater risks to patients.

The agency intends to “exercise enforcement discretion,” according to a release, meaning it will not enforce requirements under the Federal Drug & Cosmetic Act for the majority of mobile health apps, as they pose minimal risk to consumers. 

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.


“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.”

Mobile medical apps on the market today can diagnose abnormal heart rhythms, transform smart phones into mobile ultrasound devices, or even function as a “central command” for a glucose meter used by a person with insulin-dependent diabetes, noted FDA.

While many mobile health apps can be found on internet marketplaces such as the iTunes App or Google Play stores, the agency does not regulate the sale or general consumer use of these distributors. 


The FDA received more than 130 comments on the draft guidance the agency issued in July 2011, with respondents expressing support for the FDA’s risk-based approach.

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

In the past decade, the FDA has cleared about 100 mobile medical applications, according to a release from the agency. About 40 of those were cleared in the past two years.

Written by Jason Oliva

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