The Federal Drug Administration has reportedly sent certain developers a letter asking them why they haven’t asked for approval regarding their urine analysis application for the iPhone.
The app scans pictures of urine samples to give health reports. The FDA has warned Biosense that it has 30 days to prove that it has received the approval already, or provide them with a proper explanation as to why they haven’t asked for the approval yet. The app has been developed for the iPad and iPod Touch as well. It checks chemical strips to identify various elements, such as sugar. The FDA mentioned in the letter that the strips compatible with the app are supposed to be read by the human eye, and due to what the app does, it becomes an “automated strip reader”. Therefore the Apple devices are used as medical appliances and therefore they require the FDA’s approval.