With an oversight focus on those who develop mobile medical applications (apps) that are intended to be used as an accessory to a regulated medical device or to transform a mobile platform into a regulated medical device, the U.S. Food and Drug Administration (FDA) has issued final guidance for industry and FDA staff. Those apps undergoing FDA review must comply with “the same regulatory standards” applied to medical devices, and FDA will assess them with the same “risk-based approach that the agency applies to other medical devices.”

Noting that it “does not regulate the sale or general consumer use of smartphones or tablets nor does it regulate mobile app distributors such as the ‘iTunes App store’ or the ‘Google Play store,’” FDA will not enforce Food, Drug, and Cosmetic Act requirements as to “the majority of mobile apps as they pose minimal risk to consumers” According to its September 23, 2013, press release, FDA “has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years.”