Dear Mobile Medical App Developers ...

Law360, New York (June 10, 2013, 12:10 PM EDT) -- On May 21, 2013, the U.S. Food and Drug Administration issued an “It Has Come to Our Attention Letter”[1] to Biosense Technologies Private Limited, the developer of the uChek urine analyzer app. The app, available since April 26, 2013, through the iTunes App Store, enables an iPhone camera to analyze urine dipsticks used to measure analytes such as glucose, ketone, bilirubin and others.

This type of letter appears to be a practice that the Office of In Vitro Diagnostics and Radiological Health (the OIR) uses when...
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