On March 21, 2013 the U.S. Food & Drug Administration (FDA) issued an “It Has Come to Our Attention Letter” to Biosense Technologies Private Limited for failure to obtain 510(k) clearance for its medical mobile app, uChek Urine Analyzer. The uChek Urine Analyzer is an iPhone mobile app, intended for use with Siemens and Bayer reagent strips, which allows a mobile phone to analyze the strips and determine urine analytes. You can read the letter here.
In the letter, the FDA explains that urinanalysis dipsticks are cleared only when they are interpreted by a direct visual reading. Any company intending to market a device for automated reading of the dipsticks must obtain clearance for the reader and the test strips as used together. In this case, Biosense is required to either identify an FDA clearance for the medical mobile app or provide an explanation as to why it does not believe that additional 501(k) clearance is necessary. According to the terms of the Letter, the company must submit the requested information to the FDA within 30 business days.
The FDA currently regulates medical mobile apps on a case-by-case basis. In the agency’s Draft Guidance–Medical Mobile Applications, a medical mobile app is defined as a software application that meets the definition of a device pursuant to section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA) and is either used as an accessory to a regulated medical device or transforms a mobile platform into a regulated medical device. Specifically, a mobile app is a medical device when it is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or other condition or is intended to affect the structure or any function of the body.
In sum, the FDA requires medical device manufacturers and/or marketers, including those manufacturing and marketing mobile medical apps, to submit a premarket notification, also known as a 510(k), 90 days in prior to marketing unless the device is otherwise exempt from these requirements. More information about the pre-market notification process can be found here or at our previous post here. If you have any questions about obtaining a 510(k) clearance or the regulation of medical mobile applications, please contact us at firstname.lastname@example.org.