Health IT groups and mobile application developers’ reaction to FDA’s release of final guidance for mobile health apps is mixed, the Baltimore Sun reports (Wells/Clarke, Baltimore Sun, 9/23).
Details of Final Rule
According to the final guidance issued Monday, 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 make diagnoses by viewing 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 (iHealthBeat, 9/23).
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