The FDA will release its proposed guidance on mobile health apps Wednesday with a 90 day comment period. They propose overseeing those apps that:
The FDA will release its proposed guidance on mobile health apps Wednesday with a 90 day comment period. They propose overseeing those apps that:
- Are used as an accessory to an FDA-regulated medical device. For example, an app could enable a health care professional to view medical images on an iPad and make a diagnosis;
- Transform a mobile platform into a regulated medical device. For example, an app that turns a smartphone into an electrocardiography, or ECG, machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.
@FDADeviceInfo will hold a twitter chat today at 3:00 pm using #FDAApps.
This news comes as I’ve learned about the work of mHealth Regulatory Coalition and their recent white paper on FDA regulation of mHealth. Little did I know yesterday, that progress would come so quickly.