2013年 9月 25日
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:
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 |