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FDA finalizes long-awaited guidance on regulation of mobile medical apps

Making official a preliminary document published July 21, the Food and Drug Administration (FDA) laid out its plan for regulating mobile medical applications, or smartphone and tablet apps. The guidance will lay the framework for developers, who will serve an estimated 500 million users by 2015 with their health apps.

The bedrock of the plan — which fleshes out 2011 draft guidance — is determining the function of an app, then assigning the level of regulation based on risk to the user. A majority of apps will not be regulated according to the “enforcement discretion” of the Federal Drug & Cosmetic Act.

“Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health in a press release announcing the guidance. “The FDA’s tailored policy protects patients while encouraging innovation.”

The agency draws a line between Class I, or low-risk mobile apps concerning health, such as weight-tracking apps, and apps it classifies as higher risk Class III devices which fall under device regulation. While the guidance isn’t an actual rule the FDA will enforce, it sheds light on regulators’ current thinking on smartphone apps. Other apps that can directly affect a patient’s health — the FDA offers examples of a radiology image-interpretation system or an electrocardiogram analysis tool ported to a smartphone — would fall under the more stringent Class III regulations.

Smartphones and tablets are classified as mobile platforms, and the intended use of an app will determine its classification, according to the guidance, which states: “Intended use may be shown by labeling claims, advertising materials, or oral or written statements by manufacturers or their representatives. When the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device.”

The FDA released the guidance in conjunction with its plan for Unique Device Identifiers, also several years in the making. For a more comprehensive breakdown of what apps are regulated and how, visit the FDA’s mobile medical apps portal.

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