By Stewart Eisenhart, Emergo Group
Now that the US Food and Drug Administration’s final guidance on mobile medical apps is finally published, developers and manufacturers should have a much better idea of which products will fall under regulatory oversight in the US and which will not. The guidance divides mobile apps into three broad categories:
- Mobile apps that do not qualify as medical devices in the US
- Mobile apps that do qualify as medical devices, but do not pose significant risk to users or patients and will not be regulated by the FDA
- Mobile apps that do qualify as medical devices and pose significant risk to patients, and that will fall under FDA oversight
Below are examples provided in the FDA guidance of apps that fall into each of the categories listed above.
| Mobile apps which are NOT medical devices | |
| Electronic copies of medical textbooks or dictionaries | Interactive medical diagrams or videos |
| Surgical training videos | Healthcare education apps for patients |
| Billing and administration apps | Insurance data collection apps |
| Online communication tools for doctors and patients | Apps to compare costs of drugs or medical devices for patients and users |
| Mobile medical apps the FDA will NOT regulate | |
|
Apps providing behavioral techniques to reduce psychiatric symptoms |
Apps providing educational or motivational data for physical therapy or smoking cessation patients |
|
Tools for tracking asthmatic episodes and inhaler use |
Apps that suggest possible medical conditions based on user input |
|
Apps that keep track of users’ medication dosages and schedules |
Apps to collect and share blood pressure data |
| Mobile medical apps requiring FDA registration | |
|
Apps using sensors connected to ECG equipment |
Apps using sensors to amplify sounds from electronic stethoscopes |
|
Apps that measure physiological parameters used in diagnoses |
Apps used to alter infusion pump settings or functions |
|
Apps that calibrate cochlear implants and hearing aids |
Apps connecting to nursing stations in order to display medical device data to mobile platforms |
|
Apps connecting to bedside monitors and transferring patient data to doctors or nurses |
Apps connected to perinatal monitoring equipment to enable remote labor monitoring |
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
