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In February 2015, the US Food and Drug Administration (FDA) issued a regulatory update for mobile medical applications to replace its earlier guidance issued in 2013. The update was overdue, considering the explosion in the number of mobile devices and applications since 2013. Much to the relief of health tech developers, the FDA has taken the practical approach of enforcing its regulatory oversight only for mobile apps that qualify as medical devices. In other words, the FDA distinguishes between functionality and platform, which determines whether a mobile application qualifies as a medical device.

This move is significant, as the new guidance exempts smartphones and tablets as long as the apps used on these devices do not perform medical device functions. However, the FDA will use its discretion to regulate functionalities that could pose a risk to patients if they fail to function as intended. The guidance here fails to draw a clear boundary between regulated apps, unregulated apps, and apps for which the FDA will exercise “enforcement discretion.”

The pros of the guidance

The guidance is generally deregulatory, and it indicates that the FDA is focused on reducing the classification of, or exempting, mobile devices and applications that do not pose a risk to patient safety. It is a positive step, considering that it deals with a challenging subject with broad implications. The FDA has provided a large number of app examples, although the list is not exhaustive. More importantly, the agency is committed to addressing questions on uncertain areas such as apps under enforcement discretion, which will result in future updates. Examples of mobile devices and apps that will not warrant regulatory oversight are smartphones, tablets, apps used for tracking health metrics, health and wellness apps, and mobile platforms developed for population health management.

The cons of the guidance

Although the FDA has provided a large number of app examples, the guidance lacks a clear framework to differentiate between unregulated apps, regulated apps, and apps for which it will exercise enforcement discretion. This will lead to uncertainties and result in contradicting interpretations by vendors. The FDA could rapidly increase the number of app categories for which it exercises enforcement discretion, which means vendors have to decide whether or not to incur the ongoing costs of supporting enforcement-discretion-related quality systems. The guidance also lacks clarity on whether mobile apps for clinical decision support and interoperability will qualify as medical devices.

The guidance is a positive step overall for the industry

The new guidance provides the industry and the FDA with a good starting point for discussions, and it reduces baseline uncertainties and inconsistencies that existed prior to the update. Although there are some pain points related to the application of the guidance in key areas such as clinical decision support, interoperability, and accessory policies, which need to be resolved, the industry is better off with the guidance than without it.


Further reading

“FDA clearance of Dexcom’s continuous glucose monitoring mobile apps should strengthen its position,” IT0011-000346 (January 2015)

“FDA medical mobile app regulation will create challenges for developers,” IT011-000217 (August 2011)


Srikanth Venkataraman, Analyst, Healthcare Technology

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