FDA Issues Final Guidance on Mobile Medical Apps

On September 23, 2013, the U.S. Food & Drug Administration (FDA) published its final Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications (Guidance). The Guidance is the result of a two-year process, which started when FDA issued its Draft Guidance on Mobile Medical Applications in July 2011. The final Guidance is one component of a multi-tiered, multi-agency legislative mandate to develop a comprehensive regulatory framework for health information technology.