After few years of seeking oversight approach for certain health-related mobile applications (apps), FDA announced that it is going to apply a risk-based approach to assure safety and effectiveness of some apps – specifically, for certain moderate-risk (Class II) and high-risk (Class III) mobile medical apps.
According to some experts the number of health-related apps already reached several tens of thousands. It is clear that the agency will not be able to – and is not intending to – oversee all health-related apps. Instead, FDA will regulate only a small subset of medical apps that present “a greater risk to patients if they do not work as intended.”
More information can be found on FDA’s website.