The FDA final guidance finally published last week and it included very few surprises. One new section in the final guidelines -- that was not included in the draft guidance -- is a list of the types of apps that the FDA says will fall under its enforcement discretion. That means that these apps may meet the definition of a medical device, but the "FDA intends to exercise enforcement discretion for these mobile apps because they pose lower risk to the public." So these apps won't be regulated as medical devices. It's an important section of the document since it adds to the clarity of mobile medical app regulation.
This list of apps includes 21 types of apps but the FDA also wrote that it "understands that there may be other unique and innovative mobile apps that may not be covered in this list that may also constitute healthcare related mobile apps." The agency says this list is not assumed to be or meant to be exhaustive, but rather is intended to provide some clarity.
In the pages to follow is a roundup of the FDA's list of apps that it does not intend to regulate even though they meed the definition of a medical device. This is the gray area of mobile medical app regulation so we've added some possible examples of apps that we think might illustrate each type of app the FDA describes in the abstract. These particular examples are not from the FDA -- just the quotes from the final guidance are.
#1 Some Psychiatric Apps
According to the FDA's guidance, some psychiatric apps might meet the definition of a mobile device, but it will choose not to regulate some of these apps: "Mobile apps that help patients with diagnosed psychiatric conditions (e.g., post-traumatic stress disorder (PTSD), depression, anxiety, obsessive compulsive disorder) maintain their behavioral coping skills by providing a 'Skill of the Day' behavioral technique or audio messages that the user can access when experiencing increased anxiety;"
A possible example of this type of app is MoodHacker, which was developed by ORCAS. ORCAS, which originally stood for Oregon Center for Applied Science, has been developing a number of mobile health apps backed by the National Institutes of Health and is now transitioning from a government-funded research group to a commercial company. The MoodHacker app takes a self-management approach to depression management. Users can track their mood on the app along with other factors like food and activity, to educate themselves about what things correlate to different moods. The app responds to the data with analysis and videos about depression.