FDA Says Most Smartphone Health Apps Won't Get Regulatory Scrutiny

The federal agency will reserve its attention for apps that function like medical devices.

New York Times: F.D.A. To Regulate Some Health Apps
The Food and Drug Administration said Monday that it would regulate only a small portion of the rapidly expanding universe of mobile health applications, software programs that run on smartphones and tablets and perform the same functions as medical devices (Tavernise, 9/23).

The Associated Press: FDA Lays Out Rules For Some Smartphone Health Apps
Food and Drug Administration officials say they will begin regulating a new wave of applications and gadgets that work with smartphones to take medical readings and help users monitor their health. With the rise of the iPhone, Android and other mobile devices has come a flood of applications designed to help people stay healthy. Industry analysts estimate there are already more than 17,000 medical applications available, ranging from calorie counters to high-tech heart monitors (9/23).

CQ HealthBeat: FDA Guidance On Medical Apps Targets Highest-Risk Programs
The Food and Drug Administration said Monday that it would not add new regulatory requirements for most smartphone medical applications but will target the relatively small number of apps that pose a greater risk to patients if they don’t work (Adams, 9/24).

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