In what might be
a first for the FDA (Federal Drug Administration), the agency has sent a letter to
the creators of an iOS app asking why its approval wasn't requested prior to
release. The uChek iPhone application analyzes photos of urine samples to
provide users rapid health info. Last Tuesday, the Agency informed the
developer Biosense giving it a deadline of 30 days to either show the FDA that
it already had received its approval, or provide details why the
application didn't require it to begin with.
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