There are many healthcare pundits who feel that the Food and Drug Administration should relax its rules on Medical Device Data Systems (MDDS). But we applaud the FDA for living up to its century-old mission: putting patient safety first.
There are already plenty of smartphone apps that can monitor things like a diabetic’s blood sugar readings. The FDA classifies those products as MDDS because they simply collect data. But there’s a growing number of mobile apps that let physicians view things like sonograms and EKGs in realtime. As the FDA sees it, when a product crosses the line from mere documentation to active patient monitoring, the app is no longer an MDDS but a Class II medical device.
Not surprisingly, the makers of these mobile apps are complaining that the FDA is stifling innovation. The process of getting the FDA’s 510(k) clearance as a Class II medical device is expensive and time-consuming – and many mobile app vendors feel that it’s creating an unnecessary barrier to market entry.
But in our view, the FDA is simply weighing the risks and making patient safety the top priority. FDA guidance makes a clearcut distinction between a mobile app that lets a doctor view a X-ray on an iPhone and one that lets the physician consult with colleagues and make clinical decisions.
MDDS products don’t go through a rigorous vetting process. In contrast, our remote presence devices already have 510(k) clearance for a wide array of assessments, including pre-operative, peri-operative, post-surgical, cardiovascular, neurological, pre-natal, psychological and critical care examinations.
We have nothing against today’s glut of iPhone apps with groovy graphics. But we agree with the FDA that these products must be held to a higher Class II standard.