www.fdanews.com/articles/138711-fda-issues-guidance-to-regulate-mobile-medical-applications
FDA Issues Guidance to Regulate Mobile Medical Applications
July 27, 2011
A long-awaited FDA draft guidance issued Thursday specifies how the FDA plans to regulate mobile applications (apps) used as accessories to FDA-regulated medical devices or that transform a mobile platform into a medical device.
Devices & Diagnostics Letter
Devices & Diagnostics Letter