The US Food and Drug Administration said it is “seeking input” into its proposed approach to monitoring mobile healthcare apps. In a statement, Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health (CDH), said: “our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended.” It said that this will encourage the development of new apps for this market.
MobiHealthNews reports that Bakul Patel, policy advisor of the FDA’s CDH, said that: “We are starting off with the very small tip of the pyramid. The bottom of the pyramid might include health and wellness apps. The middle of the pyramid may include some health and wellness and pure medical apps. At this time, however, those are not of interest.” At the moment, apps free from regulation include apps that are electronic representations of medical information; apps related to developing or maintaining general health and wellbeing; and apps which only automate general administrative functions, such as billing or appointment notifications.
The FDA said that its draft guidelines define “a small subset of mobile medical apps that impact or may impact the performance or functionality of current regulated medical devices.” This includes a subset of apps which are “used as an accessory to a medical device already regulated by the FDA” or “transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices.”
Input into the guidelines can be provided to the FDA for a period of 90 days from 19 July 2011.