The FDA & Mobile Medical Applications
On February 9, 2015, the Food and Drug Administration (FDA) updated Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff (The Guidance). The Guidance is meant to provide clarity and predictability for mobile medical application (app) manufacturers, and other interested parties. This CCHP fact sheet helps to clarify these recommendations- including 2 easy to understand charts; one which outlines the Mecial device classifications and requirements and one which summarizes the FDA regulatory enforcemtent of Medical Apps.