The FDA has unveiled proposed rules to regulate mobile health applications, such as smartphones and tablets, as medical devices that need agency approval, according to an FDA draft guidance.
The FDA proposal would include apps used as an accessory to an FDA-regulated device as well as apps that turn mobile devices into medical devices using attachments, sensors or other hardware or software technology.
However, the proposal would not include apps that do not require oversight, such as those used only to log or record information, automate administrative duties like billing or inventory or to provide copies of medical texts.
Read the FDA draft guidance on regulating mobile health applications.
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