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.”
Some of the approved medical apps can be found here. Examples of apps that are or will be reviewed by FDA can be found here.
More information can be found on FDA’s website.
