The FDA does not plan to regulate all mobile health applications, but rather will focus on certain "higher risk" apps, such as those used by doctors and hospitals, that could "present a potential risk to patients if they do not work as intended," said Christy Foreman, director of the Office of Device Evaluation at the FDA's device centers, at a House Energy & Commerce subcommittee hearing this week. She added that smartphones will not be subjected to the medical device tax. The FDA's final guidance on the regulation of mHealth apps will be released before Oct. 1.
FDA won't subject smartphones to device tax, official says
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