In a move that may reflect a growing interest by the U.S. Food and Drug Administration in asserting its regulatory muscle in the mobile health app space, the regulator recently sent a letter to mobile app maker Biosense Technologies Pvt Ltd. indicating that it needs 510(k) clearance for its urinalysis diagnostic, uChek Urine analyzer.
Biosense‘s uCheck urinalysis system includes an iPhone app and a kit and uses Siemens’s and Bayer’s test strips, which have been cleared by the FDA. The company outlines several uses for urinalysis on its website such as pregnancy, urinary tract infection, hepatitis and malaria, to name a few. On the uChek website, the Mumbai India-based company presents the system as a “semi-automated” device. It acknowledges on the website that uChek is a medical device and adds that Biosense is an FDA registered facility.
In the letter the FDA explained that because the app “allows a mobile phone to analyze the dipsticks, the phone and device collectively function as an automated strip reader” triggering the need for 510(k) clearance.
“…Therefore, any company intending to promote their device for use in analyzing, reading, and/or interpreting these dipsticks need to obtain clearance for the entire urinalysis test system (i.e., the strip reader and the test strips, as used together).”
An article by Mobihealth News noted that uChek came up during the Congressional hearings discussing the parameters of FDA regulation of mobile health apps when it was highlighted as an example of an app the FDA might be not be regulating appropriately. It has also gotten press attention after Biosense Technologies co-founder Myshkin Ingawale demonstrated the app during a TED talk in California earlier this year.
The FDA has given the company 30 days to write a letter to justify why its app doesn’t require 510(k) clearance that other medical devices typically need. Despite the letter, the app is still available on iTunes, after it was released at the end of April. In another month, that could change. Watch this space.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
[Photo Credit: sheelamohan]
