According to estimate by The Economist, last year there were 165000 health-related apps available for Apple or Android smartphones. Such apps were downloaded 1.7 billion times by 2017.
Scott Gottlieb, a Head of US FDA recently published an announcement about FDA plans on medical apps on FDA Voice blog.
FDA commissioner announced new FDA Digital Health Innovation Plan that is focused on fostering innovation at the intersection of medicine and digital health technology. Gottlieb states that digital apps tend to pose low risk to patients but can provide great value to the health care system. Thus, FDA will act in line with the US Congress and will make a special guidance to clarify its position on products that contain software function.
In general, FDA is looking forward to making approval process for digital health products easy. Agency is willing to create a third-party certification program under which lower risk digital health products could be marketed without FDA premarket review and higher risk products could be marketed with a streamlined FDA premarket review. Interestingly, Gottlieb does not define higher and lower risk with regards to medical applications.
FDA commisioner also announced potential creation of a unique pre-certification program for software as a medical device (SaMD) that could reduce the time and cost of market entry for digital health technologies.
These efforts are just one part of a much broader initiative that FDA is currently undertaking to advance policies that promote the development of safe and effective medical technologies. By declaring these intentions, FDA confirms one more time that it does not have intentions to be a trouble for industry, but instead, looking for a way to adjust to new reality and market evolution. Overall, this publication seems quite shady as FDA commissioner had not define anything and was very careful in his statements.