FDA Challenges Medical App uChek

5-27-2013 10-05-07 PM

The FDA is challenging mHealth app developer Biosense over its lack of FDA clearance for uChek, a medical app that the company is actively marketing. Users take a picture of the their urine dip stick and uChek helps interpret the results. The FDA has given Biosense 30 days to why the app does not require its approval.

5-27-2013 10-19-30 PM

This is an assertive decision considering that the FDA hasn’t even published its final regulatory guidance for the medical app market despite repeated requests from the industry and Congress to do so. The FDA issued temporary draft guidance in July 2011 about medical apps, promising to solidify its plan and to issue final guidance in the coming months.

FDA had not published additional guidance by March 2013, resulting in hearing before Congress to explain the delay. The agency now promises that regulations will be published by October 2013.

Meanwhile, the FDA appears to have fully embraced its regulatory role in the medical app market. In its letter to Biosense, the agency explains that because the uChek app analyzes a picture of a urinalysis dip strip that is intended to be interpreted by a human, the app turns the iPhone into an automated strip reader that requires its approval.

Biosense says it will request FDA approval for uCheck, which remains available for download in the iTunes store.

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