When does a mobile application (mobile app) meet the definition of a medical device under the Food Drug, and Cosmetic(FD&C) Act, and how does FDA intend to apply its regulatory authorities to mobile medical apps? IRBs may struggle with these questions and what their review responsibilities are when a protocol involves a mobile medical app. This session will be hosted in Zoom and attendees are encouraged use the video and audio features to actively participate in the dialogue.
Distinguish when mobile apps meet the definition of a medical device
Discuss FDA’s current approach to applying its regulatory authorities to oversight of mobile medical apps
Provide IRBs with a review framework for studies involving mobile medical apps and suggest policies and procedures to develop to ensure HRPPs remains relevant in a tech savvy world