POV: FDA Mobile Medical Apps Guidance

On July 19, 2011, the U.S. Food and Drug Administration (FDA) issued a new draft guidance on “mobile medical apps.” The new guidance expands upon the FDA’s previous definition of a medical device to include what the FDA defines as mobile medical apps.

As part of its ongoing monitoring and reporting on FDA guidance, RTCRM has produced a two-page POV that  analyzes the issued guidance and provides condensed key information, top-level points, implications and actions item.