In a new guidance document dated September 25, 2013, but released on its website 2 days early, the FDA has clarified how it will approach the regulation of medical apps.
As the use of software programs on smart phones and tablets has spread increasingly throughout healthcare settings, FDA has been increasingly concerned about regulating their use for medical purposes. In the new document, the agency takes a divide-and-conquer approach.
In the guidance, mobile medical apps are split into three categories: apps that are not medical devices; apps that are medical devices, but for which FDA will exercise enforcement discretion; and medical apps that the agency intends to actively regulate.
The guidance gives examples of each category. While apps that are not devices are fairly straightforward—products such as medical dictionaries, patient education programs, or billing automation tools—the distinction between medical apps that will and will not be regulated is less so. The agency says it will make that distinction based on risk, and that it will focus on a “small subset of mobile medical apps that could present a greater risk to health.”
In an FDA Consumer Update, the agency’s Bakul Patel gave an example of how that distinction would work. The agency, he said, “would regulate a mobile medical app that helps measure blood pressure by controlling the inflation and deflation of a blood pressure cuff.” However, it would not enforce regulation of ” a mobile app that doctors or patients use to log and track trends with their blood pressure,” even though it is a medical device.
The agency’s goal, says Patel, is to balance innovation and regulation in mobile app development. “Mobile apps are unleashing amazing creativity, and we intend to encourage these exciting innovations. 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.”
The new guidance is available for download on FDA’s website.
UPDATE: FDA conducted a Twitter chat using the hashtage #FDAApps on Friday, September 26, to discuss the new guidance. The chat can be reviewed on the Twitter website.