FDA Releases Guidance on Mobile Health Applications
On Monday, FDA issued final guidance for how it will regulate mobile health applications. According to the final guidance, FDA will focus oversight on apps that were developed to be used as accessories to regulated medical devices, such as apps that allow health care providers to view medical images on smartphones or tablets, or can transform mobile devices into regulated medical devices, such as apps that allow a smartphone to be used as an electrocardiography machine.
- "U.S. FDA Issues Final Rules on Mobile Medical Apps" (Clarke, Reuters, 9/23).
- "FDA Unveils Final Mobile Medical App Guidance" (Bowman, FierceHealthIT, 9/23).