FDA issues final guidance for developers of mobile medical apps


Posted on September 23rd, by Michael Shapiro-Barr

The U.S. Food and Drug Administration has issued final guidance on the development of mobile medical applications.  The policy aims to protect patients while encouraging innovation.  Mobile medical applications currently have the ability to diagnose abnormal heart rhythms, transform smart phones into an ultrasound device, or function as the “central command” for a glucose meter.  The FDA will review mobile medical applications using the same regulatory standards that the agency applies to other medical devices.

Read Final Guidance





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FDA Final Guidance on Mobile Medical Applications

Summary

On September 23, 2013, the FDA issued a guidance (“Final Guidance”) explaining how medical device regulations will be applied to medical mobile applications (MMAs)....