FDA Proposed Guidance on Mobile Health Apps

July 19, 2011
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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.