Lawyers Weigh In On FDA App Guidance

Diana Manos | Government Health IT | June 11, 2013

The Food and Drug Administration’s recent letter to Biosense Technologies regarding an app that can conduct urine analysis has caused healthcare attorneys to sit up and take notice.

The FDA’s May 21 “It has come to our attention” letter is not as serious as an official FDA warning letter, however it is the first letter of its kind in quite some time, says Linda Bentley, a member at the global law firm Mintz Levin and chair of the firm’s FDA practice group.

FDA wrote in the letter that the Biosense uChek Urine analyzer – intended for use with Siemens Multistix SG10, Siemens Multistix SG, Siemens Uristix, Bayer Diastix, and Bayer Keto-Diastix reagent strips – is meant to provide “qualitative and semi-quantitative determination of urine analyses including glucose, urobilinogen, pH, ketone, blood, protein, bilirubin, nitrite, leukocyte, and specific gravity.”