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FDA announces final guidance for mobile medical apps

The US Food and Drug Administration (FDA) has issued final guidance on how it will handle regulation of medical apps, which are software programs that run on mobile communication devices and perform the same functions as traditional medical devices.

The agency will not enforce requirements under the Federal Drug & Cosmetic Act for the majority of mobile apps as they pose minimal risk to consumers.

Specifically, the FDA will have oversight on mobile medical apps that are intended to be used as an accessory to a regulated medical device; or transform a mobile platform into a regulated medical device.

The FDA will assess mobile medical apps using the same regulatory standards and risk-based approach that the agency applies to other medical devices.

The agency will not regulate the sale or general consumer use of smartphones or tablets nor will not regulate mobile app distributors such as iTunes App store or the Google Play store.

FDA Center for Devices and Radiological Health director Dr Jeffrey Shuren noted 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.

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

The FDA had issued draft guidance in July 2011 and the final guidance announced on 23 September 2013 outlines the administration’s tailored approach to mobile apps.