FDA Issues Guidance for Mobile Medical Applications

The number of mobile medical applications for use on smartphones and tablets is growing rapidly as more and more app developers release new products in this area. However, until recently, the regulatory status of many of these mobile applications has been unclear.

Some of the uncertainty will be eliminated by FDA’s issuance of a nonbinding final guidance document concerning mobile medical apps on September 25, 2013. A copy of the guidance document can be accessed online at http://www.fda.gov/downloads/MedicalDevices/…/UCM263366.pdf.

Bakul Patel, M.S., MBA, senior policy advisor to the director of FDA’s Center for Devices and Radiological Health, explained that FDA wants to clarify to developers which types of apps will be regulated as medical devices and emphasized that most mobile apps will not be subject to FDA oversight. “Mobile apps are unleashing amazing creativity, and we intend to encourage these exciting innovations,” said Patel in an FDA Consumer Update. “At the same time, we have set risk-based priorities and are focusing FDA’s oversight on mobile apps that are devices for which safety and effectiveness are critical.”

Which Mobile Apps Will Be Subject to FDA Oversight?

The guidance document reveals that FDA’s focus is on the function of the app, stating that FDA only intends to regulate those mobile apps “that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were not to function as intended.” FDA calls these types of apps mobile medical apps. Not all categories of mobile medical apps will be regulated at this time, but only those apps that are meant: “(1) to be used as an accessory to a regulated medical device; or (2) to transform a mobile platform [commercial off-the-shelf computing platforms, with or without wireless connectivity, that are handheld in nature] into a regulated medical device.”

Categories of Mobile Apps That Will Be Subject to FDA Oversight at This Time

Section V(A) of the FDA guidance document provides more information regarding which categories of mobile apps will be regulated. The guidance document states that these mobile apps have met “the definition of a medical device in the FD&C Act” and that “their functionality poses a risk to a patient’s safety if the mobile app were to not function as intended.”

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