The Food and Drug Administration (FDA) this week launched its first investigation into an unregulated mobile medical app.
Medical diagnosis on-the-go offers a new opportunity for health entrepreneurs. But the FDA believes that patient safety is potentially at risk with some — but not all — of these apps. The agency has said that it wants stricter rules to govern these apps and devices.
The FDA’s final guidance on mobile medical apps, when it comes, is expected to resolve some of the uncertainty that plagues health entrepreneurs who aren’t clear whether their app should be regulated.
“What is unclear [is] how many of these companies — representing almost 40,000 apps — would fall under selective enforcement by the FDA,” said Malay Gandhi, chief strategy officer for health accelerator Rock Health.
The FDA’s letter was sent to Biosense Technologies Private Ltd., an Indian company with an app called uChek, which is designed to work alongside commercially available urinalysis test pads, also known as “dipsticks.” A typical application for dipsticks is to test for urinary tract infections.
The app gets to work when you take a photo of a test strip (already FDA approved and made by Siemens AG and Bayer AG) with an iPhone camera. The technology can identify the concentrations of certain substances in those strips, and will deliver results to patients.
The FDA’s letter to the makers of uChek is intended to serve as a warning to other developers with unregulated apps used in clinical settings. There are thousands of apps in the App Store that fall in the medical category.
“We intend to work very closely with the U.S. FDA over the coming months to ensure that we continue to deliver accurate, affordable and convenient diagnostics across the world,” Abhishek Sen, co-founder of Thane, India-based Biosense, said in an email statement to the media.