In February 2015, the Food and Drug Administration (FDA) issued
an updated “Mobile Medical Applications Guidance” (http://www.fda.
gov/downloads/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/UCM263366.pdf) which indicates the agency's
intent to regulate certain medical apps as medical devices. Is recommended
that investigators contact the FDA for questions on how this
guidance applies to clinical research.